Trastuzumab (Herceptin) for early breast cancer
This summary table contains detailed information about research studies. Summary tables are a useful way to look at the science behind many breast cancer guidelines and recommendations. However, to get the most out of the tables, it’s important to understand some key concepts. Learn how to read a research table.
Introduction: About 10-20 percent of newly diagnosed breast cancers are HER2-positive [1-2]. This means they have high amounts of a protein called HER2 on the surface of the cancer cells.
The drug trastuzumab (Herceptin) targets HER2-positive cancer cells. Chemotherapy plus trastuzumab increases overall survival compared to chemotherapy alone for women with HER2-positive early breast cancer .
Trastuzumab also improves survival for people with HER2-positive metastatic breast cancer (see the Trastuzumab for treatment of metastatic breast cancer summary research table).
Learn more about trastuzumab (Herceptin), including possible health risks.
Learn about the strengths and weaknesses of different types of studies.
Study selection criteria: Phase III clinical trials with at least 100 participants and meta-analyses.
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. 
O’Sullivan et al. 
Sig = Statistically significant improvement when trastuzumab was added to treatment with chemotherapy.
NS = No statistically significant difference between the 2 treatment groups
*About 2 years of follow-up for each study in the meta-analysis
† All women had hormone receptor-negative tumors 2 centimeters (2 cm) or smaller. Among 2,263 women with hormone receptor-positive tumors 2 cm or smaller who got hormone therapy instead of chemotherapy, trastuzumab also significantly improved survival.
- Rakha EA, Pinder SE, Bartlett JM, et al. for the National Coordinating Committee for Breast Pathology. Updated UK recommendations for HER2 assessment in breast cancer. J Clin Pathol. 68(2):93-9, 2015.
- Joe BN. Clinical features, diagnosis, and staging of newly diagnosed breast cancer. In: UpToDate. Burstein H, Vora SR (eds.). Waltham, MA: UpToDate, 2019.
- 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.
- Cameron D, Piccart-Gebhart MJ, Gelber RD, et al. for the Herceptin Adjuvant (HERA) Trial Study Team. 11 years’ follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive early breast cancer: final analysis of the HERceptin Adjuvant (HERA) trial. Lancet. 2017 Mar 25;389(10075):1195-1205, 2017.
- 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.
- 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.
- 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.
- 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.
- Moja L, Tagliabue L, Balduzzi S, et al. Trastuzumab containing regimens for early breast cancer. Cochrane Database Syst Rev. 4:CD006243, 2012.
- 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.
- O’Sullivan CC, Bradbury I, Campbell C, et al. Efficacy of adjuvant trastuzumab for patients with human epidermal growth factor receptor 2-positive early breast cancer and tumors ≤ 2 cm: a meta-analysis of the randomized trastuzumab trials. J Clin Oncol. 33(24):2600-8, 2015.