Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments bevacizumab [avastin], standard adjuvant chemotherapy
Phase phase 3
Sponsor Hoffmann-La Roche
Start date December 2007
End date February 2012
Trial size 2591 participants
Trial identifier NCT00528567, BO20289

Summary

This 2 arm open-label study is evaluating the efficacy and safety of the addition of Avastin (bevacizumab) to standard adjuvant therapy in patients with triple negative breast cancer. Patients were randomized to receive either standard chemotherapy (anthracycline +/- taxane or taxane only), or standard chemotherapy given concurrently with 1 year of Avastin (5mg/kg/week dosing equivalent i.v.). The anticipated time on study treatment was 3-12 months, and the target sample size was 500+ individuals.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
bevacizumab 5 mg/kg/week intravenous every 2- 3 weeks based on body weight in combination with chemotherapy as prescribed (anthracycline containing without taxane every 3-4 weeks or anthracycline with taxane every 2-3 weeks or taxane containing without anthracycline every 3 weeks). Participants discontinued chemotherapy and were treated with bevacizumab only for total treatment with bevacizumab approximately 52 weeks or 18 3-week cycles. Participants then entered a follow-up period.
bevacizumab [avastin]
5 mg/kg/week dosing equivalent intravenous (iv)
standard adjuvant chemotherapy
As prescribed
(Active Comparator)
Participants received chemotherapy as prescribed (anthracycline containing without taxane every 3-4 weeks or anthracycline with taxane every 2-3 weeks or taxane containing without anthracycline every 3 weeks). After completion of chemotherapy participants entered the follow-up period.
standard adjuvant chemotherapy
As prescribed

Primary Outcomes

Measure
Time to Invasive Disease-free Survival (IDFS) Event
time frame: Event driven (until data cutoff: 29 February 2012 up to 49 months)
Percentage of Participants With Invasive Disease-free Survival (IDFS) Events
time frame: Event driven (until data cutoff: 29 February 2012 up to 49 months)
Time to Invasive Disease-free Survival (IDFS) Event Excluding Second Primary Non-Breast Invasive Cancer
time frame: Event driven (until data cutoff: 29 February 2012: up to 49 months)
Percentage of Participants With Invasive Disease-free Survival (IDFS) Events Excluding Second Primary Non-Breast Invasive Cancer
time frame: Event driven (until data cutoff: 29 February 2012: up to 49 months)

Secondary Outcomes

Measure
Time to Overall Survival (OS) Event
time frame: Event driven (until data cutoff: 29 February 2012 up to 49 months)
Percentage of Participants With Overall Survival (OS) Events
time frame: Event driven (until data cutoff: 29 February 2012 up to 49 months)
Time to Breast Cancer-Free Interval (BCFI) Event
time frame: Event driven (until data cutoff: 29 February 2012 up to 49 months)
Percentage of Participants With Breast Cancer-Free Interval (BCFI) Events
time frame: Event driven (until data cutoff: 29 February 2012 up to 49 months)
Time to Disease-Free Survival (DFS) Event
time frame: Event driven (until data cutoff: 29 February 2012 up to 49 months)
Percentage of Participants With Disease-Free Survival (DFS) Events
time frame: Event driven (until data cutoff: 29 February 2012 up to 49 months)
Time to Distant Disease-Free Survival (DDFS) Event
time frame: Event driven (until data cutoff: 29 February 2012 up to 49 months)
Percentage of Participants With Distant Disease-Free Survival (DDFS) Events
time frame: Event driven (until data cutoff: 29 February 2012 up to 49 months)
Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) and Deaths
time frame: Up to 18 months for AEs and Up to 49 months for SAEs

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - adult patients, >=18 years of age; - operable primary invasive breast cancer; - completed definitive loco-regional surgery; - primary tumor centrally confirmed as triple negative. Exclusion Criteria: - locally advanced breast cancers; - previous breast cancer history; - clinically significant cardiovascular disease.

Additional Information

Official title An Open Label 2-arm Study to Evaluate the Impact of Adjuvant Bevacizumab on Invasive Disease Free Survival in Triple Negative Breast Cancer
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.