Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Recurrence

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Gemcitabine

Bevacizumab

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Antimetabolites

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.

Avastin

Abraxane

Stefan Glück, MD, PhD

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.

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.

Abraxane, Avastin, and Gemcitabine as First-Line Therapy for Patients With Metastatic Breast Cancer

A Phase II Study of Abraxane, Avastin and Gemcitabine for First Line Metastatic Breast Cancer

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 (PR+CR = ORR) in study participants according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0.

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.

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 this chemotherapy combination and relation to progression free survival.

University of Miami

Abraxane, Avastin and Gemcitabine

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Stefan Gluck MD

Median Progression-Free Survival

Overall Response Rate (ORR)

Complete Response (CR)

Partial Response (PR)

Evaluable patients are study-eligible patients who receive an initial infusion of combination chemotherapy consisting of Gemcitabine, NAB paclitaxel and Bevacizumab and have had at least one CT scan for evaluation of disease status.

Rates of Partial Response (PR), Complete Response (CR) and Overall Response (ORR) in Study Participants

Alopecia, Grade 1/2

Fatigue, Grade 1/2

Bone Pain, Grade 1/2

Nausea, Grade 1/2

Skin rash/lesions, Grade 1/2

Neutropenia, Grade 1/2

Grade 3/4 Toxicities

Rate of Toxicity in Study Participants

Data were not collected for this outcome measure.

Relationship Between Circulating Tumor Cells (CTC) and Disease Progression as Measured by Presence of CTC at Baseline and Over the Course of Study Treatment

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.

Avastin

Gemcitabine

Abraxane

Relationship Between SPARC Expression and Response to Protocol Therapy.

Rate of overall survival in study participants. Overall survival will be measured from the date of enrollment to the date of death from any cause, or the date of last contact (censored observations.)

Rate of Overall Survival in Study Participants

Overall Study

Spots Global Cancer Trial Database for Abraxane, Avastin, and Gemcitabine as First-Line Therapy for Patients With Metastatic Breast Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial