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NCT06366347 · ClinicalTrials.gov registry record · Phase 2
ALPINE: Maintenance Letrozole/Abemaciclib
A Phase 2 study of Endometrial Cancer and TP53, sponsored by Dana-Farber Cancer Institute.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
- 6
- Study locations
NCT06366347: Recruiting Phase 2 study of Endometrial Cancer and TP53, sponsored by Dana-Farber Cancer Institute.
NCT06366347 is a Phase 2 study of Endometrial Cancer and TP53 that is actively recruiting participants, run by Dana-Farber Cancer Institute. The registered enrollment target is 32 participants, below the 524-participant average among 181 other Endometrial Cancer trials with a reported enrollment target (94% lower). The trial reports 6 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06366347, a Phase 2 study of Endometrial Cancer and TP53, is actively recruiting participants, sponsored by Dana-Farber Cancer Institute.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
- 6
- Study locations
Study Summary
The purpose of this research study is to see if the study drugs abemaciclib and letrozole are effective and safe for participants with estrogen-receptor positive (ER+), mismatch repair proficient, tumor protein p53 (TP53) wild-type endometrial cancer. The names of the study drugs involved in this study are: * Abemaciclib (a type of cyclin-dependent kinase (CDK) inhibitor) * Letrozole (a type of aromatase inhibitor)
Primary Outcome
PFS is defined as the time from the date the participant was registered to the date of documented progressive disease (PD) by RECIST version 1.1 or death (regardless of cause) in the absence of progression, regardless of whether the participant withdraws from study drug or receives another anti-cancer therapy prior to progression. Participants alive without disease progression are censored at date of last disease evaluation. A participant who dies without progression, and the death is \>12 weeks
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Letrozole
- DRUG Abemaciclib
Study Locations (6)
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
- Brigham and Women's Hospital - Boston
- Dana-Farber Cancer Institute - Boston
- Dana-Farber Cancer Institute at Foxborough - Foxborough
- Dana-Farber Cancer Institute at Milford - Milford
- Dana-Farber Cancer Institute at South Shore Hospital - Weymouth
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2024-09-25 |
| Est. Completion | 2029-03-01 |
| Phase | Phase 2 |
What NCT06366347 shows while recruiting
NCT06366347 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 524-participant average among 181 other Endometrial Cancer trials with a reported enrollment target (94% lower).
The record links to 3 conditions, with Endometrial Cancer appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT06366347 lists 6 locations in 1 state (Massachusetts).
Frequently Asked Questions
What is clinical trial NCT06366347 about?
NCT06366347 is a clinical study titled "ALPINE: Maintenance Letrozole/Abemaciclib". The purpose of this research study is to see if the study drugs abemaciclib and letrozole are effective and safe for participants with estrogen-receptor positive (ER+), mismatch repair proficient, tumor protein p53 (TP53) wild-type endometrial cancer. The names of the study drugs involved in this s...
What is the current status of trial NCT06366347?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2024-09-25. Estimated completion is 2029-03-01.
What conditions does trial NCT06366347 study?
This clinical trial studies the following conditions: Endometrial Cancer, TP53, Recurrent Endometrial Cancer.
What interventions are being tested in trial NCT06366347?
The interventions under investigation include: Pembrolizumab (DRUG), Letrozole (DRUG), Abemaciclib (DRUG).
Who is sponsoring clinical trial NCT06366347?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06366347 being conducted?
This trial has 6 study locations across Massachusetts. 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 NCT06366347's enrollment target sits among peer trials
32 144th of 181 higher than 36 of 181 other Endometrial Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Endometrial 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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