Status:
UNKNOWN
Fulvestrant or Tamoxifen in Treating Postmenopausal Women Who Are Undergoing Surgery for Ductal Carcinoma in Situ of the Breast
Lead Sponsor:
Cedars-Sinai Medical Center
Conditions:
Breast Cancer
Eligibility:
FEMALE
Phase:
NA
Brief 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 fulve...
Detailed 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 e...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00126464
Start Date
November 1 2004
Last Update
November 6 2013
Active Locations (1)
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1
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048