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Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292)

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NCT04862663 · readout in 438 d

Sponsored by AstraZeneca (industry) · AZN — their whole pipeline →.

Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
893actual
Sites
225
Countries
Argentina, Australia, Belgium +20

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2021-05-10actualWhen the study began enrolling
Primary completion2027-11-01estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completion2029-08-14estimatedThe whole study's end, after follow-up
First posted2021-04-28actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-08-17actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

  • Locally Advanced (Inoperable) or Metastatic Breast Cancer

Interventions

  • Drug: Capivasertib
  • Drug: Fulvestrant
  • Drug: Palbociclib
  • Drug: Ribociclib
  • Drug: Abemaciclib

Primary outcomes

what the primary-completion date above is the date OF
Phase Ib: 1. The number of participants with dose-limiting toxicity, as defined in the protocol.
measured Within the first 28 day cycle.
Phase Ib: 2. The number of participants with treatment-related adverse events.
measured From baseline up to approximately 36 months.
Phase Ib: 3. The number of participants with treatment-related serious adverse events.
measured From baseline up to approximately 36 months.
Phase III: 1. Progression Free Survival (PFS).
measured Up to approximately 47 months.

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