Breast cancer, HER2-positive - historical

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The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only. Is there a regimen missing from this list? See the main HER2+ breast cancer page for current regimens.
Last updated on 2024-07-23:12 regimens on this page
13 variants on this page
 
=Neoadjuvant therapy, sequential regimens=
==T-FEC==
T-FEC: Taxol (Paclitaxel), followed by Fluorouracil, Epirubicin, Cyclophosphamide
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator	Comparative Efficacy
Buzdar et al. 2005	2001-2003 	Randomized (C)	TH-FEC & H	Seems to have lower pCR rate
====Chemotherapy, T portion (cycles 1 to 4)====
*Paclitaxel (Taxol) 225 mg/m2 IV continuous infusion over 24 hours, started on day 1
====Chemotherapy, FEC portion (cycles 5 to 8)====
*Fluorouracil (5-FU) 500 mg/m2 IV once per day on days 1 & 4
*Epirubicin (Ellence) 75 mg/m2 IV once on day 1 
*Cyclophosphamide (Cytoxan) 500 mg/m2 IV once on day 1
21-day cycle for 8 cycles (T x 4; FEC x 4)
====Subsequent treatment====
*Surgery
===References===
# 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 dosing details in manuscript have been reviewed by our editors EuroPMC
## Update: Buzdar AU, Valero V, Ibrahim NK, Francis D, Broglio KR, Theriault RL, Pusztai L, Green MC, Singletary SE, Hunt KK, Sahin AA, Esteva F, Symmans WF, Ewer MS, Buchholz TA, Hortobagyi GN. Neoadjuvant therapy with paclitaxel followed by 5-fluorouracil, epirubicin, and cyclophosphamide chemotherapy and concurrent trastuzumab in human epidermal growth factor receptor 2-positive operable breast cancer: an update of the initial randomized study population and data of additional patients treated with the same regimen. Clin Cancer Res. 2007 Jan 1;13(1):228-33. link to original article EuroPMC
=Adjuvant therapy, sequential regimens=
==AC-D==
AC-D: Adriamycin (Doxorubicin) & Cyclophosphamide followed by Docetaxel
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator	Comparative Efficacy
Slamon et al. 2011 (BCIRG 006)	2001-2004 	Phase 3 (C)	1. AC-TH 	Shorter OS
Slamon et al. 2011 (BCIRG 006)	2001-2004 	Phase 3 (C)	2. TCH 	Seems to have shorter OS
====Preceding treatment====
*Surgery
====Chemotherapy, AC portion (cycles 1 to 4)====
*Doxorubicin (Adriamycin) 60 mg/m2 IV once on day 1
*Cyclophosphamide (Cytoxan) 600 mg/m2 IV once on day 1
====Chemotherapy, D portion (cycles 5 to 8)====
*Docetaxel (Taxotere) 100 mg/m2 IV over 60 minutes once on day 1
21-day cycle for 8 cycles (AC x 4; D x 4)
===References===
# BCIRG 006: Slamon D, Eiermann W, Robert N, Pienkowski T, Martín 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 link to PMC article dosing details in manuscript have been reviewed by our editors EuroPMC NCT00021255
##HRQoL analysis: Au HJ, Eiermann W, Robert NJ, Pienkowski T, Crown J, Martin M, Pawlicki M, Chan A, Mackey J, Glaspy J, Pintér T, Liu MC, Fornander T, Sehdev S, Ferrero JM, Bée V, Santana MJ, Miller DP, Lalla D, Slamon DJ; Translational Research in Oncology BCIRG 006 Trial Investigators. Health-related quality of life with adjuvant docetaxel- and trastuzumab-based regimens in patients with node-positive and high-risk node-negative, HER2-positive early breast cancer: results from the BCIRG 006 Study. Oncologist. 2013;18(7):812-818. link to original article link to EuroPMC
==AC-T==
AC-T: Adriamycin (Doxorubicin) & Cyclophosphamide followed by Taxol (Paclitaxel)
===Regimen variant #1, weekly paclitaxel===
Study 	Dates of enrollment	Evidence 	Comparator	Comparative Efficacy 	Comparative Toxicity
Romond et al. 2005 (NSABP B-31) 	2000-2005 	Phase 3 (C)	AC-TH 	Shorter DFSShorter OS1OS120: 75.2% vs 84%(HR 1.59, 95% CI 1.37-2.00)	Might have worse DASI score
Romond et al. 2005 (NCCTG N9831)	2000-2005 	Phase 3 (C)	1. AC-TH 	Shorter OS 	
Romond et al. 2005 (NCCTG N9831)	2000-2005 	Phase 3 (C)	2. AC-T-H 	Not reported 	
1Reported OS efficacy for NSABP B-31 is based on the 2014 pooled update.
====Preceding treatment====
*Surgery
====Chemotherapy, AC portion (cycles 1 to 4)====
*Doxorubicin (Adriamycin) 60 mg/m2 IV once on day 1
*Cyclophosphamide (Cytoxan) 600 mg/m2 IV once on day 1
====Chemotherapy, T portion (cycles 5 to 16)====
*Paclitaxel (Taxol) 80 mg/m2 IV over 60 minutes once on day 1
21-day cycle for 4 cycles, then 7-day cycle for 12 cycles (AC x 4; wP x 12)
===Regimen variant #2, q3wk paclitaxel===
Study 	Dates of enrollment	Evidence 	Comparator	Comparative Efficacy
Romond et al. 2005 (NSABP B-31)	2000-2005 	Phase 3 (C)	AC-TH 	Shorter DFSShorter OS1OS120: 75.2% vs 84%(HR 1.59, 95% CI 1.37-2.00)
1Reported OS efficacy for NSABP B-31 is based on the 2014 pooled update.
====Preceding treatment====
*Surgery
====Chemotherapy, AC portion (cycles 1 to 4)====
*Doxorubicin (Adriamycin) 60 mg/m2 IV once on day 1
*Cyclophosphamide (Cytoxan) 600 mg/m2 IV once on day 1
====Chemotherapy, T portion (cycles 5 to 8)====
*Paclitaxel (Taxol) 175 mg/m2 IV over 3 hours once on day 1 
21-day cycle for 8 cycles (AC x 4; T x 4)
===References===
# NSABP B-31: 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 EuroPMC NCT00004067
## Pooled update: Perez EA, Romond EH, Suman VJ, Jeong JH, Davidson NE, Geyer CE Jr, Martino S, Mamounas EP, Kaufman PA, Wolmark N. Four-year follow-up of trastuzumab plus adjuvant chemotherapy for operable human epidermal growth factor receptor 2-positive breast cancer: joint analysis of data from NCCTG N9831 and NSABP B-31. J Clin Oncol. 2011 Sep 1;29(25):3366-73. Epub 2011 Jul 18. link to original article link to PMC article EuroPMC
## Pooled update: Perez EA, Romond EH, Suman VJ, Jeong JH, Sledge G, Geyer CE Jr, Martino S, Rastogi P, Gralow J, Swain SM, Winer EP, Colon-Otero G, Davidson NE, Mamounas E, Zujewski JA, Wolmark N. Trastuzumab plus adjuvant chemotherapy for human epidermal growth factor receptor 2-positive breast cancer: planned joint analysis of overall survival from NSABP B-31 and NCCTG N9831. J Clin Oncol. 2014 Nov 20;32(33):3744-52. Epub 2014 Oct 20. link to original article link to PMC article EuroPMC
## HRQoL analysis: Ganz PA, Romond EH, Cecchini RS, Rastogi P, Geyer CE Jr, Swain SM, Jeong JH, Fehrenbacher L, Gross HM, Brufsky AM, Flynn PJ, Wahl TA, Seay TE, Wade JL 3rd, Biggs DD, Atkins JN, Polikoff J, Zapas JL, Mamounas EP, Wolmark N. Long-term follow-up of cardiac function and quality of life for patients in NSABP protocol B-31/NRG Oncology: a randomized trial comparing the safety and efficacy of doxorubicin and cyclophosphamide (AC) followed by paclitaxel with AC followed by paclitaxel and trastuzumab in patients with node-positive breast cancer with tumors overexpressing human epidermal growth factor receptor 2. J Clin Oncol. 2017 Dec 10;35(35):3942-3948. Epub 2017 Oct 26. link to original article link to PMC article EuroPMC
# NCCTG N9831: 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 EuroPMC NCT00005970
## Pooled update: Perez EA, Romond EH, Suman VJ, Jeong JH, Davidson NE, Geyer CE Jr, Martino S, Mamounas EP, Kaufman PA, Wolmark N. Four-year follow-up of trastuzumab plus adjuvant chemotherapy for operable human epidermal growth factor receptor 2-positive breast cancer: joint analysis of data from NCCTG N9831 and NSABP B-31. J Clin Oncol. 2011 Sep 1;29(25):3366-73. Epub 2011 Jul 18. link to original article link to PMC article EuroPMC
## Update: Perez EA, Suman VJ, Davidson NE, Gralow JR, Kaufman PA, Visscher DW, Chen B, Ingle JN, Dakhil SR, Zujewski J, Moreno-Aspitia A, Pisansky TM, Jenkins RB. Sequential versus concurrent trastuzumab in adjuvant chemotherapy for breast cancer. J Clin Oncol. 2011 Dec 1;29(34):4491-7. Epub 2011 Oct 31. link to original article link to PMC article EuroPMC
## Pooled update: Perez EA, Romond EH, Suman VJ, Jeong JH, Sledge G, Geyer CE Jr, Martino S, Rastogi P, Gralow J, Swain SM, Winer EP, Colon-Otero G, Davidson NE, Mamounas E, Zujewski JA, Wolmark N. Trastuzumab plus adjuvant chemotherapy for human epidermal growth factor receptor 2-positive breast cancer: planned joint analysis of overall survival from NSABP B-31 and NCCTG N9831. J Clin Oncol. 2014 Nov 20;32(33):3744-52. Epub 2014 Oct 20. link to original article link to PMC article EuroPMC
==D-FEC==
D-FEC: Docetaxel followed by Fluorouracil, Epirubicin, Cyclophosphamide
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
Joensuu et al. 2006 (FinHer)	2000-2003 	Phase 3 (E-switch-ic)	1. TH-FEC2. VH-FEC	Shorter RFS
Joensuu et al. 2006 (FinHer)	2000-2003 	Phase 3 (E-switch-ic)	3. V-FEC 	Longer DDFS
====Preceding treatment====
*Surgery with axillary lymph node dissection or sentinel lymph node biopsy, within 12 weeks
====Chemotherapy, D portion (cycles 1 to 3)====
*Docetaxel (Taxotere) 100 mg/m2 IV over 60 minutes once on day 1
====Chemotherapy, FEC portion (cycles 4 to 6)====
*Fluorouracil (5-FU) 600 mg/m2 IV once on day 1
*Epirubicin (Ellence) 60 mg/m2 IV once on day 1
*Cyclophosphamide (Cytoxan) 600 mg/m2 IV once on day 1
21-day cycle for 6 cycles (D x 3; FEC x 3)
===References===
# FinHer: 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 dosing details in manuscript have been reviewed by our editors EuroPMC ISRCTN76560285
## Update: Joensuu H, Bono P, Kataja V, Alanko T, Kokko R, Asola R, Utriainen T, Turpeenniemi-Hujanen T, Jyrkkiö S, Möykkynen K, Helle L, Ingalsuo S, Pajunen M, Huusko M, Salminen T, Auvinen P, Leinonen H, Leinonen M, Isola J, Kellokumpu-Lehtinen PL. Fluorouracil, epirubicin, and cyclophosphamide with either docetaxel or vinorelbine, with or without trastuzumab, as adjuvant treatments of breast cancer: final results of the FinHer trial. J Clin Oncol. 2009 Dec 1;27(34):5685-92. Epub 2009 Nov 2. link to original article EuroPMC
==V-FEC==
V-FEC: Vinorelbine followed by Fluorouracil, Epirubicin, Cyclophosphamide
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
Joensuu et al. 2006 (FinHer)	2000-2003 	Phase 3 (C)	1. D-FEC 	Shorter DDFS
Joensuu et al. 2006 (FinHer)	2000-2003 	Phase 3 (C)	2. TH-FEC3. VH-FEC	Shorter RFS
====Preceding treatment====
*Surgery
====Chemotherapy, V portion (cycles 1 to 3)====
*Vinorelbine (Navelbine) as follows:
**Cycles 1 & 2: 25 mg/m2 IV over 5 to 10 minutes once per day on days 1, 8, 15
**Cycle 3: 25 mg/m2 IV over 5 to 10 minutes once per day on days 1 & 8
====Chemotherapy, FEC portion (cycles 4 to 6)====
*Fluorouracil (5-FU) 600 mg/m2 IV once on day 1
*Epirubicin (Ellence) 60 mg/m2 IV once on day 1
*Cyclophosphamide (Cytoxan) 600 mg/m2 IV once on day 1
21-day cycle for 6 cycles (V x 3; FEC x 3)
===References===
# FinHer: 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 dosing details in manuscript have been reviewed by our editors EuroPMC ISRCTN76560285
## Update: Joensuu H, Bono P, Kataja V, Alanko T, Kokko R, Asola R, Utriainen T, Turpeenniemi-Hujanen T, Jyrkkiö S, Möykkynen K, Helle L, Ingalsuo S, Pajunen M, Huusko M, Salminen T, Auvinen P, Leinonen H, Leinonen M, Isola J, Kellokumpu-Lehtinen PL. Fluorouracil, epirubicin, and cyclophosphamide with either docetaxel or vinorelbine, with or without trastuzumab, as adjuvant treatments of breast cancer: final results of the FinHer trial. J Clin Oncol. 2009 Dec 1;27(34):5685-92. Epub 2009 Nov 2. link to original article EuroPMC
=Metastatic disease, first-line chemotherapy=
Note: in many of these regimens, patients were allowed to have received (neo)adjuvant chemotherapy and hormonal therapy (when applicable). These are first-line regimens in the metastatic setting, with a few being specifically for the locally advanced but unresectable setting.
==Cyclophosphamide & Doxorubicin (AC)==
AC: Adriamycin (Doxorubicin) & Cyclophosphamide
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
Slamon et al. 2001	1995-1997 	Phase 3 (C)	1a. ACH1b. ECH	Seems to have shorter OSMedian OS: 20.3 vs 25.1 moShorter TTPMedian TTP: 4.6 vs 7.4 mo
====Prior treatment criteria====
*Slamon et al. 2001: No previous anthracycline exposure
====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 6 or more cycles
===References===
# 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 dosing details in manuscript have been reviewed by our editors EuroPMC
==Capecitabine monotherapy==
===Regimen===
Study 	Dates of enrollment 	Evidence 	Comparator 	Comparative Efficacy
von Minckwitz et al. 2009 (GBG 26/BIG 3-05)	2003 to not reported 	Phase 3 (C)	Capecitabine & Trastuzumab	Seems to have shorter TTPMedian TTP: 5.6 vs 8.2 mo(HR 1.45, 95% CI 1.03-2.08)
Geyer et al. 2006 (EGF100151) 	2004-03-29 to 2005-11-15	Phase 3 (C)	Capecitabine & Lapatinib 	Shorter TTP
Note: To our knowledge, this regimen was not tested as an experimental arm in an RCT prior to becoming a standard comparator arm in this context.
====Chemotherapy====
*Capecitabine (Xeloda) 1250 mg/m2 PO twice per day on days 1 to 14
21-day cycles
===References===
# EGF100151: 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 dosing details in manuscript have been reviewed by our editors EuroPMC NCT00078572
## Update: Cameron D, Casey M, Press M, Lindquist D, Pienkowski T, Romieu CG, Chan S, Jagiello-Gruszfeld A, Kaufman B, Crown J, Chan A, Campone M, Viens P, Davidson N, Gorbounova V, Raats JI, Skarlos D, Newstat B, Roychowdhury D, Paoletti P, Oliva C, Rubin S, Stein S, Geyer CE. A phase III randomized comparison of lapatinib plus capecitabine versus capecitabine alone in women with advanced breast cancer that has progressed on trastuzumab: updated efficacy and biomarker analyses. Breast Cancer Res Treat. 2008 Dec;112(3):533-43. Epub 2008 Jan 11. link to original article EuroPMC
## Update: Cameron D, Casey M, Oliva C, Newstat B, Imwalle B, Geyer CE. Lapatinib plus capecitabine in women with HER-2-positive advanced breast cancer: final survival analysis of a phase III randomized trial. Oncologist. 2010;15(9):924-34. Epub 2010 Aug 24. link to original article link to PMC article EuroPMC
# GBG 26/BIG 03-05: 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 dosing details in manuscript have been reviewed by our editors EuroPMC NCT00148876
## Update: 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 dosing details in manuscript have been reviewed by our editors EuroPMC
==Docetaxel monotherapy==
D: Docetaxel
T: Taxotere (Docetaxel)
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
Marty et al. 2005 (M77001)	2000-2002 	Randomized Phase 2 (C)	Docetaxel & Trastuzumab	Seems to have shorter OS
====Chemotherapy====
*Docetaxel (Taxotere) 100 mg/m2 IV over 60 minutes once on day 1
21-day cycles
===References===
# M77001: 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 dosing details in manuscript have been reviewed by our editors EuroPMC
==Cyclophosphamide & Epirubicin (EC)==
EC: Epirubicin & Cyclophosphamide
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
Slamon et al. 2001	1995-1997 	Phase 3 (C)	1a. ACH1b. ECH	Seems to have shorter OSMedian OS: 20.3 vs 25.1 moShorter TTPMedian TTP: 4.6 vs 7.4 mo
====Prior treatment criteria====
*Slamon et al. 2001: No previous anthracycline exposure
====Chemotherapy====
*Epirubicin (Ellence) 75 mg/m2 IV once on day 1 
*Cyclophosphamide (Cytoxan) 600 mg/m2 IV once on day 1
21-day cycle for 6 or more cycles
===References===
# 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 dosing details in manuscript have been reviewed by our editors EuroPMC
==Paclitaxel monotherapy, weekly==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator	Comparative Efficacy
Guan et al. 2013 (EGF104535)	2006-2009 	Phase 3 (C)	TL (Taxol)	Shorter OSMedian OS: 20.5 vs 27.8 mo(HR 1.35, 95% CI 1.06-1.72)
====Chemotherapy====
*Paclitaxel (Taxol) 80 mg/m2 IV once per day on days 1, 8, 15
28-day cycles
===References===
# EGF104535: Guan Z, Xu B, DeSilvio ML, Shen Z, Arpornwirat W, Tong Z, Lorvidhaya V, Jiang Z, Yang J, Makhson A, Leung WL, Russo MW, Newstat B, Wang L, Chen G, Oliva C, Gomez H. Randomized trial of lapatinib versus placebo added to paclitaxel in the treatment of human epidermal growth factor receptor 2-overexpressing metastatic breast cancer. J Clin Oncol. 2013 Jun 1;31(16):1947-53. Epub 2013 Mar 18. link to original article dosing details in manuscript have been reviewed by our editors EuroPMC NCT00281658
==Paclitaxel monotherapy, q3wk==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator	Comparative Efficacy
Slamon et al. 2001	1995-1997 	Phase 3 (C)	TH 	Seems to have shorter OSMedian OS: 20.3 vs 25.1 moShorter TTPMedian TTP: 4.6 vs 7.4 mo
====Prior treatment criteria====
*Slamon et al. 2001: Previous anthracycline exposure
====Chemotherapy====
*Paclitaxel (Taxol) 175 mg/m2 IV over 3 hours once on day 1
21-day cycles
===References===
# 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 dosing details in manuscript have been reviewed by our editors EuroPMC
=Metastatic or unresectable disease, subsequent lines=
==Lapatinib monotherapy==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
Blackwell et al. 2010 (EGF104900)	2005-11 to 2006-11 	Phase 3 (C)	Lapatinib & Trastuzumab	Shorter PFS
1Reported efficacy is based on the 2012 update.
====Targeted therapy====
*Lapatinib (Tykerb) 1500 mg PO once per day on days 1 to 28
28-day cycles
===References===
# EGF104900: Blackwell KL, Burstein HJ, Storniolo AM, Rugo H, Sledge G, Koehler M, Ellis C, Casey M, Vukelja S, Bischoff J, Baselga J, O'Shaughnessy J. Randomized study of Lapatinib alone or in combination with trastuzumab in women with ErbB2-positive, trastuzumab-refractory metastatic breast cancer. J Clin Oncol. 2010 Mar 1;28(7):1124-30. Epub 2010 Feb 1. link to original article dosing details in manuscript have been reviewed by our editors EuroPMC NCT00320385
## Update: Blackwell KL, Burstein HJ, Storniolo AM, Rugo HS, Sledge G, Aktan G, Ellis C, Florance A, Vukelja S, Bischoff J, Baselga J, O'Shaughnessy J. Overall survival benefit with lapatinib in combination with trastuzumab for patients with human epidermal growth factor receptor 2-positive metastatic breast cancer: final results from the EGF104900 Study. J Clin Oncol. 2012 Jul 20;30(21):2585-92. Epub 2012 Jun 11. link to original article EuroPMC
Category:Breast cancer regimens
Category:Historical regimens
Category:Biomarker-specific pages
Category:Disease-specific pages
Category:Malignant breast neoplasm