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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Patients will be administered Letrozole at 2.5 mg PO a day and Avastin at 15 mg/kg IV every 3 weeks for 24 weeks. Patients will then undergo surgical treatment and receive adjuvant therapy according to the treating physician.
University of Alabama at Birmingham
Birmingham, Alabama, United States
The primary objective is to estimate the pathological complete response rate of neoadjuvant therapy in operable newly diagnosed ER+ breast cancer patients using the combination of Avastin and Letrozole.
Time frame: approximately 24 weeks
A clinical response will be based upon the Response Evaluation Criteria in Solid Tumors (RECIST Criteria).
Time frame: approximately 24 weeks
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