BEATRICE Study: A Study of Bevacizumab (Avastin) Adjuvant Therapy in Triple Negative Breast Cancer

Conditions

• Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bevacizumab — DRUG
  Bevacizumab was administered at a dose equivalent of 5 mg/kg/week using 1 of 3 different scheduling options depending on the schedule of the adjuvant chemotherapy regimen selected for an individual patient.
• Standard adjuvant chemotherapy — DRUG
  All chemotherapy schedules and doses for each patient were prescribed according to the labeled indication of the country in which the patient was receiving therapy.

Study Details

The main objective of the trial is to compare Invasive Disease-Free Survival (IDFS) of patients randomised to treatment with adjuvant chemotherapy alone or to adjuvant chemotherapy with 1 year of bevacizumab. The secondary objectives of this trial are to: * compare Overall Survival (OS), Breast Cancer-Free Interval (BCFI), Disease- Free Survival (DFS) and Distant Disease-Free Survival (DDFS) of patients randomised to treatment with adjuvant chemotherapy alone or to adjuvant chemotherapy in combination with 1 year of bevacizumab * evaluate the safety and tolerability of bevacizumab An exploratory sub-study (not reported here) was to identify biomarkers (from tumour or serum) predictive of toxicity and for the level of benefit from the addition of bevacizumab to standard adjuvant systemic treatment.

Key Dates

First listed

Sep 12, 2007

Start date

Dec 31, 2007

Status verified

Aug 2015

Primary completion

Feb 29, 2012

Completion

Jun 30, 2014

Study Design

Enrollment

2,591 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Bevacizumab and Chemotherapy
  Participants randomized to receive bevacizumab in combination with chemotherapy as prescribed.
• Active Comparator: Chemotherapy
  Participants randomized to receive standard adjuvant chemotherapy as prescribed.

Primary Outcome Measure

Time to Invasive Disease-free Survival (IDFS) Event [ Time Frame: Event driven (until data cutoff: 29 February 2012: up to 49 months) ]

Locations (44)

Find similar trials in Huntsville, AL

Related Studies

• Collection of Blood From Patients With Cancer
  Recruiting · National Cancer Institute (NCI) · Bethesda, Maryland
• Harvesting Cells for Experimental Cancer Treatments
  Enrolling By Invitation · National Cancer Institute (NCI) · Bethesda, Maryland
• Follow-Up Study of Subjects Previously Enrolled in Poxviral Vector Gene Transfer Studies
  Recruiting · National Cancer Institute (NCI) · Bethesda, Maryland
• Serum Biomarkers to Characterize the Effects of Therapy on Ovarian Reserve in Premenopausal Women With Early-stage Breast Cancer or BRCA Mutations
  Recruiting · Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey