An explanatory clinical trial of breast cancer prevention, 1994 - 2004. Canadian Breast Cancer Research Initiative
Description
The long term goal of the proposed research is to determine if the incidence of
breast cancer in a high risk population can be reduced by 29% by a reduction of
dietary fat intake to a target of 15% of calories. We propose to meet this goal
by means of a multi-centre randomized controlled trial in Canada that will
enroll 4,500 subjects with extensive mammographic densities from 6 centres.
The trial is designed, as its title indicates, as an explanatory study whose
purpose is the detection of a biological effect. We have therefore consciously
restricted entry to the trial to subjects with characteristics shown in previous
work to be associated with an increased risk of cancer and with willingness to
participate and comply with the goals of the trial. Further, preliminary data
show that the dietary intervention in these subjects causes changes in plasma
sex hormone levels and mammographic densities that indicate potential mechanisms
by which a reduction in risk of breast cancer might be achieved.
Principal Investigator
Co-Principal Investigator
Research team
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