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Genistein in Preventing Breast Cancer in Women at High Risk for Breast Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Robert H. Lurie Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00290758
  Purpose

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of genistein may prevent breast cancer in women at high risk for breast cancer.

PURPOSE: This randomized phase II trial is studying how well genistein works in preventing breast cancer in women at high risk for breast cancer.


Condition Intervention Phase
Breast Cancer
Drug: genistein
Drug: placebo
Phase II

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Genistein
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control
Official Title: Phase IIb Trial of Genistein in Women At High Risk For Breast Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Treatment-related effect upon proliferation of breast epithelial cells [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Activated caspase-3 expression [ Designated as safety issue: No ]
  • Quantitative image analysis of epithelial cells [ Designated as safety issue: No ]
  • Real-time RT-PCR expression of ERα, ERβ, PgR, TGFα, TGFβ, IGF, pS2, Ki67 [ Designated as safety issue: No ]
  • Measurement of estradiol, estrone sulphate, and progesterone, by radioimmunoassay [ Designated as safety issue: No ]
  • Measurement of cathepsin D, pS2, and EGF, by ELISA [ Designated as safety issue: No ]
  • Plasma genistein concentration by HPLC [ Designated as safety issue: No ]
  • Serum estradiol and progesterone, by radioimmunoassay [ Designated as safety issue: No ]
  • Protein phosphotyrosine levels in peripheral blood mononuclear cells, by Western blot [ Designated as safety issue: No ]

Estimated Enrollment: 134
Study Start Date: January 2006
Arms Assigned Interventions
Arm I: Experimental
Patients receive oral genistein once daily for up to 6 months.
Drug: genistein
Given orally
Arm II: Placebo Comparator
Patients receive oral placebo once daily for up to 6 months.
Drug: placebo
Given orally

Detailed Description:

OBJECTIVES:

Primary

  • Determine the effect of genistein on the proliferation of breast epithelial cells obtained by fine needle aspiration (FNA), as measured by Ki-67 labeling index, in women who are at high risk for breast cancer.

Secondary

  • Determine the effect of this drug on cellular and molecular parameters using epithelial cells obtained by FNA, nipple aspirate fluid, and blood from these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to menopausal status (premenopausal vs postmenopausal) and history of breast cancer (no history of breast cancer vs history of estrogen receptor [ER] positive breast cancer vs history of ER negative breast cancer). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral genistein once daily.
  • Arm II: Patients receive oral placebo once daily. In both arms, treatment continues for up to 6 months in the absence of unacceptable toxicity.

After completion of study treatment, patients are followed at 30-37 days.

PROJECTED ACCRUAL: A total of 134 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • At increased risk of developing breast cancer in ≥ 1 previously unaffected breast, as defined by any of the following:

    • Estimated 5-year risk of developing breast cancer using the Gail model, as defined by 1 of the following:

      • Gail score ≥ 1.66%
      • Gail score ≥ 0.1% for women age 20-29 years
      • Gail score ≥ 1.0% for women age 30-39 years
    • Estimated 5-year risk of developing breast cancer using the Claus model

      • Claus score ≥ 1.66%
      • Claus score ≥ 0.1% for women age 20-29 years
      • Claus score ≥ 1.0% for women age 30-39 years
    • Prior diagnosis of unilateral in situ or invasive breast cancer OR history of atypical hyperplasia
    • BRCA 1 and/or BRCA 2 positivity
    • History of lobular carcinoma in situ
  • No evidence of breast cancer, as determined by a negative mammogram within the past 6 months and a history and physical
  • No previously diagnosed breast cancer unless all systemic therapy (including endocrine therapy) was completed at least 1 year ago

PATIENT CHARACTERISTICS:

  • Female patient
  • Pre- or postmenopausal
  • ECOG performance status 0-1
  • Hemoglobin > 10.0 g/dL
  • Platelet count > 100,000/mm^3
  • Absolute neutrophil count > 1,000/mm^3
  • Creatinine < 2.0 mg/dL
  • SGPT < 82 U/L
  • SGOT < 68 U/L
  • Bilirubin < 3 mg/dL* NOTE: * Patients with a higher level of bilirubin due to a familial metabolism may be eligible at the discretion of the investigator
  • Life expectancy > 2 years
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception
  • Must be willing to keep a dietary diary
  • No venous thrombosis within the past year
  • No known soy intolerance
  • No unrecognized or poorly controlled thyroid disease
  • No other cancer within the past 5 years except nonmelanomatous skin cancer or noninvasive cervical cancer
  • No other medical condition that, in the opinion of the investigator, would jeopardize either the patient or the integrity of the data obtained

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • None of the following for ≥ 2 weeks before the first random fine needle aspiration and during study participation:

    • Oral contraceptives
    • Soy supplements
    • High soy-containing foods
    • Fish oil supplements
    • Multivitamins
    • Vitamins C and E
    • Daily aspirin or nonsteroidal anti-inflammatory drugs
  • No other concurrent investigational agents
  • No concurrent warfarin or other blood thinners
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00290758

Locations
United States, Illinois
Lynn Sage Comprehensive Breast Center at Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Robert H. Lurie Cancer Center
Investigators
Study Chair: Seema A. Khan, MD Robert H. Lurie Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000466517, NU-NWU03-1-04, NU-NCI-04B3, NU-0835-030
Study First Received: February 9, 2006
Last Updated: August 16, 2008
ClinicalTrials.gov Identifier: NCT00290758  
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
breast cancer

Study placed in the following topic categories:
Skin Diseases
Breast Neoplasms
Genistein
Breast Diseases

Additional relevant MeSH terms:
Anticarcinogenic Agents
Estrogens
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Enzyme Inhibitors
Protein Kinase Inhibitors
Hormones
Protective Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Estrogens, Non-Steroidal
Therapeutic Uses
Phytoestrogens

ClinicalTrials.gov processed this record on January 16, 2009