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


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Open (Enrolling)
Female
Breast Cancer

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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 CenterLos Angeles, California  90048-1865