A Pilot Clinical Trial to Evaluate the Biological Activity of Fulvestrant (Faslodex) in Breast Ductal Carcinoma (DCIS)
N/A
N/A
Female
Breast Cancer
Trial Information
A Pilot Clinical Trial to Evaluate the Biological Activity of Fulvestrant (Faslodex) in Breast Ductal Carcinoma (DCIS)
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Molecular markers of the estrogen pathway as measured by immunohistochemistry at 3 weeks
Safety Issue:
No
Principal Investigator
Agustin Garcia, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Cedars-Sinai Medical Center
Authority:
United States: Federal Government
Study ID:
CDR0000430705
NCT ID:
NCT00126464
Start Date:
November 2004
Completion Date:
Related Keywords:
- Breast Cancer
- ductal breast carcinoma in situ
- breast cancer in situ
- Breast Neoplasms
- Carcinoma
- Carcinoma in Situ
- Carcinoma, Intraductal, Noninfiltrating
- Carcinoma, Ductal, Breast
- Carcinoma, Ductal
Name | Location |
|---|---|
| Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center | Los Angeles, California 90048-1865 |
