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