Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments soy, milk
Phase phase 0
Sponsor Memorial Sloan Kettering Cancer Center
Start date August 2002
End date June 2016
Trial size 140 participants
Trial identifier NCT00597532, 02-062

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose diagnostic
Arm
(Experimental)
soy (soy protein supplementation 50 grams/day)
soy
soy (soy protein supplementation 50 grams/day)
(Placebo Comparator)
milk protein supplementation 50 grams/day
milk
placebo (milk protein supplementation 50 grams/day)

Primary Outcomes

Measure
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

Eligibility Criteria

Female participants of any age.

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

Additional Information

Official title Effect of Soy Supplementation on Cellular Markers in Normal and Cancerous Breast Tissue: A Randomized Placebo Controlled Study
Principal investigator Moshe Shike, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.