Preoperative Hormone Therapy for Postmenopausal Women With ER+ Clinical Stage T2-4 Tumors

Phase 2

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

Histologically or cytologically confirmed breast cancer
ER positive (+)
Primary tumor 2-4 regional lymph nodes 0-2 (T2-4N0-2); patients may have metastatic disease, provided local-regional surgery is clinically indicated
Clinical stage II/III
Postmenopausal- defined as having had a previous bilateral oophorectomy or, for women with no prior hysterectomy, the absence of spontaneous menstrual cycles for more than 1 year
Newly diagnosed
Patients with prior non-breast malignancies are eligible if they have been disease free for >= 5 years before study entry; patients with squamous or basal cell carcinoma of the skin that has been effectively treated, carcinoma in situ of the cervix that has been treated by surgery only, or lobular carcinoma in situ (LCIS) of the ipsilateral or contralateral breast that has been treated by surgery only are eligible, even if the cancer was diagnosed within 5 years before randomization
Serum creatinine =< 1.5 x institutional upper limit of normal (ULN)
Hemoglobin within normal limits for institution
Absolute granulocyte count >= 1500
Platelet count >= 100,000
Serum glutamic oxaloacetic transaminase (SGOT), aspartate aminotransferase (AST) or serum glutamate pyruvate transaminase (SGPT), alanine aminotransferase (ALT) =< 2.5 x ULN
Total bilirubin < 2 x ULN for institution
Alkaline phosphatase < 2 x the ULN

Exclusion Criteria

Completely resected
Prior hormone or chemotherapy
Unable to take oral medication
Patients who have nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude their being subjected to protocol therapy

Arm && Interventions

Group	Intervention	Description
treatment (exemestane, tamoxifen, surgery)	Exemestane and tamoxifen	Patients receive exemestane plus tamoxifen orally daily for 4 months in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery.
Treatment (exemestane, surgery)	Exemestane	Patients receive exemestane orally daily for 4 months in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery.

Primary Outcome Measures

Name	Time	Method
Overall Response Rate as Measured by Clinical Exam, Standard Imaging, and Surgical Pathology Findings	Up to 6 months	Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Evaluated using chi-square analysis.

Secondary Outcome Measures