Camizestrant / Advanced Breast Cancer / Atirmociclib · Phase 2 Trial

Study to Evaluate the Safety and Tolerability of Camizestrant in Combination With Atirmociclib in Women With Advanced Breast Cancer

ClinicalTrials.gov · August 7, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a recruiting Phase 2 safety and tolerability study of camizestrant combined with atirmociclib in women with ER-positive, HER2-negative advanced breast cancer previously treated with CDK4/6 inhibitors. No results are currently posted in this registry record; the study is in recruitment phase with an estimated 24 participants.

What was studied

Phase 2, Interventional, Single Group, Open label, Treatment purpose. Advanced Breast Cancer; Female; age from 18 Years. Intervention: Camizestrant + Atirmociclib. n = 24. 6 sites: United States, United Kingdom.

Key findings

Safety

No efficacy outcomes are planned as primary endpoints; this is a safety and tolerability study only.

Who this may help

This record describes a planned study only. No clinical conclusions can be drawn until results are posted and analysed. The study will inform whether this drug combination is safe enough to advance to later-phase development.

Plain-language summary

This is a recruiting Phase 2 study with no results posted; it describes a planned safety and tolerability evaluation in a small population with an estimated 24 participants.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Number of participants with adverse events (AEs) and serious AEs (assessed at Up to Post-Treatment Follow up (Day 30 Post Dose))

DesignPhase 2, Interventional, Single Group, Open label, Treatment purpose

PopulationAdvanced Breast Cancer; Female; age from 18 Years

Sample size24

InterventionCamizestrant + Atirmociclib

Setting6 sites: United States, United Kingdom

Reported figures

Quoted from the source exactly as published.

Planned enrollment24

Study phasePhase 2

Primary outcome measureNumber of participants with adverse events and serious AEs up to Post-Treatment Follow up (Day 30 Post Dose)

Clinical bottom line

Caveats

This is a registry record with no results posted; the study is actively recruiting.
No sample size justification, statistical power calculation, or secondary outcomes reported in this registry entry.
Study conduct details (randomization, blinding, control arm, follow-up schedule) not provided.
No efficacy outcomes are planned as primary endpoints; this is a safety and tolerability study only.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Phase 2 interventional design with stated safety focus appropriate for early combination evaluation.

Directness

strong

Primary outcomes are adverse events and serious AEs, directly measuring safety and tolerability.

Consistency

insufficient

Registry record only; no results posted, consistency cannot be assessed.

Risk of bias

insufficient

Study design details (blinding, randomization) not reported in registry record.

Sample adequacy

limited

Estimated 24 participants is small, appropriate for Phase 2 safety work but limits generalizability.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07427394). This is a study registration, not published results. Lead sponsor: AstraZeneca. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 24 participants (ESTIMATED). Conditions: Advanced Breast Cancer. Interventions: DRUG: Camizestrant; DRUG: Atirmociclib. Primary outcome measures: Number of participants with adverse events (AEs) and serious AEs , Up to Post-Treatment Follow up (Day 30 Post Dose). Brief summary: A study to investigate camizestrant in combination with atirmociclib in participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer previously treated with a cyclin dependent kinase 4/6 (CDK4/6) inhibitor.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

CamizestrantAdvanced Breast CancerAtirmociclibNCT07427394AstraZeneca