Clinical trial NCT00597532: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Soy
Milk
Supplementation
02-062
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2008-01-18
Enrollment: 140
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 criteria: 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

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.
timeFrame: Conclusion of the study
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Moshe Shike, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shike M, Doane AS, Russo L, Cabal R, Reis-Filho JS, Gerald W, Cody H, Khanin R, Bromberg J, Norton L. The effects of soy supplementation on gene expression in breast cancer: a randomized placebo-controlled study. J Natl Cancer Inst. 2014 Sep 4;106(9):dju189. doi: 10.1093/jnci/dju189. Print 2014 Sep.