Fulvestrant or Tamoxifen in Treating Postmenopausal Women Who Are Undergoing Surgery for Ductal Carcinoma in Situ of the Breast

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Pilot Clinical Trial to Evaluate the Biological Activity of Fulvestrant (Faslodex) in Breast Ductal Carcinoma (DCIS)

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: fulvestrant
* Drug: tamoxifen citrate
* Procedure: conventional surgery
* Procedure: neoadjuvant therapy


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: fulvestrant|nan|
|Drug: tamoxifen citrate|nan|
|Procedure: conventional surgery|nan|
|Procedure: neoadjuvant therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Molecular markers of the estrogen pathway as measured by immunohistochemistry at 3 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mammographic breast density as measured by the Madena method at 3 weeks |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ductal breast carcinoma in situ, breast cancer in situ