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NCT05563220 · ClinicalTrials.gov registry record · Phase 1
Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer
A Phase 1 study of Breast Cancer and Metastatic Breast Cancer, sponsored by Stemline Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 435
- Enrollment target
- 20
- Study locations
NCT05563220 is a Phase 1 study of Breast Cancer and Metastatic Breast Cancer that is actively recruiting participants, run by Stemline Therapeutics. The registered enrollment target is 435 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (84% lower). The trial reports 20 study locations across 11 states.
The verdict
NCT05563220, a Phase 1 study of Breast Cancer and Metastatic Breast Cancer, is actively recruiting participants, sponsored by Stemline Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 435 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a multicenter, Phase 1b/2 trial in participants with estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) advanced/metastatic breast cancer. The phase 1b part of the trial will determine the recommended Phase 2 dose (RP2D) of elacestrant when administered in combination with alpelisib, everolimus, palbociclib, capivasertib, and ribociclib. The Phase 2 part of the trial will evaluate the efficacy and safety of the various combinations.
Conditions Studied
Interventions
- DRUG Everolimus
- DRUG Palbociclib
- DRUG Ribociclib
- DRUG Elacestrant
- DRUG Alpelisib
Study Locations (20)
California
- OPN Healthcare (Arcadia Location) - Arcadia
- City of Hope National Medical Center - Duarte
- Glendale Adventist - Glendale
- OPN Healthcare (Los Alamitos Location) - Los Alamitos
- Cedars Sinai - Los Angeles
- UCLA UCLA Hem/Onc - Clinical Research Unit - Los Angeles
- UCSF Helen Diller Family Comprehensive Cancer Center - San Francisco
- TOI Clinical Research - Whittier
Florida
- Advent Health (Florida Hospital) - Altamonte Springs - Altamonte Springs
- Mayo Clinic - Jacksonville - Jacksonville
- Ocala Oncology - Ocala
Alabama
- Dothan Hematology and Oncology - Dothan
Arizona
- Mayo Clinic - Arizona - Phoenix
Arkansas
- Highlands Oncology Group - Springdale
Colorado
- Rocky Mountain Cancer Centers - Lone Tree
Connecticut
- Yale School Of Medicine - Smilow Cancer Hospital - Breast Center - New Haven
District of Columbia
- George Washington Cancer Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 435 participants |
| Start Date | 2023-01-24 |
| Est. Completion | 2028-12-28 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05563220
The ClinicalTrials.gov registry entry for NCT05563220 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 435 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (84% lower). The listed sponsor is Stemline Therapeutics, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Everolimus is the first listed.
NCT05563220 reports 20 study locations spanning 11 distinct geographic areas - top geographies include California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT05563220 about?
NCT05563220 is a clinical study titled "Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer". This is a multicenter, Phase 1b/2 trial in participants with estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) advanced/metastatic breast cancer. The phase 1b part of the trial will determine the recommended Phase 2 dose (RP2D) of elacestrant when administered ...
What is the current status of trial NCT05563220?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 435 participants. The study started on 2023-01-24. Estimated completion is 2028-12-28.
What conditions does trial NCT05563220 study?
This clinical trial studies the following conditions: Breast Cancer, Metastatic Breast Cancer.
What interventions are being tested in trial NCT05563220?
The interventions under investigation include: Everolimus (DRUG), Palbociclib (DRUG), Ribociclib (DRUG), Elacestrant (DRUG), Alpelisib (DRUG).
Who is sponsoring clinical trial NCT05563220?
This trial is sponsored by Stemline Therapeutics, which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05563220 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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