Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer
NCT05563220 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 435 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stemline Therapeutics, which has 64 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05563220 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, Florida, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05563220?
The interventions under investigation include: Everolimus (DRUG), Palbociclib (DRUG), Ribociclib (DRUG), Elacestrant (DRUG), Alpelisib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05563220?
This trial is sponsored by Stemline Therapeutics, which has 64 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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