A Study of Avastin (Bevacizumab) Plus Taxane-Based Therapy in Patients With Locally Recurrent or Metastatic Breast Cancer.

Hoffmann-La Roche2,296 enrolled

Overview

This single arm study will assess the safety and efficacy of a regimen of Avastin plus a taxane, with or without additional chemotherapy, as first-line treatment in patients with locally recurrent or metastatic breast cancer. All patients will receive Avastin (10mg/kg iv every 2 weeks, or 15 mg/kg iv every 3 weeks) plus taxane-based chemotherapy. If taxanes are contraindicated, alternative chemotherapy (other than anthracyclines or pegylated liposomal doxorubicin) may be used. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

2,296

Conditions

Breast Cancer

Interventions

bevacizumab [Avastin]

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * patients, \>=18 years of age; * HER-2 negative adenocarcinoma of the breast, with locally recurrent or metastatic disease; (HER-2 positive patients only if previously treated with Herceptin in the adjuvant setting; * candidates for chemotherapy. Exclusion Criteria: * previous chemotherapy for metastatic or locally recurrent breast cancer; * concomitant hormonal therapy for metastatic or locally recurrent disease; * concomitant Herceptin therapy for treatment of metastatic or locally recurrent HER-2 positive disease; * previous radiotherapy for treatment of metastatic disease; * evidence of CNS metastases.

Locations (457)

Unnamed facility

Buenos Aires, Argentina

Unnamed facility

Buenos Aires, Argentina

Unnamed facility

La Plata, Argentina

Unnamed facility

Rosario, Argentina

Unnamed facility

San Miguel de Tucumán, Argentina

Unnamed facility

Adelaide, Australia

Outcomes

Primary Outcomes

Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) Related to Bevacizumab, Death, and AEs of Special Interest (AESIs)

Adverse events (including laboratory abnormalities) were assessed by the investigator according to the National Cancer Institute - Common Toxicity Criteria (NCI-CTC) grading systems.

Time frame: Day 1 of Cycles 1, 2, 3, 4, 5, and 6 up to 6 months after the last bevacizumab infusion

Secondary Outcomes

Percentage of Participants With Disease Progression

Disease progression was assessed by the investigator per standard clinical practice using Response Evaluation Criteria In Solid Tumors (RECIST) criteria.

Time frame: Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months

Time to Progression (TTP)

TTP was defined as the time period from the start of first-line therapy to investigator-assessed disease progression. Tumor assessments were performed according to standard clinical practice using NCI criteria. Participants who had not progressed at the time of analysis (including those who died before progressive disease \[PD\]) or who were lost to follow-up were censored at the last bevacizumab administration date. Time to disease progression was determined by Kaplan-Meier estimates.

Time frame: Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months

Percentage of Participants With Recorded Death

Time frame: Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months

Overall Survival

Overall Survival was defined as the time from start of first-line therapy to death due to any cause. Participants for whom no death was captured in the clinical database were censored at the last date they were known to be alive. Median time to overall survival was calculated by Kaplan Meier estimates.

Time frame: Baseline, Day 1 of Cycle 4, Final Visit and every 3 months during follow-up until death up to 45 months

Percentage of Participants by Best Overall Response to Treatment

Best overall response is defined as the best response shown throughout the study. Tumor assessment was performed by the investigator using standard clinical practice.

Time frame: Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months