NCT01635465UnknownNot Applicable
A Randomised Controlled Phase II Trial of Vinorelbine Plus Capecitabine Versus Docetaxel Plus Capecitabine in Anthracycline-pretreated Women With Metastatic Breast Cancer.
Tianjin Medical University Cancer Institute and Hospital1 site in 1 country120 target enrollmentStarted: November 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- RECIST 1.1
Study Overview
Brief Summary
Docetaxel plus Capecitabine in anthracycline-pretreated metastatic breast cancer is a recommended scheme in National Comprehensive Cancer Network (NCCN) guideline. Vinorelbine plus Capecitabine is also effective in Metastatic Breast Cancer (MBC) in some clinical study with small sample.
Detailed Description
A randomised controlled trial of vinorelbine plus capecitabine versus docetaxel plus capecitabine in anthracycline-pretreated women with metastatic breast cancer. The primary endpoints of the study is progression free survival (PFS). The secondary endpoints are overall response rate (ORR), overall survival (OS) and safety.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •female ≥ 18 years old ECOG 0-2
Exclusion Criteria
- •brain metastasis
Outcomes
Primary Outcomes
RECIST 1.1
Time Frame: -7 days
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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