male or pre/post-menopausal women age ≥ 18 years with locally advanced/metastatic HR+/HER2-negative BC resistant to ET + CDK4/6 inhibitors. No more than 1 prior systemic chemotherapy or ADC regimens for metastatic disease are permitted.
Conditions
Brief summary
Mean change in CelTIL score per central assessment between paired baseline and C2D1(14-21 days after treatment initiation) tumor samples in the overall population. CelTIL score = -0.8 x tumor cellularity (%) + 1.3 x tumor-infiltrating lymphocytes (TILs) (%). The minimum and maximum unscaled CelTIL scores will be −80 and 130. This unscaled CelTIL score will then be scaled to reflect a range from 0 to 100 points.
Detailed description
Overall Response Rate (ORR) defined as the proportion of patients with measurable disease with best overall response of complete response (CR) or partial response (PR), as per local investigator´s assessment and according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria., Correlation between TROP2 mRNA baseline levels and changes in CelTIL score at C2D1., Correlation coefficients between TROP2 mRNA and TROP2 IHC biomarkers., Correlation between TROP2 IHC baseline levels and changes in CelTIL score at C2D1., ORR according to TROP2 mRNA expression & TROP2 IHC expression at baseline. CBR according to TROP2 mRNA expression & TROP2 IHC expression at baseline. PFS according to TROP2 mRNA expression & TROP2 IHC expression at baseline. DoR according to TROP2 mRNA expression & TROP2 IHC expression at baseline. TtR according to TROP2 mRNA expression & TROP2 IHC expression at baseline., 1 Correlation of CelTIL score at C2D1 with ORR. 2 Correlation of CelTIL score at C2D1 with CBR. 3 Correlation of CelTIL score at C2D1 with PFS. 4 Correlation of CelTIL score at C2D1 with DoR. 5 Correlation of CelTIL score at C2D1 with TtR., Incidence, seriousness, treatment-related and severity (grade) of Treatment Emergent Adverse Events (TEAEs) assessed by the NCI Common Terminology for Classification of Adverse Events (CTCAE) version 5, including dose reductions, delays and treatment discontinuations.
Interventions
DRUGTrodelvy 200 mg powder for concentrate for solution for infusion
Sponsors
Solti Group
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in CelTIL score per central assessment between paired baseline and C2D1(14-21 days after treatment initiation) tumor samples in the overall population. CelTIL score = -0.8 x tumor cellularity (%) + 1.3 x tumor-infiltrating lymphocytes (TILs) (%). The minimum and maximum unscaled CelTIL scores will be −80 and 130. This unscaled CelTIL score will then be scaled to reflect a range from 0 to 100 points. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Response Rate (ORR) defined as the proportion of patients with measurable disease with best overall response of complete response (CR) or partial response (PR), as per local investigator´s assessment and according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria., Correlation between TROP2 mRNA baseline levels and changes in CelTIL score at C2D1., Correlation coefficients between TROP2 mRNA and TROP2 IHC biomarkers., Correlation between TROP2 IHC baseline levels and changes in CelTIL score at C2D1., ORR according to TROP2 mRNA expression & TROP2 IHC expression at baseline. CBR according to TROP2 mRNA expression & TROP2 IHC expression at baseline. PFS according to TROP2 mRNA expression & TROP2 IHC expression at baseline. DoR according to TROP2 mRNA expression & TROP2 IHC expression at baseline. TtR according to TROP2 mRNA expression & TROP2 IHC expression at baseline., 1 Correlation of CelTIL score at C2D1 with ORR. 2 Correlation of CelTIL score at | — |
Countries
Spain
Outcome results
None listed