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NCT01831076 · ClinicalTrials.gov registry record · Phase 2
Preoperative Hormone Therapy for Postmenopausal Women With ER+ Clinical Stage T2-4 Tumors
A Phase 2 study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
NCT01831076: Completed Phase 2 study, sponsored by University of Colorado, Denver.
NCT01831076 is a Phase 2 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 36 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01831076, a Phase 2 study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
Study Summary
This phase II trial studies how well exemestane before surgery works in treating postmenopausal patients with newly diagnosed estrogen receptor positive stage II-III breast cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy using exemestane may fight breast cancer by blocking the use of estrogen by the tumor cells.
Primary Outcome
Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Evaluated using chi-square analysis.
Interventions
- DRUG Exemestane
- DRUG Exemestane and tamoxifen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2002-04 |
| Est. Completion | 2022-01-06 |
| Phase | Phase 2 |
What the finished NCT01831076 record still lists
NCT01831076 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which Exemestane is the first listed.
NCT01831076 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01831076 about?
NCT01831076 is a clinical study titled "Preoperative Hormone Therapy for Postmenopausal Women With ER+ Clinical Stage T2-4 Tumors". This phase II trial studies how well exemestane before surgery works in treating postmenopausal patients with newly diagnosed estrogen receptor positive stage II-III breast cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy using exemestane may fight breast cancer by block...
What is the current status of trial NCT01831076?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2002-04. Estimated completion is 2022-01-06.
What interventions are being tested in trial NCT01831076?
The interventions under investigation include: Exemestane (DRUG), Exemestane and tamoxifen (DRUG).
Who is sponsoring clinical trial NCT01831076?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01831076's enrollment target sits among peer trials
36 1496th of 2000 higher than 477 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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