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What we already know

Many observations demonstrate two important truths:

 

By chance, IBCRF investigators found a possible way, in the face of these truths, to counteract both of these adverse effects of breast surgery.

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.

CAN BREAST TUMOR REMOVAL SURGERIES BE TIMED TO GET BETTER RESULTS?

Early Treatments Project 1:
A randomized trial of the timing of surgical oophorectomy in operable hormone receptor positive breast cancer
A Phase III Study generously funded through grants from the National Cancer Institute to 2013.

Study opened October 2003


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 500,000 Asian and 30,000 American pre-menopausal women with hormone sensitive breast cancer each year.

Study Organization:

This study includes 740 pre-menopausal Vietnamese, Filipino and Moroccan women with tumor hormone receptor positive breast cancer all of whom have been treated with surgery to remove their ovaries and tamoxifen. About a third of women had their ovary surgery delayed to occur during the estimated middle of the second half of their menstrual cycles. All women had blood hormone tests to confirm the times of the menstrual cycle they were actually in when the ovarian surgery was 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 over 90% 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.

On March 3, 2010 we had a patient forum at Philippines General Hospital in Manila in which 204 patients of our study participated.

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. We anticipate first results from this study in late 2012.


Our research team

Project Leaders:
Dr. Richard R. Love, M.D., M.S
Advisor, National Cancer Institute
Washington, D.C.
Scientific Director
International Breast Cancer Research Foundation

Dr. Ophira Ginsburg
Assistant Professor, Medical Oncology
Adjunct Scientist, Women's College Hospital
University of Toronto
Toronto, Canada
Study Statisticians:
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
     
  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
Clearing Method H6
     
  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

To learn more: Write to Dr. Richard Love at richardibcrf@gmail.com


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