Preoperative Hormone Therapy for Postmenopausal Women With ER+ Clinical Stage T2-4 Tumors
Condition: Breast Cancer; Stage II Breast Cancer; Stage III Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Exemestane; Exemestane and tamoxifen
Intervention description: Given PO; exemestane 25 mg po daily and tamoxifen 20 mg po daily given concurrently for 4 months prior to surgery
Intervention MeSH terms: Tamoxifen; Exemestane
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: Female
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Breast cancer; estrogen receptor-positive breast cancer; progesterone receptor-positive breast cancer; Postmenopausal; Exemestane; Tamoxifen

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.
    

Eligibility criteria:

        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