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Dietary Supplement

Soy Isoflavones for Breast Cancer

N/A
Waitlist Available
Led By Anna Wu
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Family history consistent with hereditary breast cancer
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at completion of 12 months on the study
Awards & highlights

Study Summary

This trial is studying whether soy isoflavones can prevent or treat early stage breast cancer in women who are at high risk for the disease.

Eligible Conditions
  • BRCA1 Mutation
  • BRCA2 Mutation
  • Ductal Carcinoma
  • Breast Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have a family history that suggests a higher risk of inherited breast cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at completion of 12 months on the study
This trial's timeline: 3 weeks for screening, Varies for treatment, and at completion of 12 months on the study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with reduced MRI volume (MRIV)
Secondary outcome measures
Percentage of cells that stain positive for Ki67, caspase 3, ratio of Ki67/caspase, ER alpha and ER beta

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm IExperimental Treatment7 Interventions
Patients receive oral soy isoflavones supplement once daily for 12 months in the absence of disease progression.
Group II: Arm IIPlacebo Group7 Interventions
Patients receive oral placebo once daily for 12 months in the absence of disease progression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
soy isoflavones
2014
Completed Phase 4
~470
magnetic resonance imaging
2002
Completed Phase 2
~1820
biopsy
2002
Completed Phase 4
~8270
mammography
2006
N/A
~54190

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor
899 Previous Clinical Trials
1,595,193 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,608 Previous Clinical Trials
40,915,222 Total Patients Enrolled
California Breast Cancer Research ProgramOTHER
15 Previous Clinical Trials
103,603 Total Patients Enrolled

Media Library

Soy Isoflavones (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT01219075 — N/A
Ductal Carcinoma Research Study Groups: Arm I, Arm II
Ductal Carcinoma Clinical Trial 2023: Soy Isoflavones Highlights & Side Effects. Trial Name: NCT01219075 — N/A
Soy Isoflavones (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01219075 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must be met in order to qualify for participation in this research project?

"Eligibility for this trial requires that patients suffer from carcinoma and are between 30 to 75 years old. This research aims to recruit 110 participants in total."

Answered by AI

Does this research program have any age restrictions?

"This study's eligibility guidelines call for patients aged between 30 and 75 years, while 133 trials are available to minors and 4502 studies target seniors."

Answered by AI

Is this research initiative currently seeking participants?

"Indications on clinicaltrials.gov reveal that this specific trial is not in the process of recruiting patients, having first been posted on July 1st 2010 and most recently updated November 12th 2022. However, there are 4610 other trials actively looking for volunteers at present."

Answered by AI
~7 spots leftby Mar 2025