Conditions: Neoplasms, Breast
Keywords: Advanced Metastatic Breast Cancer HER2 positive HER2+ breast cancer lapatinib TYVERB TYKERB Capecitabine
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 52
Healthy volunteers: no

Brief summary:
Local study in China and Hong Kong to evaluate safety and efficacy in lapatinib + capecitabine in women with Human epidermal growth factor receptor 2 (HER2) positive advanced or metastatic breast cancer.

Detailed description:
The Primary objective of the study was to evaluate the overall clinical benefit response (CBR) rate.

This was a single arm, open-label, multi-center study of lapatinib plus capecitabine in women from mainland China and Hong Kong who had advanced or metastatic breast cancer that progressed on prior chemotherapies with or without trastuzumab.

Participants received study treatment until disease progression, unacceptable toxicity, or withdrawal for any other reasons.

Arms:
arm 1: daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000mg/m2/day on days1-14 every 21 days)

Interventions: intervention 1: lapatinib intervention 2: capecitabine
Intervention descriptions: intervention 1: Lapatinib ditosylate monohydrate tablets, 250 mg, are oval, biconvex, orange, film-coated tablets taken orally. intervention 2: Capecitabine is supplied as a biconvex, oblong, light peach and peach colored, film-coated tablets for oral administration.

Protocol document: