ER+, HER2– Advanced or Metastatic Breast Cancer
Conditions
Brief summary
First-cycle DLTs and determination of a RP2D., Adverse events as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study drug combination., Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing.
Detailed description
ORR by Investigator per RECIST v1.1 in patients with measurable disease at baseline., CBR by Investigator (includes all CRs, all PRs, and SD lasting at least 24 weeks)., DOR., PK parameters
Interventions
Sponsors
Arvinas Estrogen Receptor Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| First-cycle DLTs and determination of a RP2D., Adverse events as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study drug combination., Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing. | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR by Investigator per RECIST v1.1 in patients with measurable disease at baseline., CBR by Investigator (includes all CRs, all PRs, and SD lasting at least 24 weeks)., DOR., PK parameters | — |
Countries
Spain
Outcome results
None listed