A Randomized Phase III Study to Investigate the Efficacy and Safety of Docetaxel + Capecitabine vs. Vinorelbine + Capecitabine Followed by Capecitabine Alone as 1st Therapy on Locally Advanced and Metastatic Breast Cancer Patients.
We designed the randomized non-inferiority study. Main Inclusion& exclusion Criteria
include: 1) Histologically or cytologically confirmed breast cancer with unresectable
locally advanced and/or metastatic disease; 2) Untreated patients with unresectable locally
advanced and/or metastatic disease; 3) with at least 1 lesion measurable by radiological
method(RECIST criteria); 4) Karnofsky Performance Status(KPS)≥70; 5) normal Adequate
hepatic, renal, and bone marrow function; 6) Life expectancy of at least 12 weeks; 7) No
previous chemotherapy for metastatic breast cancer. Primary endpoint is Progression free
survival(PFS), second endpoint are safety profiles (National Cancer Institute-Common
Toxicity Criteria 3.0, NCI-CTC 3.0), overall survival and response rate. During Primary
study treatment, Arm A: Capecitabine: 1,000 mg/m2 per ora(PO) twice daily (day 1-14),
Vinorelbine 25 mg/m2 intravenous(IV) over 3 hours on day 1 and 8, every 3 weeks, 21 days as
one cycle and 6-8 cycles are required; Arm B: Capecitabine: 1,000 mg/m2 PO twice daily (day
1-14), Docetaxel 75 mg/m2 IV over 3 hours on day 1, every 3 weeks, 21 days as one cycle and
6-8 cycles are required. Patients who are responding (complete or partial), or whose disease
is stable followed by Capecitabine: 1,000 mg/m2 PO twice daily (day 1-14) 21 days as one
cycle until progression or unacceptable toxicity
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression free survival(PFS)
Progress free survival is defined as the time from first dose of test drug to the first recording of disease progression or the date of death in patients with no evidence of disease progression. In addition to hazard ratios and associated 95% confidence intervals, the results from these analyses will, for each treatment arm, also be summarized by Kaplan-Meier plots, medians and 95% confidence intervals.
Up to 2 years until disease progression or death
No
Binghe Xu, MD, Ph.D
Principal Investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
China: Food and Drug Administration
ML25241
NCT01126138
July 2010
August 2015
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