PROVIDED. In a randomized clinical trial of adjuvant oophorectomy and tamoxifen in 709 premenopausal Vietnamese and Chinese women with breast cancer, the proposers have demonstrated overall benefit (increased 5-year disease-free and overall survival) and specific benefit only to hormone receptor-positive tumor-bearing patients. Morbidity and symptomatic toxicity of this therapy were low; a cost-effectiveness analysis, assuming costs in Vietnam, shows a cost per life-year gained of $351. In detailed secondary analyses, benefit from adjuvant therapy was significantly greater in women undergoing simultaneous mastectomy and oophorectomy in the history-estimated luteal phases of their menstrual cycles. Analyses of axillary node-positive and younger (<= 44) patient subsets further support a novel hypothesis that adjuvant luteal phase surgical oophorectomy is more effective than this surgery performed in the follicular phase. The investigators propose a new randomized, controlled trial to investigate this hypothesis in 510 Vietnamese and Filipino premenopausal women, <= 44 years old with regular menstrual cycles and hormone receptor-positive tumors, undergoing adjuvant surgical oophorectomy followed by tamoxifen therapy. Participants will be stratified according to their likelihood of being in luteal phase of the menstrual cycle for the entire following 1-6 days, and those so unlikely will be randomized to scheduled mid-luteal phase oophorectomy or immediate oophorectomy. Blood samples for later hormonal assays will be taken on the day of oophorectomy. With accrual over 2 to 3 years and follow-up of 3 additional years, the study has 0.78-0.86 power to demonstrate disease-free survival differences which are two-thirds of those observed in the original study. The US investigators are experienced in conducting clinical trials and have proven track records for completing and publishing useful data from their work. The collaborating institutions and investigators are also clinical trial-experienced and have the patients and systems to ensure compliance with the protocol, complete pathology specimen collection and follow-up. The investigators will meet accepted and new ethical requirements for this research. A multidisciplinary data monitoring committee will oversee the study. PERFORMANCESITE(S) (organization, city, state) University of Wisconsin-Madison, Wisconsin Hospital K, National Cancer Institute, Hanoi, Viet Nam Philippine General Hospital, Manila, Philippines KEY PERSONNEL. See instructions. Use continuation pages as neededto provide the required information in the format shown below. Start with Principal Investigator. List all other key personnel in alphabetical order, last name first. Name Organization Role on Project Richard R. Love University of Wisconsin-Madison Principal Investiqator Disclosure Permission Statement. Applicable to SBIR/STTROnly. See instructions. QYes [] No PHS 398 (Rev. 05101) Page Form Page 2 Number pages consecutively at the bottom throughout the application. Do not use suffixes such as 3a, 3b. t PrincipInavl estigator/PrDoigreracmt(oLarst, first, middle): Love, Richard R. The name of the principalinvestigator;program director mustbe provided at the top of each printedpage and each continuation page Type density and size must conformto limits and specificationsprovided inthe PHS 398 Instructions. RESEARCH GRANT TABLE OF CONTENTS Page Numbers Face Page .............................................. 1 Description,

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project (R01)
Project #
5R01CA097375-05
Application #
7354774
Study Section
Epidemiology and Disease Control Subcommittee 2 (EDC)
Program Officer
Xie, Heng
Project Start
2004-03-01
Project End
2009-02-28
Budget Start
2008-03-07
Budget End
2009-02-28
Support Year
5
Fiscal Year
2008
Total Cost
$533,075
Indirect Cost
Name
Ohio State University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
832127323
City
Columbus
State
OH
Country
United States
Zip Code
43210
Love, Richard R; Laudico, Adriano V; Van Dinh, Nguyen et al. (2015) Timing of adjuvant surgical oophorectomy in the menstrual cycle and disease-free and overall survival in premenopausal women with operable breast cancer. J Natl Cancer Inst 107:djv064
Love, Richard R; Young, Gregory S; Laudico, Adriano V et al. (2013) Bone mineral density following surgical oophorectomy and tamoxifen adjuvant therapy for breast cancer. Cancer 119:3746-52
Love, R R; Ginsburg, O M; Coleman, C N (2012) Public health oncology: a framework for progress in low- and middle-income countries. Ann Oncol 23:3040-5
Ginsburg, Ophira M; Love, Richard R (2011) Breast cancer: a neglected disease for the majority of affected women worldwide. Breast J 17:289-95
Love, Richard R; Young, Gregory S; Hade, Erinn M et al. (2011) Effects on survival of menstrual cycle phase of adjuvant surgical oophorectomy in premenopausal women with breast cancer. Breast Cancer Res Treat 126:479-85
Mostafa, Mg; Larsen, Mt; Love, Rr (2010) Estrogen Receptor, Progesterone Receptor, and Her-2/neu Oncogene Expression in Breast Cancers Among Bangladeshi Women. J Bangladesh Coll Phys Surg 28:157-162
Uy, Gemma B; Laudico, Adriano V; Carnate Jr, Jose M et al. (2010) Breast cancer hormone receptor assay results of core needle biopsy and modified radical mastectomy specimens from the same patients. Clin Breast Cancer 10:154-9
Hade, Erinn M; Jarjoura, David; Lai Wei (2010) Sample size re-estimation in a breast cancer trial. Clin Trials 7:219-26
Love, Richard R (2010) Adjuvant hormonal therapy in premenopausal women with operable breast cancer: not-so-peripheral perspectives. Oncology (Williston Park) 24:322-7
Hammond, M Elizabeth H; Hayes, Daniel F; Dowsett, Mitch et al. (2010) American Society of Clinical Oncology/College of American Pathologists guideline recommendations for immunohistochemical testing of estrogen and progesterone receptors in breast cancer. Arch Pathol Lab Med 134:907-22

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