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NCT05113966 (Trilaciclib in Patients Receiving… in Triple Negative Breast Cancer): BVCT ex-ante prediction vs. reported outcome

On 28 Apr 2023, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 28 May 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient.

Clinical Trial

NCTID
NCT05113966
Drug Name
Trilaciclib in Patients Receiving Sacituzumab Govitecan-hziy
Drug MoA
CDK4/6 inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Triple Negative Breast Cancer
Human Patients
30
Sponsor
G1 Therapeutics
Phase
Phase 2

Prediction of , index 406

Prospective Prediction
Prediction Index
406
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient additive clinical benefit for Trodelvy)
Technical Prediction
SUCCESS (statistically significant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
396 days in advance
Readout Data Interpretation
17.9 mOS vs 12.1 OS (trodelvy alone).
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Phase 2, Single-Arm, Open-Label Study of Trilaciclib Administered Prior to Sacituzumab Govitecan-hziy in Patients With Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer Who Received at Least Two Prior Treatments, at Least One in the Metastatic Setting
Phase
Phase 2
Status
Terminated
Enrollment
30
Lead sponsor
G1 Therapeutics, Inc.
Conditions
Triple Negative Breast Cancer
Interventions
DRUG: Trilaciclib; DRUG: Sacituzumab Govitecan-hziy
Design
Single group · None
Primary purpose
Treatment
Start
2021-12-08
Primary completion
2023-11-10
Completion
2024-06-13
Results first posted
2025-01-29
Primary outcomes
  • Progression Free Survival (PFS) (Up to approximately 23 months)

NCT05113966 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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