Breast cancer

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Adjuvant endocrine therapy

Anastrozole (Arimidex)

• Anastrozole (Arimidex) 1 mg PO daily

Duration of therapy: 5 years

References

1. Howell A, Cuzick J, Baum M, Buzdar A, Dowsett M, Forbes JF, Hoctin-Boes G, Houghton J, Locker GY, Tobias JS; ATAC Trialists' Group. Results of the ATAC (Arimidex, Tamoxifen, Alone or in Combination) trial after completion of 5 years' adjuvant treatment for breast cancer. Lancet. 2005 Jan 1-7;365(9453):60-2. link to original article PubMed
2. Kaufmann M, Jonat W, Hilfrich J, Eidtmann H, Gademann G, Zuna I, von Minckwitz G. Improved overall survival in postmenopausal women with early breast cancer after anastrozole initiated after treatment with tamoxifen compared with continued tamoxifen: the ARNO 95 Study. J Clin Oncol. 2007 Jul 1;25(19):2664-70. Epub 2007 Jun 11. link to original article PubMed
3. Arimidex, Tamoxifen, Alone or in Combination (ATAC) Trialists' Group, Forbes JF, Cuzick J, Buzdar A, Howell A, Tobias JS, Baum M. Effect of anastrozole and tamoxifen as adjuvant treatment for early-stage breast cancer: 100-month analysis of the ATAC trial. Lancet Oncol. 2008 Jan;9(1):45-53. link to original article PubMed

Letrozole (Femara)

• Letrozole (Femara) 2.5 mg PO daily

Duration of therapy: 5 years

References

1. 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
2. Coates AS, Keshaviah A, Thürlimann B, Mouridsen H, Mauriac L, Forbes JF, Paridaens R, Castiglione-Gertsch M, Gelber RD, Colleoni M, Láng I, Del Mastro L, Smith I, Chirgwin J, Nogaret JM, Pienkowski T, Wardley A, Jakobsen EH, Price KN, Goldhirsch A. Five years of letrozole compared with tamoxifen as initial adjuvant therapy for postmenopausal women with endocrine-responsive early breast cancer: update of study BIG 1-98. J Clin Oncol. 2007 Feb 10;25(5):486-92. Epub 2007 Jan 2. link to original article PubMed
3. Rasmussen BB, Regan MM, Lykkesfeldt AE, Dell'Orto P, Del Curto B, Henriksen KL, Mastropasqua MG, Price KN, Méry E, Lacroix-Triki M, Braye S, Altermatt HJ, Gelber RD, Castiglione-Gertsch M, Goldhirsch A, Gusterson BA, Thürlimann B, Coates AS, Viale G; BIG 1-98 Collaborative and International Breast Cancer Study Groups. Adjuvant letrozole versus tamoxifen according to centrally-assessed ERBB2 status for postmenopausal women with endocrine-responsive early breast cancer: supplementary results from the BIG 1-98 randomised trial. Lancet Oncol. 2008 Jan;9(1):23-8. Epub 2007 Dec 20. link to original article PubMed
4. 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. 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
6. Crivellari D, Sun Z, Coates AS, Price KN, Thürlimann B, Mouridsen H, Mauriac L, Forbes JF, Paridaens RJ, Castiglione-Gertsch M, Gelber RD, Colleoni M, Láng I, Del Mastro L, Gladieff L, Rabaglio M, Smith IE, Chirgwin JH, Goldhirsch A. Letrozole compared with tamoxifen for elderly patients with endocrine-responsive early breast cancer: the BIG 1-98 trial. J Clin Oncol. 2008 Apr 20;26(12):1972-9. Epub 2008 Mar 10. link to original article PubMed

Exemestane (Aromasin)

• Exemestane (Aromasin) 25 mg PO daily

Duration of therapy: 5 years

References

1. Coombes RC, Hall E, Gibson LJ, Paridaens R, Jassem J, Delozier T, Jones SE, Alvarez I, Bertelli G, Ortmann O, Coates AS, Bajetta E, Dodwell D, Coleman RE, Fallowfield LJ, Mickiewicz E, Andersen J, Lønning PE, Cocconi G, Stewart A, Stuart N, Snowdon CF, Carpentieri M, Massimini G, Bliss JM, van de Velde C; Intergroup Exemestane Study. A randomized trial of exemestane after two to three years of tamoxifen therapy in postmenopausal women with primary breast cancer. N Engl J Med. 2004 Mar 11;350(11):1081-92. link to original article PubMed
2. Coombes RC, Kilburn LS, Snowdon CF, Paridaens R, Coleman RE, Jones SE, Jassem J, Van de Velde CJ, Delozier T, Alvarez I, Del Mastro L, Ortmann O, Diedrich K, Coates AS, Bajetta E, Holmberg SB, Dodwell D, Mickiewicz E, Andersen J, Lønning PE, Cocconi G, Forbes J, Castiglione M, Stuart N, Stewart A, Fallowfield LJ, Bertelli G, Hall E, Bogle RG, Carpentieri M, Colajori E, Subar M, Ireland E, Bliss JM; Intergroup Exemestane Study. Survival and safety of exemestane versus tamoxifen after 2-3 years' tamoxifen treatment (Intergroup Exemestane Study): a randomised controlled trial. Lancet. 2007 Feb 17;369(9561):559-70. link to original article PubMed
3. 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

Tamoxifen (Nolvadex)

• Tamoxifen (Nolvadex) 20 mg PO daily

Duration of therapy: 5 years

References

1. Jaiyesimi IA, Buzdar AU, Decker DA, Hortobagyi GN. Use of tamoxifen for breast cancer: twenty-eight years later. J Clin Oncol. 1995 Feb;13(2):513-29. link to original article PubMed
2. Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 May 14-20;365(9472):1687-717. link to original article PubMed

Adjuvant chemotherapy, HER-2 negative

Dose-dense AC -> T

AC -> T: Adriamycin, Cytoxan -> Taxol

Regimen

All cycles given with Filgrastim (Neupogen) support

• Doxorubicin (Adriamycin) 60 mg/m2 IV day 1
• Cyclophosphamide (Cytoxan) 600 mg/m2 IV day 1

14-day cycles x 4 cycles, THEN

• Paclitaxel (Taxol) 175 mg/m2 IV over 3 hours day 1

14-day cycles x 4 cycles

References

1. Citron ML, Berry DA, Cirrincione C, Hudis C, Winer EP, Gradishar WJ, Davidson NE, Martino S, Livingston R, Ingle JN, Perez EA, Carpenter J, Hurd D, Holland JF, Smith BL, Sartor CI, Leung EH, Abrams J, Schilsky RL, Muss HB, Norton L. Randomized trial of dose-dense versus conventionally scheduled and sequential versus concurrent combination chemotherapy as postoperative adjuvant treatment of node-positive primary breast cancer: first report of Intergroup Trial C9741/Cancer and Leukemia Group B Trial 9741. J Clin Oncol. 2003 Apr 15;21(8):1431-9. Epub 2003 Feb 13. link to original article contains protocol PubMed
2. Burstein HJ, Parker LM, Keshaviah A, Doherty J, Partridge AH, Schapira L, Ryan PD, Younger J, Harris LN, Moy B, Come SE, Schumer ST, Bunnell CA, Haldoupis M, Gelman R, Winer EP. Efficacy of pegfilgrastim and darbepoetin alfa as hematopoietic support for dose-dense every-2-week adjuvant breast cancer chemotherapy. J Clin Oncol. 2005 Nov 20;23(33):8340-7. link to original article contains protocol PubMed

Dose-dense ATC

ATC: Adriamycin, Taxol, Cytoxan

Regimen

All cycles given with Filgrastim (Neupogen) support

• Doxorubicin (Adriamycin) 60 mg/m2 IV day 1

14-day cycles x 4 cycles, THEN

• Paclitaxel (Taxol) 200 mg/m2 IV over 3 hours day 1

14-day cycles x 4 cycles, THEN

• Cyclophosphamide (Cytoxan) 800 mg/m2 IV day 1

14-day cycles x 4 cycles

Alternate dosing per NCCN (primary reference not found):
All cycles given with Filgrastim (Neupogen) support

• Doxorubicin (Adriamycin) 60 mg/m2 IV day 1

14-day cycles x 4 cycles, THEN

• Paclitaxel (Taxol) 175 mg/m2 IV day 1

14-day cycles x 4 cycles, THEN

• Cyclophosphamide (Cytoxan) 600 mg/m2 IV day 1

14-day cycles x 4 cycles

References

1. Kahan Z, Uhercsak G, Hajnal-Papp R, Boda K, Thurzo L. Dose-dense sequential adriamycin-Paclitaxel-cyclophosphamide chemotherapy is well tolerated and safe in high-risk early breast cancer. Oncology. 2005;68(4-6):446-53. Epub 2005 Jul 13. link to original article PubMed
2. Kelemen G, Uhercsák G, Ormándi K, Eller J, Thurzó L, Kahán Z. Long-term efficiency and toxicity of adjuvant dose-dense sequential adriamycin-Paclitaxel-cyclophosphamide chemotherapy in high-risk breast cancer. Oncology. 2010;78(3-4):271-3. Epub 2010 Jun 7. link to original article PubMed

AC -> T (Taxol)

AC -> T: Adriamycin, Cytoxan -> Taxol

Regimen

• Doxorubicin (Adriamycin) 60 mg/m2 IV day 1
• Cyclophosphamide (Cytoxan) 600 mg/m2 IV day 1

21-day cycles x 4 cycles, THEN

• Paclitaxel (Taxol) 80 mg/m2 IV over 1 hour day 1

1-week cycles x 12 cycles/weeks

Alternate schedule for Paclitaxel (Taxol):

• Paclitaxel (Taxol) 175 mg/m2 IV over 3 hours day 1

3-week cycles x 4 cycles

References

1. 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 PubMed
2. 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
3. Sparano JA, Wang M, Martino S, Jones V, Perez EA, Saphner T, Wolff AC, Sledge GW Jr, Wood WC, Davidson NE. Weekly paclitaxel in the adjuvant treatment of breast cancer. N Engl J Med. 2008 Apr 17;358(16):1663-71. link to original article PubMed

AC -> T (Taxotere)

AC -> T: Adriamycin, Cytoxan -> Taxotere

Regimen

• Doxorubicin (Adriamycin) 60 mg/m2 IV day 1
• Cyclophosphamide (Cytoxan) 600 mg/m2 IV day 1

21-day cycles x 4 cycles, THEN

• Docetaxel (Taxotere) 100 mg/m2 IV day 1

21-day cycles x 4 cycles

References

1. Sparano JA, Wang M, Martino S, Jones V, Perez EA, Saphner T, Wolff AC, Sledge GW Jr, Wood WC, Davidson NE. Weekly paclitaxel in the adjuvant treatment of breast cancer. N Engl J Med. 2008 Apr 17;358(16):1663-71. link to original article PubMed

TAC

TAC: Taxotere, Adriamycin, Cytoxan

Regimen

• Docetaxel (Taxotere) 75 mg/m2 IV over 1 hour on day 1 (administered third, one hour after cyclophosphamide)
• Doxorubicin (Adriamycin) 50 mg/m2 IV over 15 minutes on day 1 (administered first)
• Cyclophosphamide (Cytoxan) 500 mg/m2 IV over 1-5 minutes on day 1 (administered second)
• Dexamethasone 8 mg PO every 12 hours x 6 total doses, starting the day before treatment
• Ciprofloxacin 500 mg PO BID on days 5-14 of every cycle (prophylaxis)
• G-CSF not originally routinely administered unless patients had febrile neutropenia, but NCCN currently recommends routine filgrastim support:

• Filgrastim (Neupogen) 5 mcg/kg SC on days 4-11
• Lenograstim 150 mcg/m2 on days 4-11

21-day cycles x 6 cycles

References

1. Martin M, Pienkowski T, Mackey J, Pawlicki M, Guastalla JP, Weaver C, Tomiak E, Al-Tweigeri T, Chap L, Juhos E, Guevin R, Howell A, Fornander T, Hainsworth J, Coleman R, Vinholes J, Modiano M, Pinter T, Tang SC, Colwell B, Prady C, Provencher L, Walde D, Rodriguez-Lescure A, Hugh J, Loret C, Rupin M, Blitz S, Jacobs P, Murawsky M, Riva A, Vogel C; Breast Cancer International Research Group 001 Investigators. Adjuvant docetaxel for node-positive breast cancer. N Engl J Med. 2005 Jun 2;352(22):2302-13. link to original article contains protocol PubMed

TC

TC: Taxotere, Cytoxan

Regimen

All cycles given with Filgrastim (Neupogen) support

• Docetaxel (Taxotere) 75 mg/m2 IV day 1
• Cyclophosphamide (Cytoxan) 600 mg/m2 IV day 1

21-day cycles x 4 cycles

References

1. Jones S, Holmes FA, O'Shaughnessy J, Blum JL, Vukelja SJ, McIntyre KJ, Pippen JE, Bordelon JH, Kirby RL, Sandbach J, Hyman WJ, Richards DA, Mennel RG, Boehm KA, Meyer WG, Asmar L, Mackey D, Riedel S, Muss H, Savin MA. Docetaxel With Cyclophosphamide Is Associated With an Overall Survival Benefit Compared With Doxorubicin and Cyclophosphamide: 7-Year Follow-Up of US Oncology Research Trial 9735. J Clin Oncol. 2009 Mar 10;27(8):1177-83. Epub 2009 Feb 9. link to original article PubMed

FAC #1

FAC: Five-FU, Adriamycin, Cytoxan

Regimen

• Fluorouracil (5-FU) 500 mg/m2 IV over 15 minutes on day 1 (administered second)
• Doxorubicin (Adriamycin) 50 mg/m2 IV over 15 minutes on day 1 (administered first)
• Cyclophosphamide (Cytoxan) 500 mg/m2 IV over 1-5 minutes on day 1 (administered third)
• If patients had febrile neutropenia or infection: Ciprofloxacin 500 mg PO BID on days 5-14 of every cycle (prophylaxis)
• G-CSF not originally routinely administered unless patients had febrile neutropenia:

• Filgrastim (Neupogen) 5 mcg/kg SC on days 4-11
• Lenograstim 150 mcg/m2 on days 4-11

21-day cycles x 6 cycles

References

1. Martin M, Pienkowski T, Mackey J, Pawlicki M, Guastalla JP, Weaver C, Tomiak E, Al-Tweigeri T, Chap L, Juhos E, Guevin R, Howell A, Fornander T, Hainsworth J, Coleman R, Vinholes J, Modiano M, Pinter T, Tang SC, Colwell B, Prady C, Provencher L, Walde D, Rodriguez-Lescure A, Hugh J, Loret C, Rupin M, Blitz S, Jacobs P, Murawsky M, Riva A, Vogel C; Breast Cancer International Research Group 001 Investigators. Adjuvant docetaxel for node-positive breast cancer. N Engl J Med. 2005 Jun 2;352(22):2302-13. link to original article contains protocol PubMed

FAC #2

FAC: Five-FU, Adriamycin, Cytoxan

Regimen

• Fluorouracil (5-FU) 500 mg/m2 IV on days 1 & 8 or days 1 & 4
• Doxorubicin (Adriamycin) 50 mg/m2 IV on day 1 or via 72-hour continuous infusion
• Cyclophosphamide (Cytoxan) 500 mg/m2 IV on day 1

21-day cycles x 6 cycles

References

1. Buzdar AU, Kau SW, Smith TL, Hortobagyi GN. Ten-year results of FAC adjuvant chemotherapy trial in breast cancer. Am J Clin Oncol. 1989 Apr;12(2):123-8. PubMed
2. Assikis V, Buzdar A, Yang Y, Smith T, Theriault R, Booser D, Valero V, Walters R, Singletary E, Ames F, Hortobagyi G. A phase III trial of sequential adjuvant chemotherapy for operable breast carcinoma: final analysis with 10-year follow-up. Cancer. 2003 Jun 1;97(11):2716-23. link to original article contains protocol PubMed

CAF

CAF: Cytoxan, Adriamycin, Five-FU

Regimen

• Cyclophosphamide (Cytoxan) 100 mg/m2 IV on days 1-14
• Doxorubicin (Adriamycin) 30 mg/m2 IV on days 1 & 8
• Fluorouracil (5-FU) 500 mg/m2 IV on days 1 & 8

28-day cycles x 6 cycles

References

1. Bull JM, Tormey DC, Li SH, Carbone PP, Falkson G, Blom J, Perlin E, Simon R. A randomized comparative trial of adriamycin versus methotrexate in combination drug therapy. Cancer. 1978 May;41(5):1649-57. PubMed

CEF

CEF: Cytoxan, Epirubicin, Five-FU

Regimen

• Cyclophosphamide (Cytoxan) 75 mg/m2 PO on days 1-14
• Epirubicin (Ellence) 60 mg/m2 IV on days 1 & 8
• Fluorouracil (5-FU) 500 mg/m2 IV on days 1 & 8
• With cotrimoxazole support

28-day cycles x 6 cycles

References

1. Levine MN, Bramwell VH, Pritchard KI, Norris BD, Shepherd LE, Abu-Zahra H, Findlay B, Warr D, Bowman D, Myles J, Arnold A, Vandenberg T, MacKenzie R, Robert J, Ottaway J, Burnell M, Williams CK, Tu D. Randomized trial of intensive cyclophosphamide, epirubicin, and fluorouracil chemotherapy compared with cyclophosphamide, methotrexate, and fluorouracil in premenopausal women with node-positive breast cancer. National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 1998 Aug;16(8):2651-8. link to original article PubMed

CMF

CMF: Cytoxan, Methotrexate, Five-FU

Regimen

• Cyclophosphamide (Cytoxan) 100 mg/m2 PO on days 1-14
• Methotrexate (MTX) 40 mg/m2 IV on days 1 & 8
• Fluorouracil (5-FU) 600 mg/m2 IV on days 1 & 8

28-day cycles x 6 cycles

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
2. Goldhirsch A, Colleoni M, Coates AS, Castiglione-Gertsch M, Gelber RD. Adding adjuvant CMF chemotherapy to either radiotherapy or tamoxifen: are all CMFs alike? The International Breast Cancer Study Group (IBCSG). Ann Oncol. 1998 May;9(5):489-93. link to original article contains protocol PubMed
3. 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. link to original article PubMed
4. Poole CJ, Earl HM, Hiller L, Dunn JA, Bathers S, Grieve RJ, Spooner DA, Agrawal RK, Fernando IN, Brunt AM, O'Reilly SM, Crawford SM, Rea DW, Simmonds P, Mansi JL, Stanley A, Harvey P, McAdam K, Foster L, Leonard RC, Twelves CJ; NEAT Investigators and the SCTBG. Epirubicin and cyclophosphamide, methotrexate, and fluorouracil as adjuvant therapy for early breast cancer. N Engl J Med. 2006 Nov 2;355(18):1851-62. link to original article PubMed

EC

EC: Epirubicin, Cytoxan

Regimen

• Epirubicin (Ellence) 100 mg/m2 IV day 1
• Cyclophosphamide (Cytoxan) 830 mg/m2 IV day 1

21-day cycles x 8 cycles

References

1. Piccart MJ, Di Leo A, Beauduin M, Vindevoghel A, Michel J, Focan C, Tagnon A, Ries F, Gobert P, Finet C, Closon-Dejardin MT, Dufrane JP, Kerger J, Liebens F, Beauvois S, Bartholomeus S, Dolci S, Lobelle JP, Paesmans M, Nogaret JM. Phase III trial comparing two dose levels of epirubicin combined with cyclophosphamide with cyclophosphamide, methotrexate, and fluorouracil in node-positive breast cancer. J Clin Oncol. 2001 Jun 15;19(12):3103-10. link to original article PubMed

FEC -> T (Taxotere)

FEC -> T: Five-FU, Epirubicin, Cytoxan -> Taxotere

Regimen

• Fluorouracil (5-FU) 500 mg/m2 IV day 1
• Epirubicin (Ellence) 100 mg/m2 IV day 1
• Cyclophosphamide (Cytoxan) 500 mg/m2 IV day 1

21-day cycles x 3 cycles, THEN

• Docetaxel (Taxotere) 100 mg/m2 IV day 1

21-day cycles x 3 cycles

References

1. Roché H, Fumoleau P, Spielmann M, Canon JL, Delozier T, Serin D, Symann M, Kerbrat P, Soulié P, Eichler F, Viens P, Monnier A, Vindevoghel A, Campone M, Goudier MJ, Bonneterre J, Ferrero JM, Martin AL, Genève J, Asselain B. Sequential adjuvant epirubicin-based and docetaxel chemotherapy for node-positive breast cancer patients: the FNCLCC PACS 01 Trial. J Clin Oncol. 2006 Dec 20;24(36):5664-71. Epub 2006 Nov 20. link to original article PubMed

FEC -> T (Taxol)

FEC -> T: Five-FU, Epirubicin, Cytoxan -> Taxol

Regimen

• Fluorouracil (5-FU) 600 mg/m2 IV day 1
• Epirubicin (Ellence) 90 mg/m2 IV day 1
• Cyclophosphamide (Cytoxan) 600 mg/m2 IV day 1

21-day cycles x 4 cycles, THEN 3 weeks of no treatment, THEN

• Paclitaxel (Taxol) 100 mg/m2 IV day 1

1-week cycles x 8 cycles/weeks

References

1. Martín M, Rodríguez-Lescure A, Ruiz A, Alba E, Calvo L, Ruiz-Borrego M, Munárriz B, Rodríguez CA, Crespo C, de Alava E, López García-Asenjo JA, Guitián MD, Almenar S, González-Palacios JF, Vera F, Palacios J, Ramos M, Gracia Marco JM, Lluch A, Alvarez I, Seguí MA, Mayordomo JI, Antón A, Baena JM, Plazaola A, Modolell A, Pelegrí A, Mel JR, Aranda E, Adrover E, Alvarez JV, García Puche JL, Sánchez-Rovira P, Gonzalez S, López-Vega JM; GEICAM 9906 Study Investigators. Randomized phase 3 trial of fluorouracil, epirubicin, and cyclophosphamide alone or followed by Paclitaxel for early breast cancer. J Natl Cancer Inst. 2008 Jun 4;100(11):805-14. Epub 2008 May 27. link to original article contains protocol PubMed

Adjuvant chemotherapy, HER-2 positive

AC -> weekly TH (Taxol)

AC -> weekly TH: Adriamycin, Cytoxan -> weekly Taxol, Herceptin

Regimen

• Doxorubicin (Adriamycin) 60 mg/m2 IV day 1
• Cyclophosphamide (Cytoxan) 600 mg/m2 IV day 1

21-day cycles x 4 cycles, THEN

• Paclitaxel (Taxol) 80 mg/m2 IV over 1 hour day 1
• Trastuzumab (Herceptin) 4 mg/kg IV with first dose of paclitaxel, then 2 mg/kg IV on subsequent weeks

1-week cycles x 12 cycles/weeks, THEN

• EITHER Trastuzumab (Herceptin) 2 mg/kg IV, 1-week cycles x 40 additional cycles/weeks to complete a total of 52 weeks of therapy
• OR Trastuzumab (Herceptin) 6 mg/kg IV, 3-week cycles x 14 additional cycles/weeks to complete a total of 52 weeks of therapy

Monitoring

• Cardiac function: echocardiogram at baseline, then every 3 months while on Trastuzumab (Herceptin)

References

1. Romond EH, Perez EA, Bryant J, Suman VJ, Geyer CE Jr, Davidson NE, Tan-Chiu E, Martino S, Paik S, Kaufman PA, Swain SM, Pisansky TM, Fehrenbacher L, Kutteh LA, Vogel VG, Visscher DW, Yothers G, Jenkins RB, Brown AM, Dakhil SR, Mamounas EP, Lingle WL, Klein PM, Ingle JN, Wolmark N. Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med. 2005 Oct 20;353(16):1673-84. link to original article PubMed

AC -> TH (Taxol)

AC -> TH: Adriamycin, Cytoxan -> Taxol, Herceptin

Regimen

• Doxorubicin (Adriamycin) 60 mg/m2 IV day 1
• Cyclophosphamide (Cytoxan) 600 mg/m2 IV day 1

21-day cycles x 4 cycles, THEN

• Paclitaxel (Taxol) 175 mg/m2 IV over 3 hours day 1
• Trastuzumab (Herceptin) 4 mg/kg IV with first dose of paclitaxel, then 2 mg/kg IV on days 8 & 15 of cycle 1; in cycles 2-4, Trastuzumab (Herceptin) is 2 mg/kg IV on days 1, 8, 15

21-day cycles x 4 cycles, THEN

• EITHER Trastuzumab (Herceptin) 2 mg/kg IV, 1-week cycles x 40 additional cycles/weeks to complete a total of 52 weeks of therapy
• OR Trastuzumab (Herceptin) 6 mg/kg IV, 3-week cycles x 14 additional cycles/weeks to complete a total of 52 weeks of therapy

Monitoring

• Cardiac function: echocardiogram at baseline, then every 3 months while on Trastuzumab (Herceptin)

References

1. Romond EH, Perez EA, Bryant J, Suman VJ, Geyer CE Jr, Davidson NE, Tan-Chiu E, Martino S, Paik S, Kaufman PA, Swain SM, Pisansky TM, Fehrenbacher L, Kutteh LA, Vogel VG, Visscher DW, Yothers G, Jenkins RB, Brown AM, Dakhil SR, Mamounas EP, Lingle WL, Klein PM, Ingle JN, Wolmark N. Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med. 2005 Oct 20;353(16):1673-84. link to original article PubMed

Dose-dense AC -> TH (Taxol)

AC -> TH: Adriamycin, Cytoxan -> Taxol, Herceptin

Regimen

All cycles given with Filgrastim (Neupogen) support

• Doxorubicin (Adriamycin) 60 mg/m2 IV day 1
• Cyclophosphamide (Cytoxan) 600 mg/m2 IV day 1

14-day cycles x 4 cycles, THEN

• Paclitaxel (Taxol) 175 mg/m2 IV over 3 hours day 1
• Trastuzumab (Herceptin) 4 mg/kg IV with first dose of paclitaxel, then 2 mg/kg IV on day 8 of cycle 1; in cycles 2-4, Trastuzumab (Herceptin) is 2 mg/kg IV on days 1 & 8

14-day cycles x 4 cycles, THEN

• EITHER Trastuzumab (Herceptin) 2 mg/kg IV, 1-week cycles x 44 additional cycles/weeks to complete a total of 52 weeks of therapy
• OR Trastuzumab (Herceptin) 6 mg/kg IV, 3-week cycles x 15 additional cycles/weeks to complete a total of 52 weeks of therapy

Monitoring

• Cardiac function: echocardiogram at baseline, then every 3 months while on Trastuzumab (Herceptin)

References

1. Dang C, Fornier M, Sugarman S, Troso-Sandoval T, Lake D, D'Andrea G, Seidman A, Sklarin N, Dickler M, Currie V, Gilewski T, Moynahan ME, Drullinsky P, Robson M, Wasserheit-Leiblich C, Mills N, Steingart R, Panageas K, Norton L, Hudis C. The safety of dose-dense doxorubicin and cyclophosphamide followed by paclitaxel with trastuzumab in HER-2/neu overexpressed/amplified breast cancer. J Clin Oncol. 2008 Mar 10;26(8):1216-22. link to original article PubMed

TCH

TCH: Taxotere, Carboplatin, Herceptin

Regimen

• Docetaxel (Taxotere) 75 mg/m2 IV day 1
• Carboplatin (Paraplatin) AUC 6 IV day 1
• Trastuzumab (Herceptin) 4 mg/kg IV on cycle 1 day 1, then 2 mg/kg IV on day 8 & 15 of cycle 1; then in cycles 2-6, Trastuzumab (Herceptin) is 2 mg/kg IV on days 1, 8, 15

21-day cycles x 6 cycles, THEN

• Trastuzumab (Herceptin) 6 mg/kg IV day 1

3-week cycles x 12 additional cycles/weeks to complete a total of 52 weeks of therapy

Monitoring

• Cardiac function: echocardiogram at baseline, then every 3 months while on Trastuzumab (Herceptin)

References

1. Slamon D, Eiermann W, Robert N, Pienkowski T, Martin M, Press M, Mackey J, Glaspy J, Chan A, Pawlicki M, Pinter T, Valero V, Liu MC, Sauter G, von Minckwitz G, Visco F, Bee V, Buyse M, Bendahmane B, Tabah-Fisch I, Lindsay MA, Riva A, Crown J; Breast Cancer International Research Group. Adjuvant trastuzumab in HER2-positive breast cancer. N Engl J Med. 2011 Oct 6;365(14):1273-83. link to original article PubMed

TH (Taxotere) -> FEC

TH -> FEC: Taxotere, Herceptin -> Five-FU, Epirubicin, Cytoxan

Regimen

• Docetaxel (Taxotere) 100 mg/m2 IV over 1 hour on day 1
• Trastuzumab (Herceptin) 4 mg/kg IV on cycle 1 day 1, then 2 mg/kg IV on days 8 & 15 of cycle 1; then in cycles 2-3, Trastuzumab (Herceptin) is 2 mg/kg IV on days 1, 8, 15

21-day cycles x 3 cycles, THEN

• Fluorouracil (5-FU) 600 mg/m2 IV day 1
• Epirubicin (Ellence) 60 mg/m2 IV day 1
• Cyclophosphamide (Cytoxan) 600 mg/m2 IV day 1

21-day cycles x 3 cycles

Monitoring

• Cardiac function: echocardiogram at baseline, after last cycle of FEC, 12 months after completion of chemotherapy, and 36 months after completion of chemotherapy

References

1. Joensuu H, Kellokumpu-Lehtinen PL, Bono P, Alanko T, Kataja V, Asola R, Utriainen T, Kokko R, Hemminki A, Tarkkanen M, Turpeenniemi-Hujanen T, Jyrkkiö S, Flander M, Helle L, Ingalsuo S, Johansson K, Jääskeläinen AS, Pajunen M, Rauhala M, Kaleva-Kerola J, Salminen T, Leinonen M, Elomaa I, Isola J; FinHer Study Investigators. Adjuvant docetaxel or vinorelbine with or without trastuzumab for breast cancer. N Engl J Med. 2006 Feb 23;354(8):809-20. link to original article PubMed

AC -> TH (Taxotere)

AC -> TH: Adriamycin, Cytoxan -> Taxotere, Herceptin

Regimen

• Doxorubicin (Adriamycin) 60 mg/m2 IV day 1
• Cyclophosphamide (Cytoxan) 600 mg/m2 IV day 1

21-day cycles x 4 cycles, THEN

• Docetaxel (Taxotere) 100 mg/m2 IV day 1
• Trastuzumab (Herceptin) 4 mg/kg IV on cycle 1 day 1, then 2 mg/kg IV on days 8 & 15 of cycle 1; then in cycles 2-4, Trastuzumab (Herceptin) is 2 mg/kg IV on days 1, 8, 15

21-day cycles x 4 cycles, THEN

• Trastuzumab (Herceptin) 6 mg/kg IV day 1

3-week cycles x 14 additional cycles/weeks to complete a total of 52 weeks of therapy

Monitoring

• Cardiac function: echocardiogram at baseline, then every 3 months while on Trastuzumab (Herceptin)

References

1. Joensuu H, Kellokumpu-Lehtinen PL, Bono P, Alanko T, Kataja V, Asola R, Utriainen T, Kokko R, Hemminki A, Tarkkanen M, Turpeenniemi-Hujanen T, Jyrkkiö S, Flander M, Helle L, Ingalsuo S, Johansson K, Jääskeläinen AS, Pajunen M, Rauhala M, Kaleva-Kerola J, Salminen T, Leinonen M, Elomaa I, Isola J; FinHer Study Investigators. Adjuvant docetaxel or vinorelbine with or without trastuzumab for breast cancer. N Engl J Med. 2006 Feb 23;354(8):809-20. link to original article PubMed

Neoadjuvant weekly TH (Taxol) -> FEC & H

weekly TH -> FEC & H: weekly Taxol, Herceptin -> Five-FU, Epirubicin, Cytoxan, Herceptin

Regimen

• Trastuzumab (Herceptin) 4 mg/kg IV on cycle 1 day 1 prior to first dose of paclitaxel, then 2 mg/kg on days 8 & 15 of cycle 1; then in cycles 2-4, Trastuzumab (Herceptin) is 2 mg/kg IV on days 1, 8, 15
• Paclitaxel (Taxol) 80 mg/m2 IV over 1 hour on days 1, 8, 15

21-day cycles x 4 cycles, THEN

• Fluorouracil (5-FU) 500 mg/m2 IV on days 1 & 4
• Epirubicin (Ellence) 75 mg/m2 IV on day 1
• Cyclophosphamide (Cytoxan) 500 mg/m2 IV on day 1
• Trastuzumab (Herceptin) 2 mg/kg IV on days 1, 8, 15

21-day cycles x 4 cycles

Neoadjuvant TH (Taxol) -> FEC & H

TH -> FEC & H: Taxol, Herceptin -> Five-FU, Epirubicin, Cytoxan, Herceptin

Regimen

• Trastuzumab (Herceptin) 4 mg/kg IV on cycle 1 day 1 prior to first dose of paclitaxel, then 2 mg/kg on days 8 & 15 of cycle 1; then in cycles 2-4, Trastuzumab (Herceptin) is 2 mg/kg IV on days 1, 8, 15
• Paclitaxel (Taxol) 225 mg/m2 IV over 24 hours on day 1

21-day cycles x 4 cycles, THEN

• Fluorouracil (5-FU) 500 mg/m2 IV on days 1 & 4
• Epirubicin (Ellence) 75 mg/m2 IV on day 1
• Cyclophosphamide (Cytoxan) 500 mg/m2 IV on day 1
• Trastuzumab (Herceptin) 2 mg/kg IV on days 1, 8, 15

21-day cycles x 4 cycles

References

1. Buzdar AU, Ibrahim NK, Francis D, Booser DJ, Thomas ES, Theriault RL, Pusztai L, Green MC, Arun BK, Giordano SH, Cristofanilli M, Frye DK, Smith TL, Hunt KK, Singletary SE, Sahin AA, Ewer MS, Buchholz TA, Berry D, Hortobagyi GN. Significantly higher pathologic complete remission rate after neoadjuvant therapy with trastuzumab, paclitaxel, and epirubicin chemotherapy: results of a randomized trial in human epidermal growth factor receptor 2-positive operable breast cancer. J Clin Oncol. 2005 Jun 1;23(16):3676-85. Epub 2005 Feb 28. link to original article PubMed

Metastatic disease, single agent therapy

Doxorubicin (Adriamycin)

Regimen

• Doxorubicin (Adriamycin) 60-75 mg/m2 IV day 1

21-day cycles

Alternate schedule:

• Doxorubicin (Adriamycin) 20 mg/m2 IV weekly

References

1. Gundersen S, Kvinnsland S, Klepp O, Kvaløy S, Lund E, Høst H. Weekly adriamycin versus VAC in advanced breast cancer. A randomized trial. Eur J Cancer Clin Oncol. 1986 Dec;22(12):1431-4. PubMed
2. Chan S, Friedrichs K, Noel D, Pintér T, Van Belle S, Vorobiof D, Duarte R, Gil Gil M, Bodrogi I, Murray E, Yelle L, von Minckwitz G, Korec S, Simmonds P, Buzzi F, González Mancha R, Richardson G, Walpole E, Ronzoni M, Murawsky M, Alakl M, Riva A, Crown J; 303 Study Group. Prospective randomized trial of docetaxel versus doxorubicin in patients with metastatic breast cancer. J Clin Oncol. 1999 Aug;17(8):2341-54. link to original article PubMed

Doxorubicin liposomal (Doxil)

Regimen

• Doxorubicin liposomal (Doxil) 50 mg/m2 IV day 1

28-day cycles

References

1. O'Brien ME, Wigler N, Inbar M, Rosso R, Grischke E, Santoro A, Catane R, Kieback DG, Tomczak P, Ackland SP, Orlandi F, Mellars L, Alland L, Tendler C; CAELYX Breast Cancer Study Group. Reduced cardiotoxicity and comparable efficacy in a phase III trial of pegylated liposomal doxorubicin HCl (CAELYX/Doxil) versus conventional doxorubicin for first-line treatment of metastatic breast cancer. Ann Oncol. 2004 Mar;15(3):440-9. link to original article PubMed

Epirubicin (Ellence)

Regimen

• Epirubicin (Ellence) 60-90 mg/m2 IV day 1

21-day cycles

References

1. Bastholt L, Dalmark M, Gjedde SB, Pfeiffer P, Pedersen D, Sandberg E, Kjaer M, Mouridsen HT, Rose C, Nielsen OS, Jakobsen P, Bentzen SM. Dose-response relationship of epirubicin in the treatment of postmenopausal patients with metastatic breast cancer: a randomized study of epirubicin at four different dose levels performed by the Danish Breast Cancer Cooperative Group. J Clin Oncol. 1996 Apr;14(4):1146-55. link to original article PubMed

Paclitaxel (Taxol)

Regimen

• Paclitaxel (Taxol) 175 mg/m2 IV day 1

21-day cycles

Alternate schedule:

• Paclitaxel (Taxol) 80 mg/m2 IV weekly

References

1. Seidman AD, Tiersten A, Hudis C, Gollub M, Barrett S, Yao TJ, Lepore J, Gilewski T, Currie V, Crown J, et al. Phase II trial of paclitaxel by 3-hour infusion as initial and salvage chemotherapy for metastatic breast cancer. J Clin Oncol. 1995 Oct;13(10):2575-81. link to original article PubMed
2. Perez EA, Vogel CL, Irwin DH, Kirshner JJ, Patel R. Multicenter phase II trial of weekly paclitaxel in women with metastatic breast cancer. J Clin Oncol. 2001 Nov 15;19(22):4216-23. link to original article PubMed

Docetaxel (Taxotere)

Regimen

• Docetaxel (Taxotere) 60-100 mg/m2 IV day 1

21-day cycles

Alternate schedule:

• Docetaxel (Taxotere) 40 mg/m2 IV weekly for weeks 1-6, then off for weeks 7-8

8-week cycles

References

1. Burris HA 3rd. Single-agent docetaxel (Taxotere) in randomized phase III trials. Semin Oncol. 1999 Jun;26(3 Suppl 9):1-6. PubMed
2. Alexandre J, Bleuzen P, Bonneterre J, Sutherland W, Misset JL, Guastalla J, Viens P, Faivre S, Chahine A, Spielman M, Bensmaïne A, Marty M, Mahjoubi M, Cvitkovic E. Factors predicting for efficacy and safety of docetaxel in a compassionate-use cohort of 825 heavily pretreated advanced breast cancer patients. J Clin Oncol. 2000 Feb;18(3):562-73. link to original article PubMed
3. Burstein HJ, Manola J, Younger J, Parker LM, Bunnell CA, Scheib R, Matulonis UA, Garber JE, Clarke KD, Shulman LN, Winer EP. Docetaxel administered on a weekly basis for metastatic breast cancer. link to original article PubMed
4. Harvey V, Mouridsen H, Semiglazov V, Jakobsen E, Voznyi E, Robinson BA, Groult V, Murawsky M, Cold S. Phase III trial comparing three doses of docetaxel for second-line treatment of advanced breast cancer. J Clin Oncol. 2006 Nov 1;24(31):4963-70. Epub 2006 Oct 10. link to original article PubMed

nab-Paclitaxel (Abraxane)

Regimen

• Paclitaxel, nanoparticle albumin-bound (Abraxane) 100 or 150 mg/m2 IV days 1, 8, 15

28-day cycles

Alternate schedule:

• Paclitaxel, nanoparticle albumin-bound (Abraxane) 260 mg/m2 IV day 1

21-day cycles

References

1. Gradishar WJ, Tjulandin S, Davidson N, Shaw H, Desai N, Bhar P, Hawkins M, O'Shaughnessy J. Phase III trial of nanoparticle albumin-bound paclitaxel compared with polyethylated castor oil-based paclitaxel in women with breast cancer. J Clin Oncol. 2005 Nov 1;23(31):7794-803. Epub 2005 Sep 19. link to original article PubMed
2. Dranitsaris G, Coleman R, Gradishar W. nab-Paclitaxel weekly or every 3 weeks compared to standard docetaxel as first-line therapy in patients with metastatic breast cancer: an economic analysis of a prospective randomized trial. Breast Cancer Res Treat. 2010 Feb;119(3):717-24. Epub 2009 Jun 3. link to original article PubMed

Capecitabine (Xeloda)

Regimen

• Capecitabine (Xeloda) 1000-1250 mg/m2 PO BID days 1-14

21-day cycles

References

1. Bajetta E, Procopio G, Celio L, Gattinoni L, Della Torre S, Mariani L, Catena L, Ricotta R, Longarini R, Zilembo N, Buzzoni R. Safety and efficacy of two different doses of capecitabine in the treatment of advanced breast cancer in older women. J Clin Oncol. 2005 Apr 1;23(10):2155-61. Epub 2005 Feb 14. link to original article PubMed

Gemcitabine (Gemzar)

Regimen

• Gemcitabine (Gemzar) 800-1200 mg/m2 IV days 1, 8, 15

28-day cycles

References

1. Carmichael J, Possinger K, Phillip P, Beykirch M, Kerr H, Walling J, Harris AL. Advanced breast cancer: a phase II trial with gemcitabine. J Clin Oncol. 1995 Nov;13(11):2731-6. link to original article PubMed
2. Seidman AD. Gemcitabine as single-agent therapy in the management of advanced breast cancer. Oncology (Williston Park). 2001 Feb;15(2 Suppl 3):11-4. PubMed

Vinorelbine (Navelbine)

Regimen

• Vinorelbine (Navelbine) 25 mg/m2 IV weekly

References

1. Gasparini G, Caffo O, Barni S, Frontini L, Testolin A, Guglielmi RB, Ambrosini G. Vinorelbine is an active antiproliferative agent in pretreated advanced breast cancer patients: a phase II study. J Clin Oncol. 1994 Oct;12(10):2094-101. link to original article PubMed
2. Zelek L, Barthier S, Riofrio M, Fizazi K, Rixe O, Delord JP, Le Cesne A, Spielmann M. Weekly vinorelbine is an effective palliative regimen after failure with anthracyclines and taxanes in metastatic breast carcinoma. Cancer. 2001 Nov 1;92(9):2267-72. PubMed

Eribulin (Halaven)

Regimen

• Eribulin (Halaven) 1.4 mg/m2 IV over 2 to 5 minutes on days 1 & 8

21-day cycles

References

1. Cortes J, O'Shaughnessy J, Loesch D, Blum JL, Vahdat LT, Petrakova K, Chollet P, Manikas A, Diéras V, Delozier T, Vladimirov V, Cardoso F, Koh H, Bougnoux P, Dutcus CE, Seegobin S, Mir D, Meneses N, Wanders J, Twelves C; EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Physician's Choice Versus E7389) investigators. Eribulin monotherapy versus treatment of physician's choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study. Lancet. 2011 Mar 12;377(9769):914-23. Epub 2011 Mar 2. link to original article contains protocol PubMed
2. Eribulin (Halaven) package insert

Metastatic disease, combination chemotherapy

CAF

CAF: Cytoxan, Adriamycin, Five-FU

Regimen

• Cyclophosphamide (Cytoxan) 100 mg/m2 PO on days 1-14
• Doxorubicin (Adriamycin) 30 mg/m2 IV on days 1 & 8
• Fluorouracil (5-FU) 500 mg/m2 IV on days 1 & 8

28-day cycles

References

1. Bull JM, Tormey DC, Li SH, Carbone PP, Falkson G, Blom J, Perlin E, Simon R. A randomized comparative trial of adriamycin versus methotrexate in combination drug therapy. Cancer. 1978 May;41(5):1649-57. PubMed

FAC

FAC: Five-FU, Adriamycin, Cytoxan

Regimen

• Fluorouracil (5-FU) 500 mg/m2 IV on days 1 & 8 or days 1 & 4
• Doxorubicin (Adriamycin) 50 mg/m2 IV on day 1
• Cyclophosphamide (Cytoxan) 500 mg/m2 IV on day 1

21-day cycles

References

1. Hortobagyi GN, Gutterman JU, Blumenschein GR, Tashima CK, Burgess MA, Einhorn L, Buzdar AU, Richman SP, Hersh EM. Combination chemoimmunotherapy of metastatic breast cancer with 5-fluorouracil, adriamycin, cyclophosphamide, and BCG. Cancer. 1979 Nov;44(5):1955-62. PubMed

FEC

FEC: Five-FU, Epirubicin, Cytoxan

Regimen

• Fluorouracil (5-FU) 500 mg/m2 IV days 1 & 8
• Epirubicin (Ellence) 50 mg/m2 IV days 1 & 8
• Cyclophosphamide (Cytoxan) 400 mg/m2 IV days 1 & 8

28-day cycles

References

1. Ackland SP, Anton A, Breitbach GP, Colajori E, Tursi JM, Delfino C, Efremidis A, Ezzat A, Fittipaldo A, Kolaric K, Lopez M, Viaro D; HEPI 013 study group. Dose-intensive epirubicin-based chemotherapy is superior to an intensive intravenous cyclophosphamide, methotrexate, and fluorouracil regimen in metastatic breast cancer: a randomized multinational study. J Clin Oncol. 2001 Feb 15;19(4):943-53. link to original article PubMed

AC

Regimen

• Doxorubicin (Adriamycin) 60 mg/m2 IV day 1
• Cyclophosphamide (Cytoxan) 600 mg/m2 IV day 1

21-day cycles

References

1. Fisher B, Brown AM, Dimitrov NV, Poisson R, Redmond C, Margolese RG, Bowman D, Wolmark N, Wickerham DL, Kardinal CG, et al. Two months of doxorubicin-cyclophosphamide with and without interval reinduction therapy compared with 6 months of cyclophosphamide, methotrexate, and fluorouracil in positive-node breast cancer patients with tamoxifen-nonresponsive tumors: results from the National Surgical Adjuvant Breast and Bowel Project B-15. J Clin Oncol. 1990 Sep;8(9):1483-96. link to original article PubMed

EC

EC: Epirubicin, Cytoxan

Regimen

• Epirubicin (Ellence) 75 mg/m2 IV day 1
• Cyclophosphamide (Cytoxan) 600 mg/m2 IV day 1

21-day cycles

References

1. Langley RE, Carmichael J, Jones AL, Cameron DA, Qian W, Uscinska B, Howell A, Parmar M. Phase III trial of epirubicin plus paclitaxel compared with epirubicin plus cyclophosphamide as first-line chemotherapy for metastatic breast cancer: United Kingdom National Cancer Research Institute trial AB01. J Clin Oncol. 2005 Nov 20;23(33):8322-30. link to original article PubMed

AT (Taxol)

AT: Adriamycin, Taxol

Regimen

• Doxorubicin (Adriamycin) 60 mg/m2 IV day 1
• Paclitaxel (Taxol) 125-200 mg/m2 IV day 1

21-day cycles

References

1. Gianni L, Munzone E, Capri G, Fulfaro F, Tarenzi E, Villani F, Spreafico C, Laffranchi A, Caraceni A, Martini C, et al. Paclitaxel by 3-hour infusion in combination with bolus doxorubicin in women with untreated metastatic breast cancer: high antitumor efficacy and cardiac effects in a dose-finding and sequence-finding study. J Clin Oncol. 1995 Nov;13(11):2688-99. link to original article PubMed

AT (Taxotere)

AT: Adriamycin, Taxotere

Regimen

• Doxorubicin (Adriamycin) 50 mg/m2 IV day 1
• Docetaxel (Taxotere) 75 mg/m2 IV day 1

21-day cycles

References

1. Nabholtz JM, Falkson C, Campos D, Szanto J, Martin M, Chan S, Pienkowski T, Zaluski J, Pinter T, Krzakowski M, Vorobiof D, Leonard R, Kennedy I, Azli N, Murawsky M, Riva A, Pouillart P; TAX 306 Study Group. Docetaxel and doxorubicin compared with doxorubicin and cyclophosphamide as first-line chemotherapy for metastatic breast cancer: results of a randomized, multicenter, phase III trial. J Clin Oncol. 2003 Mar 15;21(6):968-75. link to original article PubMed

CMF

CMF: Cytoxan, Methotrexate, Five-FU

Regimen

• Cyclophosphamide (Cytoxan) 100 mg/m2 PO on days 1-14
• Methotrexate (MTX) 40 mg/m2 IV on days 1 & 8
• Fluorouracil (5-FU) 600 mg/m2 IV on days 1 & 8

28-day cycles

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

TX (Taxotere)

TX: Taxotere, Xeloda

Regimen

• Docetaxel (Taxotere) 75 mg/m2 IV day 1
• Capecitabine (Xeloda) 950-1250 mg/m2 PO BID days 1-14

21-day cycles

References

1. O'Shaughnessy J, Miles D, Vukelja S, Moiseyenko V, Ayoub JP, Cervantes G, Fumoleau P, Jones S, Lui WY, Mauriac L, Twelves C, Van Hazel G, Verma S, Leonard R. Superior survival with capecitabine plus docetaxel combination therapy in anthracycline-pretreated patients with advanced breast cancer: phase III trial results. J Clin Oncol. 2002 Jun 15;20(12):2812-23. link to original article PubMed

GT

GT: Gemcitabine, Taxol

Regimen

• Gemcitabine (Gemzar) 1250 mg/m2 IV on days 1 & 8; on day 1, administer after paclitaxel
• Paclitaxel (Taxol) 175 mg/m2 IV day 1

21-day cycles

References

1. Albain KS, Nag SM, Calderillo-Ruiz G, Jordaan JP, Llombart AC, Pluzanska A, Rolski J, Melemed AS, Reyes-Vidal JM, Sekhon JS, Simms L, O'Shaughnessy J. Gemcitabine plus Paclitaxel versus Paclitaxel monotherapy in patients with metastatic breast cancer and prior anthracycline treatment. J Clin Oncol. 2008 Aug 20;26(24):3950-7. link to original article PubMed

Ixabepilone (Ixempra) & Capecitabine (Xeloda)

Regimen

• Ixabepilone (Ixempra) 40 mg/m2 IV on day 1
• Capecitabine (Xeloda) 2000 mg/m2 PO on days 1-14

21-day cycles

References

1. Sparano JA, Vrdoljak E, Rixe O, Xu B, Manikhas A, Medina C, Da Costa SC, Ro J, Rubio G, Rondinon M, Perez Manga G, Peck R, Poulart V, Conte P. Randomized phase III trial of ixabepilone plus capecitabine versus capecitabine in patients with metastatic breast cancer previously treated with an anthracycline and a taxane. J Clin Oncol. 2010 Jul 10;28(20):3256-63.link to original article contains protocol PubMed
2. 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. [1] contains protocol PubMed

Paclitaxel (Taxol) & Bevacizumab (Avastin)

Regimen

• Paclitaxel (Taxol) 90 mg/m2 IV over 1 hour on days 1, 8, 15
• Bevacizumab (Avastin) 10 mg/kg IV on days 1, 15

28-day cycles

References

1. Miller K, Wang M, Gralow J, Dickler M, Cobleigh M, Perez EA, Shenkier T, Cella D, Davidson NE. Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer. N Engl J Med. 2007 Dec 27;357(26):2666-76. link to original article PubMed

Metastatic disease, endocrine therapy

Anastrozole (Arimidex)

• Anastrozole (Arimidex) 1 mg PO daily

References

See references for Anastrozole (Arimidex)

Letrozole (Femara)

• Letrozole (Femara) 2.5 mg PO daily

References

See references for Letrozole (Femara)

Exemestane (Aromasin)

• Exemestane (Aromasin) 25 mg PO daily

References

See references for Exemestane (Aromasin)

Fulvestrant (Faslodex)

• Fulvestrant (Faslodex) 500 mg IM every 2 weeks x 3 doses, and then every 4 weeks thereafter

References

1. Howell A, Robertson JF, Quaresma Albano J, Aschermannova A, Mauriac L, Kleeberg UR, Vergote I, Erikstein B, Webster A, Morris C. Fulvestrant, formerly ICI 182,780, is as effective as anastrozole in postmenopausal women with advanced breast cancer progressing after prior endocrine treatment. J Clin Oncol. 2002 Aug 15;20(16):3396-403. link to original article PubMed
2. Perey L, Paridaens R, Hawle H, Zaman K, Nolé F, Wildiers H, Fiche M, Dietrich D, Clément P, Köberle D, Goldhirsch A, Thürlimann B. Clinical benefit of fulvestrant in postmenopausal women with advanced breast cancer and primary or acquired resistance to aromatase inhibitors: final results of phase II Swiss Group for Clinical Cancer Research Trial (SAKK 21/00). Ann Oncol. 2007 Jan;18(1):64-9. Epub 2006 Oct 9. link to original article PubMed
3. Chia S, Gradishar W, Mauriac L, Bines J, Amant F, Federico M, Fein L, Romieu G, Buzdar A, Robertson JF, Brufsky A, Possinger K, Rennie P, Sapunar F, Lowe E, Piccart M. Double-blind, randomized placebo controlled trial of fulvestrant compared with exemestane after prior nonsteroidal aromatase inhibitor therapy in postmenopausal women with hormone receptor-positive, advanced breast cancer: results from EFECT. J Clin Oncol. 2008 Apr 1;26(10):1664-70. Epub 2008 Mar 3. link to original article PubMed
4. Fulvestrant (Faslodex) package insert

Tamoxifen (Nolvadex)

• Tamoxifen (Nolvadex) 20 mg PO daily

References

See references for Tamoxifen (Nolvadex)

Toremifene (Fareston)

• Toremifene (Fareston) 60 mg PO daily

References

1. Hayes DF, Van Zyl JA, Hacking A, Goedhals L, Bezwoda WR, Mailliard JA, Jones SE, Vogel CL, Berris RF, Shemano I, et al. Randomized comparison of tamoxifen and two separate doses of toremifene in postmenopausal patients with metastatic breast cancer. J Clin Oncol. 1995 Oct;13(10):2556-66. link to original article PubMed
2. Gershanovich M, Garin A, Baltina D, Kurvet A, Kangas L, Ellmén J. A phase III comparison of two toremifene doses to tamoxifen in postmenopausal women with advanced breast cancer. Eastern European Study Group. Breast Cancer Res Treat. 1997 Sep;45(3):251-62. link to original article PubMed
3. Pyrhönen S, Valavaara R, Modig H, Pawlicki M, Pienkowski T, Gundersen S, Bauer J, Westman G, Lundgren S, Blanco G, Mella O, Nilsson I, Hietanen T, Hindy I, Vuorinen J, Hajba A. Comparison of toremifene and tamoxifen in post-menopausal patients with advanced breast cancer: a randomized double-blind, the 'nordic' phase III study. Br J Cancer. 1997;76(2):270-7. link to original article PubMed
4. Toremifene (Fareston) package insert

Metastatic disease, HER-2 positive

TCH

TCH: Taxol, Carboplatin, Herceptin

Regimen

• Paclitaxel (Taxol) 175 mg/m2 IV day 1
• Carboplatin (Paraplatin) AUC 6 IV day 1
• EITHER Trastuzumab (Herceptin) 4 mg/kg IV on cycle 1 day 1, then 2 mg/kg IV on day 8 & 15 of cycle 1; then on subsequent cycles, Trastuzumab (Herceptin) is 2 mg/kg IV on days 1, 8, 15
• OR Trastuzumab (Herceptin) 8 mg/kg IV on cycle 1 day 1, then on subsequent cycles Trastuzumab (Herceptin) is 6 mg/kg IV on day 1

21-day cycles

Alternate schedule:

• Paclitaxel (Taxol) 80 mg/m2 IV on days 1, 8, 15
• Carboplatin (Paraplatin) AUC 2 IV on days 1, 8, 15
• Trastuzumab (Herceptin) 4 mg/kg IV on cycle 1 day 1, then 2 mg/kg IV on days 8, 15, 22 of cycle 1; then on subsequent cycles, Trastuzumab (Herceptin) is 2 mg/kg IV on days 1, 8, 15, 22

28-day cycles

Monitoring

• Cardiac function: echocardiogram at baseline, then every 3 months while on Trastuzumab (Herceptin)

References

1. Perez EA, Suman VJ, Rowland KM, Ingle JN, Salim M, Loprinzi CL, Flynn PJ, Mailliard JA, Kardinal CG, Krook JE, Thrower AR, Visscher DW, Jenkins RB. Two concurrent phase II trials of paclitaxel/carboplatin/trastuzumab (weekly or every-3-week schedule) as first-line therapy in women with HER2-overexpressing metastatic breast cancer: NCCTG study 983252. Clin Breast Cancer. 2005 Dec;6(5):425-32. link to original article PubMed
2. Robert N, Leyland-Jones B, Asmar L, Belt R, Ilegbodu D, Loesch D, Raju R, Valentine E, Sayre R, Cobleigh M, Albain K, McCullough C, Fuchs L, Slamon D. Randomized phase III study of trastuzumab, paclitaxel, and carboplatin compared with trastuzumab and paclitaxel in women with HER-2-overexpressing metastatic breast cancer. J Clin Oncol. 2006 Jun 20;24(18):2786-92. link to original article PubMed

Paclitaxel (Taxol) & Trastuzumab (Herceptin)

Regimen

• Paclitaxel (Taxol) 175 mg/m2 IV day 1
• EITHER Trastuzumab (Herceptin) 4 mg/kg IV on cycle 1 day 1, then 2 mg/kg IV on day 8 & 15 of cycle 1; then on subsequent cycles, Trastuzumab (Herceptin) is 2 mg/kg IV on days 1, 8, 15
• OR Trastuzumab (Herceptin) 8 mg/kg IV on cycle 1 day 1, then on subsequent cycles Trastuzumab (Herceptin) is 6 mg/kg IV on day 1

21-day cycles

Alternate schedule:

• Paclitaxel (Taxol) 80-90 mg/m2 IV weekly
• Trastuzumab (Herceptin) 4 mg/kg IV on day 1, then 2 mg/kg IV weekly with paclitaxel

References

1. Slamon DJ, Leyland-Jones B, Shak S, Fuchs H, Paton V, Bajamonde A, Fleming T, Eiermann W, Wolter J, Pegram M, Baselga J, Norton L. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med. 2001 Mar 15;344(11):783-92. link to original article PubMed
2. Seidman AD, Fornier MN, Esteva FJ, Tan L, Kaptain S, Bach A, Panageas KS, Arroyo C, Valero V, Currie V, Gilewski T, Theodoulou M, Moynahan ME, Moasser M, Sklarin N, Dickler M, D'Andrea G, Cristofanilli M, Rivera E, Hortobagyi GN, Norton L, Hudis CA. Weekly trastuzumab and paclitaxel therapy for metastatic breast cancer with analysis of efficacy by HER2 immunophenotype and gene amplification. J Clin Oncol. 2001 May 15;19(10):2587-95. link to original article PubMed
3. Robert N, Leyland-Jones B, Asmar L, Belt R, Ilegbodu D, Loesch D, Raju R, Valentine E, Sayre R, Cobleigh M, Albain K, McCullough C, Fuchs L, Slamon D. Randomized phase III study of trastuzumab, paclitaxel, and carboplatin compared with trastuzumab and paclitaxel in women with HER-2-overexpressing metastatic breast cancer. J Clin Oncol. 2006 Jun 20;24(18):2786-92. link to original article PubMed
4. Seidman AD, Berry D, Cirrincione C, Harris L, Muss H, Marcom PK, Gipson G, Burstein H, Lake D, Shapiro CL, Ungaro P, Norton L, Winer E, Hudis C. Randomized phase III trial of weekly compared with every-3-weeks paclitaxel for metastatic breast cancer, with trastuzumab for all HER-2 overexpressors and random assignment to trastuzumab or not in HER-2 nonoverexpressors: final results of Cancer and Leukemia Group B protocol 9840. J Clin Oncol. 2008 Apr 1;26(10):1642-9. link to original article PubMed

Docetaxel (Taxotere) & Trastuzumab (Herceptin)

Regimen

• Docetaxel (Taxotere) 80-100 mg/m2 IV day 1
• EITHER Trastuzumab (Herceptin) 4 mg/kg IV on cycle 1 day 1, then 2 mg/kg IV on day 8 & 15 of cycle 1; then on subsequent cycles, Trastuzumab (Herceptin) is 2 mg/kg IV on days 1, 8, 15
• OR Trastuzumab (Herceptin) 8 mg/kg IV on cycle 1 day 1, then on subsequent cycles Trastuzumab (Herceptin) is 6 mg/kg IV on day 1

21-day cycles

Alternate schedule:

• Docetaxel (Taxotere) 35 mg/m2 IV weekly
• Trastuzumab (Herceptin) 4 mg/kg IV on day 1, then 2 mg/kg IV weekly with paclitaxel

References

1. Esteva FJ, Valero V, Booser D, Guerra LT, Murray JL, Pusztai L, Cristofanilli M, Arun B, Esmaeli B, Fritsche HA, Sneige N, Smith TL, Hortobagyi GN. Phase II study of weekly docetaxel and trastuzumab for patients with HER-2-overexpressing metastatic breast cancer. J Clin Oncol. 2002 Apr 1;20(7):1800-8. link to original article PubMed
2. Marty M, Cognetti F, Maraninchi D, Snyder R, Mauriac L, Tubiana-Hulin M, Chan S, Grimes D, Antón A, Lluch A, Kennedy J, O'Byrne K, Conte P, Green M, Ward C, Mayne K, Extra JM. Randomized phase II trial of the efficacy and safety of trastuzumab combined with docetaxel in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer administered as first-line treatment: the M77001 study group. J Clin Oncol. 2005 Jul 1;23(19):4265-74. Epub 2005 May 23. link to original article PubMed
3. Valero V, Forbes J, Pegram MD, Pienkowski T, Eiermann W, von Minckwitz G, Roche H, Martin M, Crown J, Mackey JR, Fumoleau P, Rolski J, Mrsic-Krmpotic Z, Jagiello-Gruszfeld A, Riva A, Buyse M, Taupin H, Sauter G, Press MF, Slamon DJ. Multicenter phase III randomized trial comparing docetaxel and trastuzumab with docetaxel, carboplatin, and trastuzumab as first-line chemotherapy for patients with HER2-gene-amplified metastatic breast cancer (BCIRG 007 study): two highly active therapeutic regimens. J Clin Oncol. 2011 Jan 10;29(2):149-56. Epub 2010 Nov 29. link to original article PubMed

Vinorelbine (Navelbine) & Trastuzumab (Herceptin)

Regimen

• Vinorelbine (Navelbine) 25 mg/m2 IV weekly
• Trastuzumab (Herceptin) 4 mg/kg IV on day 1, then 2 mg/kg IV weekly with paclitaxel

References

1. Burstein HJ, Keshaviah A, Baron AD, Hart RD, Lambert-Falls R, Marcom PK, Gelman R, Winer EP. Trastuzumab plus vinorelbine or taxane chemotherapy for HER2-overexpressing metastatic breast cancer: the trastuzumab and vinorelbine or taxane study. Cancer. 2007 Sep 1;110(5):965-72. link to original article PubMed

Capecitabine (Xeloda) & Trastuzumab (Herceptin)

Regimen

• Capecitabine (Xeloda) 1000-1250 mg/m2 PO BID days 1-14
• EITHER Trastuzumab (Herceptin) 4 mg/kg IV on cycle 1 day 1, then 2 mg/kg IV on day 8 & 15 of cycle 1; then on subsequent cycles, Trastuzumab (Herceptin) is 2 mg/kg IV on days 1, 8, 15
• OR Trastuzumab (Herceptin) 8 mg/kg IV on cycle 1 day 1, then on subsequent cycles Trastuzumab (Herceptin) is 6 mg/kg IV on day 1

21-day cycles

References

1. Bartsch R, Wenzel C, Altorjai G, Pluschnig U, Rudas M, Mader RM, Gnant M, Zielinski CC, Steger GG. Capecitabine and trastuzumab in heavily pretreated metastatic breast cancer. J Clin Oncol. 2007 Sep 1;25(25):3853-8. Epub 2007 Aug 6. link to original article PubMed

Capecitabine (Xeloda) & Lapatinib (Tykerb)

Regimen

• Capecitabine (Xeloda) 1000 mg/m2 PO BID days 1-14
• Lapatinib (Tykerb) 1250 mg PO daily days 1-21

21-day cycles

References

1. Geyer CE, Forster J, Lindquist D, Chan S, Romieu CG, Pienkowski T, Jagiello-Gruszfeld A, Crown J, Chan A, Kaufman B, Skarlos D, Campone M, Davidson N, Berger M, Oliva C, Rubin SD, Stein S, Cameron D. Lapatinib plus capecitabine for HER2-positive advanced breast cancer. N Engl J Med. 2006 Dec 28;355(26):2733-43. link to original article PubMed

Trastuzumab (Herceptin) & Lapatinib (Tykerb)

Regimen

• EITHER Trastuzumab (Herceptin) 4 mg/kg IV on cycle 1 day 1, then 2 mg/kg IV on day 8 & 15 of cycle 1; then on subsequent cycles, Trastuzumab (Herceptin) is 2 mg/kg IV on days 1, 8, 15
• OR Trastuzumab (Herceptin) 8 mg/kg IV on cycle 1 day 1, then on subsequent cycles Trastuzumab (Herceptin) is 6 mg/kg IV on day 1
• Lapatinib (Tykerb) 1250 mg PO daily days 1-21

21-day cycles

References

1. von Minckwitz G, du Bois A, Schmidt M, Maass N, Cufer T, de Jongh FE, Maartense E, Zielinski C, Kaufmann M, Bauer W, Baumann KH, Clemens MR, Duerr R, Uleer C, Andersson M, Stein RC, Nekljudova V, Loibl S. Trastuzumab beyond progression in human epidermal growth factor receptor 2-positive advanced breast cancer: a german breast group 26/breast international group 03-05 study. J Clin Oncol. 2009 Apr 20;27(12):1999-2006. Epub 2009 Mar 16. link to original article PubMed
2. von Minckwitz G, Schwedler K, Schmidt M, Barinoff J, Mundhenke C, Cufer T, Maartense E, de Jongh FE, Baumann KH, Bischoff J, Harbeck N, Lück HJ, Maass N, Zielinski C, Andersson M, Stein RC, Nekljudova V, Loibl S; GBG 26/BIG 03-05 study group and participating investigators. Trastuzumab beyond progression: overall survival analysis of the GBG 26/BIG 3-05 phase III study in HER2-positive breast cancer. Eur J Cancer. 2011 Oct;47(15):2273-81. Epub 2011 Jul 7. link to original article PubMed

Trastuzumab (Herceptin) & other single agent chemotherapy

Regimen

• EITHER Trastuzumab (Herceptin) 4 mg/kg IV on cycle 1 day 1, then 2 mg/kg IV on day 8 & 15 of cycle 1; then on subsequent cycles, Trastuzumab (Herceptin) is 2 mg/kg IV on days 1, 8, 15
• OR Trastuzumab (Herceptin) 8 mg/kg IV on cycle 1 day 1, then on subsequent cycles Trastuzumab (Herceptin) is 6 mg/kg IV on day 1
• A single agent chemotherapy regimen described above

21-day cycles

References

See single agent chemotherapy regimens