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NCT05386108 · ClinicalTrials.gov registry record · Phase 1
Study of Abemaciclib and Elacestrant in Participants With Brain Metastasis Due to ER+/HER-2- Breast Cancer
A Phase 1 study of Neoplasms and Breast Neoplasms, sponsored by Stemline Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 73
- Enrollment target
- 20
- Study locations
NCT05386108: Recruiting Phase 1 study of Neoplasms and Breast Neoplasms, sponsored by Stemline Therapeutics.
NCT05386108 is a Phase 1 study of Neoplasms and Breast Neoplasms that is actively recruiting participants, run by Stemline Therapeutics. The registered enrollment target is 73 participants, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (95% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05386108, a Phase 1 study of Neoplasms and Breast Neoplasms, is actively recruiting participants, sponsored by Stemline Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 73 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a multi-site, global, open-label study that includes a phase 1b evaluation of elacestrant in combination with abemaciclib in women and men with brain metastases from estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER-2) negative breast cancer. Phase 1b was designed to select the recommended phase 2 dose (RP2D) and is followed by an ongoing phase 2 evaluation of elacestrant in combination with abemaciclib in participants with active brain metastases from ER-positive, HER-2 negative breast cancer.
Primary Outcome
Based on the observed number of dose-limiting toxicities (DLTs) during the first cycle. Dose-limiting toxicity is based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. DLTs will be evaluated during the first cycle (28 days) of treatment in up to 3 cohorts during Phase 1b. A DLT will be defined as any of the toxicities listed in the protocol that are not clearly due to breast cancer or extraneous causes.
Conditions Studied
Interventions
- DRUG Abemaciclib
- DRUG Elacestrant
Study Locations (20)
Other
- Antwerp University Hospital - Edegem
- Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg - Leuven
- Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc - Woluwe-Saint-Lambert
- Institut de Cancerologie de l'Ouest site Paul Papin - Angers
- Hôpital Morvan - CHRU de Brest - cancérologie et d'hématologie - Brest
- Centre Francois Baclesse - Oncologie Medicale - Cancerolo - Caen
- Centre Jean Perrin - Clermont-Ferrand
- Centre Léon Bérard - Département Oncologie Médicale - Lyon
- Centre de Cancerologie du Grand Montpellier - Montpellier
California
- Providence Medical Foundation - Fullerton
- California Research Institute - Los Angeles
Texas
- University of Texas MD Anderson Cancer Center - Houston
- UT Health San Antonio University of Texas - San Antonio
Illinois
- Carle Cancer Center - Urbana
Massachusetts
- Dana-Farber Cancer Institute - Boston
Michigan
- Henry Ford Hospital - Detroit
Ohio
- Miami Valley Hospital South - Centerville
Oregon
- Oregon Health & Science University - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2022-08-31 |
| Est. Completion | 2026-12 |
| Phase | Phase 1 |
What NCT05386108 shows while recruiting
NCT05386108 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (95% lower).
The record links to 8 conditions, with Neoplasms appearing as the primary indexed condition, and to 2 interventions - of which Abemaciclib is the first listed.
NCT05386108 names 20 study sites across 10 states, led by Other, California, Texas.
Frequently Asked Questions
What is clinical trial NCT05386108 about?
NCT05386108 is a clinical study titled "Study of Abemaciclib and Elacestrant in Participants With Brain Metastasis Due to ER+/HER-2- Breast Cancer". This is a multi-site, global, open-label study that includes a phase 1b evaluation of elacestrant in combination with abemaciclib in women and men with brain metastases from estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER-2) negative breast cancer. Phase 1b was designe...
What is the current status of trial NCT05386108?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 73 participants. The study started on 2022-08-31. Estimated completion is 2026-12.
What conditions does trial NCT05386108 study?
This clinical trial studies the following conditions: Neoplasms, Breast Neoplasms, Central Nervous System Diseases, Brain Neoplasms, Brain Diseases.
What interventions are being tested in trial NCT05386108?
The interventions under investigation include: Abemaciclib (DRUG), Elacestrant (DRUG).
Who is sponsoring clinical trial NCT05386108?
This trial is sponsored by Stemline Therapeutics, which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05386108 being conducted?
This trial has 20 study locations across California, Illinois, Massachusetts, Michigan, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05386108's enrollment target sits among peer trials
73 87th of 158 higher than 72 of 158 other Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neoplasms 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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