This summary table contains detailed information about research studies. Summary tables offer an informative look at the science behind many breast cancer guidelines and recommendations. However, they should be viewed with some caution. In order to read and interpret research tables successfully, it is important to understand some key concepts. Learn how to read a research table.
Introduction: About 15 to 20 percent of breast cancers have high amounts of a protein called HER2/neu on the surface of the cancer cells (called HER2/neu-positive breast cancer or HER2/neu over-expression) [1-2]. The drug trastuzumab (Herceptin) targets HER2/neu-positive cancer cells. When attached to the HER2/neu protein, trastuzumab can slow or stop the growth of the cancer cells.
Learn more about HER2/neu status.
Studies show that chemotherapy plus trastuzumab increases overall survival compared to chemotherapy alone in women with HER2/neu- positive early breast cancer (see table below). Trastuzumab also improves survival for people with HER2/neu-positive metastatic breast cancer (see Table 50).
Trastuzumab has some health risks. Compared to chemotherapy alone, chemotherapy plus trastuzumab increases the risk of heart problems. This risk of heart problems may be higher with chemotherapy regimens that contain an anthracycline than with regimens without an anthracycline . In rare cases, deaths due to heart failure have been linked to trastuzumab use.
Learn more about trastuzumab (Herceptin).
Learn about the strengths and weaknesses of different types of studies.
Study selection criteria: Phase III clinical trials with 100 or more participants and meta-analyses.
Study Population(number of participants)
Percent Surviving—Chemotherapy plus Trastuzumab
Percent Surviving—Chemotherapy Alone(no Trastuzumab)
Absolute Improvement in Overall Survival with the Addition of Trastuzumab to Chemotherapy
Phase III clinical trials
NSABP and NCCTG trials 
HERA Study 
Breast Cancer International Research Group 
Spielmann et al. 
FinHer Study 
Dahabreh et al. 
Moja et al. 
Viani et al. 
Sig = Statistically significant improvement compared to standard treatment alone NS = No statistically significant difference between the two treatment groups *About 2 years of follow-up for each study in the meta-analysis
1. Carey LA, Perou CM, Livasy CA, et al. Race, breast cancer subtypes, and survival in the Carolina Breast cancer Study. JAMA. 295(21):2492-2502, 2006.
2. National Comprehensive Cancer Network. NCCN Guidelines for patients: Breast cancer. Version 2.2011. http://www.nccn.com, 2011.
3. Slamon D, Eiermann W, Robert N, et al. for the Breast Cancer International Research Group. Adjuvant trastuzumab in HER2-positive breast cancer. N Engl J Med. 365(14):1273-83, 2011.
4. Perez EA, Romond EH, Suman VJ, et al. 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. 29(25):3366-73, 2011.
5. Gianni L, Dafni U, Gelber RD, et al. for the Herceptin Adjuvant (HERA) Trial Study Team. Treatment with trastuzumab for 1 year after adjuvant chemotherapy in patients with HER2-positive early breast cancer: a 4-year follow-up of a randomised controlled trial. Lancet Oncol. 12(3):236-244, 2011.
6. Spielmann M, Roché H, Delozier T, et al. Trastuzumab for patients with axillary-node-positive breast cancer: results of the FNCLCC-PACS 04 trial. J Clin Oncol. 27(36):6129-34, 2009.
7. Joensuu H, Bono P, Kataja V, Alanko T, et al. 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. 27(34):5685-92, 2009.
8. Dahabreh IJ, Linardou H, Siannis F, Fountzilas G, Murray S. Trastuzumab in the adjuvant treatment of early-stage breast cancer: a systematic review and meta-analysis of randomized controlled trials. Oncologist. 13(6):620-30, 2008.
9. Moja L, Tagliabue L, Balduzzi S, et al. Trastuzumab containing regimens for early breast cancer. Cochrane Database Syst Rev. 4:CD006243, 2012.
10. Viani GA, Afonso SL, Stefano EJ, De Fendi LI, Soares FV. Adjuvant trastuzumab in the treatment of her-2-positive early breast cancer: a meta-analysis of published randomized trials. BMC Cancer. 7:153, 2007.
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