Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Disease Progression

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Paclitaxel

Bevacizumab

Albumin-Bound Paclitaxel

Taxane

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Antimetabolites

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 was supplied as a sterile liquid in glass vials.

Paclitaxel was supplied as a sterile liquid in glass vials.

Gemcitabine was supplied as a sterile liquid in glass vials.

Clinical Trials

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.

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

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

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.

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 is defined as the time from a complete or partial response to disease progression or death due to disease.

Overall survival is defined as the time from the first dose of study medication until death.

Hoffmann-La Roche

Safety population: All enrolled participants who receive at least 1 dose of medication and who satisfied all inclusion criteria and none of the exclusion criteria. 7 participants did not receive at least 1 dose of medication and 1 participant did not satisfy an inclusion criterion. These 8 participants were not included in the safety population.

Bevacizumab + Paclitaxel + Gemcitabine

Age, Continuous

Sex: Female, Male

Intent-to-treat population: All participants enrolled in the study.

Medical Communications

Intent-to-treat population: All participants who were enrolled in the study.

Progression-free Survival

Intent-to-treat population: All participants who were enrolled in the study. Only participants who had a response evaluation were included in the analysis.

Percentage of Participants With an Objective Response

Intent-to-treat population: All participants who were enrolled in the study. Only participants who had a response were included in the analysis.

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

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial