A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence
Condition(s) studied
Investigational drug(s) / intervention(s)
Elacestrant: Administered as oral tablets
Anastrozole: Administered as oral tablets
Letrozole: Administered as oral tablets
Exemestane: Administered as oral tablets
Tamoxifen: Administered as oral tablets
Study summary
The primary goal of this study is to evaluate the effectiveness of elacestrant versus standard endocrine therapy in participants with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer with high risk of recurrence.
Eligibility
Primary outcome measure(s)
- Invasive Breast Cancer-Free Survival (IBCFS) — Up to 5 years
Assessed by the time from date of randomization to the date of first occurrence of: * Ipsilateral invasive breast tumor recurrence * Local/regional invasive breast cancer recurrence * Distant recurrence * Contralateral invasive breast cancer, or * Death attributable to any cause
Trial sites (567)
| Facility | City | Region | Status |
|---|---|---|---|
| Southern Cancer Center, PC | Daphne | Alabama | Recruiting |
| Ironwood Cancer and Research Centers | Chandler | Arizona | Recruiting |
| Banner MD Anderson Cancer Center | Gilbert | Arizona | Recruiting |
| Banner University Medical Center - Phoenix Campus (Banner Good Samaritan Medical Center) | Phoenix | Arizona | Recruiting |
| Mayo Clinic | Scottsdale | Arizona | Recruiting |
| Arizona Clinical Research Center, Inc. | Tucson | Arizona | Recruiting |
| University of Arizona Cancer Center | Tucson | Arizona | Recruiting |
| Highlands Oncology Group, PA | Springdale | Arkansas | Recruiting |
| Comprehensive Blood & Cancer Center | Bakersfield | California | Withdrawn |
| UCSF Cancer Center Berkeley | Berkeley | California | Recruiting |
| Cedars-Sinai Cancer Beverly Hills | Beverly Hills | California | Recruiting |
| City of Hope National Medical Center | Duarte | California | Recruiting |
| UCSF Wash Cancer CNTR | Fremont | California | Recruiting |
| City of Hope at Irvine Lennar | Irvine | California | Recruiting |
| UC San Diego Moores Cancer Center | La Jolla | California | Recruiting |
| Helios Clinical Research | Long Beach | California | Recruiting |
| Cancer and Blood Research Center, LLC | Los Alamitos | California | Recruiting |
| USC/Norris Comprehensive Cancer Center | Los Angeles | California | Recruiting |
| UCLA Department of Medicine - Hematology/Oncology | Los Angeles | California | Recruiting |
| Pacific Cancer Care - Oncology | Monterey | California | Recruiting |
| Hoag Memorial Hospital Presbyterian | Newport Beach | California | Recruiting |
| UC Irvine Health, Chao Family Comprehensive Cancer Center | Orange | California | Recruiting |
| Stanford Women's Cancer Center | Palo Alto | California | Recruiting |
| Dignity Health dba Health Research Institute | Sacramento | California | Recruiting |
| Sutter Institute for Medical Research | Sacramento | California | Recruiting |
| UCSF Zuckerberg SF General | San Francisco | California | Recruiting |
| University of California, San Francisco (UCSF) | San Francisco | California | Recruiting |
| Southern California Kaiser Medical Center-San Marcos Medical | San Marcos | California | Recruiting |
| UCSF Cancer Center San Mateo | San Mateo | California | Recruiting |
| Sansum Clinic | Solvang | California | Recruiting |
| Torrance Memorial Physician Network- Cancer Care | Torrance | California | Recruiting |
| St. Joseph Hospital-Cancer Centers of Colorado | Denver | Colorado | Recruiting |
| Rocky Mountain Cancer Centers, LLP | Lone Tree | Colorado | Recruiting |
| AHMG Hematology and Oncology | Parker | Colorado | Recruiting |
| Cancer Care at CommonSpirit St. Anthony North Hospital | Westminster | Colorado | Withdrawn |
| Yale New Haven Hospital- Yale Cancer Center | New Haven | Connecticut | Recruiting |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | Recruiting |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | Recruiting |
| Sibley Memorial Hospital | Washington D.C. | District of Columbia | Recruiting |
| The George Washington Medical Faculty Associates | Washington D.C. | District of Columbia | Recruiting |
+ 527 more sites — see the full list on the official registry below.
More Stemline Therapeutics, Inc. trials in Belgium
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06492616 on ClinicalTrials.gov ↗ ← All trials in Belgium