Compare Daily Ulipristal Acetate and Combined Oral Contraceptive Effects on Breast Epithelial Cell Proliferation
Status:
Completed
Trial end date:
2019-10-21
Target enrollment:
Participant gender:
Summary
Breast cancer accounts for almost a quarter of all cancers in women. In the United States
(U.S.) in 2014, more than 230,000 women were diagnosed and 40,000 died of breast cancer.
There is an urgent need to develop acceptable means of preventing breast cancer both for high
risk and average risk women.
The proposed study is a clinical trial in premenopausal women aged 18-39 to evaluate the
capacity of daily Ulipristal Acetate (UPA) to reduce breast epithelial cell proliferation
(increase in number of cells in the breast) and to measure its effect compared to that found
with a combined estrogen-progestin oral contraceptive (COC). UPA is an anti-progestin in use
as daily medication up to 12 months for the treatment of abnormally heavy bleeding at
menstruation due to uterine fibroids, and is currently in trials in the U.S. to evaluate its
use as a daily contraceptive.
The investigators will use breast biopsies to compare breast cell proliferation, comparing
biopsies at the end of 3 months treatment to biopsies taken at baseline in the 2 groups (UPA
and COC). The investigators will also compare the changes in the 2 groups to each other. The
comparison of the effect of UPA to that of a conventional COC is because of UPA's potential
use as a daily contraceptive.
Cell proliferation in the breast occurs throughout the menstrual cycle. The actions of
hormones on the breast are rapid and an anti-progestin such as UPA, which will block the
action of progesterone in the breast, would be predicted to quickly lower breast cell
proliferation in premenopausal women. Effects of UPA on the uterus continue to be studied and
are reassuring. COC use has not been found to lower breast cell proliferation and is not
associated with any decrease in risk of breast cancer.
The changes in breast cell proliferation will also be compared to changes seen on breast MRI.
If the changes are highly correlated future studies will be able to be done without the need
for breast biopsies.
Phase:
Phase 1
Details
Lead Sponsor:
Columbia University
Collaborators:
Memorial Sloan Kettering Cancer Center Weill Medical College of Cornell University