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NCT04494425 (Trastuzumab deruxtecan Capecitabine Paclitaxel… in Metastatic Breast Cancer): BVCT ex-ante prediction vs. reported outcome

On 12 Dec 2023, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 29 Apr 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially probably sufficient.

Clinical Trial

NCTID
NCT04494425
Acronym
DB-06
Drug Name
Trastuzumab deruxtecan Capecitabine Paclitaxel Nab-Paclitaxel
Drug MoA
anti-HER2 mAb inhibitor conjugated with TOP1 inhibitor
Drug Modality
ADC
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Metastatic Breast Cancer
Human Patients
866
Sponsor
AstraZeneca / Daiichi Sankyo Company
Phase
Phase 3

Prediction of , index 1373

Prospective Prediction
Prediction Index
1373
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit superior to chemotherapy)
Technical Prediction
SUCCESS (statistically significant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
139 days in advance
Readout Data Interpretation
PFS superior to SoC; OS not mature yet with early positive trend.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially probably sufficient
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Phase 3, Randomized, Multi-center, Open-label Study of Trastuzumab Deruxtecan (T-DXd) Versus Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Breast Cancer Patients Whose Disease Has Progressed on Endocrine Therapy in the Metastatic Setting (DESTINY-Breast06)
Phase
Phase 3
Status
Active not recruiting
Enrollment
866
Lead sponsor
AstraZeneca
Conditions
Advanced or Metastatic Breast Cancer
Interventions
DRUG: Trastuzumab deruxtecan; DRUG: Capecitabine; DRUG: Paclitaxel; DRUG: Nab-Paclitaxel
Design
Randomized · Parallel · None
Primary purpose
Treatment
Start
2020-07-24
Primary completion
2024-03-18
Completion
2026-06-19
Results first posted
2025-04-02
Primary outcomes
  • Progression-Free Survival (PFS) Assessed by Blinded Independent Central Review (BICR) in the Hormone Receptor-Positive (HR+), Human Epidermal Growth Factor Receptor 2 (HER2)-Low Population (Response evaluations performed at screening, every 6 weeks (q6w) ± 1 week from randomization for 48 weeks, and then every 9 weeks (q9w) ± 1 week, starting at Week 48 until PD, up to PCD of 18 March 2024 (maximum of approximately 43.85 months))

NCT04494425 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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