Lapatinib In Chemotherapy-Naive Or Metastatic Breast Cancer
Part of paid clinical trials in Hollywood, Florida.
- Sponsor
- GlaxoSmithKline
- Study ID
- NCT00089999
- Phase
- PHASE2
- Status
- Completed
Conditions
- Neoplasms, Breast
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Lapatinib — DRUG
Study Details
This phase II study will evaluate and compare the efficacy and tolerability of two dose schedules (1500 mg QD and 500 mg BID) of oral Lapatinib as treatment for patients with advanced or metastatic breast cancer.
Key Dates
- Start date
- Jun 30, 2004
- Status verified
- Jan 2017
- Primary completion
- Mar 31, 2008
- Completion
- Mar 31, 2008
Study Design
- Enrollment
- 138 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Primary Outcome Measure
Number of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR), as Assessed by the Independent Review Committee (IRC) [ Time Frame: From the date of the first dose of investigational product to the first documented evidence of a confirmed CR or PR (up to Study Week 103) ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| GSK Investigational Site | Hollywood | Florida | 33021 | - |
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