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

NCT ID: NCT00126464

Last Updated: 2013-11-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-11-30

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 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.

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 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.

Conditions

Breast Cancer

Keywords

ductal breast carcinoma in situ; breast cancer in situ

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

fulvestrant

Intervention Type: DRUG

tamoxifen citrate

Intervention Type: DRUG

conventional surgery

Intervention Type: PROCEDURE

neoadjuvant therapy

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Principal Investigators

Agustin Garcia, MD

Role: STUDY_CHAIR

Cedars-Sinai Medical Center

Locations

Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

CSMC-00000244

Identifier Type: -

Identifier Source: secondary_id

CSMC-4415/CR00000244

Identifier Type: -

Identifier Source: secondary_id

ZENECA-CSMC-00000244

Identifier Type: -

Identifier Source: secondary_id

CSMC-1B-03-7

Identifier Type: -

Identifier Source: secondary_id

CDR0000430705

Identifier Type: -

Identifier Source: org_study_id