Fulvestrant or Tamoxifen in Treating Postmenopausal Women Who Are Undergoing Surgery for Ductal Carcinoma in Situ of the Breast
This trial is active, not recruiting.
|Treatments||fulvestrant, tamoxifen citrate, conventional surgery, neoadjuvant therapy|
|Sponsor||Cedars-Sinai Medical Center|
|Start date||November 2004|
|Trial size||100 participants|
|Trial identifier||NCT00126464, CDR0000430705, CSMC-00000244, CSMC-1B-03-7, CSMC-4415/CR00000244, ZENECA-CSMC-00000244|
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant or tamoxifen may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving fulvestrant or tamoxifen before surgery may be an effective treatment for breast cancer.
PURPOSE: This randomized clinical trial is studying how well giving fulvestrant or tamoxifen works in treating postmenopausal women who are undergoing surgery for ductal carcinoma in situ of the breast.
Molecular markers of the estrogen pathway as measured by immunohistochemistry at 3 weeks
Mammographic breast density as measured by the Madena method at 3 weeks
Female participants of any age.
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
|Official title||A Pilot Clinical Trial to Evaluate the Biological Activity of Fulvestrant (Faslodex) in Breast Ductal Carcinoma (DCIS)|
|Description||OBJECTIVES: Primary - Determine, preliminarily, the efficacy of neoadjuvant fulvestrant, in terms of molecular changes in markers of the estrogen pathway, cell proliferation and apoptosis, and the epidermal growth factor pathway, in postmenopausal women with newly diagnosed ductal carcinoma in situ of the breast. Secondary - Determine the toxicity profile of fulvestrant in these patients. OUTLINE: This is a randomized, placebo-controlled, pilot, multicenter study. Patients are randomized to 1 of 4 treatment arms. - Arm I: Patients receive oral placebo once daily on days 1-21. - Arm II: Patients receive oral tamoxifen once daily on days 1-21. - Arm III: Patients receive fulvestrant intramuscularly (IM) on day 1. - Arm IV: Patients receive fulvestrant IM as in arm III but at a higher dose. In all arms, treatment continues in the absence of disease progression or unacceptable toxicity. All patients undergo surgical resection of the tumor on approximately day 21. PROJECTED ACCRUAL: A total of 100 patients (25 per treatment arm) will be accrued for this study.|
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