Research table: Lapatinib (Tykerb) 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: The drug lapatinib (Tykerb) is a tyrosine-kinase inhibitor. These drugs target tyrosine-kinase enzymes, which are important for cell functions.

Lapatinib is used to treat HER2-positive metastatic breast cancer in women who’ve already had chemotherapy and trastuzumab (Herceptin).

Lapatinib combined with chemotherapy, hormone therapy or trastuzumab may increase progression-free survival (meaning it may give people more time before the cancer worsens).

Learn more about lapatinib, including its side effects.

Study selection criteria: Randomized clinical trials with 100 or more participants with HER2-positive metastatic breast cancer.

For randomized clinical trials of chemotherapy, all participants had past treatment with chemotherapy and trastuzumab for metastatic breast cancer. For randomzied clinical trials of hormone therapy, past treatment varied.  

Study	Study Population (number of participants)	Drug(s) Used		Overall Response Rate—Percent who Responded to Treatment (95% CI)	Overall Survival at One Year
Randomized clinical trials-Chemotherapy
Guan et al. [1]	444	Lapatinib with chemotherapy (paclitaxel)		69% (63%-75%)	69%*
		Chemotherapy alone (paclitaxel)		50% (43%-56%)	63%*
Geyer et al. [2]	324	Lapatinib with chemotherapy (capecitabine)		22% (16%-29%)	14%
		Chemotherapy alone (capecitabine)		14% (9%-21%)	14%
Randomized clinical trials-Hormone therapy
Burstein et al. [3]	295	Lapatinib with fulvestrant		20% (13%-29%)	77%†
		Fulvestrant alone		9% (5%-17%)	80%†
Schwartzberg et al. [4]	219 women with no prior treatment for metastatic breast cancer	Lapatinib with letrozole		28%‡
		Letrozole alone		15%‡
Johnston et al. [5]	219	Lapatinib with letrozole		33%	72%*
		Letrozole alone		32%	64%*
Randomized clinical trials-Trastuzumab
Blackwell et al. [6-7]	291	Lapatinib with trastuzumab		10%	56%
		Lapatinib alone		7%	41%

* Estimated overall survival at 15 months

† Estimated overall survival at 12 months

‡ Statistically significant difference between the 2 treatment groups

References

1. Guan Z, Xu B, DeSilvio ML, et al. Randomized trial of lapatinib versus placebo added to paclitaxel in the treatment of human epidermal growth factor receptor 2-overexpressing metastatic breast cancer. J Clin Oncol. 31(16):1947-53, 2013. 
2. Geyer CE, Forster J, Lindquist D, et al. Lapatinib plus capecitabine for HER2-positive advanced breast cancer. N Engl J Med. 355(26):2733-43, 2006.
3. Burstein HJ, Cirrincione CT, Barry WT, et al. Endocrine therapy with or without inhibition of epidermal growth factor receptor and human epidermal growth factor receptor 2: a randomized, double-blind, placebo-controlled phase III trial of fulvestrant with or without lapatinib for postmenopausal women with hormone receptor-positive advanced breast cancer-CALGB 40302 (Alliance). J Clin Oncol. 32(35):3959-66, 2014.
4. Schwartzberg LS, Franco SX, Florance A, O’Rourke L, Maltzman J, Johnston S. Lapatinib plus letrozole as first-line therapy for HER-2+ hormone receptor-positive metastatic breast cancer. Oncologist. 15(2):122-9, 2010.
5. Johnston S, Pippen J Jr, Pivot X, et al. Lapatinib combined with letrozole versus letrozole and placebo as first-line therapy for postmenopausal hormone receptor-positive metastatic breast cancer. J Clin Oncol. 27(33):5538-46, 2009.
6. 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.
7. 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.

Updated 09/11/23