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Ribociclib / Palbociclib / Locally Advanced (inoperable) Or Metastatic Breast Cancer · Phase 3 Trial
ClinicalTrials.gov · August 17, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a clinical trial registry record for CAPItello-292, a Phase 1b/3 open-label randomized study testing capivasertib combined with CDK4/6 inhibitors and fulvestrant versus CDK4/6 inhibitors and fulvestrant alone in HR+/HER2- advanced or metastatic breast cancer. No efficacy or safety results are reported in this registry entry; the study is actively recruiting with planned enrollment of 893 participants and a primary endpoint of progression-free survival assessed over approximately 47 months.
Phase 3, Interventional, Randomized, Parallel, Open label, Treatment purpose. Locally Advanced (Inoperable) or Metastatic Breast Cancer; age from 18 Years; to 99 Years. Intervention: Capivasertib Plus Palbociclib and Fulvestrant; Capivasertib Plus Ribociclib and Fulvestrant; Capivasertib Plus Abemaciclib and Fulvestrant; Capivasertib Plus Fulvestrant and Investigator's choice of…. Compared with: Fulvestrant and Investigator's choice of CDK4/6i (palbocicl… — Active Comparator. n = 893. 225 sites across 23 countries.
Planned enrollment: 893 participants in a Phase 1b/3 trial Primary outcome for Phase 3: Progression-free survival, assessed up to approximately 47 months Primary outcomes for Phase 1b: Dose-limiting toxicity within first 28-day cycle, treatment-related adverse events and serious adverse events from baseline to approximately 36 months
Registry record only; no efficacy, safety, or efficacy results are reported No interim analysis results or safety signals reported in this registry entry
This trial is currently recruiting and has not yet reported results. Clinicians and researchers should monitor for completion and outcome publication to assess whether capivasertib adds benefit to standard CDK4/6 inhibitor plus fulvestrant therapy in hormone receptor-positive metastatic breast cancer.
This is a registry record for an actively recruiting Phase 1b/3 trial with no results posted; it describes study design and planned enrollment only.
As stated by the source record.
Quoted from the source exactly as published.
This trial is currently recruiting and has not yet reported results. Clinicians and researchers should monitor for completion and outcome publication to assess whether capivasertib adds benefit to standard CDK4/6 inhibitor plus fulvestrant therapy in hormone receptor-positive metastatic breast cancer.
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.
Registry record from ClinicalTrials.gov (NCT04862663). This is a study registration, not published results. Lead sponsor: AstraZeneca. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 893 participants (ACTUAL). Conditions: Locally Advanced (Inoperable) or Metastatic Breast Cancer. Interventions: DRUG: Capivasertib; DRUG: Fulvestrant; DRUG: Palbociclib; DRUG: Ribociclib; DRUG: Abemaciclib. Primary outcome measures: Phase Ib: 1. The number of participants with dose-limiting toxicity, as defined in the protocol. , Within the first 28 day cycle.; Phase Ib: 2. The number of participants with treatment-related adverse events. , From baseline up to approximately 36 months.; Phase Ib: 3. The number of participants with treatment-related serious adverse events. , From baseline up to approximately 36 months.; Phase III: 1. Progression Free Survival (PFS). , Up to approximately 47 months.. Brief summary: A Phase Ib/III Open-label, Randomised Study of Capivasertib plus CDK4/6 Inhibitors and Fulvestrant versus CDK4/6 Inhibitors and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer (CAPItello-292)
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.