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NCT02296801 · ClinicalTrials.gov registry record · Phase 2
A Phase II Randomized Study Evaluating the Biological and Clinical Effects of the Combination of Palbociclib With Letrozole as Neoadjuvant Therapy in Post-Menopausal Women With Estrogen-Receptor Positive Primary Breast Cancer
A Phase 2 study, sponsored by NSABP Foundation.
- Completed
- Registry status
- Phase 2
- Development phase
- 307
- Enrollment target
NCT02296801: Completed Phase 2 study, sponsored by NSABP Foundation.
NCT02296801 is a Phase 2 study that has completed, run by NSABP Foundation. The registered enrollment target is 307 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (131% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02296801, a Phase 2 study, has completed, sponsored by NSABP Foundation.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 307 participants
- Enrollment target
Study Summary
This study will look at effects the combination of palbociclib and letrozole may have on estrogen receptor (ER)-positive/human epidermal growth factor receptor 2 (HER2)-negative breast cancer tumors which have not yet been treated. Letrozole is a type of endocrine therapy called an aromatase inhibitor (AI) and is standard treatment for post-menopausal women with ER-positive/HER2-negative breast cancer.
Primary Outcome
The change in Ki67 from baseline to 14 weeks.
Interventions
- DRUG Letrozole
- DRUG palbociclib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 307 participants |
| Start Date | 2015-01 |
| Est. Completion | 2019-03 |
| Phase | Phase 2 |
What the finished NCT02296801 record still lists
NCT02296801 is an interventional study that assigns participants to a tested intervention. The registered 307 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (131% higher).
The record links to 0 conditions, and to 2 interventions - of which Letrozole is the first listed.
NCT02296801 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02296801 about?
NCT02296801 is a clinical study titled "A Phase II Randomized Study Evaluating the Biological and Clinical Effects of the Combination of Palbociclib With Letrozole as Neoadjuvant Therapy in Post-Menopausal Women With Estrogen-Receptor Positive Primary Breast Cancer". This study will look at effects the combination of palbociclib and letrozole may have on estrogen receptor (ER)-positive/human epidermal growth factor receptor 2 (HER2)-negative breast cancer tumors which have not yet been treated. Letrozole is a type of endocrine therapy called an aromatase inhibit...
What is the current status of trial NCT02296801?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 307 participants. The study started on 2015-01. Estimated completion is 2019-03.
What interventions are being tested in trial NCT02296801?
The interventions under investigation include: Letrozole (DRUG), palbociclib (DRUG).
Who is sponsoring clinical trial NCT02296801?
This trial is sponsored by NSABP Foundation, which has 44 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02296801's enrollment target sits among peer trials
307 165th of 2000 higher than 1,836 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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