Fulvestrant or Tamoxifen in Treating Postmenopausal Women Who Are Undergoing Surgery for Ductal Carcinoma in Situ of the Breast
Breast Cancer
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring ductal breast carcinoma in situ, breast cancer in situ
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed ductal carcinoma in situ (DCIS) of the breast T0 disease Newly diagnosed disease by minimally invasive biopsy (e.g., a vacuum-assisted large core tool [mammotome] or an equivalent method) Biopsy tissue available for molecular marker analysis Baseline mammography performed within the past 8 weeks Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age Postmenopausal Sex Female Menopausal status Postmenopausal, as defined by 1 of the following: Age ≥ 60 Age ≥ 45 AND amenorrheic for > 1 year with uterus intact Underwent bilateral oophorectomy Follicle-stimulating hormone and estradiol levels in postmenopausal range Performance status SWOG 0-1 Life expectancy Not specified Hematopoietic Absolute granulocyte count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 8.0 g/dL Hepatic SGOT and/or SGPT ≤ 2.5 times upper limit of normal (ULN) Alkaline phosphatase ≤ 2.5 times ULN Bilirubin ≤ 2.0 times ULN Renal Creatinine ≤ 2.0 mg/dL Cardiovascular No history of deep vein thrombosis Pulmonary No history of pulmonary embolism Other Negative pregnancy test (if clinically indicated) No peripheral neuropathy > grade 1 No underlying medical, psychiatric, or social condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy More than 6 months since prior hormonal therapy, including any of the following: Antiestrogens Estrogen Selective estrogen-receptor modulators Progestins Aromatase inhibitors Radiotherapy Not specified Surgery Not specified Other No prior therapy for DCIS
Sites / Locations
- Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center