| 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
|
| |
| |
| |
| 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 |