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NCT05382299 (Trodelvy in 1L metastatic Triple-Negative Breast Cancer): BVCT ex-ante prediction vs. reported outcome

On 9 Jul 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 23 May 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically probably weakly significant (PFS) and commercially TBD (pending OS data);.

Clinical Trial

NCTID
NCT05382299
Acronym
ASCENT-03
Drug Name
Trodelvy (sacituzumab govitecan-hziy)
Drug MoA
anti-TROP2 ADC with SN38 payload
Drug Modality
ADC
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
1L metastatic Triple-Negative Breast Cancer (TNBC)
Human Patients
540
Sponsor
Gilead Sciences
Phase
Phase 3

Prediction of , index 1672

Prospective Prediction
Prediction Index
1672
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in OS non-superior to chemotherapy)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak clinical benefit in PFS/ORR maybe superior to chemotherapy)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
318 days in advance
Readout Data Interpretation
trodelvy achieved statistically significant superior-to-chemotherapy clinical benefit in PFS (without disclosure of the specific data and p-value; indicating probably weak efficacy in PFS); OS data not mature yet no OS detriment was observed
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically probably weakly significant (PFS) and commercially TBD (pending OS data);
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1 or in Patients Previously Treated With Anti-PD-(L)1 Agents in the Early Setting Whose Tumors Do Express PD-L1
Phase
Phase 3
Status
Active not recruiting
Enrollment
623
Lead sponsor
Gilead Sciences
Conditions
Triple Negative Breast Cancer; PD-L1 Negative
Interventions
DRUG: Sacituzumab Govitecan-hziy; DRUG: Paclitaxel; DRUG: nab-Paclitaxel; DRUG: Gemcitabine; DRUG: Carboplatin
Design
Randomized · Parallel · None
Primary purpose
Treatment
Start
2022-07-20
Primary completion
2028-07
Completion
2028-07
Primary outcomes
  • Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (Randomization up to approximately 57 months)

NCT05382299 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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