Phase 2 Study of Gemzar, Taxol & Avastin Combination as 1st Line Treatment for Metastatic Breast Cancer

Phase 2

Completed

• Conditions: Breast Cancer; Metastatic Breast Cancer
• Interventions: Drug: Gemcitabine; Drug: Paclitaxel; Drug: Bevacizumab

• Registration Number: NCT00403130
• Lead Sponsor: George Albert Fisher

Brief Summary

Single-institution phase 2 trial investigating the efficacy of capecitabine, oxaliplatin and bevacizumab for patients with metastatic neuroendocrine tumors.

Detailed Description

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).

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-11-22
• Study First Submitted QC: 2006-11-22
• Study First Posted: 2006-11-23
• Primary Completion: 2010-09
• Study Completion: 2012-11
• Results First Submitted: 2017-02-03
• Results First Submitted QC: 2017-02-03
• Results First Posted: 2017-03-24
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-30
• Last Update Posted: 2019-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 31

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Phase II 3-drug regimen	Gemcitabine	Gemcitabine + Paclitaxel + Bevacizumab
Phase II 3-drug regimen	Paclitaxel	Gemcitabine + Paclitaxel + Bevacizumab
Phase II 3-drug regimen	Bevacizumab	Gemcitabine + Paclitaxel + Bevacizumab

Primary Outcome Measures

Name	Time	Method
Time-to-Progression (TTP)	2 years	Time-to-Progression (TTP) was assessed as the time from start of treatment to progression, as observed on radiographic scans and assessed per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria for progressive disease (ie, a 5-mm absolute increase of the sum of the longest diameters of the target lesions in addition to a 20% increase in the sum of the target lesions)

Secondary Outcome Measures

Name	Time	Method
Response Rates	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	6 years	Overall Survival (OS) as determined by confirmed date of death. Participants without documentation as either alive or deceased as of 6 years from the start of treatment were considered lost-to-follow-up.
Overall Survival (OS), All Participants	6 years	Overall Survival (OS), based on date of death or last known date alive

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States