Genistein in Preventing Breast Cancer in Women at High Risk for Breast Cancer

NCT00290758 | Completed Phase 2 Results DMC

• 5 other identifiers: NCI-2009-00840CDR0000652922NCI-04B3NWU03-1-04N01CN35157
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Change in Breast Epithelial Cell Proliferation as Measured by Ki-67 Labeling

  Breast epithelial tissue samples are used to measure the expression of the cell proliferation marker Ki-67, by counting the percentage of positive MIB-1 immunostained cells, denoted the Ki-67 labeling index. Mean change in the Ki-67 labeling index is assessed from baseline to 6 month follow up.

  6 months - baseline

Secondary Outcomes (7)

• Measurement of Change in Concentration of Epidermal Growth Factor (EGF) Found in Nipple Aspirate Fluid (NAF)

  6 months - baseline

• Change in Cytomorphologic Assessment of Atypia and Spectral Imaging Analysis of Atypica Features in Epithelial Cells.

  6 months - baseline

• Breast Endocrine Environment Measured in Nipple Aspiration Fluid (NAF): Estradiol

  6 months - baseline

• Monitor Drug Delivery by Measuring Plasma Genistein by HPLC

  6 months - baseline

• Plasma Concentration of Sex Hormone Binding Globulin (SHBG)

  6 months - baseline

Study Arms (2)

Arm I (genistein)

EXPERIMENTAL

Patients receive oral genistein once daily for up to 6 months.

Drug: genistein; Other: laboratory biomarker analysis

Arm II (placebo)

PLACEBO COMPARATOR

Patients receive oral placebo once daily for up to 6 months.

Drug: placebo

Interventions

placebo DRUG

Given orally

Also known as: PLCB

Arm II (placebo)

genistein DRUG

Given orally

Also known as: CI 75610, genisteol, genisterin, prunetol, sophoricol

Arm I (genistein)

laboratory biomarker analysis OTHER

Correlative studies

Arm I (genistein)

Eligibility Criteria

• Age: 25 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• No known soy intolerance
• 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
• Pre- or postmenopausal

You may not qualify if:

• Women previously diagnosed with breast cancer will not be eligible unless all systemic therapy (including endocrine therapy) was completed at least one year previously
• Currently pregnant, or planning to become pregnant during the study period
• History of venous thrombosis within past year
• Medical conditions, which, in the opinion of the investigators would jeopardize either the patient or the integrity of the data obtained
• History of other cancer within the past five years, excluding non-melanomatous skin cancer, and non-invasive cervical cancer
• Known soy intolerance
• Unrecognized or uncontrolled thyroid disease, subjects may be on synthroid, but thyroid function must be in normal range or the patient's physician must document that the patient's thyroid is controlled.
• Currently receiving any other investigational agents
• Currently on coumadin, or other blood thinners
• History of breast augmentation implants.
• Rusults from patients who have \<4000 epithelial cells in either the first or the second random Fine-needle aspiration (rFNA) will not be included in the study.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• Khan SA, Chatterton RT, Michel N, Bryk M, Lee O, Ivancic D, Heinz R, Zalles CM, Helenowski IB, Jovanovic BD, Franke AA, Bosland MC, Wang J, Hansen NM, Bethke KP, Dew A, Coomes M, Bergan RC. Soy isoflavone supplementation for breast cancer risk reduction: a randomized phase II trial. Cancer Prev Res (Phila). 2012 Feb;5(2):309-19. doi: 10.1158/1940-6207.CAPR-11-0251.

  PMID: 22307566 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Genistein

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Isoflavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Seema Khan, MD
• Organization: NorthwesternU

skhan@nmh.org

312-695-0288

Study Officials

• Seema Khan

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2006
• First Posted: February 13, 2006
• Study Start: January 1, 2006
• Primary Completion: March 1, 2009
• Study Completion: July 1, 2009
• Last Updated: February 8, 2017
• Results First Posted: February 8, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)