TIMING OF ADJUVANT SURGICAL OOPHORECTOMY IN PRE-MENOPAUSAL WOMEN
Phase III Study generously funded through grants from the National Cancer Institute

Project Leader:	Study Co-ordinator:	Study Statisticians:


Dr. Richard R. Love, M.D., M.S Professor of Medicine and Public Health The Ohio State University Columbus, Ohio Senior Investigator National Cancer Institute Washington, D.C. Scientific Director International Breast Cancer Research Foundation Madison, Wisconsin	Linda McCart Research Specialist International Oncology Comprehensive Cancer Center The Ohio State University Columbus, Ohio	David Jarjoura, Ph.D. Associate Director/Administrative Director College of Medicine and Public Health School of Public Health The Ohio State University Columbus, Ohio	Stanley Lemeshow, M.S.P.H, PhD Professor and Dean Division of Biostatistics College of Public Health The Ohio State University Columbus, Ohio

Status:

Study opened October 2003.

Currently open in 9 hospitals in 3 countries: 2 Asian (Vietnam, Philippines), 1 African (Morocco).

Planned patient accrual: 510, Actual patient accrual to date: 502.

Updated: March 2008

Our study pathologist
Hue Central Hospital
Hue, Vietnam

Our team at Vicente Sotto Memorial Medical Center
Cebu, Philippines

Surgery ward
Philippine General Hospital
Manila, Philippines

Study Background:
In a 709 patient IBCRF study in Vietnam and China, after the main questions of the study were addressed, exploratory analyses suggested that if the surgical oophorectomy treatment was performed in the second half of women’s menstrual cycles, this treatment was significantly more effective than if performed during the first half of the menstrual cycle. If this were true, the benefits of treatment could be markedly increased simply by regularly scheduling surgical oophorectomy surgery to be done during their second half of the menstrual cycle. Additionally, if this were true, this finding would have major significance for the timing of other breast cancer treatments.

Study Organization:
This study will involve 510 pre-menopausal Vietnamese, Filipino and Moroccan women with tumor hormone receptor positive breast cancer all of whom will be treated with surgery to remove their ovaries and tamoxifen. About a third of women will have their ovary surgery delayed to occur during the estimated middle of the second half of their menstrual cycles. All women will have blood hormone tests to confirm the times of the menstrual cycle they are actually in when the ovarian surgery is done.

Significant Considerations:

Surgical oophorectomy and tamoxifen has been shown to be effective and safe with only limited side effects (hot flashes) in Vietnamese women. As a result this treatment is now the standard adjuvant treatment for women with hormone receptor positive tumors throughout the world.

Discovering the importance of the timing of oophorectomy in the menstrual cycle is a critical issue for understanding breast cancer control.

Tumor samples have been collected in 98% of the cases from this study for special laboratory studies in the United States.

We have used GPS technology to “map” exactly where every one of our study patients live so we can always find them. As a result we have perfect follow-up on every single Filipino patient.

We are accruing 20 new patients per month to this study so we will reach our goal of 510 this year.