Lapatinib Plus Capecitabine Versus Trastuzumab Plus Capecitabine in ErbB2 (HER2) Positive Metastatic Breast Cancer

Summary

This open label study was designed to evaluate Lapatinib effect on incidence of brain metastases in ErbB2 (HER2) positive metastatic breast cancer patients exposed to prior taxanes or anthracyclines.

Timeline

Start

2009-04-14

Primary completion

2012-06-11

Completion

2018-03-22

Outcome

Missed primary endpoint

registry Lapatinib Plus Capecitabine vs Trastuzumab Plus Capecitabine; p = 0.360; Odds Ratio (OR) 0.65 (95% CI 0.26 to 1.63); Odds Ratio NCT00820222 ↗

paper CEREBEL is inconclusive for the primary end point, and no difference was detected between lapatinb-capecitabine and trastuzumab-capecitabine for the incidence of CNS metastases. PMID 25605838 ↗

Publications

• Pivot X, Manikhas A, Zurawski B, Chmielowska E, Karaszewska B, Allerton R, Chan S, Fabi A, Bidoli P, Gori S, Ciruelos E, Dank M, Hornyak L, Margolin S, Nusch A, Parikh R, Nagi F, DeSilvio M, Santillana S, Swaby RF, Semiglazov V. 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. 2015 May 10;33(14):1564-73. doi: 10.1200/JCO.2014.57.1794. Epub 2015 Jan 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Capecitabine	Small molecule	2000 mg/m2	Oral
Subject	Capecitabine	Small molecule	2500 mg/m2	Oral
Subject	Lapatinib	Small molecule	1250 mg	Oral
Comparator	Trastuzumab	Monoclonal antibody	6 mg/kg	Other

Indications