BioinvestGPT

BioinvestGPT ApS · Research use only

NCT05909397 (Vepdegestrant in 1L ER+HER2- advanced breast cancer): BVCT ex-ante prediction vs. reported outcome

On 15 Jan 2024, BioinvestGPT's BVCT predicted technical partial success and commercial partial success for this trial. The 11 Mar 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically probably insignificant and commercially probably insufficient.

Clinical Trial

NCTID
NCT05909397
Acronym
VERITAC-3
Drug Name
Vepdegestrant
Drug MoA
PROTAC-based ER degrader
Drug Modality
small molecule
Drug Class
Best-In-Class
Therapeutic Area
Neoplasms
Indication
1L ER+HER2- advanced breast cancer
Human Patients
59
Sponsor
Arvinas / Pfizer
Phase
Phase 3

Prediction of , index 1424

Prospective Prediction
Prediction Index
1424
Prediction Date
Commercial Prediction
partial SUCCESS (commercially maybe sufficient clinical benefit non-superior-to Letrozole as 1L treatment)
Technical Prediction
partial SUCCESS (statistically maybe significant additive clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
421 days in advance
Readout Data Interpretation
vepdegestrant + palbociclib's further development has been discontinued probably due to uncompetitive clinical benefit compared with vepdegestrant + atirmociclib
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically probably insignificant and commercially probably insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A PHASE 3, RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY OF VEPDEGESTRANT (ARV-471/PF-07850327) PLUS PALBOCICLIB VERSUS LETROZOLE PLUS PALBOCICLIB FOR THE TREATMENT OF PARTICIPANTS WITH ESTROGEN RECEPTOR POSITIVE, HER2 NEGATIVE BREAST CANCER WHO HAVE NOT RECEIVED ANY PRIOR SYSTEMIC ANTI CANCER TREATMENT FOR ADVANCED DISEASE (VERITAC-3)
Phase
Phase 3
Status
Active not recruiting
Enrollment
59
Lead sponsor
Pfizer
Conditions
Breast Cancer
Interventions
DRUG: Vepdegestrant (ARV-471/PF-07850327); COMBINATION_PRODUCT: Palbociclib; DRUG: Letrozole; COMBINATION_PRODUCT: Palbociclib
Design
Randomized · Parallel · None
Primary purpose
Treatment
Start
2023-08-09
Primary completion
2026-12-30
Completion
2026-12-30
Primary outcomes
  • Study Lead-in (SLI): Incidence of Grade 4 neutropenia (From randomization date up to Cycle 4 (each cycle is 28 days).)
  • SLI: Incidence of dose reduction (From randomization date up to Cycle 4 (each cycle is 28 days).)
  • SLI: Incidence of drug discontinuation. (From randomization date up to Cycle 4 (each cycle is 28 days).)
  • Phase 3: Progression-Free Survival (From randomization date, every 12 weeks, to date of first documentation of progression or death, up to approximately 4 years.)

NCT05909397 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials