Difference between revisions of "Breast cancer, triple negative"
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![[Levels_of_Evidence#Efficacy|Efficacy]] | ![[Levels_of_Evidence#Efficacy|Efficacy]] | ||
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− | |rowspan=2|[ | + | |rowspan=2|[https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(18)30111-6/fulltext Loibl et al. 2018 (BrighTNess)] |
|rowspan=2 style="background-color:#1a9851" |Phase III (E) | |rowspan=2 style="background-color:#1a9851" |Phase III (E) | ||
|Carboplatin, Paclitaxel, Veliparib | |Carboplatin, Paclitaxel, Veliparib | ||
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*[[#AC|AC]] x 4 or [[#ddAC|ddAC]] x 4, then surgery | *[[#AC|AC]] x 4 or [[#ddAC|ddAC]] x 4, then surgery | ||
===References=== | ===References=== | ||
− | # '''BrighTNess:''' Loibl S, O'Shaughnessy J, Untch M, Sikov WM, Rugo HS, McKee MD, Huober J, Golshan M, von Minckwitz G, Maag D, Sullivan D, Wolmark N, McIntyre K, Ponce Lorenzo JJ, Metzger Filho O, Rastogi P, Symmans WF, Liu X, Geyer CE Jr. Addition of the PARP inhibitor veliparib plus carboplatin or carboplatin alone to standard neoadjuvant chemotherapy in triple-negative breast cancer (BrighTNess): a randomised, phase 3 trial. Lancet Oncol. 2018 Apr;19(4):497-509. Epub 2018 Feb 28. [ | + | # '''BrighTNess:''' Loibl S, O'Shaughnessy J, Untch M, Sikov WM, Rugo HS, McKee MD, Huober J, Golshan M, von Minckwitz G, Maag D, Sullivan D, Wolmark N, McIntyre K, Ponce Lorenzo JJ, Metzger Filho O, Rastogi P, Symmans WF, Liu X, Geyer CE Jr. Addition of the PARP inhibitor veliparib plus carboplatin or carboplatin alone to standard neoadjuvant chemotherapy in triple-negative breast cancer (BrighTNess): a randomised, phase 3 trial. Lancet Oncol. 2018 Apr;19(4):497-509. Epub 2018 Feb 28. [https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(18)30111-6/fulltext link to original article] '''contain protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/29501363 PubMed] |
==Cisplatin monotherapy {{#subobject:82336a|Regimen=1}}== | ==Cisplatin monotherapy {{#subobject:82336a|Regimen=1}}== | ||
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|style="background-color:#fc8d59"|Seems to have inferior pCR rate | |style="background-color:#fc8d59"|Seems to have inferior pCR rate | ||
|- | |- | ||
− | |rowspan=2|[ | + | |rowspan=2|[https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(18)30111-6/fulltext Loibl et al. 2018 (BrighTNess)] |
|rowspan=2 style="background-color:#1a9851" |Phase III (C) | |rowspan=2 style="background-color:#1a9851" |Phase III (C) | ||
|[[#Carboplatin_.26_Paclitaxel|Carboplatin & Paclitaxel]] | |[[#Carboplatin_.26_Paclitaxel|Carboplatin & Paclitaxel]] | ||
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<!-- Presented in part at the San Antonio Breast Cancer Symposium, December 10–14, 2013. --> | <!-- Presented in part at the San Antonio Breast Cancer Symposium, December 10–14, 2013. --> | ||
# '''I-SPY 2:''' Rugo HS, Olopade OI, DeMichele A, Yau C, van 't Veer LJ, Buxton MB, Hogarth M, Hylton NM, Paoloni M, Perlmutter J, Symmans WF, Yee D, Chien AJ, Wallace AM, Kaplan HG, Boughey JC, Haddad TC, Albain KS, Liu MC, Isaacs C, Khan QJ, Lang JE, Viscusi RK, Pusztai L, Moulder SL, Chui SY, Kemmer KA, Elias AD, Edmiston KK, Euhus DM, Haley BB, Nanda R, Northfelt DW, Tripathy D, Wood WC, Ewing C, Schwab R, Lyandres J, Davis SE, Hirst GL, Sanil A, Berry DA, Esserman LJ; I-SPY 2 Investigators. Adaptive randomization of veliparib-carboplatin treatment in breast cancer. N Engl J Med. 2016 Jul 7;375(1):23-34. [http://www.nejm.org/doi/full/10.1056/NEJMoa1513749 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5259561/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/27406347 PubMed] | # '''I-SPY 2:''' Rugo HS, Olopade OI, DeMichele A, Yau C, van 't Veer LJ, Buxton MB, Hogarth M, Hylton NM, Paoloni M, Perlmutter J, Symmans WF, Yee D, Chien AJ, Wallace AM, Kaplan HG, Boughey JC, Haddad TC, Albain KS, Liu MC, Isaacs C, Khan QJ, Lang JE, Viscusi RK, Pusztai L, Moulder SL, Chui SY, Kemmer KA, Elias AD, Edmiston KK, Euhus DM, Haley BB, Nanda R, Northfelt DW, Tripathy D, Wood WC, Ewing C, Schwab R, Lyandres J, Davis SE, Hirst GL, Sanil A, Berry DA, Esserman LJ; I-SPY 2 Investigators. Adaptive randomization of veliparib-carboplatin treatment in breast cancer. N Engl J Med. 2016 Jul 7;375(1):23-34. [http://www.nejm.org/doi/full/10.1056/NEJMoa1513749 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5259561/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/27406347 PubMed] | ||
− | # '''BrighTNess:''' Loibl S, O'Shaughnessy J, Untch M, Sikov WM, Rugo HS, McKee MD, Huober J, Golshan M, von Minckwitz G, Maag D, Sullivan D, Wolmark N, McIntyre K, Ponce Lorenzo JJ, Metzger Filho O, Rastogi P, Symmans WF, Liu X, Geyer CE Jr. Addition of the PARP inhibitor veliparib plus carboplatin or carboplatin alone to standard neoadjuvant chemotherapy in triple-negative breast cancer (BrighTNess): a randomised, phase 3 trial. Lancet Oncol. 2018 Apr;19(4):497-509. Epub 2018 Feb 28. [ | + | # '''BrighTNess:''' Loibl S, O'Shaughnessy J, Untch M, Sikov WM, Rugo HS, McKee MD, Huober J, Golshan M, von Minckwitz G, Maag D, Sullivan D, Wolmark N, McIntyre K, Ponce Lorenzo JJ, Metzger Filho O, Rastogi P, Symmans WF, Liu X, Geyer CE Jr. Addition of the PARP inhibitor veliparib plus carboplatin or carboplatin alone to standard neoadjuvant chemotherapy in triple-negative breast cancer (BrighTNess): a randomised, phase 3 trial. Lancet Oncol. 2018 Apr;19(4):497-509. Epub 2018 Feb 28. [https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(18)30111-6/fulltext link to original article] '''contain protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/29501363 PubMed] |
=Adjuvant chemotherapy= | =Adjuvant chemotherapy= | ||
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''This was an important negative trial, so is included here for reference purposes, only.'' | ''This was an important negative trial, so is included here for reference purposes, only.'' | ||
===References=== | ===References=== | ||
− | # Cameron D, Brown J, Dent R, Jackisch C, Mackey J, Pivot X, Steger GG, Suter TM, Toi M, Parmar M, Laeufle R, Im YH, Romieu G, Harvey V, Lipatov O, Pienkowski T, Cottu P, Chan A, Im SA, Hall PS, Bubuteishvili-Pacaud L, Henschel V, Deurloo RJ, Pallaud C, Bell R. Adjuvant bevacizumab-containing therapy in triple-negative breast cancer (BEATRICE): primary results of a randomised, phase 3 trial. Lancet Oncol. 2013 Sep;14(10):933-42. Epub 2013 Aug 7. [ | + | # Cameron D, Brown J, Dent R, Jackisch C, Mackey J, Pivot X, Steger GG, Suter TM, Toi M, Parmar M, Laeufle R, Im YH, Romieu G, Harvey V, Lipatov O, Pienkowski T, Cottu P, Chan A, Im SA, Hall PS, Bubuteishvili-Pacaud L, Henschel V, Deurloo RJ, Pallaud C, Bell R. Adjuvant bevacizumab-containing therapy in triple-negative breast cancer (BEATRICE): primary results of a randomised, phase 3 trial. Lancet Oncol. 2013 Sep;14(10):933-42. Epub 2013 Aug 7. [https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(13)70335-8/fulltext link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/23932548 PubMed] |
=Metastatic disease, first-line therapy= | =Metastatic disease, first-line therapy= | ||
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![[Levels_of_Evidence#Efficacy|Efficacy]] | ![[Levels_of_Evidence#Efficacy|Efficacy]] | ||
|- | |- | ||
− | |[ | + | |[https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(15)70064-1/fulltext Hu et al. 2015 (CBCSG006)] |
|style="background-color:#1a9851"|Phase III | |style="background-color:#1a9851"|Phase III | ||
|Gemcitabine & Paclitaxel | |Gemcitabine & Paclitaxel | ||
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===References=== | ===References=== | ||
− | # '''CBCSG006:''' Hu XC, Zhang J, Xu BH, Cai L, Ragaz J, Wang ZH, Wang BY, Teng YE, Tong ZS, Pan YY, Yin YM, Wu CP, Jiang ZF, Wang XJ, Lou GY, Liu DG, Feng JF, Luo JF, Sun K, Gu YJ, Wu J, Shao ZM. Cisplatin plus gemcitabine versus paclitaxel plus gemcitabine as first-line therapy for metastatic triple-negative breast cancer (CBCSG006): a randomised, open-label, multicentre, phase 3 trial. Lancet Oncol. 2015 Apr;16(4):436-46. Epub 2015 Mar 18. [ | + | # '''CBCSG006:''' Hu XC, Zhang J, Xu BH, Cai L, Ragaz J, Wang ZH, Wang BY, Teng YE, Tong ZS, Pan YY, Yin YM, Wu CP, Jiang ZF, Wang XJ, Lou GY, Liu DG, Feng JF, Luo JF, Sun K, Gu YJ, Wu J, Shao ZM. Cisplatin plus gemcitabine versus paclitaxel plus gemcitabine as first-line therapy for metastatic triple-negative breast cancer (CBCSG006): a randomised, open-label, multicentre, phase 3 trial. Lancet Oncol. 2015 Apr;16(4):436-46. Epub 2015 Mar 18. [https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(15)70064-1/fulltext link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/25795409 PubMed] |
==Paclitaxel monotherapy {{#subobject:3e5448|Regimen=1}}== | ==Paclitaxel monotherapy {{#subobject:3e5448|Regimen=1}}== | ||
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![[Levels_of_Evidence#Efficacy|Efficacy]] | ![[Levels_of_Evidence#Efficacy|Efficacy]] | ||
|- | |- | ||
− | |[ | + | |[https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(17)30450-3/fulltext Kim et al. 2017 (LOTUS)] |
|style="background-color:#1a9851"|Randomized Phase II (C) | |style="background-color:#1a9851"|Randomized Phase II (C) | ||
|Ipatasertib & Paclitaxel | |Ipatasertib & Paclitaxel | ||
Line 355: | Line 355: | ||
===References=== | ===References=== | ||
− | # '''LOTUS:''' Kim SB, Dent R, Im SA, Espié M, Blau S, Tan AR, Isakoff SJ, Oliveira M, Saura C, Wongchenko MJ, Kapp AV, Chan WY, Singel SM, Maslyar DJ, Baselga J; LOTUS investigators. Ipatasertib plus paclitaxel versus placebo plus paclitaxel as first-line therapy for metastatic triple-negative breast cancer (LOTUS): a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Oncol. 2017 Oct;18(10):1360-1372. Epub 2017 Aug 8. [ | + | # '''LOTUS:''' Kim SB, Dent R, Im SA, Espié M, Blau S, Tan AR, Isakoff SJ, Oliveira M, Saura C, Wongchenko MJ, Kapp AV, Chan WY, Singel SM, Maslyar DJ, Baselga J; LOTUS investigators. Ipatasertib plus paclitaxel versus placebo plus paclitaxel as first-line therapy for metastatic triple-negative breast cancer (LOTUS): a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Oncol. 2017 Oct;18(10):1360-1372. Epub 2017 Aug 8. [https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(17)30450-3/fulltext link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/28800861 PubMed] |
=Metastatic disease, subsequent lines of therapy= | =Metastatic disease, subsequent lines of therapy= |
Revision as of 16:50, 20 May 2018
Section editor transclusions Note: this page has regimens which are specific to breast cancer that is triple negative. Please see the breast cancer page for other chemotherapy regimens.
46 regimens on this page
66 variants on this page
|
Guidelines
ASCO
- 2016: Use of biomarkers to guide decisions on adjuvant systemic therapy for women with early-stage invasive breast cancer: American Society of Clinical Oncology clinical practice guideline
- 2015: Use of biomarkers to guide decisions on systemic therapy for women with metastatic breast cancer: American Society of Clinical Oncology Clinical practice guideline
Neoadjuvant chemotherapy
AC
back to top |
AC: Adriamycin (Doxorubicin) & Cyclophosphamide
Regimen
Study | Evidence |
---|---|
Rugo et al. 2016 (I-SPY 2) | Non-randomized portion of RCT |
Note: this is a component of a sequential treatment protocol; to our knowledge there are no references to support using it as a stand-alone treatment.
Preceding treatment
- T x 12 wk or Paclitaxel & VC x 12 wk
Chemotherapy
- Doxorubicin (Adriamycin) 60 mg/m2 IV once on day 1
- Cyclophosphamide (Cytoxan) 600 mg/m2 IV once on day 1
21-day cycle for 4 cycles
Subsequent treatment
- Surgery
References
- Rugo HS, Olopade OI, DeMichele A, Yau C, van 't Veer LJ, Buxton MB, Hogarth M, Hylton NM, Paoloni M, Perlmutter J, Symmans WF, Yee D, Chien AJ, Wallace AM, Kaplan HG, Boughey JC, Haddad TC, Albain KS, Liu MC, Isaacs C, Khan QJ, Lang JE, Viscusi RK, Pusztai L, Moulder SL, Chui SY, Kemmer KA, Elias AD, Edmiston KK, Euhus DM, Haley BB, Nanda R, Northfelt DW, Tripathy D, Wood WC, Ewing C, Schwab R, Lyandres J, Davis SE, Hirst GL, Sanil A, Berry DA, Esserman LJ; I-SPY 2 Investigators. Adaptive randomization of veliparib-carboplatin treatment in breast cancer. N Engl J Med. 2016 Jul 7;375(1):23-34. link to original article contains verified protocol link to PMC article PubMed
Carboplatin & Docetaxel
back to top |
CbD: Carboplatin & Docetaxel
Regimen
Study | Evidence | ORR |
---|---|---|
Sharma et al. 2016 | Phase II | 56-59% pCR rate |
Chemotherapy
- Carboplatin (Paraplatin) AUC 6 IV once on day 1
- Docetaxel (Taxotere) 75 mg/m2 IV once on day 1
21-day cycle for 6 cycles
Subsequent treatment
- Surgery
References
- Sharma P, López-Tarruella S, García-Saenz JA, Ward C, Connor CS, Gómez HL, Prat A, Moreno F, Jerez-Gilarranz Y, Barnadas A, Picornell AC, Del Monte-Millán M, Gonzalez-Rivera M, Massarrah T, Pelaez-Lorenzo B, Palomero MI, González Del Val R, Cortes J, Fuentes Rivera H, Bretel Morales D, Márquez-Rodas I, Perou CM, Wagner JL, Mammen JM, McGinness MK, Klemp JR, Amin AL, Fabian CJ, Heldstab J, Godwin AK, Jensen RA, Kimler BF, Khan QJ, Martin M. Efficacy of neoadjuvant carboplatin plus docetaxel in triple-negative breast cancer: Combined analysis of two cohorts. Clin Cancer Res. 2017 Feb 1;23(3):649-657. Epub 2016 Jun 14. link to original article contains protocol link to PMC article PubMed
Carboplatin & Paclitaxel
back to top |
Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Loibl et al. 2018 (BrighTNess) | Phase III (E) | Carboplatin, Paclitaxel, Veliparib | Seems not superior |
Paclitaxel | Not reported in abstract |
Note: this is a component of a sequential treatment protocol; to our knowledge there are no references to support using it as a stand-alone treatment.
Chemotherapy
- Carboplatin (Paraplatin) AUC 6 IV once on day 1
- Paclitaxel (Taxol) 80 mg/m2 IV once per day on days 1, 8, 15
21-day cycle for 4 cycles
Subsequent treatment
References
- BrighTNess: Loibl S, O'Shaughnessy J, Untch M, Sikov WM, Rugo HS, McKee MD, Huober J, Golshan M, von Minckwitz G, Maag D, Sullivan D, Wolmark N, McIntyre K, Ponce Lorenzo JJ, Metzger Filho O, Rastogi P, Symmans WF, Liu X, Geyer CE Jr. Addition of the PARP inhibitor veliparib plus carboplatin or carboplatin alone to standard neoadjuvant chemotherapy in triple-negative breast cancer (BrighTNess): a randomised, phase 3 trial. Lancet Oncol. 2018 Apr;19(4):497-509. Epub 2018 Feb 28. link to original article contain protocol PubMed
Cisplatin monotherapy
back to top |
Regimen
Study | Evidence | Efficacy |
---|---|---|
Silver et al. 2010 | Phase II | 50% good pathologic response |
Chemotherapy
- Cisplatin (Platinol) 75 mg/m2 IV once on day 1
21-day cycle for 4 cycles
Subsequent treatment
- Surgery
References
- Silver DP, Richardson AL, Eklund AC, Wang ZC, Szallasi Z, Li Q, Juul N, Leong CO, Calogrias D, Buraimoh A, Fatima A, Gelman RS, Ryan PD, Tung NM, De Nicolo A, Ganesan S, Miron A, Colin C, Sgroi DC, Ellisen LW, Winer EP, Garber JE. Efficacy of neoadjuvant cisplatin in triple-negative breast cancer. J Clin Oncol. 2010 Mar 1;28(7):1145-53. Epub 2010 Jan 25. link to original article contains verified protocol link to PMC article PubMed
ddAC
back to top |
ddAC: dose-dense Adriamycin (Doxorubicin) & Cyclophosphamide
Regimen
Study | Evidence |
---|---|
Rugo et al. 2016 (I-SPY 2) | Non-randomized portion of RCT |
Note: this is a component of a sequential treatment protocol; to our knowledge there are no references to support using it as a stand-alone treatment.
Preceding treatment
- T x 12 wk or Paclitaxel & VC x 12 wk
Chemotherapy
- Doxorubicin (Adriamycin) 60 mg/m2 IV once on day 1
- Cyclophosphamide (Cytoxan) 600 mg/m2 IV once on day 1
Supportive medications
14-day cycle for 4 cycles
Subsequent treatment
- Surgery
References
- CALGB 40603: Sikov WM, Berry DA, Perou CM, Singh B, Cirrincione CT, Tolaney SM, Kuzma CS, Pluard TJ, Somlo G, Port ER, Golshan M, Bellon JR, Collyar D, Hahn OM, Carey LA, Hudis CA, Winer EP. Impact of the addition of carboplatin and/or bevacizumab to neoadjuvant once-per-week paclitaxel followed by dose-dense doxorubicin and cyclophosphamide on pathologic complete response rates in stage II to III triple-negative breast cancer: CALGB 40603 (Alliance). J Clin Oncol. 2015 Jan 1;33(1):13-21. Epub 2014 Aug 4. link to original article link to PMC article PubMed
- I-SPY 2: Rugo HS, Olopade OI, DeMichele A, Yau C, van 't Veer LJ, Buxton MB, Hogarth M, Hylton NM, Paoloni M, Perlmutter J, Symmans WF, Yee D, Chien AJ, Wallace AM, Kaplan HG, Boughey JC, Haddad TC, Albain KS, Liu MC, Isaacs C, Khan QJ, Lang JE, Viscusi RK, Pusztai L, Moulder SL, Chui SY, Kemmer KA, Elias AD, Edmiston KK, Euhus DM, Haley BB, Nanda R, Northfelt DW, Tripathy D, Wood WC, Ewing C, Schwab R, Lyandres J, Davis SE, Hirst GL, Sanil A, Berry DA, Esserman LJ; I-SPY 2 Investigators. Adaptive randomization of veliparib-carboplatin treatment in breast cancer. N Engl J Med. 2016 Jul 7;375(1):23-34. link to original article contains verified protocol link to PMC article PubMed
Docetaxel & Bevacizumab
back to top |
Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
von Minckwitz et al. 2012 (GeparQuinto) | Phase III | See link | See link |
Note: this is a component of a sequential treatment protocol; to our knowledge there are no references to support using it as a stand-alone treatment.
Preceding treatment
- EC & Bevacizumab x 4
Chemotherapy
- Docetaxel (Taxotere) 100 mg/m2 IV once on day 1
- Bevacizumab (Avastin) 15 mg/kg IV once on day 1
21-day cycle for 4 cycles
Subsequent treatment
- Surgery
References
- von Minckwitz G, Eidtmann H, Rezai M, Fasching PA, Tesch H, Eggemann H, Schrader I, Kittel K, Hanusch C, Kreienberg R, Solbach C, Gerber B, Jackisch C, Kunz G, Blohmer JU, Huober J, Hauschild M, Fehm T, Müller BM, Denkert C, Loibl S, Nekljudova V, Untch M; German Breast Group; Arbeitsgemeinschaft Gynäkologische Onkologie–Breast Study Groups. Neoadjuvant chemotherapy and bevacizumab for HER2-negative breast cancer. N Engl J Med. 2012 Jan 26;366(4):299-309. link to original article contains verified protocol PubMed
EC & Bevacizumab
back to top |
EC & Bevacizumab: Epirubicin, Cyclophosphamide, Bevacizumab
Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
von Minckwitz et al. 2012 (GeparQuinto) | Phase III | See link | See link |
Note: this is a component of a sequential treatment protocol; to our knowledge there are no references to support using it as a stand-alone treatment.
Chemotherapy
- Epirubicin (Ellence) 90 mg/m2 IV once on day 1
- Cyclophosphamide (Cytoxan) 600 mg/m2 IV once on day 1
- Bevacizumab (Avastin) 15 mg/kg IV once on day 1
21-day cycle for 4 cycles
Subsequent treatment
- Docetaxel & Bevacizumab, then surgery
References
- von Minckwitz G, Eidtmann H, Rezai M, Fasching PA, Tesch H, Eggemann H, Schrader I, Kittel K, Hanusch C, Kreienberg R, Solbach C, Gerber B, Jackisch C, Kunz G, Blohmer JU, Huober J, Hauschild M, Fehm T, Müller BM, Denkert C, Loibl S, Nekljudova V, Untch M; German Breast Group; Arbeitsgemeinschaft Gynäkologische Onkologie–Breast Study Groups. Neoadjuvant chemotherapy and bevacizumab for HER2-negative breast cancer. N Engl J Med. 2012 Jan 26;366(4):299-309. link to original article contains verified protocol PubMed
Paclitaxel monotherapy
back to top |
T: Taxol (Paclitaxel)
Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Rugo et al. 2016 (I-SPY 2) | Adaptively Randomized Phase II | Paclitaxel & VC | Seems to have inferior pCR rate |
Loibl et al. 2018 (BrighTNess) | Phase III (C) | Carboplatin & Paclitaxel | Not reported in abstract |
Carboplatin, Paclitaxel, Veliparib | Inferior pCR rate |
Note: this is a component of a sequential treatment protocol; to our knowledge there are no references to support using it as a stand-alone treatment.
Chemotherapy
- Paclitaxel (Taxol) 80 mg/m2 IV once per week
12-week course
Subsequent treatment
References
- CALGB 40603: Sikov WM, Berry DA, Perou CM, Singh B, Cirrincione CT, Tolaney SM, Kuzma CS, Pluard TJ, Somlo G, Port ER, Golshan M, Bellon JR, Collyar D, Hahn OM, Carey LA, Hudis CA, Winer EP. Impact of the addition of carboplatin and/or bevacizumab to neoadjuvant once-per-week paclitaxel followed by dose-dense doxorubicin and cyclophosphamide on pathologic complete response rates in stage II to III triple-negative breast cancer: CALGB 40603 (Alliance). J Clin Oncol. 2015 Jan 1;33(1):13-21. Epub 2014 Aug 4. link to original article link to PMC article PubMed
- I-SPY 2: Rugo HS, Olopade OI, DeMichele A, Yau C, van 't Veer LJ, Buxton MB, Hogarth M, Hylton NM, Paoloni M, Perlmutter J, Symmans WF, Yee D, Chien AJ, Wallace AM, Kaplan HG, Boughey JC, Haddad TC, Albain KS, Liu MC, Isaacs C, Khan QJ, Lang JE, Viscusi RK, Pusztai L, Moulder SL, Chui SY, Kemmer KA, Elias AD, Edmiston KK, Euhus DM, Haley BB, Nanda R, Northfelt DW, Tripathy D, Wood WC, Ewing C, Schwab R, Lyandres J, Davis SE, Hirst GL, Sanil A, Berry DA, Esserman LJ; I-SPY 2 Investigators. Adaptive randomization of veliparib-carboplatin treatment in breast cancer. N Engl J Med. 2016 Jul 7;375(1):23-34. link to original article contains verified protocol link to PMC article PubMed
- BrighTNess: Loibl S, O'Shaughnessy J, Untch M, Sikov WM, Rugo HS, McKee MD, Huober J, Golshan M, von Minckwitz G, Maag D, Sullivan D, Wolmark N, McIntyre K, Ponce Lorenzo JJ, Metzger Filho O, Rastogi P, Symmans WF, Liu X, Geyer CE Jr. Addition of the PARP inhibitor veliparib plus carboplatin or carboplatin alone to standard neoadjuvant chemotherapy in triple-negative breast cancer (BrighTNess): a randomised, phase 3 trial. Lancet Oncol. 2018 Apr;19(4):497-509. Epub 2018 Feb 28. link to original article contain protocol PubMed
Adjuvant chemotherapy
Bevacizumab-containing therapy
This was an important negative trial, so is included here for reference purposes, only.
References
- Cameron D, Brown J, Dent R, Jackisch C, Mackey J, Pivot X, Steger GG, Suter TM, Toi M, Parmar M, Laeufle R, Im YH, Romieu G, Harvey V, Lipatov O, Pienkowski T, Cottu P, Chan A, Im SA, Hall PS, Bubuteishvili-Pacaud L, Henschel V, Deurloo RJ, Pallaud C, Bell R. Adjuvant bevacizumab-containing therapy in triple-negative breast cancer (BEATRICE): primary results of a randomised, phase 3 trial. Lancet Oncol. 2013 Sep;14(10):933-42. Epub 2013 Aug 7. link to original article PubMed
Metastatic disease, first-line therapy
Carboplatin & Gemcitabine
back to top |
GC: Gemcitabine & Carboplatin
Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
O'Shaughnessy et al. 2014 | Phase III (C) | GC & Iniparib | Might have inferior PFS |
Chemotherapy
- Carboplatin (Paraplatin) AUC 2 IV once per day on days 1 & 8
- Gemcitabine (Gemzar) 1000 mg/m2 IV once per day on days 1 & 8
21-day cycles
References
- O'Shaughnessy J, Schwartzberg L, Danso MA, Miller KD, Rugo HS, Neubauer M, Robert N, Hellerstedt B, Saleh M, Richards P, Specht JM, Yardley DA, Carlson RW, Finn RS, Charpentier E, Garcia-Ribas I, Winer EP. Phase III study of iniparib plus gemcitabine and carboplatin versus gemcitabine and carboplatin in patients with metastatic triple-negative breast cancer. J Clin Oncol. 2014 Dec 1;32(34):3840-7. Epub 2014 Oct 27. link to original article contains protocol PubMed
Cisplatin & Gemcitabine
back to top |
Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Hu et al. 2015 (CBCSG006) | Phase III | Gemcitabine & Paclitaxel | Superior PFS |
Chemotherapy
- Cisplatin (Platinol) 75 mg/m2 IV once on day 1
- Gemcitabine (Gemzar) 1250 mg/m2 IV once per day on days 1 & 8
21-day cycle for up to 8 cycles
References
- CBCSG006: Hu XC, Zhang J, Xu BH, Cai L, Ragaz J, Wang ZH, Wang BY, Teng YE, Tong ZS, Pan YY, Yin YM, Wu CP, Jiang ZF, Wang XJ, Lou GY, Liu DG, Feng JF, Luo JF, Sun K, Gu YJ, Wu J, Shao ZM. Cisplatin plus gemcitabine versus paclitaxel plus gemcitabine as first-line therapy for metastatic triple-negative breast cancer (CBCSG006): a randomised, open-label, multicentre, phase 3 trial. Lancet Oncol. 2015 Apr;16(4):436-46. Epub 2015 Mar 18. link to original article contains protocol PubMed
Paclitaxel monotherapy
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Regimen, 80 mg/m2 3 weeks on, 1 week off
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Kim et al. 2017 (LOTUS) | Randomized Phase II (C) | Ipatasertib & Paclitaxel | Seems to have inferior PFS |
Chemotherapy
- Paclitaxel (Taxol) 80 mg/m2 IV once per day on days 1, 8, 15
28-day cycles
References
- LOTUS: Kim SB, Dent R, Im SA, Espié M, Blau S, Tan AR, Isakoff SJ, Oliveira M, Saura C, Wongchenko MJ, Kapp AV, Chan WY, Singel SM, Maslyar DJ, Baselga J; LOTUS investigators. Ipatasertib plus paclitaxel versus placebo plus paclitaxel as first-line therapy for metastatic triple-negative breast cancer (LOTUS): a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Oncol. 2017 Oct;18(10):1360-1372. Epub 2017 Aug 8. link to original article PubMed
Metastatic disease, subsequent lines of therapy
Capecitabine & Ixabepilone
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Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Thomas et al. 2007 | Phase III (E) | Capecitabine | Superior PFS |
Note: 25% of the patients in this trial had TNBC.
Chemotherapy
- Capecitabine (Xeloda) 2000 mg/m2 PO once per day on days 1 to 14
- Ixabepilone (Ixempra) 40 mg/m2 IV once on day 1
21-day cycles
References
- Thomas ES, Gomez HL, Li RK, Chung HC, Fein LE, Chan VF, Jassem J, Pivot XB, Klimovsky JV, de Mendoza FH, Xu B, Campone M, Lerzo GL, Peck RA, Mukhopadhyay P, Vahdat LT, Roché HH. Ixabepilone plus capecitabine for metastatic breast cancer progressing after anthracycline and taxane treatment. J Clin Oncol. 2007 Nov 20;25(33):5210-7. link to original article contains verified protocol PubMed
Carboplatin & Gemcitabine
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GC: Gemcitabine & Carboplatin
Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
O'Shaughnessy et al. 2014 | Phase III (C) | GC & Iniparib | Might have inferior PFS |
Chemotherapy
- Carboplatin (Paraplatin) AUC 2 IV once per day on days 1 & 8
- Gemcitabine (Gemzar) 1000 mg/m2 IV once per day on days 1 & 8
21-day cycles
References
- O'Shaughnessy J, Schwartzberg L, Danso MA, Miller KD, Rugo HS, Neubauer M, Robert N, Hellerstedt B, Saleh M, Richards P, Specht JM, Yardley DA, Carlson RW, Finn RS, Charpentier E, Garcia-Ribas I, Winer EP. Phase III study of iniparib plus gemcitabine and carboplatin versus gemcitabine and carboplatin in patients with metastatic triple-negative breast cancer. J Clin Oncol. 2014 Dec 1;32(34):3840-7. Epub 2014 Oct 27. link to original article contains protocol PubMed
Enzalutamide monotherapy
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Regimen
Study | Evidence | Efficacy |
---|---|---|
Traina et al. 2018 | Phase II | CBR @ 16 wks: 25% (95% CI 17-33) |
Patients had AR-positive TNBC.
Endocrine therapy
- Enzalutamide (Xtandi) 160 mg PO once per day
Continued until progression
References
- Traina TA, Miller K, Yardley DA, Eakle J, Schwartzberg LS, O'Shaughnessy J, Gradishar W, Schmid P, Winer E, Kelly C, Nanda R, Gucalp A, Awada A, Garcia-Estevez L, Trudeau ME, Steinberg J, Uppal H, Tudor IC, Peterson A, Cortes J. Enzalutamide for the treatment of androgen receptor-expressing triple-negative breast cancer. J Clin Oncol. 2018 Mar 20;36(9):884-890. Epub 2018 Jan 26. link to original article contains verified protocol PubMed
Investigational agents
Drugs with some degree of promising activity in clinical trials.