Answers
06/07/1994

<TITLE>Advisory Committee Reevaluates Tamoxifen Prevention Trial</TITLE>
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T94-29                                         Susan M. Cruzan
June 7, l994                                   301-443-3285
                                
    Advisory Committee Reevaluates Tamoxifen Prevention Trial

     FDA's Oncologic Drugs Advisory committee, a group of outside
experts, today recommended that the tamoxifen breast cancer
prevention trial be continued with additional endometrial
monitoring to assure safety of women in the study.   The following
may be used to answer inquiries.  
     In l990 an FDA advisory committee supported the concept of a
large long-term randomized study to determine the effect of
tamoxifen in healthy women and in l991 recommended that FDA allow
such a trial to proceed.  
     The NCI-funded prevention study was designed to determine
whether tamoxifen can reduce the incidence of breast cancer in
healthy women who are at increased risk for this disease, and to
evaluate the risks and benefits of tamoxifen treatment in this
study population.   The trial is based on evidence that the drug
reduces the risk of a new cancer in the other breast in women
taking the drug after surgery for breast cancer.  The trial has
enrolled over 10,000 subjects since it began in 1992.
     In April l994, based on the latest data in a Swedish trial and
the B-14 trial conducted by the National Surgical Breast and Bowel
Project (NSABP), the drug's package insert was revised to relect an
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                                       Page 2, T94-29, Tamoxifen
updated warning on the increased risk of cancer of the uterus.  The
informed consent for the tamoxifen breast cancer prevention study 
was also updated in early l994.    
     The committee was asked to evaluate several questions.  They 
discussed whether patients should be required to undergo
endometrial procedures and whether such procdures could be expected
to reduce uterine cancer morbidity and mortality.  The committee
concluded that no procedure was studied well enough to be
recommended but that the usefulness of various screening procedures
should be vigorously evaluated. They also discussed whether
revisions of the study design were necessary, such as limiting
duration of treatment, changes in the eligibilty criteria,
inclusion of a significant number of minorities and consideration
of increasing the sample size.  They concluded that no changes were
needed.   
     FDA emphasizes that tamoxifen should not be used as a
preventive in women who have not had breast cancer outside of a
clinical trial.
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