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| Sponsor: | University of Alabama at Birmingham |
|---|---|
| Collaborator: |
Genentech |
| Information provided by: | University of Alabama at Birmingham |
| ClinicalTrials.gov Identifier: | NCT00161291 |
Purpose
The purpose of this study is to determine pathological response to a maximum of 18 weeks of neoadjuvant therapy using a combination of letrozole and Bevacizumab in post-menopausal women with pathologically confirmed invasive ductal cancer or invasive lobular cancer of the breast whose tumors are hormone positive.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: Letrozole in combination with Bevacizumab |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
| Official Title: | A Phase II Open Label Trial of Pre-Operative (Neoadjuvant) Letrozole in Combination With Bevacizumab in Post-Menopausal Women With Newly Diagnosed Operable Breast Cancer |
| Enrollment: | 28 |
| Study Start Date: | June 2005 |
| Study Completion Date: | November 2006 |
| Primary Completion Date: | November 2006 (Final data collection date for primary outcome measure) |
This is an open label, single arm, and Phase II study of the combination of Letrozole and Bevacizumab in patients with newly diagnosed breast cancer. Patients meeting the eligibility criteria and who have signed the consent form will start Letrozole 2.5 mg by mouth a day and Bevacizumab 15 mg per Kg IV every 3 weeks for 18 weeks (24 weeks if still responding at week 18 if approved by the PI). After neoadjuvant therapy, participants will undergo surgical treatment and will receive adjuvant therapy according to the treating physician.
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| Principal Investigator: | Andres Forero-Torres, MD | University of Alabama at Birmingham |
More Information
| Responsible Party: | UAB ( Andres Forero, M.D. ) |
| Study ID Numbers: | F041222006, UAB 0467 |
| Study First Received: | September 8, 2005 |
| Last Updated: | December 28, 2009 |
| ClinicalTrials.gov Identifier: | NCT00161291 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Carcinoma of the breast Breast cancer |
|
Skin Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Breast Neoplasms Letrozole Enzyme Inhibitors Bevacizumab |
Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Aromatase Inhibitors Breast Diseases |