Dose Finding Study for Combination of Capecitabine, Lapatinib and Vinorelbine in Metastatic Breast Cancer
NCT01238029 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2014-11-21
Summary
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.
Conditions
- Metastatic Breast Cancer
- HER2 Positive
- First or Second Line Therapy
- Failure or Contraindication of Trastuzumab Therapy
Interventions
- DRUG
-
Lapatinib and Capecitabine and Vinorelbine
Dose 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
Sponsors & Collaborators
-
iOMEDICO AG
collaborator INDUSTRY -
Arbeitsgemeinschaft fur Internistische Onkologie
collaborator OTHER -
Arbeitskreis Klinische Studien
collaborator OTHER - collaborator INDUSTRY
-
Sponsor GmbH
lead OTHER
Principal Investigators
-
Ulrike Soeling, MD · Goethestr. 47, 34119 , Kassel, Germany
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-10-31
- Primary Completion
- 2014-07-31
- Completion
- 2014-07-31
Countries
- Germany
Study Locations
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