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CompletedNCT00597532Updated Apr 13, 2016

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

An interventional study of Soy and Milk in Breast Cancer, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 1 site in United States. Open to female participants. Per ClinicalTrials.gov, last updated 2016-04-13.

Sponsored by Memorial Sloan Kettering Cancer Center · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Randomized
Sex
Female
01

Study 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.
Read the 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.
02

Conditions studied

  • Breast Cancer

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Keywords

  • Breast Cancer
  • Soy
  • Milk
  • Supplementation
  • 02-062
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 140 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.

Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
140 participants (actual)

Study arms

  • Experimental
    1

    soy (soy protein supplementation 50 grams/day)

    Dietary Supplement: Soy

  • Placebo comparator
    2

    milk protein supplementation 50 grams/day

    Dietary Supplement: Milk

Interventions

  • Dietary supplementSoy

    soy (soy protein supplementation 50 grams/day)

  • Dietary supplementMilk

    placebo (milk protein supplementation 50 grams/day)

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 site
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10065, United States
08

References and documents

Publications

  • 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. PubMed 25190728 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00597532
Lead sponsor
Memorial Sloan Kettering Cancer Center
Responsible party
Sponsor
First posted
Jan 18, 2008
Start date
Aug 2002
Primary completion
Apr 2016
Completion
Apr 2016
Last update
Apr 13, 2016

Study contacts

Moshe Shike, MD
principal investigator · Memorial Sloan Kettering Cancer Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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