A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy
Condition(s) studied
Investigational drug(s) / intervention(s)
Camizestrant: Camizestrant. Experimental. Administered orally
Tamoxifen: Tamoxifen. Comparator. Administered per local approved label
Anastrozole: Anastrozole. Comparator. Administered per local approved label
Letrozole: Letrozole. Comparator. Administered per local approved label
Exemestane: Exemestane. Comparator. Administered per local approved label
Study summary
This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard endocrine therapy in patients with ER+/HER2 - early breast cancer with intermediate or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy) and standard adjuvant endocrine therapy (ET) for at least 2 years and up to 5 years. The planned duration of treatment in either arm of the study is 60 months.
Eligibility
Primary outcome measure(s)
- Invasive breast cancer-free survival (IBCFS) — Up to 10 years
IBCFS is defined as time from randomisation until date of first occurrence of: * Invasive ipsilateral breast tumour recurrence (invasive IBTR) * Locoregional invasive breast cancer recurrence * Distant recurrence * Invasive contralateral breast cancer * Death attributable to any cause.
Trial sites (709)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Birmingham | Alabama | Active Not Recruiting |
| Research Site | Dothan | Alabama | Active Not Recruiting |
| Research Site | Anchorage | Alaska | Active Not Recruiting |
| Research Site | Chandler | Arizona | Active Not Recruiting |
| Research Site | Hot Springs | Arkansas | Active Not Recruiting |
| Research Site | Anaheim | California | Active Not Recruiting |
| Research Site | Beverly Hills | California | Active Not Recruiting |
| Research Site | Concord | California | Active Not Recruiting |
| Research Site | Corona | California | Active Not Recruiting |
| Research Site | Fountain Valley | California | Active Not Recruiting |
| Research Site | Greenbrae | California | Active Not Recruiting |
| Research Site | Los Alamitos | California | Active Not Recruiting |
| Research Site | Palo Alto | California | Active Not Recruiting |
| Research Site | San Diego | California | Active Not Recruiting |
| Research Site | San Diego | California | Active Not Recruiting |
| Research Site | Whittier | California | Active Not Recruiting |
| Research Site | Aurora | Colorado | Withdrawn |
| Research Site | Hartford | Connecticut | Active Not Recruiting |
| Research Site | Fort Myers | Florida | Active Not Recruiting |
| Research Site | Gainesville | Florida | Active Not Recruiting |
| Research Site | Miami Beach | Florida | Active Not Recruiting |
| Research Site | Orlando | Florida | Active Not Recruiting |
| Research Site | Plantation | Florida | Active Not Recruiting |
| Research Site | Port Saint Lucie | Florida | Active Not Recruiting |
| Research Site | Saint Augustine | Florida | Active Not Recruiting |
| Research Site | St. Petersburg | Florida | Active Not Recruiting |
| Research Site | St. Petersburg | Florida | Active Not Recruiting |
| Research Site | Tallahassee | Florida | Active Not Recruiting |
| Research Site | West Palm Beach | Florida | Active Not Recruiting |
| Research Site | Winter Haven | Florida | Active Not Recruiting |
| Research Site | Atlanta | Georgia | Active Not Recruiting |
| Research Site | Atlanta | Georgia | Active Not Recruiting |
| Research Site | Columbus | Georgia | Active Not Recruiting |
| Research Site | Honolulu | Hawaii | Withdrawn |
| Research Site | Chicago | Illinois | Withdrawn |
| Research Site | Chicago | Illinois | Active Not Recruiting |
| Research Site | Decatur | Illinois | Active Not Recruiting |
| Research Site | Elmhurst | Illinois | Active Not Recruiting |
| Research Site | Hinsdale | Illinois | Active Not Recruiting |
| Research Site | Park Ridge | Illinois | Terminated |
+ 669 more sites — see the full list on the official registry below.
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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 NCT05774951 on ClinicalTrials.gov ↗ ← All trials in South Korea