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

Completed · Not applicable · Has a placebo group

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00597532

Run by

Memorial Sloan Kettering Cancer Center

People needed

140

Starts

2002-08-01

Expected to finish

2016-04-01

Last updated by the study team

2016-04-13

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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