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NCT04799249 (Trilaciclib Placebo Gemcitabine Carboplatin in TNBC - Triple-Negative Breast Cancer): BVCT ex-ante prediction vs. reported outcome

On 5 Feb 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 24 Jun 2024 readout is classified on the dashboard as False Positive (FP), a missed prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT04799249
Acronym
PRESERVE 2
Drug Name
Trilaciclib Placebo Gemcitabine Carboplatin
Drug MoA
CDK4/6 inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
TNBC - Triple-Negative Breast Cancer
Human Patients
194
Sponsor
G1 Therapeutics
Phase
Phase 3

Prediction of , index 407

Prospective Prediction
Prediction Index
407
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient additive clinical benefit in OS)
Technical Prediction
SUCCESS (statistically significant additive clinical benefit in OS)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
140 days in advance
Readout Data Interpretation
OS endpoint not met
Press Release
Prediction Result
Prediction Accuracy
Missed Prediction
Due to
due to suboptimal combotherapy causal modeling in metastatic TNBC that has been permanently corrected.
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
False Positive (FP)

ClinicalTrials.gov record

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

Official title
A Phase 3, Randomized, Double-Blind Study of Trilaciclib or Placebo in Patients Receiving First- or Second-Line Gemcitabine and Carboplatin Chemotherapy for Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer (PRESERVE 2)
Phase
Phase 3
Status
Completed
Enrollment
194
Lead sponsor
G1 Therapeutics, Inc.
Conditions
TNBC - Triple-Negative Breast Cancer; Breast Cancer
Interventions
DRUG: Trilaciclib; DRUG: Placebo; DRUG: Gemcitabine; DRUG: Carboplatin
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2021-05-14
Primary completion
2024-05-24
Completion
2024-05-24
Primary outcomes
  • Effect on Overall Survival (OS) (Cohort 1:From date of randomization up to 39 months)
  • Effect on Overall Survival (OS) (Cohort 2: From date of randomization up to 28 months)

NCT04799249 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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