Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer
Public ClinicalTrials.gov record NCT05563220. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1b/2, Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05563220
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 435 participants
Conditions and interventions
Conditions
Interventions
- Elacestrant Drug
- Alpelisib Drug
- Everolimus Drug
- Ribociclib Drug
- Palbociclib Drug
- Capivasertib Drug
- Abemaciclib Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 24, 2023 (Actual)
- Primary completion
- Dec 27, 2026 (Estimated)
- Completion
- Dec 28, 2028 (Estimated)
- Last update posted
- Jun 12, 2026
2023 – 2028
United States locations
- U.S. sites
- 35
- U.S. states
- 22
- U.S. cities
- 33
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Dothan Hematology and Oncology | Dothan | Alabama | 36303 | — |
| Mayo Clinic - Arizona | Phoenix | Arizona | 85054 | — |
| Highlands Oncology Group | Springdale | Arkansas | 72762 | — |
| City of Hope National Medical Center | Duarte | California | 91010 | — |
| OPN Healthcare (Los Alamitos Location) | Los Alamitos | California | 90720 | — |
| Cedars Sinai | Los Angeles | California | 90048 | — |
| UCLA UCLA Hem/Onc - Clinical Research Unit | Los Angeles | California | 90095 | — |
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94158 | — |
| TOI Clinical Research | Whittier | California | 90603 | — |
| Rocky Mountain Cancer Centers | Lone Tree | Colorado | 80124 | — |
| George Washington Cancer Center | Washington D.C. | District of Columbia | 20037 | — |
| Advent Health (Florida Hospital) - Altamonte Springs | Altamonte Springs | Florida | 32701 | — |
| Mayo Clinic - Jacksonville | Jacksonville | Florida | 32224 | — |
| Northwestern Feinberg Scholl of Medicine Prentice Women's Hospital | Chicago | Illinois | 60611 | — |
| MD Alliance for Multispecialty Research, LLC | Merriam | Kansas | 66204 | — |
| Johns Hopkins School of Medicine | Baltimore | Maryland | 21287 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201 | — |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55905 | — |
| Washington University School of Medicine in St. Louis | St Louis | Missouri | 63110 | — |
| Astera Cancer Care | East Brunswick | New Jersey | 08816 | — |
| Summit Medical Group | Florham Park | New Jersey | 07932 | — |
| Cooperman Barnabas Medical Center | New Brunswick | New Jersey | 08901 | — |
| NYU Langone Health | New York | New York | 10016 | — |
| W&IH of RI Breast Health Center of Women and Infants Hospital of Rhode Island | Providence | Rhode Island | 02905 | — |
| Sarah Cannon Research Institute / Tennessee Oncology | Nashville | Tennessee | 37203 | — |
| Texas Oncology - Baylor Charles A. Sammons Cancer Center | Dallas | Texas | 75246 | — |
| MD Anderson Cancer Center Texas | Houston | Texas | 77030 | — |
| UT Health San Antonio | San Antonio | Texas | 78229 | — |
| Virginia Cancer Specialists | Fairfax | Virginia | 22031 | — |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | — |
| Cancer Care Northwest | Spokane Valley | Washington | 99216 | — |
| Northwest Medical Specialties (Nwms) - Puyallup - Medical Oncology (Rainier Hematology-Oncology)/Exigent Research Network; LLC | Tacoma | Washington | 98405 | — |
| University of WI - Carbone Cancer Center (Phase II only) | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 48 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05563220, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 12, 2026 · Synced Oct 16, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05563220 live on ClinicalTrials.gov.