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NCT00555477 · ClinicalTrials.gov registry record · Phase 2
Aromatase Inhibitors in Premenopausal Breast Cancer Patients With Chemotherapy-Induced Ovarian Failure
A Phase 2 study, sponsored by University of Michigan Rogel Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 69
- Enrollment target
NCT00555477 is a Phase 2 study that was terminated before completion, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 69 participants.
The verdict
NCT00555477, a Phase 2 study, was terminated before completion, sponsored by University of Michigan Rogel Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 69 participants
- Enrollment target
Study 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 trea
Interventions
- DRUG anastrozole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2007-08 |
| Est. Completion | 2013-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00555477
The ClinicalTrials.gov registry entry for NCT00555477 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 69 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan Rogel Cancer Center, which has 292 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which anastrozole is the first listed.
NCT00555477 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00555477 about?
NCT00555477 is a clinical study titled "Aromatase Inhibitors in Premenopausal Breast Cancer Patients With Chemotherapy-Induced Ovarian Failure". 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 preme...
What is the current status of trial NCT00555477?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 69 participants. The study started on 2007-08. Estimated completion is 2013-09.
What interventions are being tested in trial NCT00555477?
The interventions under investigation include: anastrozole (DRUG).
Who is sponsoring clinical trial NCT00555477?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
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