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NCT02947685 (Palbociclib in HR+/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 13 Dec 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant (in PFS) and commercially TBD (wait for OS data).

Clinical Trial

NCTID
NCT02947685
Acronym
PATINA
Drug Name
Palbociclib
Drug MoA
CDK4/6 inhibitor
Drug Modality
small molecule
Drug Class
Best-In-Class
Therapeutic Area
Neoplasms
Indication
HR+/HER2+ advanced breast cancer
Human Patients
496
Sponsor
Pfizer
Phase
Phase 3

Prediction of , index 1421

Prospective Prediction
Prediction Index
1421
Prediction Date
Commercial Prediction
partial SUCCESS (commercially sufficient yet limited additive clinical benefit in PFS but not in OS)
Technical Prediction
partial SUCCESS (statistically significant additive clinical benefit in PFS but not in OS)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
333 days in advance
Readout Data Interpretation
palbociclib + anti-HER2 therapy + endocrine therapy achieved 44.3 months mPFS; superior to anti-HER2 therapy + endocrine therapy that achieved 29.1 months mPFS (p=0.0074); OS analysis remains immature yet palbociclib's improvement in 5-year survival rate is small (74.3% vs 69.8% HR 0.86; 95% CI)
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant (in PFS) and commercially TBD (wait for OS data)
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Randomized, Open Label, Phase III Trial to Evaluate the Efficacy and Safety of Palbociclib + Anti-HER2 Therapy + Endocrine Therapy vs. Anti-HER2 Therapy + Endocrine Therapy After Induction Treatment for Hormone Receptor Positive (HR+)/HER2-Positive Metastatic Breast Cancer
Phase
Phase 3
Status
Active not recruiting
Enrollment
518
Lead sponsor
Alliance Foundation Trials, LLC.
Conditions
HER-2 Positive Breast Cancer; Estrogen Receptor Positive Breast Cancer
Interventions
DRUG: palbociclib; DRUG: trastuzumab; DRUG: pertuzumab; DRUG: letrozole; DRUG: Anastrozole; DRUG: Exemestane; DRUG: Fulvestrant
Design
Randomized · Parallel · None
Primary purpose
Treatment
Start
2017-06-21
Primary completion
2024-10-15
Completion
2026-07-31
Results first posted
2026-02-12
Primary outcomes
  • Progression-free Survival (PFS) as Assessed by Investigator (7 years 3 months)

NCT02947685 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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