Research table: Trastuzumab (Herceptin) for metastatic 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. It may be used alone or in combination with chemotherapy.

Studies show trastuzumab can shrink tumors and improve survival in people with HER2-positive metastatic breast cancer.

Trastuzumab is effective as a first treatment for HER2-positive metastatic breast cancer, as well as a treatment for metastatic breast cancer that has progressed on chemotherapy.  

Learn more about trastuzumab and metastatic breast cancer treatment, including the health risks of trastuzumab.   

Study selection criteria: Phase III clinical trials with 200 or more participants with HER2-positive metastatic breast cancer.  

Study	Study Population (number of participants)	Percent who had Previous Chemotherapy for Metastatic Breast Cancer	Drug(s) Used	Overall Response Rate— Percent who Responded to Treatment (95% CI)	Overall Survival at One Year
Phase III clinical trials
Baselga et al. [3]	406	0%	Trastuzumab with chemotherapy (docetaxel)	69%	62%*
Gelmon et al. [4]	326	0%	Trastuzumab with chemotherapy (paclitaxel or docetaxel)	55%	73%
Blackwell et al. [5-6]	291 women who progressed on chemotherapy with trastuzumab	100%	Trastuzumab with lapatinib	10% (3-12%)	56%
Andersson et al. [7]	284	0%	Trastuzumab with chemotherapy (docetaxel)	59%	88%
			Trastuzumab with chemotherapy (vinorelbine)	59%	88%
Pivot et al. [8]	269	49%	Trastuzumab with chemotherapy (capecitabine)	32%	NA
Valero et al. [9]	263	0%	Trastuzumab with chemotherapy (doxetaxel)	73%	89%
			Trastuzumab with chemotherapy (doxetaxel and carboplatin)	73%	91%
Slamon et al. [10]	235	0%	Trastuzumab with chemotherapy (anthracycline and cyclophosphamide; or paclitaxel)	50%Sig (44-57%)	78%Sig
			Chemotherapy alone (anthracycline and cyclophosphamide; or paclitaxel)	32% (26-38%)	67%
Rugo et al. [11]	228	0%	Trastuzumab with chemotherapy (doxetaxel or paclitaxel)	64% (58-70%)	85%†
Urruticoechea et al. [12]	224	100%	Trastuzumab with chemotherapy (capecitabine)	33% (26-41%)	85%‡
Gianni et al. [13]	208	0%	Trastuzumab with chemotherapy (docetaxel)	70%	NA

CI = Confidence interval

Sig = Statistically significant improvement compared to chemotherapy alone

NA = Not available

* Estimated survival at 15 months of follow-up

† Estimated survival at 10 months of follow-up (estimated survival at 20 months of follow-up was 58%)

‡ Estimated survival at 11 months of follow-up

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, 2023.
3. Baselga J, Cortés J, Kim S, et al. for the CLEOPATRA Study Group. Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. N Engl J Med. 366(2):109-19, 2012.
4. Gelmon KA, Boyle FM, Kaufman B, et al. Lapatinib or trastuzumab plus taxane therapy for human epidermal growth factor receptor 2-positive advanced breast Cancer: final results of NCIC CTG MA.31. J Clin Oncol. 33(14):1574-83, 2015.
5. Blackwell KL, Burstein HJ, Storniolo AM, et al. Randomized study of lapatinib alone or in combination with trastuzumab in women with ErbB2-positive, trastuzumab-refractory metastatic breast cancer. J Clin Oncol. 28(7):1124-30, 2010.
6. Blackwell KL, Burstein HJ, Storniolo AM, et al. 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. 30(21):2585-92, 2012.
7. Andersson M, Lidbrink E, Bjerre K, et al. Phase III randomized study comparing docetaxel plus trastuzumab with vinorelbine plus trastuzumab as first-line therapy of metastatic or locally advanced human epidermal growth factor receptor 2-positive breast cancer: the HERNATA study. J Clin Oncol. 29(3):264-71, 2011.
8. Pivot X, Manikhas A, Żurawski B, et al. CEREBEL (EGF111438): A phase III, randomized, open-label study of lapatinib plus capecitabine versus trastuzumab plus capecitabine in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer. J Clin Oncol. 33(14):1564-73, 2015.
9. Valero V, Forbes J, Pegram MD, et al. Multicenter phase III randomized trial comparing docetaxel and trastuzumab with docetaxel, carboplatin, and trastuzumab as first-line chemotherapy for patients with HER2-gene-amplified metastatic breast cancer (BCIRG 007 study): two highly active therapeutic regimens. J Clin Oncol. 29(2):149-56, 2011.
10. Slamon DJ, Leyland-Jones B, Shak S, et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med. 344(11):783-92, 2001.
11. Rugo HS, Barve A, Waller CF, et al. for the Heritage Study Investigators. Effect of a proposed trastuzumab biosimilar compared with trastuzumab on overall response rate in patients with ERBB2 (HER2)-positive metastatic breast cancer: a randomized clinical trial. JAMA. 317(1):37-47, 2017.
12. Urruticoechea A, Rizwanullah M, Im SA, et al. Randomized phase III trial of trastuzumab plus capecitabine with or without pertuzumab in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer who experienced disease progression during or after trastuzumab-based therapy. J Clin Oncol. 35(26):3030-3038, 2017.
13. Gianni L, Romieu GH, Lichinitser M, et al. AVEREL: a randomized phase III Trial evaluating bevacizumab in combination with docetaxel and trastuzumab as first-line therapy for HER2-positive locally recurrent/metastatic breast cancer. J Clin Oncol. 31(14):1719-25, 2013.

Updated 09/11/23