PIK3CA-mutant Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Locally Advanced or Metastatic Breast Cancer
Conditions
Brief summary
PFS is defined as the time from randomization until radiographic progression per RECIST v1.1, or death due to any cause.
Detailed description
OS is defined as the time from randomization to the date of death by any cause., PFS is defined as the time from randomization until radiographic progression per RECIST v1.1, or death due to any cause., ORR is defined as the percentage of participants with CR or PR per RECIST v1.1., DOR is defined as the time from the date of first documented response per RECIST v1.1 until date of documented progression or death in the absence of disease progression., CBR is defined as the percentage of participants who achieved CR or PR at any time or SD maintained for ≥24 weeks per RECIST v1.1 (without subsequent therapy) after randomization., • Frequency, severity, timing, and relationship to RLY-2608/fulvestrant or capivasertib/fulvestrant of any AEs, SAEs, changes in vital signs, ECGs, and safety laboratory tests. All AEs and SAEs will be collected and graded according to the NCI CTCAE, Version 5.0. • Dose intensity. • Dose modification., Plasma concentrations of RLY-2608 (and its metabolites as appropriate)., Evaluation of EORTC QLQ-C30, EORTC QLQ-BR23 scale/item scores including change from baseline and time to deterioration., Health state utility data for economic evaluation will be derived by using the EQ-5D-5L health state utility index.
Interventions
DRUGFulvestrant Dr. Reddy’s 250 mg Solution For Injection in Pre-Filled Syringe
DRUGFulvestrant Dr. Reddys 250 mg solución inyectable en jeringa precargada EFG
DRUGRLY-2608
DRUGFulvestrant EVER Pharma 250 mg solution for injection in pre-filled syringe
Sponsors
Relay Therapeutics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS is defined as the time from randomization until radiographic progression per RECIST v1.1, or death due to any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| OS is defined as the time from randomization to the date of death by any cause., PFS is defined as the time from randomization until radiographic progression per RECIST v1.1, or death due to any cause., ORR is defined as the percentage of participants with CR or PR per RECIST v1.1., DOR is defined as the time from the date of first documented response per RECIST v1.1 until date of documented progression or death in the absence of disease progression., CBR is defined as the percentage of participants who achieved CR or PR at any time or SD maintained for ≥24 weeks per RECIST v1.1 (without subsequent therapy) after randomization., • Frequency, severity, timing, and relationship to RLY-2608/fulvestrant or capivasertib/fulvestrant of any AEs, SAEs, changes in vital signs, ECGs, and safety laboratory tests. All AEs and SAEs will be collected and graded according to the NCI CTCAE, Version 5.0. • Dose intensity. • Dose modification., Plasma concentrations of RLY-2608 (and its metabolites as a | — |
Countries
Austria, Belgium, Bulgaria, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Portugal, Spain
Outcome results
None listed