Drug Withdrawal in Women With Progressive Breast Cancer While on Aromatase Inhibitor Therapy
Status: | Archived |
---|---|
Conditions: | Breast Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | Any |
Updated: | 7/1/2011 |
Start Date: | August 2006 |
End Date: | August 2010 |
A Phase II Clinical Trial of Drug Withdrawal in Women With Progressive Breast Cancer While on Aromatase Inhibitor Therapy
The purpose of this research study is to study the effects of stopping aromatase inhibitory
(AI) therapy on breast cancer progression. Aromatase inhibitors are a class of drugs used
to treat breast cancer in postmenopausal women. They work by decreasing the level of
estrogen, which is believed to stimulate the growth of tumor tissue. Breast cancer that
progresses despite therapy with an AI is thought to have been resistant to AI therapy.
There is scientific evidence to suggest that resistant breast cancer cells learn to grow at
the very low levels of estrogen present on AI therapy and that increasing estrogen levels
even slightly by stopping AI therapy with inhibit the breast cancer cells. An improvement
or stabilization of breast cancer has been observed after stopping therapy with tamoxifen, a
different anti-estrogen therapy, and has been reported in the literature after stopping AI
therapy. This research study will be the first study to formally test the rate of disease
improvement (response) or stabilization after stopping AI therapy.
- Participants will have the following tests and procedures done at 8 weeks, 16 weeks,
and 24 weeks after stopping AI therapy: Physical examination; blood tests; tumor
assessment by physical exam (if possible); chest x-ray or CT scan of chest; CT scans of
abdomen and pelvis; and bone scan.
- After week 24, these procedures will be repeated every 12 weeks while the participant
is on the study.
We found this trial at
3
sites
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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