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BEATRICE Study: A Study of Avastin (Bevacizumab) Adjuvant Therapy in Triple Negative Breast Cancer.
This study is ongoing, but not recruiting participants.
Study NCT00528567   Information provided by Hoffmann-La Roche
First Received: September 11, 2007   Last Updated: November 16, 2009   History of Changes

September 11, 2007
November 16, 2009
February 2007
 
Invasive disease-free survival [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Invasive disease-free survival.
Complete list of historical versions of study NCT00528567 on ClinicalTrials.gov Archive Site
  • Overall survival, breast cancer-free interval, disease-free interval, distant disease-free survival. [ Time Frame: Event driven. ] [ Designated as safety issue: No ]
  • AEs, and laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Overall survival, breast cancer-free interval, disease-free survival, distant disease-free survival. Safety and tolerability
 
BEATRICE Study: A Study of Avastin (Bevacizumab) Adjuvant Therapy in Triple Negative Breast Cancer.
An Open Label 2-arm Study to Evaluate the Impact of Adjuvant Bevacizumab on Invasive Disease Free Survival in Triple Negative Breast Cancer

This 2 arm open-label study will evaluate the efficacy and safety of the addition of Avastin (bevacizumab) to standard adjuvant therapy in patients with triple negative breast cancer. Patients will be 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 is 3-12 months, and the target sample size is 500+ individuals.

 
Phase III
Interventional
Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Breast Cancer
  • Drug: bevacizumab [Avastin]
  • Drug: Standard adjuvant chemotherapy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
2530
September 2014
 

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Austria,   Belgium,   Bosnia and Herzegovina,   Brazil,   Canada,   China,   Costa Rica,   Czech Republic,   Finland,   France,   Germany,   Greece,   Hong Kong,   Israel,   Italy,   Japan,   Korea, Republic of,   Macedonia, The Former Yugoslav Republic of,   Malaysia,   Mexico,   Netherlands,   New Zealand,   Peru,   Philippines,   Poland,   Portugal,   Romania,   Russian Federation,   Serbia,   Singapore,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   Thailand,   United Kingdom
 
NCT00528567
Disclosures Group, Hoffmann-La Roche
BO20289
Hoffmann-La Roche
 
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP