Abraxane, Avastin, and Gemcitabine as First-Line Therapy for Patients With Metastatic Breast Cancer
- Registration Number
- NCT00503906
- Lead Sponsor
- University of Miami
- Brief Summary
The investigators hypothesize that the combination of Gemzar®, Abraxane® and Avastin will increase the progression-free survival (PFS) in patients with first line metastatic breast cancer and in patients who received neoadjuvant and/or adjuvant chemotherapy present with definable metastatic disease, 6 or more months after primary treatment.
- Detailed Description
This is a phase 2, single arm study. Participants will be treated with combination Gemzar, Abraxane and Avastin therapy until disease progression. Each treatment cycle is 28 days.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Abraxane, Avastin and Gemcitabine Avastin Each treatment cycle is 28 days. Participants will be treated until disease progression: * Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by; * Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by; * Avastin: 10 mg/kg IV on days 1 and 15 of each cycle. Abraxane, Avastin and Gemcitabine Gemcitabine Each treatment cycle is 28 days. Participants will be treated until disease progression: * Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by; * Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by; * Avastin: 10 mg/kg IV on days 1 and 15 of each cycle. Abraxane, Avastin and Gemcitabine Abraxane Each treatment cycle is 28 days. Participants will be treated until disease progression: * Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by; * Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by; * Avastin: 10 mg/kg IV on days 1 and 15 of each cycle.
- Primary Outcome Measures
Name Time Method Median Progression-Free Survival Up to 24 months Progression-free survival will be measured from the first dose date to the earliest date of documented evidence of progressive disease or the date of death due to any causes, whichever occurs first.
- Secondary Outcome Measures
Name Time Method Relationship Between Circulating Tumor Cells (CTC) and Disease Progression as Measured by Presence of CTC at Baseline and Over the Course of Study Treatment Baseline, over the course of Treatment, about 1 year Exploration of the relationship between circulating tumor cells (CTC) and disease progression, by measuring CTC at baseline and over the course of treatment.
Relationship Between SPARC Expression and Response to Protocol Therapy. Baseline, over the course of treatment, about 1 year Relationship between SPARC expression and response to this chemotherapy combination and relation to progression free survival.
Rates of Partial Response (PR), Complete Response (CR) and Overall Response (ORR) in Study Participants After two cycles, about 60 days Rates of partial response (PR), complete response (CR) and overall response (PR+CR = ORR) in study participants according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0.
Rate of Toxicity in Study Participants Over the course of study treatment. Determination of safety and side effect profile of the protocol therapy including the rate of toxicity in study participants. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for adverse event reporting.
Trial Locations
- Locations (1)
University of Miami
🇺🇸Miami, Florida, United States