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Clinical Trials in China / NCT05774951
Recruiting Phase 3

A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy

NCT05774951 · tracked via the Priya Life Science China tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2023-03-31
Last updated
2026-08-19

Condition(s) studied

Breast Cancer, Early Breast Cancer

Investigational drug(s) / intervention(s)

Camizestrant →Tamoxifen →Anastrozole →Letrozole →Exemestane →

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

Sex
ALL
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
Inclusion Criteria: * Women and Men, ≥18 years at the time of screening (or per national guidelines) * Histologically confirmed ER+/HER2- early-stage resected invasive breast cancer with high or intermediate risk of recurrence, based on clinical-pathological risk features, as defined in the protocol. * Completed adequate (definitive) locoregional therapy (surgery with or without radiotherapy) for the primary breast tumour(s), with or without (neo)adjuvant chemotherapy * Completed at least 2 years but no more than 5 years (+3 months) of adjuvant ET (+/- CDK4/6 inhibitor) * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 * Adequate organ and marrow function Exclusion criteria: * Inoperable locally advanced or metastatic breast cancer * Pathological complete response following treatment with neoadjuvant therapy * History of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix or considered at very low risk of recurrence per investigator judgement) unless in complete remission with no therapy for a minimum of 5 years from the date of randomisation * Any evidence of severe or uncontrolled systemic diseases which, in the investigator's opinion precludes participation in the study or compliance * Known LVEF \<50% with heart failure NYHA Grade ≥2. * Mean resting QTcF interval \>480 ms at screening * Concurrent exogenous sex hormone therapy * Any concurrent anti-cancer treatment not specified in the protocol with the exception of bisphosphonates (e.g. zoledronic acid) or RANKL inhibitors (eg, denosumab) * Previous treatment with camizestrant, investigational SERDs/investigational ER targeting agents, or fulvestrant * Currently pregnant (confirmed with positive serum pregnancy test) or breastfeeding * Patients with known hypersensitivity to active or inactive excipients of camizestrant or drugs with a similar chemical structure or class to camizestrant. In pre-/peri-menopausal female and male patients, known hypersensitivity or intolerance to LHRH agonists, that would preclude the patient from receiving any LHRH agonist

Primary outcome measure(s)

Trial sites (709)

FacilityCityRegionStatus
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.

More AstraZeneca trials in China

Other trials for the same condition

Official registry record

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 China