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

Phase 2

Completed

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

• Registration Number: NCT00846027
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-02-17
• Study First Submitted QC: 2009-02-17
• Study First Posted: 2009-02-18
• Primary Completion: 2011-12
• Study Completion: 2013-01
• Results First Submitted: 2014-05-27
• Results First Submitted QC: 2014-05-27
• Results First Posted: 2014-06-26
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-09
• Last Update Posted: 2014-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bevacizumab + paclitaxel + gemcitabine	Bevacizumab	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.
Bevacizumab + paclitaxel + gemcitabine	Gemcitabine	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.
Bevacizumab + paclitaxel + gemcitabine	Paclitaxel	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.

Primary Outcome Measures

Name	Time	Method
Progression-free Survival	Baseline to the end of the study (up to 2 years 10 months)	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With an Objective Response	Baseline to the end of the study (up to 2 years 10 months)	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.
Duration of the Objective Response	Baseline to the end of the study (up to 2 years 10 months)	Duration of the objective response is defined as the time from a complete or partial response to disease progression or death due to disease.
Overall Survival	Baseline to the end of the study (up to 2 years 10 months)	Overall survival is defined as the time from the first dose of study medication until death.