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NCT00204477 · ClinicalTrials.gov registry record · Phase 2

Soy Protein and Breast Cancer Risk Reduction

A Phase 2 study of Breast Cancer, sponsored by The University of Texas Medical Branch, Galveston.

Completed
Registry status
Phase 2
Development phase
321
Enrollment target
1
Study location

NCT00204477: Completed Phase 2 study of Breast Cancer, sponsored by The University of Texas Medical Branch, Galveston.

NCT00204477 is a Phase 2 study of Breast Cancer that has completed, run by The University of Texas Medical Branch, Galveston. The registered enrollment target is 321 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00204477, a Phase 2 study of Breast Cancer, has completed, sponsored by The University of Texas Medical Branch, Galveston.

COMPLETED
Registry status
Phase 2
Development phase
321 participants
Enrollment target
1
Study location

Study Summary

Soy consumption has been associated with reduced risk for developing breast cancer. Ovarian hormones and breast density are considered breast cancer risk markers. We propose to test the hypothesis that consumption of soy protein reduces ovarian steroid hormones and results in a corresponding reduction in breast density comparing to casein protein.

Primary Outcome

Breast images were acquired by digital mammography. Fibroglandular tissue were segmented from fatty breast tissue. The total breast area is the sum of the fibroglandular tissue area and fatty breast tissue area. Mammographic density (breast density) is the percentage of fibroglandular tissue in the total breast.

Conditions Studied

Interventions

  • DIETARY_SUPPLEMENT soy milk
  • DIETARY_SUPPLEMENT cow's milk

Study Locations (1)

Texas

  • General Clinical Research Center, The University of Texas Medical Branch - Galveston

Trial Details

FieldValue
Enrollment Target 321 participants
Start Date 2002-04
Est. Completion 2023-05-29
Phase Phase 2

What the finished NCT00204477 record still lists

NCT00204477 is an interventional study that assigns participants to a tested intervention. The registered 321 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (89% lower).

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which soy milk is the first listed.

NCT00204477 reports a single indexed study location in Texas.

Frequently Asked Questions

What is clinical trial NCT00204477 about?

NCT00204477 is a clinical study titled "Soy Protein and Breast Cancer Risk Reduction". Soy consumption has been associated with reduced risk for developing breast cancer. Ovarian hormones and breast density are considered breast cancer risk markers. We propose to test the hypothesis that consumption of soy protein reduces ovarian steroid hormones and results in a corresponding reducti...

What is the current status of trial NCT00204477?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 321 participants. The study started on 2002-04. Estimated completion is 2023-05-29.

What conditions does trial NCT00204477 study?

This clinical trial studies the following conditions: Breast Cancer.

What interventions are being tested in trial NCT00204477?

The interventions under investigation include: soy milk (DIETARY_SUPPLEMENT), cow's milk (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT00204477?

This trial is sponsored by The University of Texas Medical Branch, Galveston, which has 203 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00204477 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Breast Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00204477's enrollment target sits among peer trials

321 266th of 1224 higher than 959 of 1,224 other Breast Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00204477, the US trial registry maintained by the National Library of Medicine. NCT00204477 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.