Patients with metastatic ER-positive/HER2-positive BC who have previously received at least one line of HER2-targeted therapy for advanced disease, including prior treatment with Trastuzumab deruxtecan (T-DXd).
Conditions
Brief summary
Incidence of dose-limiting toxicities (DLTs) during Cycle 1 (28 days), used to determine the MTD and RP2D of the combination regimen., 6-month progression-free survival (PFS6) rate, defined as the Kaplan-Meier estimate of the probability of being alive and free from disease progression at 6 months (26 weeks) from C1D1 at the RP2D. Progression is assessed by the investigator per RECIST v1.1 (and RANO-BM for CNS lesions) or, where applicable, as clinical progression. The primary analysis is performed in the RP2D population
Detailed description
Objective response rate (ORR): proportion of patients achieving CR or PR according to RECIST v1.1. as assessed by investigators., Duration of response (DoR): time from first documented CR or PR to disease progression or death, whichever comes first., Clinical benefit rate (CBR): proportion of patients achieving CR, PR, or stable disease ≥24 weeks., Overall survival (OS): time from first dose to death from any cause., Incidence and severity of AEs., Incidence of SAEs and deaths., Incidence and severity of laboratory abnormalities., Incidence of ECG and LVEF abnormalities., Incidence of AEs of special interest (AESIs) including: * ≥10% decrease in LVEF. * Symptomatic heart failure. * ≥ grade 2 pneumonitis/interst itial lung disease. * Hepatotoxicity/DILI. ALT/AST>5.0xULN and/or Bilirubin >2.0xULN., Frequency of dose reductions., Frequency of treatment discontinuations due to AEs., Change from baseline in: • EORTC QLQ-C30. • EORTC QLQ-BR42. • EuroQol-5D., Progression-free survival (PFS): time from first dose to disease progression or death, whichever occurs first
Interventions
DRUGBI 1810631
DRUGKisqali 200 mg film-coated tablets
Sponsors
Solti Group
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of dose-limiting toxicities (DLTs) during Cycle 1 (28 days), used to determine the MTD and RP2D of the combination regimen., 6-month progression-free survival (PFS6) rate, defined as the Kaplan-Meier estimate of the probability of being alive and free from disease progression at 6 months (26 weeks) from C1D1 at the RP2D. Progression is assessed by the investigator per RECIST v1.1 (and RANO-BM for CNS lesions) or, where applicable, as clinical progression. The primary analysis is performed in the RP2D population | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR): proportion of patients achieving CR or PR according to RECIST v1.1. as assessed by investigators., Duration of response (DoR): time from first documented CR or PR to disease progression or death, whichever comes first., Clinical benefit rate (CBR): proportion of patients achieving CR, PR, or stable disease ≥24 weeks., Overall survival (OS): time from first dose to death from any cause., Incidence and severity of AEs., Incidence of SAEs and deaths., Incidence and severity of laboratory abnormalities., Incidence of ECG and LVEF abnormalities., Incidence of AEs of special interest (AESIs) including: * ≥10% decrease in LVEF. * Symptomatic heart failure. * ≥ grade 2 pneumonitis/interst itial lung disease. * Hepatotoxicity/DILI. ALT/AST>5.0xULN and/or Bilirubin >2.0xULN., Frequency of dose reductions., Frequency of treatment discontinuations due to AEs., Change from baseline in: • EORTC QLQ-C30. • EORTC QLQ-BR42. • EuroQol-5D., Progression-free survival (P | — |
Outcome results
None listed