Giredestrant: Participants will receive treatment with giredestrant 30 milligrams (mg) orally once a day (QD) on Days 1-28 of each 28-day cycle until unacceptable toxicity or disease progression as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1).
Exemestane: If exemestane is chosen as the physician's choice of endocrine therapy, the participant will receive exemestane at a dose of 25 mg orally once a day (QD) on Days 1-28 of each 28-day cycle or as per local label, until unacceptable toxicity or disease progression as determined by investigator according to RECIST v1.1.
Fulvestrant: If fulvestrant is chosen as the physician's choice of endocrine therapy, the participant will receive fulvestrant in the clinic at a dose of 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, then Day 1 of each cycle thereafter (1 cycle is 28 days) or as per local prescribing information, until unacceptable toxicity or disease progression as determined by investigator according to RECIST v1.1.
Tamoxifen: If tamoxifen is chosen as the physician's choice of endocrine therapy, the participant will receive tamoxifen at a dose of 20 mg orally QD on Days 1-28 of each 28-day cycle or as per local prescribing information, until unacceptable toxicity or disease progression as determined by investigator according to RECIST v1.1.
Everolimus: Participants will receive treatment with everolimus 10 mg orally QD during each 28-day cycle until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1.
LHRH Agonist: Only premenopausal/perimenopausal female participants and male participants will receive a luteinizing hormone-releasing hormone (LHRH) agonist on Day 1 of each 28-day treatment cycle. The investigator will determine and supply the appropriate LHRH agonist locally approved for use in breast cancer.
Dexamethasone Mouth Rinse: A compounded alcohol-free mouthwash of dexamethasone (0.5 mg in 5 mL) will be supplied, where feasible. It is strongly recommended for prophylaxis or treatment of stomatitis/mucositis. Participants should use the alcohol-free mouthwash of dexamethasone four times QD for 8 weeks started concurrently with study treatment, and use it reactively thereafter with the first appearance of symptoms.
This Phase III, randomized, open-label, multicenter study will evaluate the efficacy and safety of giredestrant plus everolimus compared with the physician's choice of endocrine therapy plus everolimus in participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer who have had previous treatment with cyclin-dependent kinase 4/6 inhibitors (CDK4/6is) and endocrine therapy, either in the locally advanced/metastatic or the adjuvant setting.
| Facility | City | Region | Status |
|---|---|---|---|
| Alaska Oncology & Hematology, LLC | Anchorage | Alaska | |
| Arizona Oncology Associates, PC-CASA | Tucson | Arizona | |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | |
| Alta Bates Summit Medical Center | Berkeley | California | |
| Beverly Hills Cancer Center | Beverly Hills | California | |
| TOI Clinical Research | Cerritos | California | |
| Women's Cancer Care | Fresno | California | |
| Scripps Health | La Jolla | California | |
| Los Angeles Hematology Oncology Medical Group | Los Angeles | California | |
| University of California, Irvine Medical Center | Orange | California | |
| Yale Cancer Center | New Haven | Connecticut | |
| Mount Sinai Medical Center | Miami Beach | Florida | |
| Orlando Health Cancer Institute | Orlando | Florida | |
| Northwest Georgia Oncology Centers PC - Marietta | Marietta | Georgia | |
| Summit Cancer Care PC | Savannah | Georgia | |
| Northwestern University | Chicago | Illinois | |
| Springfield Clinic | Springfield | Illinois | |
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | |
| University of Kansas Cancer Center | Westwood | Kansas | |
| Eastern Maine Medical Center | Brewer | Maine | |
| New England Cancer Specialists | Scarborough | Maine | |
| Anne Arundel Medical Center | Annapolis | Maryland | |
| University of Maryland Greenebaum Cancer Center | Baltimore | Maryland | |
| Mercy Medical Center | Baltimore | Maryland | |
| Dana Farber Cancer Institute | Boston | Massachusetts | |
| Metro-Minnesota Community Oncology Research Consortium | Saint Louis Park | Minnesota | |
| Oncology Hematology West, PC dba Nebraska Cancer Specialists | Omaha | Nebraska | |
| Renown Regional Medical Center | Reno | Nevada | |
| Memorial Sloan Kettering - Basking Ridge | Basking Ridge | New Jersey | |
| Memorial Sloan Kettering - Monmouth | Middletown | New Jersey | |
| San Juan Oncology Associates | Farmington | New Mexico | |
| The Blavatnik Family ? Chelsea Medical Center at Mount Sinai | New York | New York | |
| Icahn School of Medicine at Mount Sinai | New York | New York | |
| Memorial Sloan-Kettering Cancer Center | New York | New York | |
| Stony Brook University Medical Center | Stony Brook | New York | |
| SCRI Mark H. Zangmeister Center | Columbus | Ohio | |
| Oklahoma Cancer Specialists and Research Institute | Tulsa | Oklahoma | |
| St Charles Medical Center Bend | Bend | Oregon | |
| Abramson Cancer Center | Philadelphia | Pennsylvania | |
| UPMC Hillman Cancer Center - Magee-Women?s Hospital | Pittsburgh | Pennsylvania |
+ 96 more sites — see the full list on the official registry below.
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 NCT05306340 on ClinicalTrials.gov ↗ ← All trials in the UK