Difference between revisions of "Breast cancer - null regimens"

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|[[Breast_cancer#CMF|CMF]]
 
|[[Breast_cancer#CMF|CMF]]
 
|style="background-color:#d73027"|Inferior RFS
 
|style="background-color:#d73027"|Inferior RFS
−
|-
 
−
|[https://doi.org/10.1080/0284186X.2017.1400179 Jensen et al. 2017 (CBC 02)]
 
−
|1975-1978
 
−
| style="background-color:#1a9851" |Phase 3 (C)
 
−
|[[Breast_cancer,_ER-positive#Tamoxifen_monotherapy_2|Tamoxifen]] x 2 y
 
−
| style="background-color:#fc8d59" |Seems to have inferior OS
 
 
|-
 
|-
 
|[https://doi.org/10.1016/S0140-6736(83)91385-5 Rubens et al. 1983]
 
|[https://doi.org/10.1016/S0140-6736(83)91385-5 Rubens et al. 1983]
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|[[Breast_cancer_-_historical#Melphalan_monotherapy|Melphalan]]
 
|[[Breast_cancer_-_historical#Melphalan_monotherapy|Melphalan]]
 
| style="background-color:#fee08b" |Might have inferior RFS
 
| style="background-color:#fee08b" |Might have inferior RFS
−
|-
 
−
|[https://doi.org/10.1016/S0140-6736(83)91683-5 Baum et al. 1983 (NATO)]
 
−
|1977-1981
 
−
| style="background-color:#1a9851" |Phase 3 (C)
 
−
|[[Breast_cancer,_ER-positive#Tamoxifen_monotherapy_2|Tamoxifen]] x 2 y
 
−
| style="background-color:#d73027" |Inferior OS
 
 
|-
 
|-
 
|rowspan=3|[https://doi.org/10.1007/BF01806239 Brinker et al. 1983 (DBCG 77B)]
 
|rowspan=3|[https://doi.org/10.1007/BF01806239 Brinker et al. 1983 (DBCG 77B)]
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|[[Breast_cancer_-_historical#PT|PT]]
 
|[[Breast_cancer_-_historical#PT|PT]]
 
| style="background-color:#fc8d59" |Seems to have inferior DFS
 
| style="background-color:#fc8d59" |Seems to have inferior DFS
−
|-
 
−
|[https://doi.org/10.1016/S0140-6736(87)90762-8 Stewart et al. 1987 (Scottish Tamoxifen Trial)]
 
−
|1978-1984
 
−
| style="background-color:#1a9851" |Phase 3 (C)
 
−
|[[Breast_cancer,_ER-positive#Tamoxifen_monotherapy_2|Tamoxifen]] x 5 y
 
−
| style="background-color:#d73027" |Inferior OS<sup>2</sup>
 
 
|-
 
|-
 
|[https://doi.org/10.1056/NEJM198902233200801 Fisher et al. 1989 (NSABP B-13)]
 
|[https://doi.org/10.1056/NEJM198902233200801 Fisher et al. 1989 (NSABP B-13)]
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| style="background-color:#1a9851" |Phase 3 (C)
 
| style="background-color:#1a9851" |Phase 3 (C)
 
|[[Breast_cancer_-_historical#MF|MF]]; sequential
 
|[[Breast_cancer_-_historical#MF|MF]]; sequential
−
| style="background-color:#d73027" |Inferior DFS<sup>3</sup>
+
| style="background-color:#d73027" |Inferior DFS<sup>2</sup>
 
|-
 
|-
 
|[https://doi.org/10.1056/NEJM198902233200803 Mansour et al. 1989 (ECOG E1180)]
 
|[https://doi.org/10.1056/NEJM198902233200803 Mansour et al. 1989 (ECOG E1180)]
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|[[#AV-CMF_999|AV-CMF]]
 
|[[#AV-CMF_999|AV-CMF]]
 
| style="background-color:#ffffbf" |Did not meet primary endpoint of DFS60
 
| style="background-color:#ffffbf" |Did not meet primary endpoint of DFS60
−
|-
 
−
|[https://doi.org/10.1016/j.ejca.2004.06.030 Rydén et al. 2005 (SBII:2pre)]
 
−
|1986-1991
 
−
| style="background-color:#1a9851" |Phase 3 (C)
 
−
|[[Breast_cancer,_ER-positive#Tamoxifen_monotherapy|Tamoxifen]] x 2 y
 
−
| style="background-color:#d73027" |Inferior RFS
 
 
|-
 
|-
 
|[http://www.jle.com/fr/revues/bdc/e-docs/epirubicin_based_chemotherapy_as_adjuvant_treatment_for_poor_prognosis_node_negative_breast_cancer_10_year_follow_up_results__272048/article.phtml Héry et al. 2006 (FASG 03)]
 
|[http://www.jle.com/fr/revues/bdc/e-docs/epirubicin_based_chemotherapy_as_adjuvant_treatment_for_poor_prognosis_node_negative_breast_cancer_10_year_follow_up_results__272048/article.phtml Héry et al. 2006 (FASG 03)]
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|[[Breast_cancer#CMF|CMF]] x 6
 
|[[Breast_cancer#CMF|CMF]] x 6
 
| style="background-color:#fc8d59" |Seems to have inferior DFS
 
| style="background-color:#fc8d59" |Seems to have inferior DFS
−
|-
 
−
|[https://doi.org/10.1200/jco.2005.08.071 Hutchins et al. 2005 (INT-0102)]
 
−
|1989-1993
 
−
| style="background-color:#1a9851" |Phase 3 (C)
 
−
|[[Breast_cancer,_ER-positive#Tamoxifen_monotherapy_2|Tamoxifen]] x 5 y
 
−
| style="background-color:#ffffbf" |Did not meet primary endpoint of DFS
 
 
|-
 
|-
 
|[https://doi.org/10.1200/JCO.2001.19.19.3929 Paradiso et al. 2001]
 
|[https://doi.org/10.1200/JCO.2001.19.19.3929 Paradiso et al. 2001]
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|[[Breast_cancer#FEC_2|FEC50]] x 6
 
|[[Breast_cancer#FEC_2|FEC50]] x 6
 
| style="background-color:#d73027" |Inferior DFS
 
| style="background-color:#d73027" |Inferior DFS
−
|-
 
−
|[https://doi.org/10.1200/JCO.2005.03.0783 Colleoni et al. 2006 (IBCSG 13-93)]
 
−
|1993-1999
 
−
| style="background-color:#1a9851" |Phase 3 (C)
 
−
|[[Breast_cancer,_ER-positive#Tamoxifen_monotherapy|Tamoxifen]] x 5 y
 
−
| style="background-color:#d73027" |Inferior DFS<sup>4</sup>
 
 
|-
 
|-
 
|[https://doi.org/10.1200/jco.2003.02.063 Henderson et al. 2003 (INT 0148/CALGB 9344)]
 
|[https://doi.org/10.1200/jco.2003.02.063 Henderson et al. 2003 (INT 0148/CALGB 9344)]
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|[[Breast_cancer,_triple_negative#Capecitabine_monotherapy|Capecitabine]]
 
|[[Breast_cancer,_triple_negative#Capecitabine_monotherapy|Capecitabine]]
 
| style="background-color:#ffffbf" |Did not meet primary endpoint of DFS
 
| style="background-color:#ffffbf" |Did not meet primary endpoint of DFS
−
|-
 
−
|[https://doi.org/10.1093/annonc/mdw055 Zdenkowski et al. 2016 (ANZ0501 LATER)]
 
−
|2007-2012
 
−
| style="background-color:#1a9851" |Phase 3 (C)
 
−
|[[Breast_cancer,_ER-positive#Letrozole_monotherapy_2|Letrozole]] x 5 y
 
−
| style="background-color:#fee08b" |Might have inferior DFS
 
 
|-
 
|-
 
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4671866/ Nasr et al. 2015]
 
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4671866/ Nasr et al. 2015]
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|}
 
|}
 
''<sup>1</sup>Reported efficacy for DBCG 77B is based on the 2010 update.''<br>
 
''<sup>1</sup>Reported efficacy for DBCG 77B is based on the 2010 update.''<br>
−
''<sup>2</sup>Reported efficacy for the Scottish Tamoxifen Trial is based on the 2001 update.''<br>
+
''<sup>2</sup>Reported efficacy for NSABP B-13 is based on the 1996 update.''<br>
−
''<sup>3</sup>Reported efficacy for NSABP B-13 is based on the 1996 update.''<br>
 
−
''<sup>4</sup>Reported efficacy for IBCSG 13-93 is for the ER+ cohort.''<br>
 
 
''Note: No further systemic treatment; many of these trials incorporated RT, however (see individual papers for details). Jakesz et al. 1998 was conducted prior to routine testing of HER2, so it technically included "double-negative" patients. ECOG E1180 is also known as INT-0011.''
 
''Note: No further systemic treatment; many of these trials incorporated RT, however (see individual papers for details). Jakesz et al. 1998 was conducted prior to routine testing of HER2, so it technically included "double-negative" patients. ECOG E1180 is also known as INT-0011.''
 
<div class="toccolours" style="background-color:#cbd5e8">
 
<div class="toccolours" style="background-color:#cbd5e8">
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*INT 0148/CALGB 9344: [[Surgery#Breast_cancer_surgery|Surgery]], then [[Breast_cancer#Cyclophosphamide_.26_Doxorubicin_.28AC.29_2|AC]] x 4 versus [[Breast_cancer#Cyclophosphamide_.26_Doxorubicin_.28AC.29_2|AC]]; high-dose x 4 versus [[Breast_cancer#Cyclophosphamide_.26_Doxorubicin_.28AC.29_2|AC]]; very-high-dose x 4
 
*INT 0148/CALGB 9344: [[Surgery#Breast_cancer_surgery|Surgery]], then [[Breast_cancer#Cyclophosphamide_.26_Doxorubicin_.28AC.29_2|AC]] x 4 versus [[Breast_cancer#Cyclophosphamide_.26_Doxorubicin_.28AC.29_2|AC]]; high-dose x 4 versus [[Breast_cancer#Cyclophosphamide_.26_Doxorubicin_.28AC.29_2|AC]]; very-high-dose x 4
 
*NSABP B-28: [[Surgery#Breast_cancer_surgery|Surgery]], then [[Breast_cancer#Cyclophosphamide_.26_Doxorubicin_.28AC.29_2|AC]] x 4
 
*NSABP B-28: [[Surgery#Breast_cancer_surgery|Surgery]], then [[Breast_cancer#Cyclophosphamide_.26_Doxorubicin_.28AC.29_2|AC]] x 4
−
*INT-0102: [[Surgery#Breast_cancer_surgery|Surgery]], then [[Breast_cancer#FAC_2|CAF]] x 6 versus [[Breast_cancer#CMF|CMF]] x 6
 
−
*IBCSG 13-93: [[Surgery#Breast_cancer_surgery|Surgery]], then [[Breast_cancer#AC-CMF|AC-CMF]] or [[Breast_cancer#EC-CMF|EC-CMF]]
 
−
*ANZ0501 LATER: At least 4 years of any [[Regimen_classes#Endocrine_therapy-based_regimen|endocrine therapy]]
 
 
*Jakesz et al. 1998: [[Surgery#Breast_cancer_surgery|Surgery]]
 
*Jakesz et al. 1998: [[Surgery#Breast_cancer_surgery|Surgery]]
 
*IBCSG 22-00: [[Surgery#Breast_cancer_surgery|Surgery]], then adjuvant [[Regimen_classes#Chemotherapy-based_regimen|chemotherapy]]
 
*IBCSG 22-00: [[Surgery#Breast_cancer_surgery|Surgery]], then adjuvant [[Regimen_classes#Chemotherapy-based_regimen|chemotherapy]]
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## '''Update:''' Bonadonna G, Valagussa P, Moliterni A, Zambetti M, Brambilla C. Adjuvant cyclophosphamide, methotrexate, and fluorouracil in node-positive breast cancer: the results of 20 years of follow-up. N Engl J Med. 1995 Apr 6;332(14):901-6. [https://doi.org/10.1056/NEJM199504063321401 link to original article] [https://pubmed.ncbi.nlm.nih.gov/7877646/ PubMed]
 
## '''Update:''' Bonadonna G, Valagussa P, Moliterni A, Zambetti M, Brambilla C. Adjuvant cyclophosphamide, methotrexate, and fluorouracil in node-positive breast cancer: the results of 20 years of follow-up. N Engl J Med. 1995 Apr 6;332(14):901-6. [https://doi.org/10.1056/NEJM199504063321401 link to original article] [https://pubmed.ncbi.nlm.nih.gov/7877646/ PubMed]
 
# Lacour J, Lacour F, Spira A, Michelson M, Petit JY, Delage G, Sarrazin D, Contesso G, Viguier J. Adjuvant treatment with polyadenylic-polyuridylic acid (Polya-Polyu) in operable breast cancer. Lancet. 1980 Jul 26;2(8187):161-4. [https://doi.org/10.1016/S0140-6736(80)90057-4 link to original article] [https://pubmed.ncbi.nlm.nih.gov/6105336/ PubMed]
 
# Lacour J, Lacour F, Spira A, Michelson M, Petit JY, Delage G, Sarrazin D, Contesso G, Viguier J. Adjuvant treatment with polyadenylic-polyuridylic acid (Polya-Polyu) in operable breast cancer. Lancet. 1980 Jul 26;2(8187):161-4. [https://doi.org/10.1016/S0140-6736(80)90057-4 link to original article] [https://pubmed.ncbi.nlm.nih.gov/6105336/ PubMed]
−
# '''NATO:''' Baum M, Brinkley DM, Dosset JA, McPherson K, Patterson JS, Rubens RD, Smiddy FG, Stoll BA, Wilson A, Lea JC, Richards D, Ellis SH. Controlled trial of tamoxifen as adjuvant agent in management of early breast cancer: interim analysis at four years by Nolvadex Adjuvant Trial Organisation. Lancet. 1983 Feb 5;1(8319):257-61. [https://doi.org/10.1016/S0140-6736(83)91683-5 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/6130291/ PubMed]
 
−
## '''Update:''' Baum M, Brinkley DM, Dosset JA, McPherson K, Patterson JS, Rubens RD, Smiddy FG, Stoll BA, Wilson A, Richards D, Ellis SH. Controlled trial of tamoxifen as single adjuvant agent in management of early breast cancer: analysis at six years by Nolvadex Adjuvant Trial Organisation. Lancet. 1985 Apr 13;1(8433):836-40. [https://doi.org/10.1016/S0140-6736(85)92206-8 link to original article] [https://pubmed.ncbi.nlm.nih.gov/2858709/ PubMed]
 
 
# Rubens RD, Hayward JL, Knight RK, Bulbrook RD, Fentiman IS, Chaudary M, Howell A, Bush H, Crowther D, Sellwood RA, George WD, Howat JM. Controlled trial of adjuvant chemotherapy with melphalan for breast cancer. Lancet. 1983 Apr 16;1(8329):839-43. [https://doi.org/10.1016/S0140-6736(83)91385-5 link to original article] [https://pubmed.ncbi.nlm.nih.gov/6132179/ PubMed]
 
# Rubens RD, Hayward JL, Knight RK, Bulbrook RD, Fentiman IS, Chaudary M, Howell A, Bush H, Crowther D, Sellwood RA, George WD, Howat JM. Controlled trial of adjuvant chemotherapy with melphalan for breast cancer. Lancet. 1983 Apr 16;1(8329):839-43. [https://doi.org/10.1016/S0140-6736(83)91385-5 link to original article] [https://pubmed.ncbi.nlm.nih.gov/6132179/ PubMed]
 
# '''DBCG 77B:''' Brincker H, Mouridsen HT, Andersen KW. Adjuvant chemotherapy with cyclophosphamide or CMF in premenopausal women with stage II breast cancer. Breast Cancer Res Treat. 1983;3(1):91-5. [https://doi.org/10.1007/BF01806239 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/6347278/ PubMed]
 
# '''DBCG 77B:''' Brincker H, Mouridsen HT, Andersen KW. Adjuvant chemotherapy with cyclophosphamide or CMF in premenopausal women with stage II breast cancer. Breast Cancer Res Treat. 1983;3(1):91-5. [https://doi.org/10.1007/BF01806239 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/6347278/ PubMed]
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# '''LBCS III/IV:''' Goldhirsch A; Ludwig Breast Cancer Study Group. Randomised trial of chemo-endocrine therapy, endocrine therapy, and mastectomy alone in postmenopausal patients with operable breast cancer and axillary node metastasis. Lancet. 1984 Jun 9;1(8389):1256-60. [https://doi.org/10.1016/S0140-6736(84)92445-0 link to original article] [https://pubmed.ncbi.nlm.nih.gov/6144974/ PubMed]
 
# '''LBCS III/IV:''' Goldhirsch A; Ludwig Breast Cancer Study Group. Randomised trial of chemo-endocrine therapy, endocrine therapy, and mastectomy alone in postmenopausal patients with operable breast cancer and axillary node metastasis. Lancet. 1984 Jun 9;1(8389):1256-60. [https://doi.org/10.1016/S0140-6736(84)92445-0 link to original article] [https://pubmed.ncbi.nlm.nih.gov/6144974/ PubMed]
 
# Howell A, Bush H, George WD, Howat JM, Crowther D, Sellwood RA, Rubens RD, Hayward JL, Bulbrook RD, Fentiman IS, Chaudary M. Controlled trial of adjuvant chemotherapy with cyclophosphamide, methotrexate, and fluorouracil for breast cancer. Lancet. 1984 Aug 11;2(8398):307-11. [https://doi.org/10.1016/S0140-6736(84)92684-9 link to original article] [https://pubmed.ncbi.nlm.nih.gov/6146861/ PubMed]
 
# Howell A, Bush H, George WD, Howat JM, Crowther D, Sellwood RA, Rubens RD, Hayward JL, Bulbrook RD, Fentiman IS, Chaudary M. Controlled trial of adjuvant chemotherapy with cyclophosphamide, methotrexate, and fluorouracil for breast cancer. Lancet. 1984 Aug 11;2(8398):307-11. [https://doi.org/10.1016/S0140-6736(84)92684-9 link to original article] [https://pubmed.ncbi.nlm.nih.gov/6146861/ PubMed]
−
# '''Scottish Tamoxifen Trial:''' Stewart HJ, Taylor W, Forrest P. Adjuvant tamoxifen in the management of operable breast cancer: the Scottish Trial: report from the Breast Cancer Trials Committee, Scottish Cancer Trials Office (MRC), Edinburgh. Lancet. 1987 Jul 25;2(8552):171-5. [https://doi.org/10.1016/S0140-6736(87)90762-8 link to original article] [https://pubmed.ncbi.nlm.nih.gov/2885637/ PubMed]
 
−
## '''Update:''' Stewart HJ, Forrest AP, Everington D, McDonald CC, Dewar JA, Hawkins RA, Prescott RJ, George WD; Scottish Cancer Trials Breast Group. Randomised comparison of 5 years of adjuvant tamoxifen with continuous therapy for operable breast cancer. Br J Cancer. 1996 Jul;74(2):297-9. [https://www.nature.com/articles/bjc1996356 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2074573/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/8688340/ PubMed]
 
−
## '''Update:''' Stewart HJ, Prescott RJ, Forrest AP. Scottish adjuvant tamoxifen trial: a randomized study updated to 15 years. J Natl Cancer Inst. 2001 Mar 21;93(6):456-62. [https://academic.oup.com/jnci/article/93/6/456/2906503 link to original article] [https://pubmed.ncbi.nlm.nih.gov/11259471/ PubMed]
 
 
# '''NSABP B-13:''' Fisher B, Redmond C, Dimitrov NV, Bowman D, Legault-Poisson S, Wickerham DL, Wolmark N, Fisher ER, Margolese R, Sutherland C, Glass A, Foster R, Caplan R. A randomized clinical trial evaluating sequential methotrexate and fluorouracil in the treatment of patients with node-negative breast cancer who have estrogen-receptor-negative tumors. N Engl J Med. 1989 Feb 23;320(8):473-8. [https://doi.org/10.1056/NEJM198902233200801 link to original article] [https://pubmed.ncbi.nlm.nih.gov/2644531/ PubMed]
 
# '''NSABP B-13:''' Fisher B, Redmond C, Dimitrov NV, Bowman D, Legault-Poisson S, Wickerham DL, Wolmark N, Fisher ER, Margolese R, Sutherland C, Glass A, Foster R, Caplan R. A randomized clinical trial evaluating sequential methotrexate and fluorouracil in the treatment of patients with node-negative breast cancer who have estrogen-receptor-negative tumors. N Engl J Med. 1989 Feb 23;320(8):473-8. [https://doi.org/10.1056/NEJM198902233200801 link to original article] [https://pubmed.ncbi.nlm.nih.gov/2644531/ PubMed]
 
## '''Update:''' Fisher B, Dignam J, Mamounas EP, Costantino JP, Wickerham DL, Redmond C, Wolmark N, Dimitrov NV, Bowman DM, Glass AG, Atkins JN, Abramson N, Sutherland CM, Aron BS, Margolese RG. Sequential methotrexate and fluorouracil for the treatment of node-negative breast cancer patients with estrogen receptor-negative tumors: eight-year results from National Surgical Adjuvant Breast and Bowel Project (NSABP) B-13 and first report of findings from NSABP B-19 comparing methotrexate and fluorouracil with conventional cyclophosphamide, methotrexate, and fluorouracil. J Clin Oncol. 1996 Jul;14(7):1982-92. [https://doi.org/10.1200/JCO.1996.14.7.1982 link to original article] [https://pubmed.ncbi.nlm.nih.gov/8683228/ PubMed]
 
## '''Update:''' Fisher B, Dignam J, Mamounas EP, Costantino JP, Wickerham DL, Redmond C, Wolmark N, Dimitrov NV, Bowman DM, Glass AG, Atkins JN, Abramson N, Sutherland CM, Aron BS, Margolese RG. Sequential methotrexate and fluorouracil for the treatment of node-negative breast cancer patients with estrogen receptor-negative tumors: eight-year results from National Surgical Adjuvant Breast and Bowel Project (NSABP) B-13 and first report of findings from NSABP B-19 comparing methotrexate and fluorouracil with conventional cyclophosphamide, methotrexate, and fluorouracil. J Clin Oncol. 1996 Jul;14(7):1982-92. [https://doi.org/10.1200/JCO.1996.14.7.1982 link to original article] [https://pubmed.ncbi.nlm.nih.gov/8683228/ PubMed]
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# Paradiso A, Schittulli F, Cellamare G, Mangia A, Marzullo F, Lorusso V, De Lena M. Randomized clinical trial of adjuvant fluorouracil, epirubicin, and cyclophosphamide chemotherapy for patients with fast-proliferating, node-negative breast cancer. J Clin Oncol. 2001 Oct 1;19(19):3929-37. [https://doi.org/10.1200/JCO.2001.19.19.3929 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/11579113/ PubMed]
 
# Paradiso A, Schittulli F, Cellamare G, Mangia A, Marzullo F, Lorusso V, De Lena M. Randomized clinical trial of adjuvant fluorouracil, epirubicin, and cyclophosphamide chemotherapy for patients with fast-proliferating, node-negative breast cancer. J Clin Oncol. 2001 Oct 1;19(19):3929-37. [https://doi.org/10.1200/JCO.2001.19.19.3929 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/11579113/ PubMed]
 
# '''INT 0148/CALGB 9344:''' Henderson IC, Berry DA, Demetri GD, Cirrincione CT, Goldstein LJ, Martino S, Ingle JN, Cooper MR, Hayes DF, Tkaczuk KH, Fleming G, Holland JF, Duggan DB, Carpenter JT, Frei E 3rd, Schilsky RL, Wood WC, Muss HB, Norton L. Improved outcomes from adding sequential paclitaxel but not from escalating doxorubicin dose in an adjuvant chemotherapy regimen for patients with node-positive primary breast cancer. J Clin Oncol. 2003 Mar 15;21(6):976-83. [https://doi.org/10.1200/jco.2003.02.063 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/12637460/ PubMed]
 
# '''INT 0148/CALGB 9344:''' Henderson IC, Berry DA, Demetri GD, Cirrincione CT, Goldstein LJ, Martino S, Ingle JN, Cooper MR, Hayes DF, Tkaczuk KH, Fleming G, Holland JF, Duggan DB, Carpenter JT, Frei E 3rd, Schilsky RL, Wood WC, Muss HB, Norton L. Improved outcomes from adding sequential paclitaxel but not from escalating doxorubicin dose in an adjuvant chemotherapy regimen for patients with node-positive primary breast cancer. J Clin Oncol. 2003 Mar 15;21(6):976-83. [https://doi.org/10.1200/jco.2003.02.063 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/12637460/ PubMed]
−
# '''SBII:2pre:''' Rydén L, Jönsson PE, Chebil G, Dufmats M, Fernö M, Jirström K, Källström AC, Landberg G, Stål O, Thorstenson S, Nordenskjöld B; South Swedish Breast Cancer Group; South-East Swedish Breast Cancer Group. Two years of adjuvant tamoxifen in premenopausal patients with breast cancer: a randomised, controlled trial with long-term follow-up. Eur J Cancer. 2005 Jan;41(2):256-64. [https://doi.org/10.1016/j.ejca.2004.06.030 link to original article] [https://pubmed.ncbi.nlm.nih.gov/15661551/ PubMed]
 
−
## '''Update:''' Ekholm M, Bendahl PO, Fernö M, Nordenskjöld B, Stål O, Rydén L. Two years of adjuvant tamoxifen provides a survival benefit compared with no systemic treatment in premenopausal patients with primary breast cancer: Long-term follow-up (> 25 years) of the phase III SBII:2pre trial. J Clin Oncol. 2016 Jul 1;34(19):2232-8. Epub 2016 May 9. [https://doi.org/10.1200/jco.2015.65.6272 link to original article] [https://pubmed.ncbi.nlm.nih.gov/27161974/ PubMed]
 
 
<!-- Presented in abstract form at the 39th Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, May 31-June 3, 2003; interim results were presented at the 2000 NIH Consensus Development Conference, Bethesda, MD, November 1-3, 2000. -->
 
<!-- Presented in abstract form at the 39th Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, May 31-June 3, 2003; interim results were presented at the 2000 NIH Consensus Development Conference, Bethesda, MD, November 1-3, 2000. -->
 
# '''NSABP B-28:''' Mamounas EP, Bryant J, Lembersky B, Fehrenbacher L, Sedlacek SM, Fisher B, Wickerham DL, Yothers G, Soran A, Wolmark N. Paclitaxel after doxorubicin plus cyclophosphamide as adjuvant chemotherapy for node-positive breast cancer: results from NSABP B-28. J Clin Oncol. 2005 Jun 1;23(16):3686-96. Epub 2005 May 16. [https://doi.org/10.1200/jco.2005.10.517 link to original article] [https://pubmed.ncbi.nlm.nih.gov/15897552/ PubMed]
 
# '''NSABP B-28:''' Mamounas EP, Bryant J, Lembersky B, Fehrenbacher L, Sedlacek SM, Fisher B, Wickerham DL, Yothers G, Soran A, Wolmark N. Paclitaxel after doxorubicin plus cyclophosphamide as adjuvant chemotherapy for node-positive breast cancer: results from NSABP B-28. J Clin Oncol. 2005 Jun 1;23(16):3686-96. Epub 2005 May 16. [https://doi.org/10.1200/jco.2005.10.517 link to original article] [https://pubmed.ncbi.nlm.nih.gov/15897552/ PubMed]
−
# '''INT-0102:''' Hutchins LF, Green SJ, Ravdin PM, Lew D, Martino S, Abeloff M, Lyss AP, Allred C, Rivkin SE, Osborne CK. Randomized, controlled trial of cyclophosphamide, methotrexate, and fluorouracil versus cyclophosphamide, doxorubicin, and fluorouracil with and without tamoxifen for high-risk, node-negative breast cancer: treatment results of intergroup protocol INT-0102. J Clin Oncol. 2005 Nov 20;23(33):8313-21. [https://doi.org/10.1200/jco.2005.08.071 link to original article] [https://pubmed.ncbi.nlm.nih.gov/16293862/ PubMed]
 
 
# Arriagada R, Spielmann M, Koscielny S, Le Chevalier T, Delozier T, Rémé-Saumon M, Ducourtieux M, Tursz T, Hill C. Results of two randomized trials evaluating adjuvant anthracycline-based chemotherapy in 1146 patients with early breast cancer. Acta Oncol. 2005;44(5):458-66. [https://doi.org/10.1080/02841860510029987 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/16118079/ PubMed]
 
# Arriagada R, Spielmann M, Koscielny S, Le Chevalier T, Delozier T, Rémé-Saumon M, Ducourtieux M, Tursz T, Hill C. Results of two randomized trials evaluating adjuvant anthracycline-based chemotherapy in 1146 patients with early breast cancer. Acta Oncol. 2005;44(5):458-66. [https://doi.org/10.1080/02841860510029987 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/16118079/ PubMed]
−
# '''IBCSG 13-93:''' Colleoni M, Gelber S, Goldhirsch A, Aebi S, Castiglione-Gertsch M, Price KN, Coates AS, Gelber RD; International Breast Cancer Study Group. Tamoxifen after adjuvant chemotherapy for premenopausal women with lymph node-positive breast cancer: International Breast Cancer Study Group Trial 13-93. J Clin Oncol. 2006 Mar 20;24(9):1332-41. Epub 2006 Feb 27. [https://doi.org/10.1200/JCO.2005.03.0783 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/16505417/ PubMed]
 
 
# '''FASG 03:''' Héry M, Bonneterre J, Roché H, Luporsi E, Kerbrat P, Namer M, Fumoleau P, Monnier A, Fargeot P. Epirubicin-based chemotherapy as adjuvant treatment for poor prognosis, node-negative breast cancer: 10-year follow-up results of the French Adjuvant Study Group 03 trial. Bull Cancer. 2006 Oct;93(10):E109-14. [http://www.jle.com/fr/revues/bdc/e-docs/epirubicin_based_chemotherapy_as_adjuvant_treatment_for_poor_prognosis_node_negative_breast_cancer_10_year_follow_up_results__272048/article.phtml link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/17074656/ PubMed]
 
# '''FASG 03:''' Héry M, Bonneterre J, Roché H, Luporsi E, Kerbrat P, Namer M, Fumoleau P, Monnier A, Fargeot P. Epirubicin-based chemotherapy as adjuvant treatment for poor prognosis, node-negative breast cancer: 10-year follow-up results of the French Adjuvant Study Group 03 trial. Bull Cancer. 2006 Oct;93(10):E109-14. [http://www.jle.com/fr/revues/bdc/e-docs/epirubicin_based_chemotherapy_as_adjuvant_treatment_for_poor_prognosis_node_negative_breast_cancer_10_year_follow_up_results__272048/article.phtml link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/17074656/ PubMed]
 
#'''CALOR:''' Aebi S, Gelber S, Anderson SJ, Láng I, Robidoux A, Martín M, Nortier JW, Paterson AH, Rimawi MF, Cañada JM, Thürlimann B, Murray E, Mamounas EP, Geyer CE Jr, Price KN, Coates AS, Gelber RD, Rastogi P, Wolmark N, Wapnir IL; CALOR investigators. Chemotherapy for isolated locoregional recurrence of breast cancer (CALOR): a randomised trial. Lancet Oncol. 2014 Feb;15(2):156-63. Epub 2014 Jan 16. [https://doi.org/10.1016/s1470-2045(13)70589-8 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc3982874/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/24439313/ PubMed] [https://clinicaltrials.gov/study/NCT00074152 NCT00074152]
 
#'''CALOR:''' Aebi S, Gelber S, Anderson SJ, Láng I, Robidoux A, Martín M, Nortier JW, Paterson AH, Rimawi MF, Cañada JM, Thürlimann B, Murray E, Mamounas EP, Geyer CE Jr, Price KN, Coates AS, Gelber RD, Rastogi P, Wolmark N, Wapnir IL; CALOR investigators. Chemotherapy for isolated locoregional recurrence of breast cancer (CALOR): a randomised trial. Lancet Oncol. 2014 Feb;15(2):156-63. Epub 2014 Jan 16. [https://doi.org/10.1016/s1470-2045(13)70589-8 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc3982874/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/24439313/ PubMed] [https://clinicaltrials.gov/study/NCT00074152 NCT00074152]
 
##'''Update:''' Wapnir IL, Price KN, Anderson SJ, Robidoux A, Martín M, Nortier JWR, Paterson AHG, Rimawi MF, Láng I, Baena-Cañada JM, Thürlimann B, Mamounas EP, Geyer CE Jr, Gelber S, Coates AS, Gelber RD, Rastogi P, Regan MM, Wolmark N, Aebi S; International Breast Cancer Study Group; NRG Oncology; GEICAM Spanish Breast Cancer Group; BOOG Dutch Breast Cancer Trialists' Group; Breast International Group. Efficacy of Chemotherapy for ER-Negative and ER-Positive Isolated Locoregional Recurrence of Breast Cancer: Final Analysis of the CALOR Trial. J Clin Oncol. 2018 Apr 10;36(11):1073-1079. Epub 2018 Feb 14. [https://doi.org/10.1200/jco.2017.76.5719 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc5891132/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/29443653/ PubMed]
 
##'''Update:''' Wapnir IL, Price KN, Anderson SJ, Robidoux A, Martín M, Nortier JWR, Paterson AHG, Rimawi MF, Láng I, Baena-Cañada JM, Thürlimann B, Mamounas EP, Geyer CE Jr, Gelber S, Coates AS, Gelber RD, Rastogi P, Regan MM, Wolmark N, Aebi S; International Breast Cancer Study Group; NRG Oncology; GEICAM Spanish Breast Cancer Group; BOOG Dutch Breast Cancer Trialists' Group; Breast International Group. Efficacy of Chemotherapy for ER-Negative and ER-Positive Isolated Locoregional Recurrence of Breast Cancer: Final Analysis of the CALOR Trial. J Clin Oncol. 2018 Apr 10;36(11):1073-1079. Epub 2018 Feb 14. [https://doi.org/10.1200/jco.2017.76.5719 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc5891132/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/29443653/ PubMed]
 
# Nasr KE, Osman MA, Elkady MS, Ellithy MA. Metronomic methotrexate and cyclophosphamide after carboplatin included adjuvant chemotherapy in triple negative breast cancer: a phase III study. Ann Transl Med. 2015 Nov;3(19):284. [https://doi.org/10.3978/j.issn.2305-5839.2015.11.14 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4671866/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/26697444/ PubMed]
 
# Nasr KE, Osman MA, Elkady MS, Ellithy MA. Metronomic methotrexate and cyclophosphamide after carboplatin included adjuvant chemotherapy in triple negative breast cancer: a phase III study. Ann Transl Med. 2015 Nov;3(19):284. [https://doi.org/10.3978/j.issn.2305-5839.2015.11.14 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4671866/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/26697444/ PubMed]
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# '''ANZ0501 LATER:''' Zdenkowski N, Forbes JF, Boyle FM, Kannourakis G, Gill PG, Bayliss E, Saunders C, Della-Fiorentina S, Kling N, Campbell I, Mann GB, Coates AS, Gebski V, Davies L, Thornton R, Reaby L, Cuzick J, Green M; Australia and New Zealand Breast Cancer Trials Group. Observation versus late reintroduction of letrozole as adjuvant endocrine therapy for hormone receptor-positive breast cancer (ANZ0501 LATER): an open-label randomised, controlled trial. Ann Oncol. 2016 May;27(5):806-12. Epub 2016 Feb 9. [https://doi.org/10.1093/annonc/mdw055 link to original article] [https://pubmed.ncbi.nlm.nih.gov/26861603/ PubMed] ACTRN12607000137493
 
 
# '''IBCSG 22-00:''' Colleoni M, Gray KP, Gelber S, Láng I, Thürlimann B, Gianni L, Abdi EA, Gomez HL, Linderholm BK, Puglisi F, Tondini C, Kralidis E, Eniu A, Cagossi K, Rauch D, Chirgwin J, Gelber RD, Regan MM, Coates AS, Price KN, Viale G, Goldhirsch A. Low-dose oral cyclophosphamide and methotrexate maintenance for hormone receptor-negative early breast cancer: International Breast Cancer Study Group trial 22-00. J Clin Oncol. 2016 Oct 1;34(28):3400-8. Epub 2016 Jun 20. [https://doi.org/10.1200/JCO.2015.65.6595 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5035120/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/27325862/ PubMed] [https://clinicaltrials.gov/study/NCT00022516 NCT00022516]
 
# '''IBCSG 22-00:''' Colleoni M, Gray KP, Gelber S, Láng I, Thürlimann B, Gianni L, Abdi EA, Gomez HL, Linderholm BK, Puglisi F, Tondini C, Kralidis E, Eniu A, Cagossi K, Rauch D, Chirgwin J, Gelber RD, Regan MM, Coates AS, Price KN, Viale G, Goldhirsch A. Low-dose oral cyclophosphamide and methotrexate maintenance for hormone receptor-negative early breast cancer: International Breast Cancer Study Group trial 22-00. J Clin Oncol. 2016 Oct 1;34(28):3400-8. Epub 2016 Jun 20. [https://doi.org/10.1200/JCO.2015.65.6595 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5035120/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/27325862/ PubMed] [https://clinicaltrials.gov/study/NCT00022516 NCT00022516]
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# '''CBC 02:''' Jensen MB, Krarup JF, Palshof T, Mouridsen HT, Ejlertsen B. Two years of tamoxifen or no adjuvant systemic therapy for patients with high-risk breast cancer: long-term follow-up of the Copenhagen Breast Cancer Trial. Acta Oncol. 2018 Jan;57(1):26-30. Epub 2017 Nov 22. [https://doi.org/10.1080/0284186X.2017.1400179 link to original article] [https://pubmed.ncbi.nlm.nih.gov/29165021/ PubMed]
 
 
# '''GEICAM/2003-11; CIBOMA/2004-01:''' Lluch A, Barrios CH, Torrecillas L, Ruiz-Borrego M, Bines J, Segalla J, Guerrero-Zotano Á, García-Sáenz JA, Torres R, de la Haba J, García-Martínez E, Gómez HL, Llombart A, Bofill JS, Baena-Cañada JM, Barnadas A, Calvo L, Pérez-Michel L, Ramos M, Fernández I, Rodríguez-Lescure Á, Cárdenas J, Vinholes J, Martínez de Dueñas E, Godes MJ, Seguí MA, Antón A, López-Álvarez P, Moncayo J, Amorim G, Villar E, Reyes S, Sampaio C, Cardemil B, Escudero MJ, Bezares S, Carrasco E, Martín M; GEICAM Spanish Breast Cancer Group; CIBOMA (Iberoamerican Coalition for Research in Breast Oncology); LACOG (Latin American Cooperative Oncology Group). Phase III Trial of Adjuvant Capecitabine After Standard Neo-/Adjuvant Chemotherapy in Patients With Early Triple-Negative Breast Cancer (GEICAM/2003-11_CIBOMA/2004-01). J Clin Oncol. 2020 Jan 20;38(3):203-213. Epub 2019 Dec 5. Erratum in: J Clin Oncol. 2020 Mar 10;38(8):847. [https://doi.org/10.1200/jco.19.00904 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6968797/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/31804894/ PubMed] [https://clinicaltrials.gov/study/NCT00130533 NCT00130533]
 
# '''GEICAM/2003-11; CIBOMA/2004-01:''' Lluch A, Barrios CH, Torrecillas L, Ruiz-Borrego M, Bines J, Segalla J, Guerrero-Zotano Á, García-Sáenz JA, Torres R, de la Haba J, García-Martínez E, Gómez HL, Llombart A, Bofill JS, Baena-Cañada JM, Barnadas A, Calvo L, Pérez-Michel L, Ramos M, Fernández I, Rodríguez-Lescure Á, Cárdenas J, Vinholes J, Martínez de Dueñas E, Godes MJ, Seguí MA, Antón A, López-Álvarez P, Moncayo J, Amorim G, Villar E, Reyes S, Sampaio C, Cardemil B, Escudero MJ, Bezares S, Carrasco E, Martín M; GEICAM Spanish Breast Cancer Group; CIBOMA (Iberoamerican Coalition for Research in Breast Oncology); LACOG (Latin American Cooperative Oncology Group). Phase III Trial of Adjuvant Capecitabine After Standard Neo-/Adjuvant Chemotherapy in Patients With Early Triple-Negative Breast Cancer (GEICAM/2003-11_CIBOMA/2004-01). J Clin Oncol. 2020 Jan 20;38(3):203-213. Epub 2019 Dec 5. Erratum in: J Clin Oncol. 2020 Mar 10;38(8):847. [https://doi.org/10.1200/jco.19.00904 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6968797/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/31804894/ PubMed] [https://clinicaltrials.gov/study/NCT00130533 NCT00130533]
 
# '''SYSUCC-001:''' Wang X, Wang SS, Huang H, Cai L, Zhao L, Peng RJ, Lin Y, Tang J, Zeng J, Zhang LH, Ke YL, Wang XM, Liu XM, Chen QJ, Zhang AQ, Xu F, Bi XW, Huang JJ, Li JB, Pang DM, Xue C, Shi YX, He ZY, Lin HX, An X, Xia W, Cao Y, Guo Y, Su YH, Hua X, Wang XY, Hong RX, Jiang KK, Song CG, Huang ZZ, Shi W, Zhong YY, Yuan ZY; South China Breast Cancer Group (SCBCG). Effect of Capecitabine Maintenance Therapy Using Lower Dosage and Higher Frequency vs Observation on Disease-Free Survival Among Patients With Early-Stage Triple-Negative Breast Cancer Who Had Received Standard Treatment: The SYSUCC-001 Randomized Clinical Trial. JAMA. 2021 Jan 5;325(1):50-58. [https://doi.org/10.1001/jama.2020.23370 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7729589/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/33300950/ PubMed] [https://clinicaltrials.gov/study/NCT01112826 NCT01112826]
 
# '''SYSUCC-001:''' Wang X, Wang SS, Huang H, Cai L, Zhao L, Peng RJ, Lin Y, Tang J, Zeng J, Zhang LH, Ke YL, Wang XM, Liu XM, Chen QJ, Zhang AQ, Xu F, Bi XW, Huang JJ, Li JB, Pang DM, Xue C, Shi YX, He ZY, Lin HX, An X, Xia W, Cao Y, Guo Y, Su YH, Hua X, Wang XY, Hong RX, Jiang KK, Song CG, Huang ZZ, Shi W, Zhong YY, Yuan ZY; South China Breast Cancer Group (SCBCG). Effect of Capecitabine Maintenance Therapy Using Lower Dosage and Higher Frequency vs Observation on Disease-Free Survival Among Patients With Early-Stage Triple-Negative Breast Cancer Who Had Received Standard Treatment: The SYSUCC-001 Randomized Clinical Trial. JAMA. 2021 Jan 5;325(1):50-58. [https://doi.org/10.1001/jama.2020.23370 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7729589/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/33300950/ PubMed] [https://clinicaltrials.gov/study/NCT01112826 NCT01112826]

Revision as of 12:10, 27 August 2023

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The purpose of this page is to provide references to "null therapy" such as placebo and observation. While not clinically relevant, these references provide further insight into the historical development of the treatment landscape. See the main breast cancer page for current regimens.


Neoadjuvant therapy

No neoadjuvant therapy

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Smith et al. 2020 (POETIC) 2008-2014 Phase 3 (C) 1a. Anastrozole
1b. Letrozole 		Did not meet primary endpoint of TTR

No treatment prior to surgical resection.

Subsequent treatment

References

  1. POETIC: Smith I, Robertson J, Kilburn L, Wilcox M, Evans A, Holcombe C, Horgan K, Kirwan C, Mallon E, Sibbering M, Skene A, Vidya R, Cheang M, Banerji J, Morden J, Sidhu K, Dodson A, Bliss JM, Dowsett M. Long-term outcome and prognostic value of Ki67 after perioperative endocrine therapy in postmenopausal women with hormone-sensitive early breast cancer (POETIC): an open-label, multicentre, parallel-group, randomised, phase 3 trial. Lancet Oncol. 2020 Nov;21(11):1443-1454. link to original article link to PMC article PubMed NCT02338310

Adjuvant therapy

Observation

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Lacour et al. 1980 1972-1979 Phase 3 (C) Polya.Polyu Might have inferior OS
Bonadonna et al. 1976 1973-1975 Phase 3 (C) CMF Inferior RFS
Rubens et al. 1983 1975-1979 Phase 3 (C) Melphalan Might have inferior RFS
Brinker et al. 1983 (DBCG 77B) 1977-1983 Phase 3 (C) 1. CMF Seems to have inferior OS1
2. Cyclophosphamide Seems to have inferior OS1
3. Levamisole Did not meet co-primary endpoints of IDFS/OS
Goldhirsch et al. 1984 (LBCS III) 1978-1981 Phase 3 (C) 1. CMFPT Inferior DFS
2. PT Inferior DFS
Goldhirsch et al. 1984 (LBCS IV) 1978-1981 Phase 3 (C) PT Seems to have inferior DFS
Fisher et al. 1989 (NSABP B-13) 1981-1988 Phase 3 (C) MF; sequential Inferior DFS2
Mansour et al. 1989 (ECOG E1180) 1981-1988 Phase 3 (C) CMFP Inferior DFS
Jakesz et al. 1998 1984-1990 Phase 3 (C) AV-CMF Did not meet primary endpoint of DFS60
Héry et al. 2006 (FASG 03) 1988-1994 Phase 3 (C) FEC50 x 6 Did not meet primary endpoint of DFS120
Amadori et al. 2000 1989-1993 Phase 3 (C) CMF x 6 Seems to have inferior DFS
Paradiso et al. 2001 1989-1994 Phase 3 (C) FEC x 6 Seems to have inferior DFS
Arriagada et al. 2005 1989-1996 Phase 3 (C) FEC50 x 6 Inferior DFS
Henderson et al. 2003 (INT 0148/CALGB 9344) 1994-1999 Phase 3 (C) Paclitaxel; q3wk Inferior OS
Mamounas et al. 2005 (NSABP B-28) 1995-1998 Phase 3 (C) Paclitaxel; q3wk Inferior DFS
Colleoni et al. 2016 (IBCSG 22-00) 2000-2012 Phase 3 (C) CM Did not meet primary endpoint of DFS
Aebi et al. 2014 (CALOR) 2003-2010 Phase 3 (C) Chemotherapy Seems to have inferior DFS
Lluch et al. 2019 (GEICAM/2003-11; CIBOMA/2004-01) 2006-2011 Phase 3 (C) Capecitabine Did not meet primary endpoint of DFS
Nasr et al. 2015 2008-2014 Phase 3 (C) CM Seems to have inferior OS
Wang et al. 2021 (SYSUCC-001) 2010-2016 Phase 3 (C) Capecitabine Inferior DFS

1Reported efficacy for DBCG 77B is based on the 2010 update.
2Reported efficacy for NSABP B-13 is based on the 1996 update.
Note: No further systemic treatment; many of these trials incorporated RT, however (see individual papers for details). Jakesz et al. 1998 was conducted prior to routine testing of HER2, so it technically included "double-negative" patients. ECOG E1180 is also known as INT-0011.

Preceding treatment

References

  1. Bonadonna G, Brusamolino E, Valagussa P, Rossi A, Brugnatelli L, Brambilla C, De Lena M, Tancini G, Bajetta E, Musumeci R, Veronesi U. Combination chemotherapy as an adjuvant treatment in operable breast cancer. N Engl J Med. 1976 Feb 19;294(8):405-10. link to original article PubMed
    1. Update: Bonadonna G, Rossi A, Valagussa P, Banfi A, Veronesi U. The CMF program for operable breast cancer with positive axillary nodes: updated analysis on the disease-free interval, site of relapse and drug tolerance. Cancer. 1977 Jun;39(6 Suppl):2904-15. link to original article PubMed
    2. Update: Bonadonna G, Valagussa P, Rossi A, Tancini G, Brambilla C, Zambetti M, Veronesi U. Ten-year experience with CMF-based adjuvant chemotherapy in resectable breast cancer. Breast Cancer Res Treat. 1985;5(2):95-115. link to original article PubMed
    3. Update: Bonadonna G, Valagussa P, Moliterni A, Zambetti M, Brambilla C. Adjuvant cyclophosphamide, methotrexate, and fluorouracil in node-positive breast cancer: the results of 20 years of follow-up. N Engl J Med. 1995 Apr 6;332(14):901-6. link to original article PubMed
  2. Lacour J, Lacour F, Spira A, Michelson M, Petit JY, Delage G, Sarrazin D, Contesso G, Viguier J. Adjuvant treatment with polyadenylic-polyuridylic acid (Polya-Polyu) in operable breast cancer. Lancet. 1980 Jul 26;2(8187):161-4. link to original article PubMed
  3. Rubens RD, Hayward JL, Knight RK, Bulbrook RD, Fentiman IS, Chaudary M, Howell A, Bush H, Crowther D, Sellwood RA, George WD, Howat JM. Controlled trial of adjuvant chemotherapy with melphalan for breast cancer. Lancet. 1983 Apr 16;1(8329):839-43. link to original article PubMed
  4. DBCG 77B: Brincker H, Mouridsen HT, Andersen KW. Adjuvant chemotherapy with cyclophosphamide or CMF in premenopausal women with stage II breast cancer. Breast Cancer Res Treat. 1983;3(1):91-5. link to original article contains dosing details in manuscript PubMed
    1. Update: Ejlertsen B, Mouridsen HT, Jensen MB, Andersen J, Andersson M, Kamby C, Knoop AS; Danish Breast Cancer Cooperative Group. Cyclophosphamide, methotrexate, and fluorouracil; oral cyclophosphamide; levamisole; or no adjuvant therapy for patients with high-risk, premenopausal breast cancer. Cancer. 2010 May 1;116(9):2081-9. link to original article PubMed
  5. LBCS III/IV: Goldhirsch A; Ludwig Breast Cancer Study Group. Randomised trial of chemo-endocrine therapy, endocrine therapy, and mastectomy alone in postmenopausal patients with operable breast cancer and axillary node metastasis. Lancet. 1984 Jun 9;1(8389):1256-60. link to original article PubMed
  6. Howell A, Bush H, George WD, Howat JM, Crowther D, Sellwood RA, Rubens RD, Hayward JL, Bulbrook RD, Fentiman IS, Chaudary M. Controlled trial of adjuvant chemotherapy with cyclophosphamide, methotrexate, and fluorouracil for breast cancer. Lancet. 1984 Aug 11;2(8398):307-11. link to original article PubMed
  7. NSABP B-13: Fisher B, Redmond C, Dimitrov NV, Bowman D, Legault-Poisson S, Wickerham DL, Wolmark N, Fisher ER, Margolese R, Sutherland C, Glass A, Foster R, Caplan R. A randomized clinical trial evaluating sequential methotrexate and fluorouracil in the treatment of patients with node-negative breast cancer who have estrogen-receptor-negative tumors. N Engl J Med. 1989 Feb 23;320(8):473-8. link to original article PubMed
    1. Update: Fisher B, Dignam J, Mamounas EP, Costantino JP, Wickerham DL, Redmond C, Wolmark N, Dimitrov NV, Bowman DM, Glass AG, Atkins JN, Abramson N, Sutherland CM, Aron BS, Margolese RG. Sequential methotrexate and fluorouracil for the treatment of node-negative breast cancer patients with estrogen receptor-negative tumors: eight-year results from National Surgical Adjuvant Breast and Bowel Project (NSABP) B-13 and first report of findings from NSABP B-19 comparing methotrexate and fluorouracil with conventional cyclophosphamide, methotrexate, and fluorouracil. J Clin Oncol. 1996 Jul;14(7):1982-92. link to original article PubMed
    2. Pooled update: Taghian AG, Jeong JH, Mamounas EP, Parda DS, Deutsch M, Costantino JP, Wolmark N. Low locoregional recurrence rate among node-negative breast cancer patients with tumors 5 cm or larger treated by mastectomy, with or without adjuvant systemic therapy and without radiotherapy: results from five national surgical adjuvant breast and bowel project randomized clinical trials. J Clin Oncol. 2006 Aug 20;24(24):3927-32. link to original article PubMed
  8. ECOG E1180: Mansour EG, Gray R, Shatila AH, Osborne CK, Tormey DC, Gilchrist KW, Cooper MR, Falkson G. Efficacy of adjuvant chemotherapy in high-risk node-negative breast cancer: an intergroup study. N Engl J Med. 1989 Feb 23;320(8):485-90. link to original article PubMed
  9. LCBS V: Goldhirsch A, Gelber RD; Ludwig Breast Cancer Study Group. Prolonged disease-free survival after one course of perioperative adjuvant chemotherapy for node-negative breast cancer. N Engl J Med. 1989 Feb 23;320(8):491-6. link to original article PubMed
  10. EORTC 09771: Clahsen PC, van de Velde CJ, Welvaart K, Repelaer van Driel OJ, Sylvester RJ; Cooperating Investigators. Ten-year results of a randomized trial evaluating prolonged low-dose adjuvant chemotherapy in node-positive breast cancer: a joint European Organisation for Research and Treatment of Cancer-Dutch Breast Cancer Working Party Study. J Clin Oncol. 1995 Jan;13(1):33-41. link to original article contains dosing details in abstract PubMed
  11. Jakesz R, Samonigg H, Gnant M, Kubista E, Steindorfer P, Hausmaninger H, Sevelda P, Tschurtschenthaler B, Fridrik M, Stierer M, Kolb R, Steger G; Austrian Breast Cancer Study Group. Very low-dose adjuvant chemotherapy in steroid receptor negative stage I breast cancer patients. Eur J Cancer. 1998 Jan; 34 (1): 66-70. link to original article PubMed
  12. Amadori D, Nanni O, Marangolo M, Pacini P, Ravaioli A, Rossi A, Gambi A, Catalano G, Perroni D, Scarpi E, Giunchi DC, Tienghi A, Becciolini A, Volpi A. Disease-free survival advantage of adjuvant cyclophosphamide, methotrexate, and fluorouracil in patients with node-negative, rapidly proliferating breast cancer: a randomized multicenter study. J Clin Oncol. 2000 Sep;18(17):3125-34. link to original article contains dosing details in manuscript PubMed
    1. Update: Amadori D, Nanni O, Volpi A, Casadei Giunchi D, Marangolo M, Livi L, Ravaioli A, Rossi AP, Gambi A, Luzi Fedeli S, Perroni D, Scarpi E, Becciolini A, Silvestrini R. Phase III randomized multicenter study on the effects of adjuvant CMF in patients with node-negative, rapidly proliferating breast cancer: twelve-year results and retrospective subgroup analysis. Breast Cancer Res Treat. 2008 Mar;108(2):259-64. Epub 2007 May 26. link to original article PubMed
  13. Paradiso A, Schittulli F, Cellamare G, Mangia A, Marzullo F, Lorusso V, De Lena M. Randomized clinical trial of adjuvant fluorouracil, epirubicin, and cyclophosphamide chemotherapy for patients with fast-proliferating, node-negative breast cancer. J Clin Oncol. 2001 Oct 1;19(19):3929-37. link to original article contains dosing details in manuscript PubMed
  14. INT 0148/CALGB 9344: Henderson IC, Berry DA, Demetri GD, Cirrincione CT, Goldstein LJ, Martino S, Ingle JN, Cooper MR, Hayes DF, Tkaczuk KH, Fleming G, Holland JF, Duggan DB, Carpenter JT, Frei E 3rd, Schilsky RL, Wood WC, Muss HB, Norton L. Improved outcomes from adding sequential paclitaxel but not from escalating doxorubicin dose in an adjuvant chemotherapy regimen for patients with node-positive primary breast cancer. J Clin Oncol. 2003 Mar 15;21(6):976-83. link to original article contains dosing details in manuscript PubMed
  15. NSABP B-28: Mamounas EP, Bryant J, Lembersky B, Fehrenbacher L, Sedlacek SM, Fisher B, Wickerham DL, Yothers G, Soran A, Wolmark N. Paclitaxel after doxorubicin plus cyclophosphamide as adjuvant chemotherapy for node-positive breast cancer: results from NSABP B-28. J Clin Oncol. 2005 Jun 1;23(16):3686-96. Epub 2005 May 16. link to original article PubMed
  16. Arriagada R, Spielmann M, Koscielny S, Le Chevalier T, Delozier T, Rémé-Saumon M, Ducourtieux M, Tursz T, Hill C. Results of two randomized trials evaluating adjuvant anthracycline-based chemotherapy in 1146 patients with early breast cancer. Acta Oncol. 2005;44(5):458-66. link to original article contains dosing details in manuscript PubMed
  17. FASG 03: Héry M, Bonneterre J, Roché H, Luporsi E, Kerbrat P, Namer M, Fumoleau P, Monnier A, Fargeot P. Epirubicin-based chemotherapy as adjuvant treatment for poor prognosis, node-negative breast cancer: 10-year follow-up results of the French Adjuvant Study Group 03 trial. Bull Cancer. 2006 Oct;93(10):E109-14. link to original article contains dosing details in abstract PubMed
  18. CALOR: Aebi S, Gelber S, Anderson SJ, Láng I, Robidoux A, Martín M, Nortier JW, Paterson AH, Rimawi MF, Cañada JM, Thürlimann B, Murray E, Mamounas EP, Geyer CE Jr, Price KN, Coates AS, Gelber RD, Rastogi P, Wolmark N, Wapnir IL; CALOR investigators. Chemotherapy for isolated locoregional recurrence of breast cancer (CALOR): a randomised trial. Lancet Oncol. 2014 Feb;15(2):156-63. Epub 2014 Jan 16. link to original article link to PMC article PubMed NCT00074152
    1. Update: Wapnir IL, Price KN, Anderson SJ, Robidoux A, Martín M, Nortier JWR, Paterson AHG, Rimawi MF, Láng I, Baena-Cañada JM, Thürlimann B, Mamounas EP, Geyer CE Jr, Gelber S, Coates AS, Gelber RD, Rastogi P, Regan MM, Wolmark N, Aebi S; International Breast Cancer Study Group; NRG Oncology; GEICAM Spanish Breast Cancer Group; BOOG Dutch Breast Cancer Trialists' Group; Breast International Group. Efficacy of Chemotherapy for ER-Negative and ER-Positive Isolated Locoregional Recurrence of Breast Cancer: Final Analysis of the CALOR Trial. J Clin Oncol. 2018 Apr 10;36(11):1073-1079. Epub 2018 Feb 14. link to original article link to PMC article PubMed
  19. Nasr KE, Osman MA, Elkady MS, Ellithy MA. Metronomic methotrexate and cyclophosphamide after carboplatin included adjuvant chemotherapy in triple negative breast cancer: a phase III study. Ann Transl Med. 2015 Nov;3(19):284. link to original article link to PMC article PubMed
  20. IBCSG 22-00: Colleoni M, Gray KP, Gelber S, Láng I, Thürlimann B, Gianni L, Abdi EA, Gomez HL, Linderholm BK, Puglisi F, Tondini C, Kralidis E, Eniu A, Cagossi K, Rauch D, Chirgwin J, Gelber RD, Regan MM, Coates AS, Price KN, Viale G, Goldhirsch A. Low-dose oral cyclophosphamide and methotrexate maintenance for hormone receptor-negative early breast cancer: International Breast Cancer Study Group trial 22-00. J Clin Oncol. 2016 Oct 1;34(28):3400-8. Epub 2016 Jun 20. link to original article link to PMC article PubMed NCT00022516
  21. GEICAM/2003-11; CIBOMA/2004-01: Lluch A, Barrios CH, Torrecillas L, Ruiz-Borrego M, Bines J, Segalla J, Guerrero-Zotano Á, García-Sáenz JA, Torres R, de la Haba J, García-Martínez E, Gómez HL, Llombart A, Bofill JS, Baena-Cañada JM, Barnadas A, Calvo L, Pérez-Michel L, Ramos M, Fernández I, Rodríguez-Lescure Á, Cárdenas J, Vinholes J, Martínez de Dueñas E, Godes MJ, Seguí MA, Antón A, López-Álvarez P, Moncayo J, Amorim G, Villar E, Reyes S, Sampaio C, Cardemil B, Escudero MJ, Bezares S, Carrasco E, Martín M; GEICAM Spanish Breast Cancer Group; CIBOMA (Iberoamerican Coalition for Research in Breast Oncology); LACOG (Latin American Cooperative Oncology Group). Phase III Trial of Adjuvant Capecitabine After Standard Neo-/Adjuvant Chemotherapy in Patients With Early Triple-Negative Breast Cancer (GEICAM/2003-11_CIBOMA/2004-01). J Clin Oncol. 2020 Jan 20;38(3):203-213. Epub 2019 Dec 5. Erratum in: J Clin Oncol. 2020 Mar 10;38(8):847. link to original article link to PMC article PubMed NCT00130533
  22. SYSUCC-001: Wang X, Wang SS, Huang H, Cai L, Zhao L, Peng RJ, Lin Y, Tang J, Zeng J, Zhang LH, Ke YL, Wang XM, Liu XM, Chen QJ, Zhang AQ, Xu F, Bi XW, Huang JJ, Li JB, Pang DM, Xue C, Shi YX, He ZY, Lin HX, An X, Xia W, Cao Y, Guo Y, Su YH, Hua X, Wang XY, Hong RX, Jiang KK, Song CG, Huang ZZ, Shi W, Zhong YY, Yuan ZY; South China Breast Cancer Group (SCBCG). Effect of Capecitabine Maintenance Therapy Using Lower Dosage and Higher Frequency vs Observation on Disease-Free Survival Among Patients With Early-Stage Triple-Negative Breast Cancer Who Had Received Standard Treatment: The SYSUCC-001 Randomized Clinical Trial. JAMA. 2021 Jan 5;325(1):50-58. link to original article link to PMC article PubMed NCT01112826
  23. SWOG S1418: NCT02954874

Placebo

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Fisher et al. 1975 (NSABP B-05) 1972-1975 Phase 3 (C) Melphalan Might have inferior DFS1
Fisher et al. 1989 (NSABP B-14) 1982-1987 Phase 3 (C) Tamoxifen Inferior OS2
Fisher et al. 2001 (NSABP B-23) 1991-1998 Phase 3 (C) Tamoxifen Did not meet primary endpoint of OS
Goss et al. 2003 (NCIC-CTG MA.17) 1998-2002 Phase 3 (C) Letrozole Inferior DFS
Mamounas et al. 2008 (NSABP B-33) 2001-2003 Phase 3 (C) Exemestane Inferior RFS
Paterson et al. 2012 (NSABP B-34) 2001-2004 Phase 3 (C) Clodronate Did not meet primary endpoint of DFS
Coombes et al. 2021 (REACT) 2007-2012 Phase 3 (C) Celecoxib Did not meet primary endpoint of DFS
Coleman et al. 2019 (D-CARE) 2010-2012 Phase 3 (C) Denosumab Did not meet primary composite endpoint of bone MFS
Goodwin et al. 2022 (NCIC CTG MA.32) 2010-2013 Phase 3 (C) Metformin Did not meet primary endpoint of IDFS
Mittendorf et al. 2019 (PRESENT) 2011-2015 Phase 3 (C) Nelipepimut-S Did not meet primary endpoint of DFS
Tutt et al. 2021 (OlympiA) 2014-2019 Phase 3 (C) Olaparib Inferior OS3

1Reported efficacy for NSABP B-05 is based on the 1986 update.
2Reported efficacy for NSABP B-14 is based on the 2004 update.
3Reported efficacy for OlympiA is based on the 2022 update.
No active antineoplastic treatment within the study design. Used as a comparator arm. Note that some trials do have other ongoing antineoplastic treatments outside of the study design, such as adjuvant endocrine therapy.

Preceding treatment

References

  1. NSABP B-05: Fisher B, Carbone P, Economou SG, Frelick R, Glass A, Lerner H, Redmond C, Zelen M, Band P, Katrych DL, Wolmark N, Fisher ER. 1-Phenylalanine mustard (L-PAM) in the management of primary breast cancer: a report of early findings. N Engl J Med. 1975 Jan 16;292(3):117-22. link to original article PubMed
    1. Update: Fisher B, Glass A, Redmond C, Fisher ER, Barton B, Such E, Carbone P, Economou S, Foster R, Frelick R, Lerner H, Levitt M, Margolese R, MacFarlane J, Plotkin D, Shibata H, Volk H. L-phenylalanine mustard (L-PAM) in the management of primary breast cancer: an update of earlier findings and a comparison with those utilizing L-PAM plus 5-fluorouracil (5-FU). Cancer. 1977 Jun;39(6 Suppl):2883-903. link to original article PubMed
    2. Update: Fisher B, Fisher ER, Redmond C. Ten-year results from the National Surgical Adjuvant Breast and Bowel Project (NSABP) clinical trial evaluating the use of L-phenylalanine mustard (L-PAM) in the management of primary breast cancer. J Clin Oncol. 1986 Jun;4(6):929-41. link to original article PubMed
  2. NSABP B-14: Fisher B, Costantino J, Redmond C, Poisson R, Bowman D, Couture J, Dimitrov NV, Wolmark N, Wickerham DL, Fisher ER, Margolese R, Robidoux A, Shibata H, Terz J, Peterson AHG, Feldman MI, Farrar W, Evans J, Lickley HL, Ketner M. A randomized clinical trial evaluating tamoxifen in the treatment of patients with node-negative breast cancer who have estrogen-receptor-positive tumors. N Engl J Med. 1989 Feb 23;320(8):479-84. link to original article contains dosing details in manuscript PubMed
    1. Update: Fisher B, Dignam J, Bryant J, DeCillis A, Wickerham DL, Wolmark N, Costantino J, Redmond C, Fisher ER, Bowman DM, Deschênes L, Dimitrov NV, Margolese RG, Robidoux A, Shibata H, Terz J, Paterson AH, Feldman MI, Farrar W, Evans J, Lickley HL. Five versus more than five years of tamoxifen therapy for breast cancer patients with negative lymph nodes and estrogen receptor-positive tumors. J Natl Cancer Inst. 1996 Nov 6;88(21):1529-42. link to original article PubMed
    2. Update: Fisher B, Dignam J, Bryant J, Wolmark N. Five versus more than five years of tamoxifen for lymph node-negative breast cancer: updated findings from the National Surgical Adjuvant Breast and Bowel Project B-14 randomized trial. J Natl Cancer Inst. 2001 May 2;93(9):684-90. link to original article PubMed
    3. Pooled update: Fisher B, Jeong JH, Bryant J, Anderson S, Dignam J, Fisher ER, Wolmark N; National Surgical Adjuvant Breast and Bowel Project randomised clinical trials. Treatment of lymph-node-negative, oestrogen-receptor-positive breast cancer: long-term findings from National Surgical Adjuvant Breast and Bowel Project randomised clinical trials. Lancet. 2004 Sep 4-10;364(9437):858-68. link to original article PubMed
    4. Pooled update: Taghian AG, Jeong JH, Mamounas EP, Parda DS, Deutsch M, Costantino JP, Wolmark N. Low locoregional recurrence rate among node-negative breast cancer patients with tumors 5 cm or larger treated by mastectomy, with or without adjuvant systemic therapy and without radiotherapy: results from five national surgical adjuvant breast and bowel project randomized clinical trials. J Clin Oncol. 2006 Aug 20;24(24):3927-32. link to original article PubMed
  3. NSABP B-23: Fisher B, Anderson S, Tan-Chiu E, Wolmark N, Wickerham DL, Fisher ER, Dimitrov NV, Atkins JN, Abramson N, Merajver S, Romond EH, Kardinal CG, Shibata HR, Margolese RG, Farrar WB. Tamoxifen and chemotherapy for axillary node-negative, estrogen receptor-negative breast cancer: findings from National Surgical Adjuvant Breast and Bowel Project B-23. J Clin Oncol. 2001 Feb 15;19(4):931-42. link to original article PubMed
    1. Pooled update: Taghian AG, Jeong JH, Mamounas EP, Parda DS, Deutsch M, Costantino JP, Wolmark N. Low locoregional recurrence rate among node-negative breast cancer patients with tumors 5 cm or larger treated by mastectomy, with or without adjuvant systemic therapy and without radiotherapy: results from five national surgical adjuvant breast and bowel project randomized clinical trials. J Clin Oncol. 2006 Aug 20;24(24):3927-32. link to original article PubMed
  4. NCIC-CTG MA.17: Goss PE, Ingle JN, Martino S, Robert NJ, Muss HB, Piccart MJ, Castiglione M, Tu D, Shepherd LE, Pritchard KI, Livingston RB, Davidson NE, Norton L, Perez EA, Abrams JS, Therasse P, Palmer MJ, Pater JL. A randomized trial of letrozole in postmenopausal women after five years of tamoxifen therapy for early-stage breast cancer. N Engl J Med. 2003 Nov 6;349(19):1793-802. Epub 2003 Oct 9. link to original article PubMed NCT00003140
    1. Update: Goss PE, Ingle JN, Martino S, Robert NJ, Muss HB, Piccart MJ, Castiglione M, Tu D, Shepherd LE, Pritchard KI, Livingston RB, Davidson NE, Norton L, Perez EA, Abrams JS, Cameron DA, Palmer MJ, Pater JL. Randomized trial of letrozole following tamoxifen as extended adjuvant therapy in receptor-positive breast cancer: updated findings from NCIC-CTG MA.17. J Natl Cancer Inst. 2005 Sep 7;97(17):1262-71. link to original article PubMed
    2. HRQoL analysis: Whelan TJ, Goss PE, Ingle JN, Pater JL, Tu D, Pritchard K, Liu S, Shepherd LE, Palmer M, Robert NJ, Martino S, Muss HB. Assessment of quality of life in MA.17: a randomized, placebo-controlled trial of letrozole after 5 years of tamoxifen in postmenopausal women. J Clin Oncol. 2005 Oct 1;23(28):6931-40. Epub 2005 Sep 12. link to original article PubMed
    3. Update: Muss HB, Tu D, Ingle JN, Martino S, Robert NJ, Pater JL, Whelan TJ, Palmer MJ, Piccart MJ, Shepherd LE, Pritchard KI, He Z, Goss PE. Efficacy, toxicity, and quality of life in older women with early-stage breast cancer treated with letrozole or placebo after 5 years of tamoxifen: NCIC-CTG intergroup trial MA.17. J Clin Oncol. 2008 Apr 20;26(12):1956-64. Epub 2008 Mar 10. link to original article PubMed
    4. Subgroup analysis: Goss PE, Ingle JN, Pater JL, Martino S, Robert NJ, Muss HB, Piccart MJ, Castiglione M, Shepherd LE, Pritchard KI, Livingston RB, Davidson NE, Norton L, Perez EA, Abrams JS, Cameron DA, Palmer MJ, Tu D. Late extended adjuvant treatment with letrozole improves outcome in women with early-stage breast cancer who complete 5 years of tamoxifen. J Clin Oncol. 2008 Apr 20;26(12):1948-55. Epub 2008 Mar 10. link to original article PubMed
    5. Update: Jin H, Tu D, Zhao N, Shepherd LE, Goss PE. Longer-term outcomes of letrozole versus placebo after 5 years of tamoxifen in the NCIC-CTG MA.17 trial: analyses adjusting for treatment crossover. J Clin Oncol. 2012 Mar 1;30(7):718-21. Epub 2011 Oct 31. link to original article link to PMC article PubMed
  5. NSABP B-33: Mamounas EP, Jeong JH, Wickerham DL, Smith RE, Ganz PA, Land SR, Eisen A, Fehrenbacher L, Farrar WB, Atkins JN, Pajon ER, Vogel VG, Kroener JF, Hutchins LF, Robidoux A, Hoehn JL, Ingle JN, Geyer CE Jr, Costantino JP, Wolmark N. Benefit from exemestane as extended adjuvant therapy after 5 years of adjuvant tamoxifen: intention-to-treat analysis of the National Surgical Adjuvant Breast And Bowel Project B-33 trial. J Clin Oncol. 2008 Apr 20;26(12):1965-71. Epub 2008 Mar 10. link to original article PubMed NCT00016432
  6. NSABP B-34: Paterson AH, Anderson SJ, Lembersky BC, Fehrenbacher L, Falkson CI, King KM, Weir LM, Brufsky AM, Dakhil S, Lad T, Baez-Diaz L, Gralow JR, Robidoux A, Perez EA, Zheng P, Geyer CE Jr, Swain SM, Costantino JP, Mamounas EP, Wolmark N. Oral clodronate for adjuvant treatment of operable breast cancer (National Surgical Adjuvant Breast and Bowel Project protocol B-34): a multicentre, placebo-controlled, randomised trial. Lancet Oncol. 2012 Jul;13(7):734-42. Epub 2012 Jun 14. link to original article link to PMC article PubMed NCT00009945
  7. PRESENT: Mittendorf EA, Lu B, Melisko M, Price Hiller J, Bondarenko I, Brunt AM, Sergii G, Petrakova K, Peoples GE. Efficacy and Safety Analysis of Nelipepimut-S Vaccine to Prevent Breast Cancer Recurrence: A Randomized, Multicenter, Phase III Clinical Trial. Clin Cancer Res. 2019 Jul 15;25(14):4248-4254. Epub 2019 Apr 29. link to original article PubMed NCT01479244
  8. D-CARE: Coleman R, Finkelstein DM, Barrios C, Martin M, Iwata H, Hegg R, Glaspy J, Periañez AM, Tonkin K, Deleu I, Sohn J, Crown J, Delaloge S, Dai T, Zhou Y, Jandial D, Chan A. Adjuvant denosumab in early breast cancer (D-CARE): an international, multicentre, randomised, controlled, phase 3 trial. Lancet Oncol. 2020 Jan;21(1):60-72. Epub 2019 Dec 2. link to original article PubMed NCT01077154
  9. OlympiA: Tutt ANJ, Garber JE, Kaufman B, Viale G, Fumagalli D, Rastogi P, Gelber RD, de Azambuja E, Fielding A, Balmaña J, Domchek SM, Gelmon KA, Hollingsworth SJ, Korde LA, Linderholm B, Bandos H, Senkus E, Suga JM, Shao Z, Pippas AW, Nowecki Z, Huzarski T, Ganz PA, Lucas PC, Baker N, Loibl S, McConnell R, Piccart M, Schmutzler R, Steger GG, Costantino JP, Arahmani A, Wolmark N, McFadden E, Karantza V, Lakhani SR, Yothers G, Campbell C, Geyer CE Jr; OlympiA Clinical Trial Steering Committee and Investigators. Adjuvant Olaparib for Patients with BRCA1- or BRCA2-Mutated Breast Cancer. N Engl J Med. 2021 Jun 24;384(25):2394-2405. Epub 2021 Jun 3. link to original article contains dosing details in manuscript PubMed NCT02032823
    1. Update: Geyer CE Jr, Garber JE, Gelber RD, Yothers G, Taboada M, Ross L, Rastogi P, Cui K, Arahmani A, Aktan G, Armstrong AC, Arnedos M, Balmaña J, Bergh J, Bliss J, Delaloge S, Domchek SM, Eisen A, Elsafy F, Fein LE, Fielding A, Ford JM, Friedman S, Gelmon KA, Gianni L, Gnant M, Hollingsworth SJ, Im SA, Jager A, Jóhannsson ÓÞ, Lakhani SR, Janni W, Linderholm B, Liu TW, Loman N, Korde L, Loibl S, Lucas PC, Marmé F, Martinez de Dueñas E, McConnell R, Phillips KA, Piccart M, Rossi G, Schmutzler R, Senkus E, Shao Z, Sharma P, Singer CF, Španić T, Stickeler E, Toi M, Traina TA, Viale G, Zoppoli G, Park YH, Yerushalmi R, Yang H, Pang D, Jung KH, Mailliez A, Fan Z, Tennevet I, Zhang J, Nagy T, Sonke GS, Sun Q, Parton M, Colleoni MA, Schmidt M, Brufsky AM, Razaq W, Kaufman B, Cameron D, Campbell C, Tutt ANJ; OlympiA Clinical Trial Steering Committee and Investigators. Overall survival in the OlympiA phase III trial of adjuvant olaparib in patients with germline pathogenic variants in BRCA1/2 and high-risk, early breast cancer. Ann Oncol. 2022 Dec 1;33(12):1250-1268. Epub 2022 Oct 10. link to original article PubMed
  10. REACT: Coombes RC, Tovey H, Kilburn L, Mansi J, Palmieri C, Bartlett J, Hicks J, Makris A, Evans A, Loibl S, Denkert C, Murray E, Grieve R, Coleman R, Borley A, Schmidt M, Rautenberg B, Kunze CA, Rhein U, Mehta K, Mousa K, Dibble T, Lu XL, von Minckwitz G, Bliss JM; Randomized European Celecoxib Trial (REACT) Trial Management Group and Investigators. Effect of Celecoxib vs Placebo as Adjuvant Therapy on Disease-Free Survival Among Patients With Breast Cancer: The REACT Randomized Clinical Trial. JAMA Oncol. 2021 Sep 1;7(9):1291-1301. link to original article link to PMC article PubMed NCT02429427
  11. NCIC CTG MA.32: Goodwin PJ, Chen BE, Gelmon KA, Whelan TJ, Ennis M, Lemieux J, Ligibel JA, Hershman DL, Mayer IA, Hobday TJ, Bliss JM, Rastogi P, Rabaglio-Poretti M, Mukherjee SD, Mackey JR, Abramson VG, Oja C, Wesolowski R, Thompson AM, Rea DW, Stos PM, Shepherd LE, Stambolic V, Parulekar WR. Effect of Metformin vs Placebo on Invasive Disease-Free Survival in Patients With Breast Cancer: The MA.32 Randomized Clinical Trial. JAMA. 2022 May 24;327(20):1963-1973. link to original article link to PMC article PubMed NCT01101438

Metastatic disease, maintenance after first-line therapy

Observation

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Falkson et al. 1998 (INT-0077) 1982-1992 Phase 3 (C) CMF(P)TH Inferior RFS
Sparano et al. 2004 (ECOG E2196) 1997-2001 Phase 3 (C) Marimastat Did not meet primary endpoint of PFS
Alba et al. 2010 (GEICAM 2001-01) 2002-2007 Phase 3 (C) PLD x 6 Inferior TTP
Park et al. 2013 (KCSG-BR07-02) 2007-2010 Phase 3 (C) PG Seems to have inferior OS

No further treatment.

Preceding treatment

  • ECOG E2196: Doxorubicin- and/or taxane-containing chemotherapy x 6-8
  • GEICAM 2001-01: A-D
  • KCSG-BR07-02: PG x 6

References

  1. INT-0077: Falkson G, Gelman RS, Pandya KJ, Osborne CK, Tormey D, Cummings FJ, Sledge GW, Abeloff MD. Eastern Cooperative Oncology Group randomized trials of observation versus maintenance therapy for patients with metastatic breast cancer in complete remission following induction treatment. J Clin Oncol. 1998 May;16(5):1669-76. link to original article PubMed
  2. ECOG E2196: Sparano JA, Bernardo P, Stephenson P, Gradishar WJ, Ingle JN, Zucker S, Davidson NE. Randomized phase III trial of marimastat versus placebo in patients with metastatic breast cancer who have responding or stable disease after first-line chemotherapy: Eastern Cooperative Oncology Group trial E2196. J Clin Oncol. 2004 Dec 1;22(23):4683-90. Erratum in: J Clin Oncol. 2005 Jan 1;23(1):248. link to original article PubMed NCT00003010
  3. GEICAM 2001-01: Alba E, Ruiz-Borrego M, Margelí M, Rodríguez-Lescure A, Sánchez-Rovira P, Ruiz A, Mel-Lorenzo JR, Ramos-Vázquez M, Ribelles N, Calvo E, Casado A, Márquez A, Vicente D, García-Sáenz JA, Martín M. Maintenance treatment with pegylated liposomal doxorubicin versus observation following induction chemotherapy for metastatic breast cancer: GEICAM 2001-01 study. Breast Cancer Res Treat. 2010 Jul;122(1):169-76. Epub 2010 Apr 2. link to original article PubMed NCT00128778
  4. KCSG-BR07-02: Park YH, Jung KH, Im SA, Sohn JH, Ro J, Ahn JH, Kim SB, Nam BH, Oh DY, Han SW, Lee S, Park IH, Lee KS, Kim JH, Kang SY, Lee MH, Park HS, Ahn JS, Im YH. Phase III, multicenter, randomized trial of maintenance chemotherapy versus observation in patients with metastatic breast cancer after achieving disease control with six cycles of gemcitabine plus paclitaxel as first-line chemotherapy: KCSG-BR07-02. J Clin Oncol. 2013 May 10;31(14):1732-9. Epub 2013 Apr 8. link to original article contains dosing details in manuscript PubMed NCT00561119
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