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
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00126464
First received: August 2, 2005
Last updated: November 5, 2013
Last verified: July 2006

August 2, 2005
November 5, 2013
November 2004
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Molecular markers of the estrogen pathway as measured by immunohistochemistry at 3 weeks [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00126464 on ClinicalTrials.gov Archive Site
Mammographic breast density as measured by the Madena method at 3 weeks [ Designated as safety issue: No ]
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Fulvestrant or Tamoxifen in Treating Postmenopausal Women Who Are Undergoing Surgery for Ductal Carcinoma in Situ of the Breast
A Pilot Clinical Trial to Evaluate the Biological Activity of Fulvestrant (Faslodex) in Breast Ductal Carcinoma (DCIS)

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.

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.

Interventional
Not Provided
Allocation: Randomized
Primary Purpose: Treatment
Breast Cancer
  • Drug: fulvestrant
  • Drug: tamoxifen citrate
  • Procedure: conventional surgery
  • Procedure: neoadjuvant therapy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
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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
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00126464
CDR0000430705, CSMC-00000244, CSMC-4415/CR00000244, ZENECA-CSMC-00000244, CSMC-1B-03-7
Not Provided
Not Provided
Cedars-Sinai Medical Center
Not Provided
Study Chair: Agustin Garcia, MD Cedars-Sinai Medical Center
National Cancer Institute (NCI)
July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP