ClinicalTrials.gov record
Phase 3 Trial of Elacestrant Versus Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer
ClinicalTrials.gov ID: NCT03778931
Public ClinicalTrials.gov record NCT03778931. 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
Elacestrant Monotherapy vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer Following CDK4/6 Inhibitor Therapy: A Phase 3 Randomized, Open-label, Active-controlled, Multicenter Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This Phase 3 clinical study compares the efficacy and safety of elacestrant to the standard of care (SoC) options of fulvestrant or an aromatase inhibitor (AI) in women and men with breast cancer whose disease has advanced on at least one endocrine therapy including a CDK4/6 inhibitor in combination with fulvestrant or an aromatase inhibitor (AI).
Study identification
- NCT ID
- NCT03778931
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 478 participants
Conditions and interventions
Conditions
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
- May 9, 2019
- Primary completion
- Aug 23, 2021
- Completion
- Aug 21, 2024
- Last update posted
- Sep 14, 2025
2019 – 2024
United States locations
- U.S. sites
- 104
- U.S. states
- 35
- U.S. cities
- 87
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The University of Arizona Cancer Center | Tucson | Arizona | 85724 | — |
| St Bernard's Cancer Care | Jonesboro | Arkansas | 72401 | — |
| St. Jude Heritage Healthcare | Fullerton | California | 92835 | — |
| Adventist Health Glendale | Glendale | California | 91206 | — |
| Moores Cancer Center at UC San Diego Health | La Jolla | California | 92093 | — |
| Keck Hospital of USC-Norris Healthcare (HC3), Investigational Drug Service (IDS) | Los Angeles | California | 90033 | — |
| Keck Medical Center of USC | Los Angeles | California | 90033 | — |
| USC IDS Pharmacy | Los Angeles | California | 90033 | — |
| UCLA Hematology/Oncology | Los Angeles | California | 90095 | — |
| UCLA West Medical Pharmacy 159 | Los Angeles | California | 90095 | — |
| TMPN Cancer Care | Redondo Beach | California | 90277 | — |
| UC Davis Medical Center, Investigational Drug Service | Sacramento | California | 95817 | — |
| UCSF Medical Center | San Francisco | California | 94115 | — |
| Ridley-Tree Cancer Center | Santa Barbara | California | 93105 | — |
| Anschutz Cancer Center Pavilion | Aurora | Colorado | 80045 | — |
| US Oncology - Rocky Mountain Cancer Centers - Midtown | Denver | Colorado | 80218 | — |
| Poudre Valley Health Care, Inc. d/b/a Poudre Valley Health System | Fort Collins | Colorado | 80528 | — |
| UCHealth Cancer Center | Fort Collins | Colorado | 80528 | — |
| Yale Cancer Center | New Haven | Connecticut | 06511 | — |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | — |
| Orlando Health Cancer Institute | Orlando | Florida | 32806 | — |
| Moffitt Cancer Center | Tampa | Florida | 33612 | — |
| Piedmont Cancer Institute, P.C. - Oncology | Atlanta | Georgia | 30318 | — |
| Suburban Hematology-Oncology Associates | Lawrenceville | Georgia | 30046 | — |
| Northwest Georgia Oncology Centers | Marietta | Georgia | 30060 | — |
| Chicago Association for Research and Education in Science | Chicago | Illinois | 60141 | — |
| Rush University Cancer Center | Chicago | Illinois | 60612 | — |
| Cancer Care Center of Decatur | Decatur | Illinois | 62526 | — |
| Joliet Oncology-Hematology Associates | Joliet | Illinois | 60435 | — |
| Presence Medical Group Hematology Oncology | Skokie | Illinois | 60077 | — |
| Simmons Cancer Institute | Springfield | Illinois | 62702 | — |
| Healthcare Research Network II | Tinley Park | Illinois | 60487 | — |
| Fort Wayne Medical Oncology And Hematology | Fort Wayne | Indiana | 46815 | — |
| Goshen Center for Cancer Care | Goshen | Indiana | 46526 | — |
| Hematology Oncology Of Indiana | Indianapolis | Indiana | 46260 | — |
| Cancer Resource Centre | Munster | Indiana | 46321 | — |
| University of Kansas Cancer Center | Westwood | Kansas | 66205 | — |
| Norton Cancer Institute | Louisville | Kentucky | 40207 | — |
| Pikeville Medical Center - Oncology/Hematology | Pikeville | Kentucky | 41501 | — |
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | — |
| Highland Clinic | Shreveport | Louisiana | 71105 | — |
| New England Cancer Specialists | Scarborough | Maine | 04074 | — |
| The Gynecologic Oncology Center at Mercy | Baltimore | Maryland | 21202 | — |
| Weinberg Cancer Institute at Franklin Square | Baltimore | Maryland | 21237 | — |
| Maryland Oncology Hematology | Frederick | Maryland | 21702 | — |
| Boston Medical Center | Boston | Massachusetts | 02111 | — |
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | — |
| Mass General Cancer Center at Newton Wellesley - Oncology | Boston | Massachusetts | 02462 | — |
| Mass General North Shore Cancer Center - Oncology | Danvers | Massachusetts | 01923 | — |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | — |
| Minnesota Oncology | Minneapolis | Minnesota | 55404 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Jackson Oncology Associates, PLLC. | Jackson | Mississippi | 39202 | — |
| Chub O'Reilly Cancer Center | Springfield | Missouri | 65807 | — |
| The Fred & Pamela Buffett Cancer Center | Omaha | Nebraska | 68105 | — |
| Precision Cancer Research | Freehold | New Jersey | 07728 | — |
| Saint Barnabas Medical Center - Cancer Center | Livingston | New Jersey | 07039 | — |
| The Steeplechase Cancer Center | Somerville | New Jersey | 08876 | — |
| New Mexico Oncology Hematology Consultants - Oncology | Albuquerque | New Mexico | 87109 | — |
| New Mexico Cancer Care Alliance | Albuquerque | New Mexico | 87131 | — |
| New York Oncology Hematology | Albany | New York | 12206 | — |
| Northern Westchester Hospital Cancer Center | Mount Kisco | New York | 10549 | — |
| New York University Clinical Cancer Center | New York | New York | 10016 | — |
| Stony Brook University | Stony Brook | New York | 11794 | — |
| Montefiore Medical Center | The Bronx | New York | 10461 | — |
| Oncology and Hematology of White Plains | White Plains | New York | 10601 | — |
| Carolina Institute For Clinical Research | Fayetteville | North Carolina | 28304 | — |
| US Oncology Network | Cincinnati | Ohio | 45242 | — |
| University Hospitals of Cleveland | Cleveland | Ohio | 44106 | — |
| Dayton Oncology & Hematology | Kettering | Ohio | 45409 | — |
| Toledo Clinic Cancer Center | Toledo | Ohio | 43623 | — |
| Oregon Health and Science University | Portland | Oregon | 97239 | — |
| Gettysburg Cancer Center | Gettysburg | Pennsylvania | 17325 | — |
| Pinnacle Health Cancer Institute | Harrisburg | Pennsylvania | 17109 | — |
| Abington Hematology Oncology Associates | Willow Grove | Pennsylvania | 19090 | — |
| Lankenau Medical Center | Wynnewood | Pennsylvania | 19096 | — |
| Charleston Oncology | Charleston | South Carolina | 29414 | — |
| MUSC Hollings Cancer Center | Charleston | South Carolina | 29425 | — |
| West Cancer Center | Germantown | Tennessee | 38138 | — |
| Brig Center For Cancer Care And Survivorship | Knoxville | Tennessee | 37909 | — |
| Texas Oncology - Central Austin Cancer Center | Austin | Texas | 78731 | — |
| Austin Cancer Centers | Austin | Texas | 78759 | — |
| Elligo Health Research | Austin | Texas | 78759 | — |
| Texas Oncology-Beaumont | Beaumont | Texas | 77702 | — |
| Texas Oncology-Methodist Dallas Cancer Center | Dallas | Texas | 75203 | — |
| Texas Oncology-Medical City Dallas | Dallas | Texas | 75230 | — |
| Texas Oncology-Presbyterian Cancer Center Dallas | Dallas | Texas | 75231 | — |
| Texas Oncology - Willowbrook | Houston | Texas | 77070 | — |
| Texas Oncology - McAllen | McAllen | Texas | 78053 | — |
| Texas Oncology-Mesquite | Mesquite | Texas | 75150 | — |
| Texas Oncology-Paris | Paris | Texas | 76022 | — |
| Texas Oncology-Plano West | Plano | Texas | 75093 | — |
| Texas Oncology-Plano East | Plano | Texas | 80211 | — |
| Cancer Therapy and Research Center at UTHSCSA | San Antonio | Texas | 78229 | — |
| Renovatio Medical The Woodlands | The Woodlands | Texas | 77380 | — |
| Texas Oncology - The Woodlands, Gynecologic Oncology | The Woodlands | Texas | 77380 | — |
| USO Texas Oncology - Tyler | Tyler | Texas | 75702 | — |
| Utah Cancer Specialists | Salt Lake City | Utah | 84124 | — |
| University of Virginia Cancer Center | Charlottesville | Virginia | 22908 | — |
| Inova Schar Cancer Institute | Fairfax | Virginia | 22031 | — |
| Fort Belvoir Community Hospital | Fort Belvoir | Virginia | 22060 | — |
| Benaroya Research Institute at Virginia Mason | Seattle | Washington | 98101 | — |
| University of Wisconsin Carbone Cancer Center | Madison | Wisconsin | 53705 | — |
| Colombia St. Mary's Medical Oncology | Milwaukee | Wisconsin | 53211 | — |
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 140 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03778931, 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 Sep 14, 2025 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03778931 live on ClinicalTrials.gov.