UAB 0467 PHASE II TRIAL OF LETROZOLE WITH BEVACIZUMAB IN WOMEN WITH BREAST CANCE

这个子项目是众多研究子项目之一

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The primary objective of this study will be to determine the pathological response to neoadjuvant therapy using a combination of Letrozole and Bevacizumab in patients with pathologically confirmed invasive ductal carcinoma or invasive lobular carcinoma of the breast whose tumors are estrogen receptor positive. Secondary objectives include evaluating 1) clinical response; 2) tolerability and toxicity; 3) specific biomarkers for prognostic value and as markers for response/resistance to the therapy; and 4) the correlation between 18 F-FDG PET scan "metabolic response" with objective response rate and duration of response parameters. It is hypothesized that the efficacy of hormonal therapy in women with ER+ and/or PR+ breast cancer can be augmented by means of Bevacizumab, a recombinant humanized antibody to vascular endothelial cell growth factor. To be enrolled, patients must be 60 years or older, have measurable disease by mammogram and/or ultrasound, and ECOG performance status 0, 1 or 2. Prior to starting therapy, patients will have a PET scan. Standard CT evaluations of the chest, abdomen and pelvis, and bone scan will be done only if there is suggestion of metastasis in the PET scan. Blood counts, UA, 24-hour urine, urinary protein/creatinine ratio, and blood chemistries will be obtained. Mammogram and ultrasound of the breast will also be obtained and used as baseline evaluations. Standard biopsies will be performed at the time of diagnosis in order to provide adequate tissue for diagnosis as well as to allow assays of biomarkers and estrogen/progesterone expression. Patients will take oral Letrozole daily and receive Bevacizumab IV infusions every 3 weeks. At 6 weeks patients will have the first evaluation of response including mammogram/ultrasound of the breast and a PET scan. A biopsy will be performed for evaluation of biomarkers. Patients with objective response or stable disease will continue the same regimen with restaging every 6 weeks for a total of 18 weeks, or until progression is observed. Definitive surgery of the primary tumor will be performed at the discretion of the surgeon after the last evaluation.