Fulvestrant or Tamoxifen in Treating Postmenopausal Women Who Are Undergoing Surgery for Ductal Carcinoma in Situ of the Breast
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2006 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Cedars-Sinai Medical Center
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00126464
First received: August 2, 2005
Last updated: February 6, 2009
Last verified: July 2006
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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: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | A Pilot Clinical Trial to Evaluate the Biological Activity of Fulvestrant (Faslodex) in Breast Ductal Carcinoma (DCIS) |
Resource links provided by NLM:
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 |
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:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00126464 History of Changes |
| Other 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 |
| 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:
|
Breast Neoplasms Carcinoma Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Carcinoma, Ductal, Breast Carcinoma, Ductal Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Adenocarcinoma Neoplasms, Ductal, Lobular, and Medullary |
Tamoxifen Fulvestrant Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Bone Density Conservation Agents Estrogen Antagonists |
ClinicalTrials.gov processed this record on May 22, 2013