Abraxane, Avastin, and Gemcitabine as First-Line Therapy for Patients With Metastatic Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00503906|
Recruitment Status : Completed
First Posted : July 19, 2007
Results First Posted : April 2, 2013
Last Update Posted : May 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Avastin Drug: Gemcitabine Drug: Abraxane||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Abraxane, Avastin and Gemcitabine for First Line Metastatic Breast Cancer|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||March 2011|
Experimental: Abraxane, Avastin and Gemcitabine
Each treatment cycle is 28 days. Participants will be treated until disease progression:
Other Name: Bevacizumab
Other Name: Gemzar
Other Name: Albumin-Bound Paclitaxel Formulation
- Median Progression-Free Survival [ Time Frame: 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.
- Rates of Partial Response (PR), Complete Response (CR) and Overall Response (ORR) in Study Participants [ Time Frame: 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 [ Time Frame: 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.
- Relationship Between Circulating Tumor Cells (CTC) and Disease Progression as Measured by Presence of CTC at Baseline and Over the Course of Study Treatment [ Time Frame: 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. [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00503906
|United States, Florida|
|University of Miami|
|Miami, Florida, United States, 33136|
|Principal Investigator:||Stefan Glück, MD, PhD||University of Miami|