NCT05501886Phase 3Active not recruiting

Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1)

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2026-06-30Estimated

Enrollment · participants701Estimated

Source updated2026-02-10Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2025-12-15 · 2 fields changed

Primary completion date changed

− Before

~~30 Jun 2025~~

+ After

30 Jun 2026

Recruitment status changed

− Before

~~Recruiting~~

+ After

Active not recruiting

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Study details

Conditions studied

Breast Cancer

Treatments or interventions studied

GedatolisibDrugAlso known as PF-05212384, PKI-587
PalbociclibDrugAlso known as IBRANCE, PD-0332991
FulvestrantDrugAlso known as Faslodex
AlpelisibDrugAlso known as Piqray, Vijoice, BYL719

Primary outcomes · main study measures

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measure: Progression Free Survival (PFS) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer; description: PFS is defined as the time from randomization to death or the first documented progression, whichever occurs first, confirmed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria, as determined based on blinded independent central review (BICR); timeFrame: Approximately 48 months

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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