Aromatase Inhibitors in Premenopausal Breast Cancer Patients With Chemotherapy-Induced Ovarian Failure
Status:
Terminated
Trial end date:
2013-09-01
Target enrollment:
Participant gender:
Summary
Women with hormone-receptor positive breast cancer are typically treated with hormone therapy
as part of their treatment after surgery. In the past few years it has been found that
treatment with aromatase inhibitors is superior to tamoxifen in postmenopausal women.
Tamoxifen is still used for premenopausal women, however, because aromatase inhibitors are
not effective in women who have functioning ovaries. Some women are premenopausal at the time
they are diagnosed with breast cancer, but then stop having menstrual periods when they are
treated with chemotherapy. It is unclear if these women can also be treated safely with
aromatase inhibitors.
In this clinical trial the researchers will try to answer this question. Women with hormone
receptor positive breast cancer who become postmenopausal with chemotherapy will be invited
to participate in this study. Each woman will be treated with one of the aromatase
inhibitors, anastrozole (Arimidex), and then carefully monitored to ensure that her ovaries
do not start making estrogen. If her estrogen level remains low, then she will continued to
be followed for 18 months. If the level increases to the level typically seen in
premenopausal women, however, then she will stop taking part in this study.
The study will also evaluate multiple factors that may help doctors predict who will tolerate
the therapy without having their ovaries start making estrogen again. Some of the factors to
be evaluated include other hormone levels (blood tests) as well as family history of early
menopause (mother, sisters). In addition, changes in certain genes that affect how patients'
bodies handle chemotherapy drugs will be tested to see if they affect whether or not patients
recover ovarian function. Overall, the purpose of the study is to determine which patients
who become postmenopausal from chemotherapy are likely to tolerate aromatase inhibitor
treatment safely, and how often the patients' ovarian function needs to be tested during
treatment.
Phase:
Phase 2
Details
Lead Sponsor:
University of Michigan Cancer Center University of Michigan Rogel Cancer Center