Trial · NCT06366347
ALPINE: Maintenance Letrozole/Abemaciclib
NCT06366347, Phase 2, Recruiting, Dana-Farber Cancer Institute
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. ALPINE: Maintenance Letrozole/Abemaciclib. Trials, record NCT06366347. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06366347
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ALPINE: Maintenance Letrozole/Abemaciclib
- NCT number
- NCT06366347
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 32 participants, estimated
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Endometrial Cancer, Recurrent Endometrial Cancer, TP53
- Interventions
- Abemaciclib, Letrozole, Pembrolizumab
- First posted
- 2024-04-15
- Last updated
- 2026-10-15
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Median Progression Free Survival (PFS) | Up to 2 years | 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 after the last evaluable tumor assessment, is censored for PFS at the date of last disease evaluation. A participant who has no baseline or no post treatment tumor assessment is censored at 0 days for PFS, unless she dies \< 12 weeks from randomization, in which case the PFS event date is the death date. Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum, taking as reference the smallest sum on study with at least 5 mm absolute increase. |
| Secondary | Grade 3-5 Adverse Events (AE) Rate | Up to 2 years and 1 month | Grade 3-5 AE rate is defined as the proportion of patients who experience a grade 3-5 adverse event based on the Common Toxicity Criteria for Adverse Events version 5.0 as reported on case report form. |
| Secondary | Median Overall Survival (OS) | Up to 5 years | OS is defined as the time from registration to death due to any cause, or censored at date last known alive based on Kaplan-Meier methodology. |
| Secondary | Objective Response Rate (ORR) | Up to 2 years | The percentage of participants who achieved complete response (CR) and partial response (PR) based on RECIST 1.1 criteria. Complete Response (CR) for target lesion: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to \< 10 mm. Partial Response (PR) for target lesion: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06366347
GET https://conductscience.org/api/trials/v1/NCT06366347/registered