TIMING OF SURGICAL OOPHORECTOMY TREATMENT FOR METASTATIC BREAST CANCER IN PRE-MENOPAUSAL WOMEN
Phase III IBCRF Study generously funded through grants from BCRF, New York

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

Heather Roberto, M.P.H.

Research Specialist
International Oncology
Comprehensive Cancer Center
The Ohio State University
Columbus, Ohio

Erinn Hade

Senior consulting research statistician
The Ohio State University Center for Biostatistics
Columbus, Ohio

Greg Young

Senior consulting research statistician
The Ohio State University Center for Biostatistics
Columbus, Ohio

Status:

Study opened in 2004.

Currently open in 21 hospitals in 9 countries: 1 North American (USA), 6 Asian (Philippines, China, Indonesia, Bangladesh, Vietnam, Malaysia), and 2 African (Morocco, Nigeria).

Planned patient accrual: 350, Actual patient accrual to date: 99.

Updated: May 2007

Researchers in three collaborating hospitals

Univ. of Malaya Medical Center
Kuala Lumpur, Malaysia.

Univ. of Indonesia Hospital
Jakarta, Indonesia

National Cancer Institute
Hanoi, Vietnam

Study Background:
Detailed analysis of a study of 709 pre-menopausal women with breast cancer in Vietnam and China suggested that if surgical oophorectomy (removal of the ovaries) treatment was done during the second (luteal) half of the menstrual cycle rather than the first (follicular) half of the cycle the surgery was shown to be significantly more effective. If this is really true then simply changing the time of the surgery could markedly increase the benefits of this important hormonal treatment. This kind of treatment would be appropriate, for example, for the 200,000 Asian and 30,000 American pre-menopausal women who develop metastatic breast cancer annually.

Study Organization:
This study will involve 350 women who have breast cancer that has spread to other parts of their bodies, and for which, based on hormone receptor tests of their tumors, a hormonal treatment like surgical oophorectomy is the best treatment. We are seeking participants in Asian and African countries because larger numbers of young women with breast cancer are in these countries with large populations.

Qilu Hospital-Shandong University Consortium
Jinan, China

Significant Results:

Surgical oophorectomy is a practical, inexpensive and non-toxic breast cancer treatment. If this study shows that luteal phase oophorectomy is more effective treatment, this would be a breakthrough for all women, everywhere.

If surgical oophorectomy during the luteal phase of the menstrual cycle is more effective treatment, this means the specific hormonal changes with this surgery cause other major changes in the blood (in other growth promoting or inhibiting substances), changes that will be very important to identify.

This study could open up a completely different way of thinking about treatments for breast cancer. A positive result from this study would mean alterable conditions in the body at the time other treatments or procedures (like mammography) are given, can have a big effect on whether cancers grow or die.

Future Plans :

During Summer 2007 a consortium of hospitals in Taiwan is joining the study and in late May we will be training their staff for the study.

In Bangladesh beginning in 2007 we have opened a free breast problem-screening walk-in clinic in a rural town called Bagerhat in the southern part of the country. This year we are trying to create 4 more such clinics from which we hope to find more women for the study (See Frontlines article on Bangladesh clinics). Project Co-ordinator will be Ms. Heather Roberto, M.P.H., Research Specialist, International Oncology, Comprehensive Cancer Center, The Ohio State University.