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

Sponsor:	Cedars-Sinai Medical Center
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00126464

Purpose

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.

Condition	Intervention
Breast Cancer	Drug: fulvestrant Drug: tamoxifen citrate Procedure: conventional surgery Procedure: neoadjuvant therapy

Study Type:	Interventional
Study Design:	Treatment, Randomized, Placebo Control
Official Title:	A Pilot Clinical Trial to Evaluate the Biological Activity of Fulvestrant (Faslodex) in Breast Ductal Carcinoma (DCIS)

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Surgery

Drug Information available for: Tamoxifen Tamoxifen citrate Ici 182780

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Molecular markers of the estrogen pathway as measured by immunohistochemistry at 3 weeks [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mammographic breast density as measured by the Madena method at 3 weeks [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	November 2004

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.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00126464

Locations

United States, California
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048

Sponsors and Collaborators

Cedars-Sinai Medical Center

Investigators

Study Chair:

Agustin Garcia, MD

Cedars-Sinai Medical Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000430705, CSMC-00000244, CSMC-4415/CR00000244, ZENECA-CSMC-00000244, CSMC-1B-03-7
Study First Received:	August 2, 2005
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00126464 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

ductal breast carcinoma in situ
breast cancer in situ

Additional relevant MeSH terms:

Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Fulvestrant
Hormones, Hormone Substitutes, and Hormone Antagonists
Bone Density Conservation Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Neoplasms by Site
Carcinoma in Situ
Therapeutic Uses
Breast Diseases
Estrogen Antagonists
Neoplasms by Histologic Type

Skin Diseases
Antineoplastic Agents, Hormonal
Breast Neoplasms
Tamoxifen
Pharmacologic Actions
Carcinoma
Carcinoma, Ductal
Neoplasms
Carcinoma, Ductal, Breast
Carcinoma, Intraductal, Noninfiltrating
Neoplasms, Ductal, Lobular, and Medullary
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on February 04, 2010