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NCT05508906 (Palazestrant in 2L treatment for HR+/HER2- Metastatic Breast…): BVCT ex-ante prediction vs. reported outcome

On 18 Jun 2023, BioinvestGPT's BVCT predicted technical partial success and commercial partial success for this trial. The 10 Dec 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially TBD (wait for OS data).

Clinical Trial

NCTID
NCT05508906
Drug Name
Palazestrant (OP-125)
Drug MoA
CERAN and SERD
Drug Modality
small molecule
Drug Class
Best-In-Class
Therapeutic Area
Neoplasms
Indication
2L treatment for HR+/HER2- Metastatic Breast Cancer
Human Patients
155
Sponsor
Olema Pharmaceuticals
Phase
Phase 1

Prediction of , index 522

Prospective Prediction
Prediction Index
522
Prediction Date
Commercial Prediction
partial SUCCESS (commercially sufficient additive clinical benefit for OP-1250 + ribociclib) partial FAILURE (commercially insufficient additive clinical benefit for OP-1250 + alpelisib)
Technical Prediction
partial SUCCESS (statistically significant additive clinical benefit for OP-1250 + ribociclib) partial FAILURE (statistically insignificant additive clinical benefit for OP-1250 + alpelisib)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
541 days in advance
Readout Data Interpretation
palazestrant + ribociclib achieved 27% ORR (10/37); superior to both sacituzumab govitecan's 21% ORR and chemotherapy's 14% ORR (see add'l link below); no data disclosed for OP-1250 + alpelisib
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant 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 Phase 1b Open-Label Multicenter Study of OP-1250 (Palazestrant) in Combination With the CDK4/6 Inhibitor Ribociclib, With the PI3K Inhibitor Alpelisib, With the mTOR Inhibitor Everolimus, or With CDK4 Inhibitor Atirmociclib in Adult Subjects With Advanced and/or Metastatic ER Positive, HER2 Negative Breast Cancer
Phase
Phase 1
Status
Active not recruiting
Enrollment
190
Lead sponsor
Olema Pharmaceuticals, Inc.
Conditions
Metastatic Breast Cancer; ER-positive Breast Cancer; HER2-negative Breast Cancer; Breast Cancer; Locally Advanced Breast Cancer
Interventions
DRUG: Palazestrant; DRUG: Ribociclib; DRUG: Alpelisib; DRUG: Everolimus; DRUG: Atirmociclib
Design
Non randomized · Parallel · None
Primary purpose
Treatment
Start
2022-08-31
Primary completion
2027-12-31
Completion
2028-01-31
Primary outcomes
  • Dose Limiting Toxicities (DLTs) (The first 28 days of treatment)
  • Characterize the incidence, nature and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of palazestrant when administered with ribociclib, alpelisib, everolimus, or atirmociclib. (Up to 30 days after last dose of study drug(s) treatment)
  • Pharmacokinetics (PK) of palazestrant when administered with ribociclib (Treatment Group 1) or alpelisib (Treatment Group 2), everolimus (Treatment Group 3), or atirmociclib (Treatment Group 4) . (Every 28 days)

NCT05508906 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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