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Sponsored by: |
Hoffmann-La Roche |
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Information provided by: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00774241 |
This single arm study will assess the efficacy and safety of first line combination treatment with Avastin + docetaxel in patients with HER2 negative metastatic breast cancer.Patients will receive Avastin (15mg/kg iv every 3 weeks) plus docetaxel (75mg/m2 every 3 weeks for 6 cycles). The anticipated time on study treatment is until disease progression, and the target sample size is 100 individuals.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: bevacizumab [Avastin] Drug: docetaxel |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open Label Study of the Effect of First Line Combination Treatment With Avastin and Docetaxel on Disease Response in Patients With Metastatic Breast Cancer |
Estimated Enrollment: | 100 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | November 2011 |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: bevacizumab [Avastin]
15mg/kg iv every 3 weeks
Drug: docetaxel
75mg/m2 every 3 weeks for 18 weeks
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Please reference Study ID Number: ML21343 | 973-235-5000 | |
Contact: or | 800-526-6367 (FOR US ONLY) |
Mexico | |
MEXICO CITY, Mexico, 16200 | |
OBREGON, Mexico, 85000 | |
MADERO, Mexico, 89400 | |
SALTILLO, Mexico, 25000 | |
Chihuahua, Mexico, 31328 | |
MEXICO CITY, Mexico, 14140 | |
LEON, Mexico, 37000 | |
PUEBLA, Mexico, 72240 | |
GUADALAJARA, Mexico, 2292 | |
CUERNAVACA, MORELOS, Mexico, 62290 | |
GUADALAJARA, Mexico, 44280 | |
ACAPULCO, Mexico, 39670 | |
MONTERREY, Mexico, 64380 | |
LA PAZ, Mexico, 23040 | |
CUERNAVACA, Mexico, 62270 | |
LEON, Mexico, 37160 | |
MERIDA, Mexico, 97150 | |
MEXICALI, Mexico, 21100 | |
MONTERREY, Mexico, 64020 | |
CHIAPAS, Mexico, 84300 | |
CHIAPAS, Mexico, 49000 | |
TORREON, Mexico, 27200 |
Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
Study ID Numbers: | ML21343 |
Study First Received: | October 16, 2008 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00774241 |
Health Authority: | Mexico:Ministry of Health (COFEPRIS) |
Docetaxel Skin Diseases Breast Neoplasms Bevacizumab Breast Diseases |
Neoplasms Neoplasms by Site Antineoplastic Agents Growth Substances Therapeutic Uses |
Physiological Effects of Drugs Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |