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SOY AND ESTROGEN INTERACTIONS IN THE BREAST

Award Number: R01AT000639
ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/01/2005
PERIOD OF PERFORMANCE END DATE: 06/30/2013

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SOY AND ESTROGEN INTERACTIONS IN THE BREAST - DESCRIPTION (provided by applicant): Dietary soy consumption has been associated with decreased breast cancer risk in demographic and observational studies in women, and the protective effects appear to be stronger when soy is consumed earlier in life. Rodent studies have demonstrated profound protective effects for animals exposed early in life to soy isoflavones. Our data in the postmenopausal monkey model clearly show antiproliferative effects of soy consumption on the breast, and we have also observed that soy consumption reduces estrogen exposure of the breast. We have demonstrated the predictive value of the monkey model for breast cancer risk in the postmenopausal setting, and we believe that the model is particularly applicable to studies of pubertal breast development, which is difficult to study in human patients. We hypothesize that dietary soy consumption during puberty reduces breast proliferation, induces breast differentiation, and reduces hormonal exposure to the developing breast; such an effect would explain the observed lower risk of breast cancer in women and animals exposed to soy diets early in life. To test this hypothesis, we propose to randomize 40 pre-pubertal female cynomolgus monkeys to receive either a high-soy diet (modeling a soy-supplemented diet) or no dietary soy (modeling a typical North American diet), and to follow them longitudinally through the course of menarche and pubertal breast development by repeated sampling via breast biopsies and serum collection. Our specific aims are: 1) to determine breast tissue responses to soy consumption during puberty; 2) to determine the effects of dietary soy on ovarian hormones during menarche and menstrual cycling; 3) to determine intratissue estrogens and the enzymes that regulate local estrogen production in the breast; and 4) to explore patterns of gene expression in mammary epithelium which may be modulated by soy consumption. The proposed work will provide a unique view of an otherwise inaccessible period of breast development in a primate model with high genetic and physiologic similarity to human beings.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2012 ( Subtotal = $0 )
2012	2009	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BOULEVARD	WINSTON SALEM	NC	27157	FORSYTH	USA	Research and Training in Complementary and Integrative Health	000	9	7/19/2012	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2009 ( Subtotal = $562,583 )
2009	2009	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BOULEVARD	WINSTON SALEM	NC	27157	FORSYTH	USA	Research and Training in Complementary and Integrative Health	000	9	6/24/2009	NON-COMPETING CONTINUATION	$562,583
														Subtotal = $562,583

Issue Date FY: 2008 ( Subtotal = $575,666 )
2008	2008	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BOULEVARD	WINSTON SALEM	NC	27157	FORSYTH	USA	Research and Training in Complementary and Integrative Health	000	8	5/29/2008	NON-COMPETING CONTINUATION	$575,666
														Subtotal = $575,666

Issue Date FY: 2007 ( Subtotal = $580,432 )
2007	2007	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BOULEVARD	WINSTON SALEM	NC	27157	FORSYTH	USA	Research and Training in Complementary and Integrative Health	000	7	5/7/2007	NON-COMPETING CONTINUATION	$580,432
														Subtotal = $580,432

Issue Date FY: 2006 ( Subtotal = $561,600 )
2006	2006	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BOULEVARD	WINSTON SALEM	NC	27157	FORSYTH	USA	Research and Training in Complementary and Integrative Health	000	6	7/4/2006	NON-COMPETING CONTINUATION	$561,600
														Subtotal = $561,600

Issue Date FY: 2005 ( Subtotal = $526,420 )
2005	2005	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BOULEVARD	WINSTON SALEM	NC	27157	FORSYTH	USA	Research and Training in Complementary and Integrative Health	000	5	1/31/2005	COMPETING CONTINUATION	$526,420
														Subtotal = $526,420

Issue Date FY: 2003 ( Subtotal = $429,820 )
2003	2003	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BOULEVARD	WINSTON SALEM	NC	27157	FORSYTH	USA	Research and Training in Complementary and Integrative Health	000	4	5/19/2003	NON-COMPETING CONTINUATION	$429,820
														Subtotal = $429,820

Issue Date FY: 2002 ( Subtotal = $476,192 )
2002	2002	WAKE FOREST UNIVERSITY SCHOOL OF MEDICINE	MEDICAL CENTER BOULEVARD	WINSTON-SALEM	NC	27157		USA	Research and Training in Complementary and Integrative Health	000	3	6/21/2002	NON-COMPETING CONTINUATION	$476,192
														Subtotal = $476,192

Issue Date FY: 2001 ( Subtotal = $465,479 )
2001	2001	WAKE FOREST UNIVERSITY SCHOOL OF MEDICINE	MEDICAL CENTER BOULEVARD	WINSTON-SALEM	NC	27157		USA	Research and Training in Complementary and Integrative Health	000	2	7/17/2001	NON-COMPETING CONTINUATION	$464,205
2001	2001	WAKE FOREST UNIVERSITY SCHOOL OF MEDICINE	MEDICAL CENTER BOULEVARD	WINSTON-SALEM	NC	27157		USA	Research and Training in Complementary and Integrative Health	001	1	5/7/2001	SUPPLEMENT FOR EXPANSION	$1,274
														Subtotal = $465,479

Issue Date FY: 2000 ( Subtotal = $526,051 )
2000	2000	WAKE FOREST UNIVERSITY SCHOOL OF MEDICINE	MEDICAL CENTER BOULEVARD	WINSTON-SALEM	NC	27157		USA	Research and Training in Complementary and Integrative Health	000	1	9/18/2000	NEW	$526,051
														Subtotal = $526,051

Grand Total All Awards = $4,704,243

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SOY AND ESTROGEN INTERACTIONS IN THE BREAST

Award Number: R01AT000639

ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 07/01/2005

PERIOD OF PERFORMANCE END DATE: 06/30/2013

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