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Phase IIb Trial of G-2535 (Unconjugated Isoflavones-100) in Women at High Risk for Breast Cancer


Phase 2
25 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Phase IIb Trial of G-2535 (Unconjugated Isoflavones-100) in Women at High Risk for Breast Cancer


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 150 patients will be accrued for this study.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

Determine effect upon proliferation of breast epithelial cells obtained by fine needle aspiration (FNA)

Outcome Description:

Determine intervention related effect upon proliferation of breast epithelial cells, obtained by fine needle aspiration (FNA), as measured by Ki-67 labeling index at screening and at six months.

Outcome Time Frame:

At screening and at six months

Safety Issue:

Yes

Principal Investigator

Seema A. Khan, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI 04B3

NCT ID:

NCT00290758

Start Date:

January 2006

Completion Date:

May 2011

Related Keywords:

  • Breast Cancer
  • breast cancer
  • Breast Neoplasms

Name

Location

Northwestern UniversityChicago, Illinois  60611
Lynn Sage Comprehensive Breast Center at Northwestern Memorial HospitalChicago, Illinois  60611