Status:
RECRUITING
A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy
Lead Sponsor:
AstraZeneca
Conditions:
Breast Cancer, Early Breast Cancer
Eligibility:
All Genders
18-130 years
Phase:
PHASE3
Brief 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 f...
Detailed Description
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 who completed definitive locoreg...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 29 2036
Estimated Enrollment :
4300 Patients enrolled
Trial Details
Trial ID
NCT05774951
Start Date
March 31 2023
End Date
May 29 2036
Last Update
February 25 2026
Active Locations (727)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Birmingham, Alabama, United States, 35205
2
Research Site
Dothan, Alabama, United States, 36303
3
Research Site
Anchorage, Alaska, United States, 99508
4
Research Site
Chandler, Arizona, United States, 85224