Online citations, reference lists, and bibliographies.
← Back to Search

Trastuzumab Plus Adjuvant Chemotherapy For Operable HER2-positive Breast Cancer.

E. H. Romond, E. Perez, J. Bryant, V. Suman, C. Geyer, N. Davidson, E. Tan-chiu, S. Martino, S. Paik, P. Kaufman, S. Swain, T. Pisansky, L. Fehrenbacher, L. Kutteh, V. Vogel, D. Visscher, G. Yothers, R. Jenkins, A. Brown, S. Dakhil, E. Mamounas, W. Lingle, P. M. Klein, J. Ingle, N. Wolmark
Published 2005 · Medicine

Cite This
Download PDF
Analyze on Scholarcy
Share
BACKGROUND We present the combined results of two trials that compared adjuvant chemotherapy with or without concurrent trastuzumab in women with surgically removed HER2-positive breast cancer. METHODS The National Surgical Adjuvant Breast and Bowel Project trial B-31 compared doxorubicin and cyclophosphamide followed by paclitaxel every 3 weeks (group 1) with the same regimen plus 52 weeks of trastuzumab beginning with the first dose of paclitaxel (group 2). The North Central Cancer Treatment Group trial N9831 compared three regimens: doxorubicin and cyclophosphamide followed by weekly paclitaxel (group A), the same regimen followed by 52 weeks of trastuzumab after paclitaxel (group B), and the same regimen plus 52 weeks of trastuzumab initiated concomitantly with paclitaxel (group C). The studies were amended to include a joint analysis comparing groups 1 and A (the control group) with groups 2 and C (the trastuzumab group). Group B was excluded because trastuzumab was not given concurrently with paclitaxel. RESULTS By March 15, 2005, 394 events (recurrent, second primary cancer, or death before recurrence) had been reported, triggering the first scheduled interim analysis. Of these, 133 were in the trastuzumab group and 261 in the control group (hazard ratio, 0.48; P<0.0001). This result crossed the early stopping boundary. The absolute difference in disease-free survival between the trastuzumab group and the control group was 12 percent at three years. Trastuzumab therapy was associated with a 33 percent reduction in the risk of death (P=0.015). The three-year cumulative incidence of class III or IV congestive heart failure or death from cardiac causes in the trastuzumab group was 4.1 percent in trial B-31 and 2.9 percent in trial N9831. CONCLUSIONS Trastuzumab combined with paclitaxel after doxorubicin and cyclophosphamide improves outcomes among women with surgically removed HER2-positive breast cancer. (ClinicalTrials.gov numbers, NCT00004067 and NCT00005970.)
This paper references
10.1200/JCO.2002.20.5.1215
Cardiac dysfunction in the trastuzumab clinical trials experience.
A. Seidman (2002)
10.1016/S0140-6736(02)09088-8
Anastrozole alone or in combination with tamoxifen versus tamoxifen alone for adjuvant treatment of postmenopausal women with early breast cancer: first results of the ATAC randomised trial.
M. Baum (2002)
HER 2 testing by local , central and reference laboratories in the NCCTG N 9831 trial
M Piccart-Gebhart
10.2307/2529712
Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial.
S. Pocock (1975)
10.1038/bjc.1978.124
Allocation of patients to treatment groups in a controlled clinical study.
S. White (1978)
USE OF CHEMOTHERAPY PLUS A MONOCLONAL ANTIBODY AGAINST HER 2 FOR METASTATIC BREAST CANCER THAT OVEREXPRESSES HER 2
Ennis (2001)
10.1002/cncr.11436
Central nervous system metastases in women who receive trastuzumab‐based therapy for metastatic breast carcinoma
J. Bendell (2003)
10.1136/bmj.322.7300.1479
Forest plots: trying to see the wood and the trees
S. Lewis (2001)
10.1200/JCO.2004.01.175
CNS metastases in breast cancer.
N. Lin (2004)
Trastuzumab ( Herceptin ) cardiotoxicity : clinical course and cardiac biopsy correlations
E TanChiu (2002)
juvant chemohormonal therapy for primary breast cancer should be sequential instead of concurrent : initial results from North American Intergroup Trial 0100 ( SWOG - 8814 )
KS Albain (2002)
10.1056/NEJM200103153441101
Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2.
D. Slamon (2001)
10.1093/JNCI/92.24.1991
HER2 and choice of adjuvant chemotherapy for invasive breast cancer: National Surgical Adjuvant Breast and Bowel Project Protocol B-15.
S. Paik (2000)
10.1038/sj.bjc.6601970
Incidence of cerebral metastases in patients treated with trastuzumab for metastatic breast cancer
A. Clayton (2004)
10.1200/JCO.2005.02.4091
Assessment of cardiac dysfunction in a randomized trial comparing doxorubicin and cyclophosphamide followed by paclitaxel, with or without trastuzumab as adjuvant therapy in node-positive, human epidermal growth factor receptor 2-overexpressing breast cancer: NSABP B-31.
E. Tan-chiu (2005)
10.1126/SCIENCE.3798106
Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene.
D. Slamon (1987)



This paper is referenced by
10.1200/JCO.2005.05.1037
Late cardiac mortality and morbidity in early-stage breast cancer patients after breast-conservation treatment.
E. Harris (2006)
10.1517/14712598.6.11.1161
Non-fucosylated therapeutic antibodies as next-generation therapeutic antibodies
M. Satoh (2006)
10.1007/s00262-007-0316-1
NY-BR-1 protein expression in breast carcinoma: a mammary gland differentiation antigen as target for cancer immunotherapy
Jean-Philippe Theurillat (2007)
10.1111/j.1752-8062.2011.00345.x
Widening the Path to Personalized Medicine
S. Waldman (2011)
10.2217/fon.10.178
Trastuzumab: a new treatment option for HER2-positive metastatic gastric and gastroesophageal junction cancer.
F. Lordick (2011)
10.2217/17455057.5.2.135
Role of Trastuzumab in the Adjuvant Treatment of HER2-Positive Early Breast Cancer
B. Haq (2009)
Is chemotherapy necessary in all breast cancer patients?
V. Kovčin (2009)
MicroRNA-4649-3 p inhibits cell proliferation by targeting protein tyrosine phosphatase SHP-1 in nasopharyngeal carcinoma cells
Xiaofen Pan (2015)
16 Targeting EGFR and HER 2 for Molecular Imaging of Cancer
Lakshmi Sampath (2012)
COMPARISON OF CARDIOTOXIC EFFECTS OF DIFFERENT ERB-B 2 INHIBITORS AND THEIR ASSOCIATED MECHANISMS Candidate
F. Carmine (2011)
Treatment of breast cancer.
K. Maughan (2010)
10.1371/journal.pone.0231999
The genomic landscape of metastatic breast cancer: Insights from 11,000 tumors
J. Rinaldi (2020)
10.1200/JCO.2010.28.15_SUPPL.625
High pathologic complete response (pCR) in HER2-positive breast cancer to novel nonanthracycline neoadjuvant chemotherapy.
A. Zelnak (2010)
10.1007/s10549-020-05614-5
Comparison of outcomes in a population-based cohort of metastatic breast cancer patients receiving anti-HER2 therapy with clinical trial outcomes
I. Gong (2020)
1 Epidermal growth factor receptor family
()
10.1017/S0266462310000103
Budget impact analysis of trastuzumab in early breast cancer: a hospital district perspective.
T. Purmonen (2010)
10.1186/bcr2568
High-resolution genomic and expression analyses of copy number alterations in HER2-amplified breast cancer
J. Staaf (2009)
10.2147/BCTT.S6956
Progress in the development of a therapeutic vaccine for breast cancer.
A. Coveler (2010)
10.1309/ajcpi00tvgigyxaa
Chromogenic In Situ Hybridization Is a Reliable Method for Detecting HER 2 Gene Status in Breast Cancer
Y. Gong (2009)
10.1017/S1470903106004378
Modest benefits of adjuvant chemotherapy in hormone receptor-positive breast cancer
T. Svahn (2006)
THE AUSTRALIA NEW ZEALAND BREAST CANCER TRIALS GROUP: SOME CONTRIBUTIONS TO BREAST CANCER TRIALS
J. Forbes (2006)
10.4255/MCPHARMACOL.10.25
Epigenetic Reactivation of Estrogen Receptor: Promising Tools for Restoring Response to Endocrine Therapy.
N. K. Saxena (2010)
10.3816/CBC.2006.N.025
Concordance between central and local laboratory HER2 testing from a community-based clinical study.
J. Reddy (2006)
Prognostic and Predictive Markers in Primary Breast Cancer - Quality Assurance and Long-term Effects of Adjuvant tamoxifen Treatment
M. Ekholm (2018)
10.1016/j.critrevonc.2010.07.014
Prevention and management of major side effects of targeted agents in breast cancer.
O. Metzger Filho (2012)
10.1080/10543400902802474
Current Issues in Oncology Drug Development, with a Focus on Phase II Trials
D. Sargent (2009)
10.2217/bmm.12.75
Biomarkers in the diagnosis of primary and recurrent breast cancer.
S. Tang (2012)
10.14797/mdcj-15-4-250
Heart Failure in Relation to Tumor-Targeted Therapies and Immunotherapies.
Tolulope A. Agunbiade (2019)
Targeting alternative pathways in HER2-positive breast cancer.
P. Rastogi (2010)
Characterization of a naturally occurring breast cancer subset enriched in EMT and stem cell characteristics
B. Hennessy (2009)
Utilidad clínica de la biopsia selectiva del ganglio centinela tras quimioterapia neoadyuvante en pacientes con cáncer de mama
Romero Vargas (2016)
10.1016/j.ijrobp.2009.04.059
The association between biological subtype and isolated regional nodal failure after breast-conserving therapy.
Jennifer Y. Wo (2010)
See more
Semantic Scholar Logo Some data provided by SemanticScholar