NCT00508274

Lapatinib +Capecitabine Treatment for Advanced Metastatic Breast Cancer in Women From China

An Open-Label Multicenter Study Administering Lapatinib and Capecitabine (Xeloda) in Women With Advanced or Metastatic Breast Cancer

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neoplasms, Breast

Interventions

Type	Name	Description
DRUG	lapatinib	Lapatinib ditosylate monohydrate tablets, 250 mg, are oval, biconvex, orange, film-coated tablets taken orally.
DRUG	capecitabine	Capecitabine is supplied as a biconvex, oblong, light peach and peach colored, film-coated tablets for oral administration.

Timeline

• Start date: 2007-07-18
• Primary completion: 2015-12-02
• Completion: 2020-07-01
• First posted: 2007-07-27
• Last updated: 2021-09-21
• Results posted: 2009-09-03

Locations

11 sites across 2 countries: China, Hong Kong