WHAT WE ALREADY KNOW
The “stress” of breast (or any) surgery causes biochemical changes which unfortunately promote growth of any cancer cells or groups of cells in the body.
By chance, IBCRF investigators found a possible way, in the face of these truths, to counteract both of these adverse effects.
We found that if surgery to remove the ovaries (which is an effective hormonal treatment for the two-thirds of breast cancers which are hormone sensitive), is done in the second half (luteal phase) of the menstrual cycle instead of the first half (follicular phase) in pre-menopausal women who are having breast tumor –removing surgery also at the same time, the long term chances of cure are much better.
We believe that this occurs because the rapid changes in hormones in the blood which occur with luteal phase oophorectomy surgery are markedly different from those with follicular phase surgery, and these changes are anti-breast cancer cell growth in nature.
Metastatic study project 1:
Timing of Surgical Oophorectomy Treatment For Metastatic Breast Cancer In Pre-menopausal Women: A Phase III Study Generously Funded Through Grants from BCRF, New York
Status:
- Study opened in 2004
- Currently open in 25 hospitals in 9 countries: 7 Asian (Philippines, China, Indonesia, Bangladesh, Vietnam, Malaysia, Taiwan), and 2 African (Morocco and Nigeria), and hopefully soon also in one hospital in India and one in Thailand
- Planned patient accrual: 350, Actual patient accrual to date: 236
Updated December, 2010
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 10,000 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.
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.
Early results show that in the first 163 patients, the time to progression of cancer growth again is longer than we have expected and many patients are more than three years from first treatment with good control of their disease.
Future Plans:
The principal clinical site focus for this study is now Bangladesh where we have entered 86 patients in three years and now have 3 major hospitals in Dhaka, and two in the rural division of Khulna participating in the study.
A wonderful oncology leader in Bangladesh Professor ABMF Karim is helping us. Our real study champion is Dr Syed Mozammel Hossain in Khulna.
Our Research Team
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Project Leader:
Dr. Richard R. Love, M.D., M.S
Senior Advisor
National Cancer Institute
Washington, D.C.
Scientific Director
International Breast Cancer Research Foundation |
Study Coordinator:
Heather Story, M.P.H.
Research Specialist
International Breast Cancer
Research Foundation |
Study Statisticians:
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 |
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Researchers in five collaborating hospitals
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Univ. of Malaya Medical Center
Kuala Lumpur, Malaysia |
Univ. of Indonesia Hospital
Jakarta, Indonesia |
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 Dr. Syed Mozammel Hossain
Associate Professor of Obstetrics
and Gynecology
Khulna Medical College Khulna, Bangladesh
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National Cancer Institute
Hanoi, Vietnam |
Qilu Hospital-Shandong University Consortium,
Jinan, China |
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