Dose Finding Study for Combination of Capecitabine, Lapatinib and Vinorelbine in Metastatic Breast Cancer
- Sponsor
- Sponsor GmbH
- Study ID
- NCT01238029
- Phase
- PHASE1
- Status
- Terminated
Conditions
- Failure or Contraindication of Trastuzumab Therapy
- First or Second Line Therapy
- HER2 Positive
- Metastatic Breast Cancer
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Lapatinib and Capecitabine and Vinorelbine — DRUGDose finding Study Lapatinib: 1000-1250 oral, once daily, days 1-21 Capecitabine: 1000 mg/sqm oral, bid, days 1-14 Vinorelbine 10-22,5 mg/sqm, i.v. Day 1 + 8
Study Details
The purpose of the study is to investigate safety and efficiency of the triple combination of capecitabine, lapatinib and vinorelbine in patients with metastatic breast cancer.
Key Dates
- Start date
- Oct 31, 2010
- Status verified
- Nov 2014
- Primary completion
- Jul 31, 2014
- Completion
- Jul 31, 2014
Study Design
- Enrollment
- 12 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Capecitabine, Lapatinib, Vinorelbine
Primary Outcome Measure
Identification of maximal tolerable Dose (MTD) of combination with Capecitabine and Lapatinib and Vinorelbine [ Time Frame: 4 months ]
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