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Sponsored by: |
Hoffmann-La Roche |
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Information provided by: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00717405 |
This single arm study will assess the efficacy and safety of preoperative treatment with Avastin combined with Herceptin-based chemotherapy in patients with primary inflammatory HER2-positive breast cancer. Patients will be treated with a total of 8 cycles of pre-operative chemotherapy + Avastin + Herceptin. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: trastuzumab [Herceptin] Drug: bevacizumab [Avastin] Drug: Standard chemotherapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open Label Study to Assess the Rate of Pathological Complete Response in Patients With Primary Inflammatory HER2-Positive Breast Cancer Treated With Avastin + Herceptin Based Chemotherapy |
Estimated Enrollment: | 50 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | July 2013 |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: trastuzumab [Herceptin]
8mg/kg iv loading dose followed by 6mg/kg iv 3 weekly in cycles 5-8.
Drug: bevacizumab [Avastin]
15mg/kg iv 3 weekly in cycles 1-8
Drug: Standard chemotherapy
As prescribed
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Please reference Study ID Number: ML21531 | 973-235-5000 | |
Contact: or | 800-526-6367 (FOR US ONLY) |
France | |
Recruiting | |
MARSEILLE, France, 13273 | |
Recruiting | |
LYON, France, 69373 | |
Recruiting | |
SAINT HERBLAIN, France, 44805 | |
Recruiting | |
CAEN, France, 14076 | |
Recruiting | |
NICE, France, 06189 | |
Recruiting | |
DIJON, France, 21000 | |
Recruiting | |
MONTPELLIER, France, 34298 | |
Recruiting | |
SAINT-CLOUD, France, 92210 | |
Recruiting | |
PARIS, France, 75249 | |
Recruiting | |
TOULOUSE, France, 31052 | |
Recruiting | |
VILLEJUIF, France, 94805 | |
Not yet recruiting | |
BORDEAUX, France, 33076 | |
Recruiting | |
ROUEN, France, 76000 | |
Not yet recruiting | |
ANGERS, France, 49033 | |
Recruiting | |
RENNES, France, 35062 | |
Recruiting | |
STRASBOURG, France, 67065 | |
Recruiting | |
CLERMONT-FERRAND, France, 63011 | |
Recruiting | |
STRASBOURG, France, 67098 | |
Recruiting | |
REIMS, France, 51056 | |
Recruiting | |
PARIS, France, 75970 | |
Recruiting | |
PARIS, France, 75010 | |
Recruiting | |
SAINT BRIEUC, France, 22000 | |
Not yet recruiting | |
AVIGNON, France, 84082 | |
Not yet recruiting | |
GRENOBLE, France, 38100 | |
Recruiting | |
BESANCON, France, 25030 | |
Not yet recruiting | |
LE MANS, France, 72000 | |
Recruiting | |
BREST, France, 29609 | |
Recruiting | |
SAINT-PRIEST-EN-JAREZ, France, 42270 | |
Recruiting | |
GRENOBLE, France, 38043 | |
Recruiting | |
BORDEAUX, France, 33030 | |
Not yet recruiting | |
TOURS, France, 37044 | |
Recruiting | |
LILLE, France, 59020 | |
Recruiting | |
NANTES, France, 44202 | |
Recruiting | |
VANDOEUVRE-LES-NANCY, France, 54511 |
Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
Study ID Numbers: | ML21531, 2008-000783-16 |
Study First Received: | July 16, 2008 |
Last Updated: | April 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00717405 History of Changes |
Health Authority: | France: Agence francaise de securite sanitaire des produits de sante (AFSSAPS) |
Skin Diseases Trastuzumab Breast Neoplasms |
Bevacizumab Angiogenesis Inhibitors Breast Diseases |
Skin Diseases Antineoplastic Agents Growth Substances Physiological Effects of Drugs Breast Neoplasms Bevacizumab Angiogenesis Inhibitors Pharmacologic Actions |
Neoplasms Neoplasms by Site Therapeutic Uses Trastuzumab Growth Inhibitors Angiogenesis Modulating Agents Breast Diseases |