A meta-analysis of 8 breast cancer adjuvant therapy trials from the l97Os has suggested that adjuvant oophorectomy may be associated with long-term increases in disease-free and overall survival. Essentially all breast cancer adjuvant trials of all types have been conducted with populations in Western or developed countries and most have not standardized treatment on relapse, which makes interpretation of overall survival results difficult. Concerns about severe menopausal symptoms and about long-term adverse effects of oophorectomy on the cardiovascular system and skeleton, have prevented initiation of new adjuvant oophorectomy studies. The addition of tamoxifen following oophorectomy is suggested by recent data demonstrating that tamoxifen has estrogen-like favorable effects on cardiovascular risk factors and on bone density. A premenopausal population with a lower estrogen profile such as is observed in Asian women might be expected to derive the greatest net benefit from an oophorectomy/tamoxifen adjuvant regimen. Breast cancer is the most common malignancy in women in northern Vietnam and the second most common cancer in the south. In Vietnam, financial and other resources for treatment are limited, and the standard of care for operable breast cancer throughout Vietnam is observation after surgical +/-radiotherapy treatment. The investigators have begun a randomized controlled trial of surgical oophorectomy and tamoxifen versus this treatment on first recurrence for premenopausal Vietnamese women with TNM Stage II-IIIA carcinoma of the breast. Three and five year overall and disease-free survival are the study endpoints; the accrual goal is 600 women over 3 years. This study plan provides 80-90% power for overall survival at 3 years, and 70-80% power at 5 years. One-hundred and forty- two women have entered the study in 15 months and detailed symptom reports in the first 121 women followed have indicated acceptable vasomotor toxicity. Several histopathologic prognostic factors will be investigated and used in the survival analysis including immunohistochemically determined estrogen add progesterone receptor protein content. The investigators have functional systems in place to conduct this trial to a successful conclusion yielding direct information on the impact of adjuvant oophorectomy and tamoxifen in Vietnamese women. These results will have important implications for adjuvant therapy given to women with breast cancer in Asia in particular, but also worldwide and in the United States. Support is requested only for the American operations component of this trial.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project (R01)
Project #
5R01CA064339-03
Application #
2443098
Study Section
Epidemiology and Disease Control Subcommittee 2 (EDC)
Project Start
1995-07-01
Project End
1998-06-30
Budget Start
1997-07-01
Budget End
1998-06-30
Support Year
3
Fiscal Year
1997
Total Cost
Indirect Cost
Name
University of Wisconsin Madison
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
161202122
City
Madison
State
WI
Country
United States
Zip Code
53715
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
Love, Richard R (2010) Adjuvant hormonal therapy in premenopausal women with operable breast cancer: not-so-peripheral perspectives. Oncology (Williston Park) 24:322-7
Love, Richard R (2008) Defining a global research agenda for breast cancer. Cancer 113:2366-71
Love, Richard R; Van Dinh, Nguyen; Quy, Tran Tu et al. (2008) Survival after adjuvant oophorectomy and tamoxifen in operable breast cancer in premenopausal women. J Clin Oncol 26:253-7
Love, Richard R; Niederhuber, John E (2004) Models of breast cancer growth and investigations of adjuvant surgical oophorectomy. Ann Surg Oncol 11:818-28
Mohsin, Syed K; Weiss, Heidi; Havighurst, Thomas et al. (2004) Progesterone receptor by immunohistochemistry and clinical outcome in breast cancer: a validation study. Mod Pathol 17:1545-54
Love, Richard R; Duc, Nguyen Ba; Baumann, Linda C et al. (2004) Duration of signs and survival in premenopausal women with breast cancer. Breast Cancer Res Treat 86:117-24
Love, Richard R; Ba Duc, Nguyen; Cong Binh, Nguyen et al. (2003) Postmastectomy radiotherapy in premenopausal Vietnamese and Chinese women with breast cancer treated in an adjuvant hormonal therapy study. Int J Radiat Oncol Biol Phys 56:697-703
Love, Richard R; Astrow, Stephanie H; Cheeks, Alan M et al. (2003) Ornithine decarboxylase (ODC) as a prognostic factor in operable breast cancer. Breast Cancer Res Treat 79:329-34

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