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NCT03628066 · ClinicalTrials.gov registry record · Phase 2
Biological and Clinical Effects of Palbociclib With Ovarian Suppression and Letrozole in the Neoadjuvant Treatment of Breast Cancer
A Phase 2 study of Breast Cancer, sponsored by NSABP Foundation.
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
- 15
- Study locations
NCT03628066: Completed Phase 2 study of Breast Cancer, sponsored by NSABP Foundation.
NCT03628066 is a Phase 2 study of Breast Cancer that has completed, run by NSABP Foundation. The registered enrollment target is 24 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 15 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03628066, a Phase 2 study of Breast Cancer, has completed, sponsored by NSABP Foundation.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
- 15
- Study locations
Study Summary
This study will look at the safety and effectiveness of the combination of palbociclib and letrozole and ovarian suppression for premenopausal patients who have ER-positive/HER2-negative breast cancer that has not yet been treated.
Primary Outcome
Percentage of patients with a Ki67 less than 2.7%
Conditions Studied
Interventions
- DRUG Letrozole
- DRUG Palbociclib
- DRUG Goserelin
- DIAGNOSTIC_TEST Oncotype DX Breast Recurrence Score
Study Locations (15)
California
- Breast Cancer Care Specialist - Fountain Valley
- Orange Coast Blood and Cancer Care - Fountain Valley
- Saddleback Memorial Medical Center - Laguna Hills
- Coast Hematology-Oncology Associates Medical Group - Long Beach
- Long Beach Memorial Medical Center - Long Beach
- Oncology Hematology Consultants - Long Beach
Quebec
- Centre Hospitalier de l'Universite de Montreal - Montreal
- Jewish General Hospital - Montreal - Montreal
- McGill University Health Centre-Cedars Cancer Centre - Montreal
- CHU de Quebec - Hopital de Saint-Sacrement - Québec
Illinois
- Cancer Care Specialists of Central Illinois - Decatur
South Dakota
- Avera Cancer Institute-Sioux Falls - Sioux Falls
Texas
- Lester and Sue Smith Breast Center - Houston
West Virginia
- West Virginia University - Morgantown
Wisconsin
- Froedtert Hospital - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2018-10-22 |
| Est. Completion | 2021-01-30 |
| Phase | Phase 2 |
What the finished NCT03628066 record still lists
NCT03628066 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 4 interventions - of which Letrozole is the first listed.
NCT03628066 lists 15 locations in 7 states (California, Quebec, Illinois).
Frequently Asked Questions
What is clinical trial NCT03628066 about?
NCT03628066 is a clinical study titled "Biological and Clinical Effects of Palbociclib With Ovarian Suppression and Letrozole in the Neoadjuvant Treatment of Breast Cancer". This study will look at the safety and effectiveness of the combination of palbociclib and letrozole and ovarian suppression for premenopausal patients who have ER-positive/HER2-negative breast cancer that has not yet been treated.
What is the current status of trial NCT03628066?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2018-10-22. Estimated completion is 2021-01-30.
What conditions does trial NCT03628066 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT03628066?
The interventions under investigation include: Letrozole (DRUG), Palbociclib (DRUG), Goserelin (DRUG), Oncotype DX Breast Recurrence Score (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03628066?
This trial is sponsored by NSABP Foundation, which has 44 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03628066 being conducted?
This trial has 15 study locations across California, Illinois, South Dakota, Texas, West Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03628066's enrollment target sits among peer trials
24 1042nd of 1224 higher than 170 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer 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.
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