Conditions: Breast Cancer Stage II Breast Cancer Stage III Breast Cancer
Keywords: Breast cancer estrogen receptor-positive breast cancer progesterone receptor-positive breast cancer Postmenopausal Exemestane Tamoxifen
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 36
Healthy volunteers: no

Brief summary:
This phase II trial studies how well exemestane before surgery works in treating postmenopausal patients with newly diagnosed estrogen receptor positive stage II-III breast cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy using exemestane may fight breast cancer by blocking the use of estrogen by the tumor cells.

Detailed description:
This study will develop preliminary data regarding the efficacy and safety of exemestane in the preoperative treatment of postmenopausal women with ER+ or PR+ tumors. This trial is also designed to develop a predictive model to correlate expression of the known isoforms of ER and progesterone receptor (PR) and the aromatase enzyme with response to estrogenic deprivation using exemestane.

Arms:
arm 1: Patients receive exemestane orally daily for 4 months in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery. arm 2: Patients receive exemestane plus tamoxifen orally daily for 4 months in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery.

Interventions: intervention 1: Exemestane intervention 2: Exemestane and tamoxifen
Intervention descriptions: intervention 1: Given PO intervention 2: exemestane 25 mg po daily and tamoxifen 20 mg po daily given concurrently for 4 months prior to surgery

Protocol document: