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Sponsors and Collaborators: |
University of Alabama at Birmingham Genentech Breast Cancer Research Foundation |
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Information provided by: | University of Alabama at Birmingham |
ClinicalTrials.gov Identifier: | NCT00530868 |
This purpose of this trial is to show that the combination of Avastin and hormone therapy should be more effective than hormone therapy alone for the treatment of breast cancer.
Condition | Intervention | Phase |
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Breast Cancer Cancer of the Breast Breast Neoplasm |
Other: Letrozole (Femara) Drug: Letrozole; Avastin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Phase II, Randomized, Open Label Trial of Pre-Operative (Neoadjuvant)Letrozole (Femara) vs. Letrozole in Combination With Avastin in Post Menopausal Women With Newly Diagnosed Operable Breast Cancer |
Estimated Enrollment: | 75 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Letrozole plus Avastin
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Other: Letrozole (Femara)
Letrozole 2.5 mg PO a day for 24 weeks
Drug: Letrozole; Avastin
Letrozole 2.5 mg PO a day and Avastin 15 mg/kg IV every 3 weeks
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2: Experimental
Letrozole alone.
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Other: Letrozole (Femara)
Letrozole 2.5 mg PO a day for 24 weeks
Drug: Letrozole; Avastin
Letrozole 2.5 mg PO a day and Avastin 15 mg/kg IV every 3 weeks
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Preclinical and clinical data have demonstrated that up-regulation of tumor cell VEGF is an important mechanism to subvert estrogen dependence in hormone responsive breast cancer resulting in reduced therapy response or tumor resistance to hormonal therapy; thus, it is hypothesized that the combination of an anti-VEGF agent (Avastin, an anti-VEGF monoclonal antibody) and hormonal therapy should be more effective than hormonal therapy alone for the treatment of breast cancer.
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
All patients must meet the following criteria to be eligible for study entry:
Patients must be postmenopausal, defined as one of the following:
Exclusion Criteria:
Contact: Valerie Caterinicchia, RN, BSN, OCN | (205) 934-5367 | Valerie.Caterinicchia@ccc.uab.edu |
United States, Alabama | |
University of Alabama at Birmingham | Recruiting |
Birmingham, Alabama, United States, 35294 - 0104 | |
Principal Investigator: Andres Forero, M.D. | |
Sub-Investigator: Lisle Nabell, M.D. | |
Sub-Investigator: John Carpenter, M.D. | |
Sub-Investigator: Carla Falkson, M.D. | |
United States, California | |
University of California, San Francisco Comprehensive Cancer Center | Recruiting |
San Francisco, California, United States, 94115 | |
Contact: Michael Pelayo 415-885-3789 pelayom@cc.ucsf.edu | |
Principal Investigator: Hope Rugo, M.D. | |
United States, District of Columbia | |
Georgetown University Medical Center | Recruiting |
Washington, District of Columbia, United States, 20007 | |
Contact: Minetta Liu, M.D. 202-444-3677 | |
United States, Indiana | |
Indiana University | Recruiting |
Indianapolis, Indiana, United States, 46202 | |
Contact: Shannon Aranjo 317-274-8136 saranjo@iupui.edu | |
Principal Investigator: Anna Maria Storniolo, M.D. | |
United States, Massachusetts | |
Dana Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Nicole Ryabin 617-632-6767 nryabin@partners.org | |
Principal Investigator: Nancy Lin, M.D. | |
United States, North Carolina | |
University of of North Carolina at Chapel Hill | Recruiting |
Chapel Hill, North Carolina, United States, 27599-7600 | |
Contact: Maureen Beeler, RN, BSN 919-966-4432 maureen_beeler@med.unc.edu | |
Principal Investigator: Lisa Carey, M.D. |
Principal Investigator: | Andres Forero, M.D. | University of Alabama at Birmingham |
Responsible Party: | UAB ( Andres Forero, M.D./Principal Investigator ) |
Study ID Numbers: | F061229006, UAB 0648 |
Study First Received: | September 14, 2007 |
Last Updated: | December 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00530868 |
Health Authority: | United States: Institutional Review Board |
Hormonal and antibody therapy for breast cancer Hormonal therapy for breast cancer Antibody therapy for breast cancer |
Antibodies Skin Diseases Breast Neoplasms Letrozole |
Bevacizumab Menopause Breast Diseases Immunoglobulins |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors Angiogenesis Inhibitors Pharmacologic Actions |
Neoplasms Neoplasms by Site Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors Aromatase Inhibitors |