OncoMatch/Clinical Trials/NCT05774951
A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy
Is NCT05774951 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for breast cancer, early breast cancer.
Treatment: Camizestrant · Tamoxifen · Anastrozole · Letrozole · Exemestane — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) negative
Required: ESR1 positive
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: adjuvant endocrine therapy — adjuvant
Completed at least 2 years but no more than 5 years (+3 months) of adjuvant ET (+/- CDK4/6 inhibitor)
Must have received: locoregional therapy — definitive
Completed adequate (definitive) locoregional therapy (surgery with or without radiotherapy) for the primary breast tumour(s), with or without (neo)adjuvant chemotherapy
Cannot have received: camizestrant (camizestrant)
Previous treatment with camizestrant
Cannot have received: investigational SERD
investigational SERDs/investigational ER targeting agents
Cannot have received: fulvestrant (fulvestrant)
fulvestrant
Lab requirements
Blood counts
Adequate organ and marrow function
Kidney function
Adequate organ and marrow function
Liver function
Adequate organ and marrow function
Cardiac function
Known LVEF <50% with heart failure NYHA Grade ≥2 [excluded]; Mean resting QTcF interval >480 ms at screening [excluded]
Adequate organ and marrow function; Known LVEF <50% with heart failure NYHA Grade ≥2 [excluded]; Mean resting QTcF interval >480 ms at screening [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Research Site · Birmingham, Alabama
- Research Site · Dothan, Alabama
- Research Site · Anchorage, Alaska
- Research Site · Chandler, Arizona
- Research Site · Hot Springs, Arkansas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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