A Study of Avastin (Bevacizumab) in Combination With Taxane-based Chemotherapy as First Line Treatment in Patients With HER-2 Negative Breast Cancer

Study Overview
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Brief Summary
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This single-arm study assessed the efficacy and safety of first-line treatment with Avastin (bevacizumab) in combination with taxane-based chemotherapy (paclitaxel and gemcitabine) in patients with HER-2 negative breast cancer. Patients received Avastin 10 mg/kg iv, paclitaxel 150 mg/m^2 iv, and gemcitabine 200 mg/m^2 iv on Day 1 and Day 15 of each 4-week treatment cycle until disease progression, death, or withdrawal of consent.

Official Title
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An Open Label Study to Assess the Effect of First Line Treatment With Avastin in Combination With Paclitaxel and Gemcitabine in Progression-free Survival in Patients With HER-2 Negative Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Bevacizumab
* Drug: Paclitaxel
* Drug: Gemcitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients, ≥ 18 years of age. Breast cancer, with measurable, locally recurrent or metastatic lesions, or patients with bone metastasis only. HER-2 negative disease. Candidates for chemotherapy. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. Exclusion Criteria: Previous chemotherapy for metastatic or locally advanced breast cancer. Previous radiotherapy for treatment of metastatic breast cancer. Any prior adjuvant treatment with anthracyclines completed < 6 months prior to enrollment. Chronic daily treatment with corticosteroids (≥ 10 mg/day), aspirin (> 325 mg/day) or clopidogrel (> 75mg/day).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bevacizumab + paclitaxel + gemcitabine<br>Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m^2 IV, and gemcitabine 2000 mg/m^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent. | Drug: Bevacizumab<br>* Bevacizumab was supplied as a sterile liquid in glass vials.<br>* Other names: Avastin;Drug: Paclitaxel<br>* Paclitaxel was supplied as a sterile liquid in glass vials.<br>* Other names: Taxol;Drug: Gemcitabine<br>* Gemcitabine was supplied as a sterile liquid in glass vials.<br>* Other names: Gemzar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival | Progression-free survival was defined as the time from enrollment in the study to the first documented disease progression using Response Evaluation Criteria In Solid Tumors (RECIST) or death from any cause, whichever occurred first. | Baseline to the end of the study (up to 2 years 10 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With an Objective Response | An objective response was defined as a complete or partial response determined on 2 consecutive occasions ≥ 4 weeks apart using Response Evaluation Criteria in Solid Tumors (RECIST). Complete response was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must be < 10 mm on the short axis. Partial response was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum. | Baseline to the end of the study (up to 2 years 10 months) | 
| Duration of the Objective Response | Duration of the objective response is defined as the time from a complete or partial response to disease progression or death due to disease. | Baseline to the end of the study (up to 2 years 10 months) | 
| Overall Survival | Overall survival is defined as the time from the first dose of study medication until death. | Baseline to the end of the study (up to 2 years 10 months) |