Effect of Soy Supplementation on Cellular Markers in Normal and Cancerous Breast Tissue: A Randomized Placebo Controlled Study

April 12, 2016 updated by: Memorial Sloan Kettering Cancer Center

To Test Effect of Soy Supplementation on Cellular Markers in Normal and Cancerous Breast Tissue using a Randomized Placebo Controlled Study.

Objectives:

  • To determine (by immunohistochemistry) whether specific cellular markers and gene products associated with breast carcinoma can be altered by soy therapy.
  • To identify genes that can be altered by soy therapy in normal and neoplastic breast tissues by unbiased gene expression analysis using microarrays.
  • To compare specific cellular markers and pathways (immunohistochemistry), and gene expression using microarrays in normal and cancerous breast tissue.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patient Population:

Pre and post menopausal women with breast cancer diagnosed by core needle biopsy scheduled to undergo breast cancer resection for an invasive carcinoma.

Objectives:

  • To determine (by immunohistochemistry) whether specific cellular markers and gene products associated with breast carcinoma can be altered by soy therapy.
  • To identify genes that can be altered by soy therapy in normal and neoplastic breast tissues by unbiased gene expression analysis using microarrays.
  • To compare specific cellular markers and pathways (immunohistochemistry), and gene expression using microarrays in normal and cancerous breast tissue.

Study Design and Intervention Plan:

  • Eligible patients will be consented at the time of visit with MSKCC breast surgeon and randomized to receive soy (soy protein supplementation 50 grams/day), or placebo (milk protein supplementation 50 grams/day) over the period until their surgery.
  • The diagnostic biopsy (already available at time of appointment with MSKCC surgeon) will be analyzed by immunohistochemistry for proliferation (Ki67) and apoptosis (TUNEL). Additional immunohistochemistry will include HER2, TP53, cyclin D1, p27, BCL2, ER and PR.
  • Excision of the breast carcinoma (lumpectomy or mastectomy) will proceed in standard fashion.
  • The post-therapy excision specimen will be processed in a standard fashion. Pathologic features, margin status, and tumor size will be assessed by a light microscopic examination of histological sections. In addition to this routine processing, immunohistochemistry assays for proliferation (Ki67), apoptosis (TUNEL), HER2, TP53, cyclin D1, p27, BCL2, ER, and PR will be performed. For correlative biological studies pathologists will select approximately .5 cubic mm representative sections of the neoplastic tissues and normal adjacent breast tissue, which will be snap frozen for gene expression analysis using microarrays.

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Informed consent obtained
  • Breast mass > .5 cm (determined by mammogram, ultrasound, MRI, or palpable criteria)
  • Core biopsy diagnosis of invasive carcinoma of the breast

Exclusion Criteria:

  • History of active malignancy within previous two years (except for non-melanoma skin cancer and history of breast cancer).
  • Regular soy consumption (consumption of more than 3 serving of soy or soy products/supplements per week)
  • Allergy to soy or milk protein

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
soy (soy protein supplementation 50 grams/day)
Dietary supplement: Soy
soy (soy protein supplementation 50 grams/day)
Placebo Comparator: 2
milk protein supplementation 50 grams/day
Dietary supplement: Milk
placebo (milk protein supplementation 50 grams/day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary outcome of the study is comparison of the change in proliferation (Ki67) and apoptosis (TUNEL) in cancerous tissue between the 2 groups.
Time Frame: Conclusion of the study
Conclusion of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Moshe Shike, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2002

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

December 26, 2007

First Submitted That Met QC Criteria

January 10, 2008

First Posted (Estimate)

January 18, 2008

Study Record Updates

Last Update Posted (Estimate)

April 13, 2016

Last Update Submitted That Met QC Criteria

April 12, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02-062

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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