A Randomised Controlled Phase II Trial of Vinorelbine Plus Capecitabine Versus Docetaxel Plus Capecitabine in Anthracycline-pretreated Women With Metastatic Breast Cancer.
N/A
18 Years
N/A
18 Years
N/A
Not Enrolling
Female
Anthracycline-pretreated Metastatic Breast Cancer
Female
Anthracycline-pretreated Metastatic Breast Cancer
Trial Information
A Randomised Controlled Phase II Trial of Vinorelbine Plus Capecitabine Versus Docetaxel Plus Capecitabine in Anthracycline-pretreated Women With Metastatic Breast Cancer.
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.
Inclusion Criteria:
- female ≥ 18 years old ECOG 0-2
Exclusion Criteria:
- brain metastasis
Type of Study:
Observational
Study Design:
Observational Model: Case Control, Time Perspective: Prospective
Outcome Measure:
RECIST 1.1
Outcome Time Frame:
-7 days
Safety Issue:
Yes
Authority:
China: Food and Drug Administration
Study ID:
CIH-LSF-201205001
NCT ID:
NCT01635465
Start Date:
August 2013
Completion Date:
December 2014
Related Keywords:
- Anthracycline-pretreated Metastatic Breast Cancer
- Breast Neoplasms
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