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CLINICAL TRIAL PROFILE · UPDATED 2026-09-29

A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy

NCT05646862 · Phase 3 · Recruiting

PHASEPhase 3
STATUSRecruiting
ENROLLMENT420
EST. COMPLETION2026-11-13

Conditions

Breast Cancer

Interventions

InavolisibFulvestrantAlpelisibBupropionOmeprazoleMidazolam

Study details

SPONSORHoffmann-La Roche
START DATE2023-06-07

Related company profiles

Roche

ROG

Primary source

Trial status and dates can change. Confirm enrollment and eligibility against the linked ClinicalTrials.gov record.

Evidence & limits

Source: Open the source record

Record identifier
NCT05646862
Event / action date
Not separately retained
Source update date
Not separately retained
Platform retrieval / processing date
Not separately retained

What it supports. Study information reported by the sponsor or investigator, including status, phase, enrollment, and recorded dates.

Limits. Registration or completion does not establish clinical success or approval. Sponsor-name associations can be ambiguous. Dates may be estimated; verify the live study record.

Connection basis. Company sponsor aliases and normalized lead-sponsor containment; the NCT identifier identifies the study.

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