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 (Jun 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
Treatments studied
Endocrine / hormonal
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) negative
Required: ESR1 positive
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
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 →Frequently asked questions
Is NCT05774951 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior camizestrant, investigational SERD, fulvestrant disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 negative is a required biomarker for enrollment.
Does this trial require ESR1?
Yes, ESR1 positive is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 130 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages