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NCT00528567 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Breast Cancer, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 3
Development phase
2,591
Enrollment target
20
Study locations

NCT00528567 is a Phase 3 study of Breast Cancer that has completed, run by Hoffmann-La Roche. The registered enrollment target is 2,591 participants, roughly in line with the 2,801-participant average among 1,224 other Breast Cancer trials with a reported enrollment target. The trial reports 20 study locations across 9 states.

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The verdict

NCT00528567, a Phase 3 study of Breast Cancer, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 3
Development phase
2,591 participants
Enrollment target
20
Study locations

Study Summary

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.

Conditions Studied

Breast Cancer

Interventions

  • DRUG Bevacizumab
  • DRUG Standard adjuvant chemotherapy

Study Locations (20)

California

  • - Bakersfield
  • - Fountain Valley
  • - Greenbrae
  • - Los Angeles
  • - Pleasant Hill

Florida

  • - Gainesville
  • - Orlando
  • - Tamarac

Georgia

  • - Atlanta
  • - Augusta
  • - Lawrenceville

Alabama

  • - Huntsville
  • - Mobile

Connecticut

  • - Fairfield
  • - Stamford

Iowa

  • - Iowa City
  • - Waterloo

Arkansas

  • - Fayetteville

District of Columbia

  • - Washington D.C.

Trial Details

FieldValue
Enrollment Target 2,591 participants
Start Date 2007-12
Est. Completion 2014-06
Phase Phase 3

Sponsor

Hoffmann-La Roche

909 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00528567

The ClinicalTrials.gov registry entry for NCT00528567 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 2,591 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 2,801-participant average among 1,224 other Breast Cancer trials with a reported enrollment target. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Bevacizumab is the first listed.

NCT00528567 reports 20 study locations spanning 9 distinct geographic areas - top geographies include California, Florida, Georgia.

Frequently Asked Questions

What is clinical trial NCT00528567 about?

NCT00528567 is a clinical study titled "BEATRICE Study: A Study of Bevacizumab (Avastin) Adjuvant Therapy in Triple Negative Breast Cancer". 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 Ca...

What is the current status of trial NCT00528567?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,591 participants. The study started on 2007-12. Estimated completion is 2014-06.

What conditions does trial NCT00528567 study?

This clinical trial studies the following conditions: Breast Cancer.

What interventions are being tested in trial NCT00528567?

The interventions under investigation include: Bevacizumab (DRUG), Standard adjuvant chemotherapy (DRUG).

Who is sponsoring clinical trial NCT00528567?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00528567 being conducted?

This trial has 20 study locations across Alabama, Arkansas, California, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.