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

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
fulvestrant
tamoxifen citrate
conventional surgery
neoadjuvant therapy
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring ductal breast carcinoma in situ, breast cancer in situ

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center

Outcomes

Primary Outcome Measures

Molecular markers of the estrogen pathway as measured by immunohistochemistry at 3 weeks

Secondary Outcome Measures

Mammographic breast density as measured by the Madena method at 3 weeks

Full Information

First Posted
August 2, 2005
Last Updated
November 5, 2013
Sponsor
Cedars-Sinai Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00126464
Brief Title
Fulvestrant or Tamoxifen in Treating Postmenopausal Women Who Are Undergoing Surgery for Ductal Carcinoma in Situ of the Breast
Official Title
A Pilot Clinical Trial to Evaluate the Biological Activity of Fulvestrant (Faslodex) in Breast Ductal Carcinoma (DCIS)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2006
Overall Recruitment Status
Unknown status
Study Start Date
November 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Cedars-Sinai Medical Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
ductal breast carcinoma in situ, breast cancer in situ

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
fulvestrant
Intervention Type
Drug
Intervention Name(s)
tamoxifen citrate
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Type
Procedure
Intervention Name(s)
neoadjuvant therapy
Primary Outcome Measure Information:
Title
Molecular markers of the estrogen pathway as measured by immunohistochemistry at 3 weeks
Secondary Outcome Measure Information:
Title
Mammographic breast density as measured by the Madena method at 3 weeks

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agustin Garcia, MD
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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