NCT06757634Phase 3Recruiting

Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)

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.

Open ClinicalTrials.gov record CSV export · Pro

Primary completion2029-03-31Estimated

Enrollment · participants1180Estimated

Source updated2026-05-18Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

Pro unlocks the full available history and CSV export. View Pro features

Posted 2026-05-18 · 2 fields changed

Enrollment · participant count

Recorded edit

− Previous value

count: 674; type: ESTIMATED

+ Updated value

count: 1180; type: ESTIMATED

Primary completion date

Recorded edit

− Previous value

2027-12-31

+ Updated value

2029-03-31

Check registry source

Study details

Conditions studied

Breast Cancer

Treatments or interventions studied

Arm A: Gedatolisib + Palbociclib + FulvestrantDrugAlso known as PF-05212384, IBRANCE, Faslodex
Arm B: Ribociclib + FulvestrantDrugAlso known as KISQALI®, Faslodex
Arm C: Gedatolisib + Palbociclib + LetrozoleDrugAlso known as PF-05212384, IBRANCE, FEMARA
Arm D: Ribociclib + LetrozoleDrugAlso known as KISQALI®, FEMARA

Primary outcomes · main study measures

Read the study measures

measure: Progression Free Survival (PFS); 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: From date of randomization to the date of death due to any cause, up to 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.

How to read this history