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NCT02095184 · ClinicalTrials.gov registry record · NA
GCC 1366: Anti-Proliferative Response to NeoAdjuvant AIs in Overweight and Obese Patients
A NA study, sponsored by University of Maryland, Baltimore.
- Terminated
- Registry status
- NA
- Development phase
- 42
- Enrollment target
NCT02095184 is a NA study that was terminated before completion, run by University of Maryland, Baltimore. The registered enrollment target is 42 participants.
The verdict
NCT02095184, a NA study, was terminated before completion, sponsored by University of Maryland, Baltimore.
- TERMINATED
- Registry status
- NA
- Development phase
- 42 participants
- Enrollment target
Study Summary
More than three quarter of patients with breast cancer are treated by hormone pills called tamoxifen and aromatase inhibitors (AIs). AIs are drugs that stop female hormone production. This hormone production mostly happens in fat, muscle, and breast tissue in postmenopausal women. The female hormone estrogen is an important hormone for the growth of breast cancer cells. Anastrozole (Arimidex®) and Letrozole (Femara®) are AIs that are approved by the Food and Drug Administration (FDA). They have been used since 2005 to treat women with early stage breast cancer. When given before surgery (neoadjuvant), both anastrozole and letrozole have been shown to successfully shrink breast cancer tumors in most patients. In over 50% of patients, anastrozole and letrozole when given for about 4 months also helped to improve surgery outcomes. On top of that, whether or not a patient responds to anastrozole and letrozole before surgery can help the doctor decide whether that patient needs additional chemotherapy. One of the things may influence the level of hormone is body weight. It has been previously shown that postmenopausal women with higher body fat have higher level of female hormone as well as an increased risk of breast cancer. This is likely due to an increase in aromatase activity in the fatty tissue. However, at the current time AIs are used at the same doses in all women with breast cancer no matter whether they have different body weight. Currently, we do not know for certain whether the same doses of AIs work as well in patients with higher body fat compared to patients with less body fat. The purpose of this study is to see if women with higher body fat respond differently to AI treatment compared to women with lower body fat.
Interventions
- DRUG Anastrozole
- DRUG Letrozole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2015-05-25 |
| Est. Completion | 2024-08-02 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02095184
The ClinicalTrials.gov registry entry for NCT02095184 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Maryland, Baltimore, which has 560 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Anastrozole is the first listed.
NCT02095184 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02095184 about?
NCT02095184 is a clinical study titled "GCC 1366: Anti-Proliferative Response to NeoAdjuvant AIs in Overweight and Obese Patients". More than three quarter of patients with breast cancer are treated by hormone pills called tamoxifen and aromatase inhibitors (AIs). AIs are drugs that stop female hormone production. This hormone production mostly happens in fat, muscle, and breast tissue in postmenopausal women. The female hormone...
What is the current status of trial NCT02095184?
This trial is currently terminated. It is a NA study. The enrollment target is 42 participants. The study started on 2015-05-25. Estimated completion is 2024-08-02.
What interventions are being tested in trial NCT02095184?
The interventions under investigation include: Anastrozole (DRUG), Letrozole (DRUG).
Who is sponsoring clinical trial NCT02095184?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
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