Phase 2 Study of Gemzar, Taxol & Avastin Combination as 1st Line Treatment for Metastatic Breast Cancer
|Breast Cancer Metastatic Breast Cancer||Drug: Gemcitabine Drug: Paclitaxel Drug: Bevacizumab||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||Phase II Open Label Study of Gemcitabine, Paclitaxel and Bevacizumab Combination as First Line Treatment for Metastatic Breast Cancer|
- Time-to-Progression (TTP) [ Time Frame: 2 years ]Time-to-Progression (TTP) was assessed as the time from start of treatment to progression, as observed on radiographic scans.
- Response Rates [ Time Frame: 24 weeks ]
The best overall response was recorded for each participant from randomization until disease progression/recurrence, using any increase from the smallest measurements recorded since randomization as the indicator of Progressive Disease (PD).
Overall response was determined on the basis of response at the target and non-target lesions, and the appearance of new lesions, as follows.
Target Nontarget New Lesions Overall Response
- Complete Complete None Overall Complete Response
- Complete Incomplete response/ None Overall Partial Response Stable Disease (SD)
- Partial Not PD None Overall Partial Response
- SD Not PD None Overall Stable Disease
- PD Any Yes/No Overall PD
- Any PD Yes/No Overall PD
- Any Any Yes Overall PD
Overall Response Rate (ORR) was assessed as the sum of the Complete Response (CR) rate and the Partial Response (PR) rate.
- Overall Survival (OS), Confirmed [ Time Frame: 6 years ]Overall Survival (OS) as determined by confirmed date of death
- Overall Survival (OS), All Participants [ Time Frame: 6 years ]Overall Survival (OS), based on date of death or last known date alive
|Study Start Date:||February 2006|
|Study Completion Date:||November 2012|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
Experimental: Phase II 3-drug regimen
Gemcitabine + Paclitaxel + Bevacizumab
Gemcitabine 1000 mg/m2 by IV infusion, days 1, 8, and 15 in 28-day cycles
Other Name: GemzarDrug: Paclitaxel
Paclitaxel 80 mg/m2 by IV infusion, days 1, 8, and 15 in 28-day cycles
Other Name: TaxolDrug: Bevacizumab
Bevacizumab 10 mg/kg by IV infusion, days 1 and 15 in 28-day cycles
Other Name: Avastin
This study will evaluate the time-to-progression (TTP) in patients with metastatic breast cancer, receiving 1st line therapy with bevacizumab in combination with paclitaxel and gemcitabine.
Secondary objectives will include response rates and overall survival (OS).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00403130
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||George A Fisher, MD, PhD||Stanford University|