Recruiting
A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy
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.
ClinicalTrials.gov IDNCT05774951
PhasePHASE3
Enrollment4300
SponsorAstraZeneca
Age18 Years – 130 Years
SexALL
About this study
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.
Interventions
- Drug: Camizestrant — Camizestrant. Experimental. Administered orally
- Drug: Tamoxifen — Tamoxifen. Comparator. Administered per local approved label
- Drug: Anastrozole — Anastrozole. Comparator. Administered per local approved label
- Drug: Letrozole — Letrozole. Comparator. Administered per local approved label
- Drug: Exemestane — Exemestane. Comparator. Administered per local approved label
Primary outcomes
- Invasive breast cancer-free survival (IBCFS) (Up to 10 years)
Eligibility information
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
Study locations
- Research Site, Birmingham, Alabama 35205 United States
- Research Site, Dothan, Alabama 36303 United States
- Research Site, Anchorage, Alaska 99508 United States
- Research Site, Chandler, Arizona 85224 United States
- Research Site, Hot Springs, Arkansas 71913 United States
- Research Site, Anaheim, California 92801 United States
- Research Site, Beverly Hills, California 90211 United States
- Research Site, Concord, California 94520 United States
- Research Site, Corona, California 92882 United States
- Research Site, Fountain Valley, California 92708 United States
Showing 10 of 709 reported sites. See the official listing for all locations.
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-16.