Lapatinib +Capecitabine Treatment for Advanced Metastatic Breast Cancer in Women From China
- Sponsor
- Novartis Pharmaceuticals
- Study ID
- NCT00508274
- Phase
- PHASE3
- Status
- Terminated
Conditions
- Neoplasms, Breast
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- lapatinib — DRUGLapatinib ditosylate monohydrate tablets, 250 mg, are oval, biconvex, orange, film-coated tablets taken orally.
- capecitabine — DRUGCapecitabine is supplied as a biconvex, oblong, light peach and peach colored, film-coated tablets for oral administration.
Study Details
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.
Key Dates
- Start date
- Jul 18, 2007
- Status verified
- Aug 2021
- Primary completion
- Dec 2, 2015
- Completion
- Jul 1, 2020
Study Design
- Enrollment
- 52 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: lapatinib in combination with capecitabinedaily oral lapatinib (1250 mg/day) in combination with capecitabine (2000mg/m2/day on days1-14 every 21 days)
Primary Outcome Measure
Clinical Benefit Rate (CBR) [ Time Frame: Baseline; every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed was approx. 90 months ]