Fulvestrant or Tamoxifen in Treating Postmenopausal Women Who Are Undergoing Surgery for Ductal Carcinoma in Situ of the Breast
|ClinicalTrials.gov Identifier: NCT00126464|
Recruitment Status : Unknown
Verified July 2006 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : August 4, 2005
Last Update Posted : November 6, 2013
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 or disease||Intervention/treatment|
|Breast Cancer||Drug: fulvestrant Drug: tamoxifen citrate Procedure: conventional surgery Procedure: neoadjuvant therapy|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Official Title:||A Pilot Clinical Trial to Evaluate the Biological Activity of Fulvestrant (Faslodex) in Breast Ductal Carcinoma (DCIS)|
|Study Start Date :||November 2004|
- Molecular markers of the estrogen pathway as measured by immunohistochemistry at 3 weeks
- Mammographic breast density as measured by the Madena method at 3 weeks
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00126464
|United States, California|
|Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|Study Chair:||Agustin Garcia, MD||Cedars-Sinai Medical Center|