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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: Completed Phase 3 study of Breast Cancer, sponsored by Hoffmann-La Roche.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
IDFS, was a composite endpoint defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site);Death attributable to any cause; Contralateral (opposite side of the body) invasive breast c
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 2,591 participants |
| Start Date | 2007-12 |
| Est. Completion | 2014-06 |
| Phase | Phase 3 |
What the finished NCT00528567 record still lists
NCT00528567 is an interventional study that assigns participants to a tested intervention. Its 2,591 participants enrollment target places it among the larger protocols in the corpus, roughly in line with the 2,801-participant average among 1,224 other Breast Cancer trials with a reported enrollment target.
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 names 20 study sites across 9 states, led by 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.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00528567's enrollment target sits among peer trials
2,591 57th of 1224 higher than 1,168 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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