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
  Purpose

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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mammographic breast density as measured by the Madena method at 3 weeks [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: November 2004
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT00126464

Locations
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
Investigators
Study Chair: Agustin Garcia, MD Cedars-Sinai Medical Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00126464     History of Changes
Other Study ID Numbers: CDR0000430705, CSMC-00000244, CSMC-4415/CR00000244, ZENECA-CSMC-00000244, CSMC-1B-03-7
Study First Received: August 2, 2005
Last Updated: November 5, 2013
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma
Carcinoma in Situ
Carcinoma, Intraductal, Noninfiltrating
Carcinoma, Ductal, Breast
Carcinoma, Ductal
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary
Tamoxifen
Fulvestrant
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Selective Estrogen Receptor Modulators
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 14, 2014