SPECIAL BREAST PROGRAM; VIETNAM ADJUVANT OOPHORECTOMY/TAMOXIFEN IN PRE-MENOPAUSAL WOMEN
Phase III trial currently funded through generous grant from National Cancer Institute to The Ohio State University
Project Leader: |
| |
|
|
|
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
|
|
Status:
Study opened in 1993, currently funded through August 2008.
Program included four projects studying 709 Vietnamese and Chinese women in their 30’s and 40’s with breast cancer.
| |
Project 1: An Epidemiologic Study of Lactation and Reproductive Factors.
Project 2: Studies of Delay in Diagnosis of Breast Cancer.
Project 3: A Clinical Trial of Early vs. Late Hormonal Treatment for Breast Cancer in Pre-menopausal Women.
Project 4: A Pathology Study of Breast Tumor Characteristics in Asian Women. |
Clinical follow-up database closed September 1, 2006.
Statistical analysis and scientific reports are in process.
Updated: March 2008
Study Background:
Project 1: An Epidemiologic Study of Lactation and Reproductive Factors.
| |
Project Leader: |
|
| |
|
|
| |
Amy Trentham-Dietz, Ph.D.
Assistant Professor
Department of Population Health Sciences
University of Wisconsin – Madison
Madison, Wisconsin |
|
This project includes two studies:
Examination of the relationship between the duration of lactation and breast cancer. Because of the limited number of nursing women in the United States and the brevity of time spent nursing in this country, this element of the project is difficult to conduct in the U.S.
Analysis of reproductive history factors and their relationship to breast cancer to determine if certain causes are associated with specific characteristics of breast cancer tumors.
Significant Results:
Results of these studies show for the first time that:
Women with breast cancer who have more children are less likely to have a hormone receptor positive tumor and more likely to have a Her-2/neu negative tumor.
Women with a first pregnancy who are 24 or older are also more likely to have a hormone receptor positive tumor and more likely to have a Her-2/neu negative tumor.
These study results suggest that certain "causes" of breast cancer produce specific types of this disease.
|
|
Special Breast Program patients and Dr. Nguyen Van Dinh.
Breast Cancer Research Unit, Hanoi, Vietnam. |
Project 2: Studies of Delay in Diagnosis of Breast Cancer
An unfortunate reality in Asia and also many third world countries is that cancers of all kinds remain undiagnosed until the disease is at an advanced stage. This study offered several opportunities:
An opportunity to learn the reasons for the delay in diagnosis.
A unique opportunity to study the biologic characteristics of advanced cancers and to understand how they change over time.
Significant Results:
First results of these studies showed that delay in diagnosis of 6 or more months has limited impact on outcomes and/or survival. This tells us that this disease usually develops over a long period of time.
A publication about further results of this work are in progress.
This randomized clinical trial involved 709 women. A combined hormone treatment used in the trial has been found to be safe, inexpensive and, unlike chemotherapy, nontoxic. The results of this study, which is the first direct test of this concept in Asian women and the first comprehensive evaluation anywhere in the world, will be very important in decisions about the treatment worldwide of approximately 450,000 young women every year.
Significant Results:
First results on this study have been published and discussed in earlier IBCRF FrontLines articles and news releases. Click below to learn more.
 IBCRF Reports Breakthrough Finding
Acute Micrometastatic Arrest: A New Way of Treating Breast Cancer?
A Breast Cancer Breakthrough by Dan Rutz
A second major paper showing the excellent long term results of this treatment was published on January 15, 2008.
Study Background:
Project 4: A Pathology Study of Breast Tumor Characteristics in Asian Women
| |
Project Leader: |
|
| |
|
|
| |
Dr. Craig Allred, M.D.
Professor of Pathology
Washington University
St. Louis, Missouri |
|
This study is a careful evaluation of several characteristics of breast cancers using new antibody and genetic tests. The sizes of the tumors and the number of women involved in the study make it possible to answer many questions that cannot be answered in American studies because there isn’t enough tissue to do many tests. In addition to usual estrogen and progesterone receptor protein tests, new hormone receptor tests, and assays for the Her-2-Neu oncogene and ornithine decarboxylase are being done.
Significant Results:
This study has shown for the first time that breast cancers in Asian women have estrogen receptor protein, progesterone receptor protein and Her-2/neu oncogene over expression with exactly the same frequencies as are seen in American (mostly Caucasian) women. Laboratory investigators at Yale, Michigan, and The Ohio State Universities are conducting special hormonal receptor and Her-2/neu tests.
Click here to view a complete list of manuscripts related to this Special Breast Program and adjuvant hormonal therapy in Vietnamese breast cancer.
|
|
