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Breast CancerPhase 2NCT00290758

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

A Phase 2 study testing genistein and laboratory biomarker analysis in people with Breast Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 25 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
genistein and laboratory biomarker analysis
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
126 participants
Where
1 siteUnited States
Study dates
Jan 2006to Jul 2009
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • 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 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
  • 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
  • Female patient

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Northwestern University

    Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: Phase IIB Trial of G-2535 (Unconjugated Isoflavones-100) in Women at High Risk for Breast Cancer

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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 OBJECTIVE:

  1. 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.

Conditions
Breast Cancer
Being tested
placebo, genistein, laboratory biomarker analysis
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • placeboDrug

    Also called PLCB

    Given orally

  • genisteinDrug

    Also called CI 75610, genisteol, genisterin, prunetol

    Given orally

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00290758
Study groupRoleWhat they receive
Arm I (genistein)ExperimentalPatients receive oral genistein once daily for up to 6 months.
Receives: Drug: genistein; Other: laboratory biomarker analysis
Arm II (placebo)Placebo comparatorPatients receive oral placebo once daily for up to 6 months.
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months - baseline

Secondary outcomes (7)

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

    Mean change in the concentration of EGF found in nipple aspirate fluid is assessed from baseline to 6 month follow up.

    Measured: 6 months - baseline

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

    Cytologic atypia evaluation was performed on Papanicolau stained Thin Prep slides using standard criteria, which were also used for spectral spatial imaging. Cell clusters were used to generate image stacks with the Nuance LCTF-based imaging system (CRI Inc). The image data was collected as percent pixels assigned as "atypical". Mean change in the percent pixels assigned "atypical" is assessed from baseline to 6 month follow up.

    Measured: 6 months - baseline

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

    Mean change in concentration of estradiol measured in nipple aspiration fluid assessed from baseline to 6 month follow up.

    Measured: 6 months - baseline

  4. Monitor Drug Delivery by Measuring Plasma Genistein by HPLC

    Drug delivery is measured be concentration of genistein in plasma using High Performance Liquid Chromatography (HPLC). Mean change in concentration of plasma genistein is assessed from baseline to 6 month follow up.

    Measured: 6 months - baseline

  5. Plasma Concentration of Sex Hormone Binding Globulin (SHBG)

    Measured: 6 months - baseline

  6. Breast Endocrine Environment Measured in Nipple Aspiration Fluid (NAF): Cathepsin D

    Mean change in concentration of Cathepsin D measured in nipple aspiration fluid assessed from baseline to 6 month follow up.

    Measured: 6 months - baseline

  7. Breast Endocrine Environment Measured in Nipple Aspiration Fluid (NAF): ps2

    Mean change in concentration of protein ps2 measured in nipple aspiration fluid assessed from baseline to 6 month follow up.

    Measured: 6 month - baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2006 (estimated)
  2. Study startJan 2006
  3. Primary completionMar 2009
  4. Study completionJul 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00290758
Sponsor's protocol ID
NCI-2009-00840
Other IDs
NCI-2009-00840, CDR0000652922, NCI-04B3, NWU03-1-04, N01CN35157
Status last verified
Dec 2016
First submitted
9 Feb 2006
Last updated
8 Feb 2017
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 22307566

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing genistein and laboratory biomarker analysis in people with Breast Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 44 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Breast Epithelial Cell Proliferation as Measured by Ki-67 Labeling (time frame: 6 months - baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00290758, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2017.

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