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

Recruiting now · Phase 3

Conditions studied: Breast Cancer, Early Breast Cancer

In brief

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.

Key facts

Study ID

NCT05774951

Run by

AstraZeneca

People needed

4300

Starts

2023-03-31

Expected to finish

2036-05-29

Last updated by the study team

2026-07-20

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — Dessau, Germany (enrolling)
• Research Site — Hamburg, Germany (enrolling)
• Research Site — Londrina, Brazil (enrolling)
• Research Site — Bonn, Germany (enrolling)
• Research Site — Esslingen am Neckar, Germany (enrolling)
• Research Site — Hamburg, Germany (enrolling)
• Research Site — Pierre, South Dakota, United States (enrolling)
• Research Site — Curitiba, Brazil (enrolling)
• Research Site — Aachen, Germany (enrolling)
• Research Site — Berlin, Germany (enrolling)
• Research Site — Düsseldorf, Germany (enrolling)
• Research Site — Eggenfelden, Germany (enrolling)
• Research Site — Georgsmarienhütte, Germany (enrolling)
• Research Site — Gütersloh, Germany (enrolling)
• Research Site — Winston-Salem, North Carolina, United States (enrolling)
• Research Site — Aberdeen, South Dakota, United States (enrolling)
• Research Site — Irving, Texas, United States (enrolling)
• Research Site — Edegem, Belgium (enrolling)
• Research Site — Rio de Janeiro, Brazil (enrolling)
• Research Site — Taubaté, Brazil (enrolling)
• Research Site — Augsburg, Germany (enrolling)
• Research Site — Berlin, Germany (enrolling)
• Research Site — Dresden, Germany (enrolling)
• Research Site — Düsseldorf, Germany (enrolling)
• Research Site — Heidelberg, Germany (enrolling)

Full record on ClinicalTrials.gov

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