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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: Clinical Trial NA study, sponsored by University of Maryland, Baltimore.
NCT02095184 is a NA study that was terminated before completion, run by University of Maryland, Baltimore. The registered enrollment target is 42 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Core biopsy
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 |
Why NCT02095184 stopped before completion
NCT02095184 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Anastrozole is the first listed.
NCT02095184 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02095184's enrollment target sits among peer trials
42 1436th of 2000 higher than 555 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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