⭐️⭐️⭐️⭐️⭐️ "A total no brainer"

⭐️⭐️⭐️⭐️⭐️ "Love this, so easy."

Spots is the easy way to track your skin, mole and cancer changes.

Spots Global Cancer Trial Database for Effect of Soy Supplementation on Cellular Markers in Normal and Cancerous Breast Tissue: A Randomized Placebo Controlled Study

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

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

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

Study ID: NCT00597532

Conditions

Breast Cancer

Interventions

Soy
Milk

Study Description

Brief 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.

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.

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Contact Details

Name: Moshe Shike, MD

Affiliation: Memorial Sloan Kettering Cancer Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

Logo

Take Control of Your Skin and Body Changes Today.

Try out Spots for free, set up only takes 2 mins.

spots app storespots app store

Join others from around the world: