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Trial record 6 of 31 for:    "Breast Ductal Carcinoma" | "Bone Density Conservation Agents"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: fulvestrant Drug: tamoxifen citrate Procedure: conventional surgery Procedure: neoadjuvant therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Pilot Clinical Trial to Evaluate the Biological Activity of Fulvestrant (Faslodex) in Breast Ductal Carcinoma (DCIS)
Study Start Date : November 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Primary Outcome Measures :
  1. Molecular markers of the estrogen pathway as measured by immunohistochemistry at 3 weeks

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00126464

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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
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Study Chair: Agustin Garcia, MD Cedars-Sinai Medical Center

Layout table for additonal information Identifier: NCT00126464     History of Changes
Other Study ID Numbers: CDR0000430705
First Posted: August 4, 2005    Key Record Dates
Last Update Posted: November 6, 2013
Last Verified: July 2006
Keywords provided by National Cancer Institute (NCI):
ductal breast carcinoma in situ
breast cancer in situ
Additional relevant MeSH terms:
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Bone Density Conservation Agents
Carcinoma in Situ
Carcinoma, Ductal
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Estrogen Receptor Antagonists