Camizestrant / Er Positive HER2 Negative Breast Cancer / Ribociclib · Phase 3 Trial

A Phase IIIb Study to Evaluate Camizestrant Plus Ribociclib in ER-positive, HER2-negative Advanced Breast Cancer

ClinicalTrials.gov · August 10, 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 clinical trial registration for a Phase IIIb study of camizestrant plus ribociclib in treatment-naive ER-positive, HER2-negative advanced breast cancer. No results are posted in this registry record. The study is actively recruiting and remains in preliminary phase pending completion and data reporting.

What was studied

Phase 3, Interventional, Non Randomized, Single Group, Open label, Treatment purpose. ER-Positive HER2-Negative Breast Cancer; age from 18 Years; to 130 Years. Intervention: Camizestrant and Ribociclib. n = 150. 89 sites across 9 countries.

Key findings

Safety

This is a registry record only; no efficacy, safety, or tolerability results are reported.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

Phase IIIb registration record with no results posted; describes planned enrollment and primary outcome measure only, without efficacy or safety data.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Efficacy of camizestrant and ribociclib by time to next treatment (TTNT) (assessed at Following first dose of study treatment until earliest of subsequent therapy, d…)

DesignPhase 3, Interventional, Non Randomized, Single Group, Open label, Treatment purpose

PopulationER-Positive HER2-Negative Breast Cancer; age from 18 Years; to 130 Years

Sample size150

InterventionCamizestrant and Ribociclib

Setting89 sites across 9 countries

Reported figures

Quoted from the source exactly as published.

PhasePHASE3

Estimated enrollment150

Primary outcome measureTime to next treatment (TTNT), followed from first dose until earliest of subsequent therapy, death, or 2 years after first dose

Study statusRECRUITING

Caveats

This is a registry record only; no efficacy, safety, or tolerability results are reported.
No details provided on randomization method, blinding, control arm, or comparator arm structure.
No sample size justification or power calculation stated in registry record.
Study recruitment status is active; results are not yet available for clinical decision-making.

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 IIIb interventional design; registration record lacks detail on blinding, randomization method, or control arm structure.

Directness

strong

Primary outcome is time to next treatment in treatment-naive ER+HER2- advanced breast cancer patients.

Consistency

insufficient

No results reported in registry record; consistency with prior work cannot be assessed.

Risk of bias

insufficient

Registry record does not describe blinding, allocation concealment, or other bias mitigation strategies.

Sample adequacy

limited

Estimated enrollment 150 participants; sample size calculation or justification not stated in registry.

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 (NCT07647328). This is a study registration, not published results. Lead sponsor: AstraZeneca. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 150 participants (ESTIMATED). Conditions: ER-Positive HER2-Negative Breast Cancer. Interventions: DRUG: Camizestrant; DRUG: Ribociclib. Primary outcome measures: Efficacy of camizestrant and ribociclib by time to next treatment (TTNT) , Following first dose of study treatment until earliest of subsequent therapy, death and 2 years after first dose of study treatment.. Brief summary: The purpose of this study is to investigate the efficacy, safety, and tolerability of camizestrant in combination with ribociclib in patients with ER+ HER2- BC who have not received any other systemic treatment for advanced disease. Participants will be treated within the trial until they discontinue the study treatment for any reason.

Follow from this

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

CamizestrantEr Positive HER2 Negative Breast CancerNCT07647328RibociclibAstraZeneca