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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cedars-Sinai Medical Center
• Treatments: Estradiol; Fulvestrant; Tamoxifen

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