Research table: Trastuzumab (Herceptin) for early breast cancer treatment

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% to 20% of newly diagnosed breast cancers are HER2-positive [1-2]. HER2-positive tumors have a lot of the 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 [1].  

Learn more about trastuzumab (including side effects) and treatment for early breast cancer.

Learn about trastuzumab and treatment for metastatic breast cancer.

Learn about the strengths and weaknesses of different types of studies.

Study selection criteria: Randomized clinical trials with at least 200 participants and meta-analyses.

Study	Study Population (number of participants)	Follow-up (years)	Percent Surviving— Chemotherapy plus Trastuzumab	Percent Surviving— Chemotherapy Alone (no Trastuzumab)	Absolute Improvement in Overall Survival with the Addition of Trastuzumab to Chemotherapy
Randomized clinical trials
NSABP and NCCTG trials [3]	4,046	8	84%	75%	9% Sig
HERA Study [4]	3,399	12	79%	73%	6% Sig
Breast Cancer International Research Group [5]	3,222	5	91%-92%	87%	4%-5% Sig
Spielmann et al. [6]	528	4	93%	92%	NS
FinHer Study [7]	231	5	90%	82%	NS
Meta-analyses
Dahabreh et al. [8]	13,493	2-3	–	–	Sig
Moja et al. [9]	9,945 (7 studies)	2-5	–	–	Sig
Viani et al. [10]	9,117	2*	94%	92%	Sig
O’Sullivan et al. [11]	1,957 (5 studies)†	8	88%	79%	Sig

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.

References

1. 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. 
2. Joe BN. Clinical features, diagnosis, and staging of newly diagnosed breast cancer. In: UpToDate. Burstein H, Vora SR (eds.). Waltham, MA: UpToDate, 2024.
3. Perez EA, Romond EH, Suman VJ, et al. 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. 32(33):3744-52, 2014.
4. 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.
5. 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. 
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.
11. 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. 

Updated 08/09/24