Last reviewed · How we verify
NCT06366347
ALPINE: Maintenance Letrozole/Abemaciclib
Phase 2 trial testing Abemaciclib in Endometrial Cancer in 32 participants. Currently enrolling.
1 September 2027
Quick facts
| Lead sponsor | Dana-Farber Cancer Institute |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 32 |
| Start date | 25 September 2024 |
| Primary completion | 1 September 2027 |
| Estimated completion | 1 March 2029 |
| Sites | 6 locations across United States |
Drugs / interventions tested
- Abemaciclib (abemaciclib) — full drug profile →
- Letrozole — full drug profile →
- Pembrolizumab (pembrolizumab) — full drug profile →
Conditions studied
- Endometrial Cancer — all drugs for Endometrial Cancer →
- Recurrent Endometrial Cancer — all drugs for Recurrent Endometrial Cancer →
- TP53 — all drugs for TP53 →
Sponsor
Dana-Farber Cancer Institute
Who can join
18 and older, any sex, with Endometrial Cancer or Recurrent Endometrial Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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)
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Current insights and future directions of Li-Fraumeni syndrome.
Hosseini MS. · · 2024 · cited 7× · PMID 39404911 · DOI 10.1007/s12672-024-01435-w -
Drug discovery in advanced and recurrent endometrial cancer: Recent advances.
Francoeur AA, Ayoub N, Greenberg D, Tewari KS. · · 2025 · cited 4× · PMID 40612873 · DOI 10.32604/or.2025.061120 -
Endocrine Therapy for Endometrial Carcinoma: Current Evidence, Resistance Mechanisms, and Biomarker-Driven Patient Selection.
Yamanaka T, Yoshida H, Shimoi T, Sudo K, et al · · 2026 · PMID 41744888 · DOI 10.3390/curroncol33020124
Verify or expand the search:
- PubMed search for NCT06366347
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Abemaciclib
Trials testing the same drug.
- NCT07492641 — BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer · Phase 3 · not yet recruiting
- NCT07428018 — Pragmatic Study to Optimize Neoadjuvant Treatment and Surgical De-escalation in HR+/HER2- Early Breast Cancer Using Onco · Phase 2 · not yet recruiting
- NCT07191717 — Imlunestrant and Abemaciclib for the Treatment of Estrogen Receptor Positive Breast Cancer in Patients With Minimal Resi · Phase 2 · not yet recruiting
- NCT06498648 — Testing the Addition of an Anti-cancer Drug, Abemaciclib, to the Usual Chemotherapy Treatment (Gemcitabine) for Soft Tis · Phase 1, PHASE2 · recruiting
- NCT07441369 — Abemaciclib Combined With FOLFOX/FOLFIRI Regimen in Patients With Advanced Colorectal Liver Metastases Cancer · Phase 2 · enrolling by invitation
Other recruiting trials for Endometrial Cancer
Currently open trials in the same condition.
- NCT07419841 — A Phase 1 Study of the Safety and Tolerability of CTX-10726 · Phase 1 · recruiting
- NCT07382583 — Development of a Shared Decision Tool to Facilitate Uptake of the Levonorgestrel-releasing Intrauterine System for the P · recruiting
- NCT07377734 — Intrauterine Injection of Type III Collage in FST of EC/AEH · Phase 2 · recruiting
- NCT07319429 — Refining Fertility-sparing Treatment in Endometrial Carcinoma Based on Molecular Classification · Phase 2, PHASE3 · recruiting
- NCT07397624 — Endoscopic Suture Gastroplasty (ESG) for Treatment of Obese Patients With Endometrial Cancer · recruiting
Other Dana-Farber Cancer Institute trials
Trials by the same sponsor.
- NCT07519200 — Sexual Health and Rehabilitation for Women With Metastatic Breast Cancer (SHARE-MC): An Educational Intervention · NA · not yet recruiting
- NCT07499999 — Randomized Double-Blind Phase II Trial of Baby Exemestane Versus Baby Tamoxifen in Post-Menopausal Women at High Risk fo · Phase 2 · not yet recruiting
- NCT05825469 — Development and Testing of Nutritional Algorithms (NACHO) · NA · not yet recruiting
- NCT07516353 — my.naviGATE: A Guide to After-Treatment Effects for Adolescents and Young Adults · NA · not yet recruiting
- NCT07513324 — Risk-adapted Therapy in HPV-positive Oropharyngeal Cancer Using Circulating Tumor (ct) HPV DNA Profiling (ReACT 2.0) · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06366347 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Dana-Farber Cancer Institute
- Last refreshed: 11 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06366347.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing