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Camizestrant for ER+/HER2- Early Breast Cancer After Endocrine Therapy

This study is looking at whether camizestrant, an experimental oral drug, can improve outcomes for people with early-stage breast cancer that is estrogen receptor-positive (ER+) and HER2-negative (HER2-). You would have already completed at least two years of standard hormone therapy (like tamoxifen, anastrozole, letrozole, or exemestane). The study compares camizestrant to these standard hormone therapies. We are looking for people aged 18 and older, of all genders, who have a high or intermediate risk of their cancer returning. The main goal is to see if camizestrant helps people live longer without their invasive breast cancer coming back. The study plans to enroll 4300 participants, but its current status is unclear.

Study design
This is a Phase III, open-label study, meaning both you and your doctors will know which treatment you are receiving. It compares camizestrant to standard hormone therapies.
What's involved
You would receive treatment for 60 months (5 years).
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 10 years after the last patient is randomized.

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NCT05774951

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
AstraZeneca
~4,300 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:CamizestrantTamoxifenAnastrozoleLetrozoleExemestane

At a glance

Recruiting sites
37 of 709 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Invasive breast cancer-free survival (IBCFS)
Measured over Up to 10 years

Conditions

Breast Cancer, Early Breast Cancer

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Breast Carcinoma

Where it's being run

709 sites across 80 states
China66
Spain44
Brazil37
Germany35
France34
Japan34
India18
Argentina16

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
Email the study team

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Do you actually qualify for this trial?

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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

What this trial measures

  • Invasive breast cancer-free survival (IBCFS)Up to 10 years

    IBCFS is defined as time from randomisation until date of first occurrence of: * Invasive ipsilateral breast tumour recurrence (invasive IBTR) * Locoregional invasive breast cancer recurrence * Distant recurrence * Invasive contralateral breast cancer * Death attributable to any cause.