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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. The completion date has passed and the status has not been verified in more than two years.
Verified July 2006 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: August 2, 2005
Last updated: November 5, 2013
Last verified: July 2006

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

Secondary Outcome Measures:
  • Mammographic breast density as measured by the Madena method at 3 weeks

Estimated Enrollment: 100
Study Start Date: November 2004
Detailed Description:



  • 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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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



  • Postmenopausal


  • 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


  • Absolute granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 8.0 g/dL


  • SGOT and/or SGPT ≤ 2.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Bilirubin ≤ 2.0 times ULN


  • Creatinine ≤ 2.0 mg/dL


  • No history of deep vein thrombosis


  • No history of pulmonary embolism


  • Negative pregnancy test (if clinically indicated)
  • No peripheral neuropathy > grade 1
  • No underlying medical, psychiatric, or social condition that would preclude study participation


Biologic therapy

  • Not specified


  • 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


  • Not specified


  • Not specified


  • No prior therapy for DCIS
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00126464

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
Study Chair: Agustin Garcia, MD Cedars-Sinai Medical Center
  More Information Identifier: NCT00126464     History of Changes
Other Study ID Numbers: CDR0000430705
Study First Received: August 2, 2005
Last Updated: November 5, 2013

Keywords provided by National Cancer Institute (NCI):
ductal breast carcinoma in situ
breast cancer in situ

Additional relevant MeSH terms:
Carcinoma in Situ
Carcinoma, Ductal
Carcinoma, Intraductal, Noninfiltrating
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents processed this record on April 21, 2017