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

Hoffmann-La Roche90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

BevacizumabDRUG

Bevacizumab was supplied as a sterile liquid in glass vials.

PaclitaxelDRUG

Paclitaxel was supplied as a sterile liquid in glass vials.

GemcitabineDRUG

Gemcitabine was supplied as a sterile liquid in glass vials.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (23)

Unnamed facility

Elda, Alicante, Spain

Unnamed facility

Barcelona, Barcelona, Spain

Unnamed facility

Outcomes

Primary Outcomes

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.

Time frame: Baseline to the end of the study (up to 2 years 10 months)

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline to the end of the study (up to 2 years 10 months)

Data from ClinicalTrials.gov

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