Hormone Receptor-Positive, HER2-Negative Advanced/Metastatic Breast Cancer
Conditions
Brief summary
PFS, defined as the time from the date of randomization to the date of first documented disease progression, as determined by blinded independent central review (BICR) per RECIST v1.1, or death due to any cause in the absence of progressive disease (PD), whichever occurs first.
Detailed description
OS, defined as the time from the date of randomization to the date of death due to any cause., Objective Response (OR) by BICR per RECIST v1.1, DoR by BICR per RECIST v1.1, Clinical Benefit Response (CBR: complete response [CR], partial response [PR], or stable disease [SD] /non-CR/non-progression [non-PD] ≥24 weeks) by BICR per RECIST v1.1, Type, incidence, severity (as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE v5.0]), seriousness of adverse events (AEs), any laboratory test or electrocardiogram (ECG) abnormalities, and characterization PF-07248144 effect on corrected QT interval (QTc) from baseline., Ctrough (lowest plasma concentration before scheduled dose) of PF-07248144
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS, defined as the time from the date of randomization to the date of first documented disease progression, as determined by blinded independent central review (BICR) per RECIST v1.1, or death due to any cause in the absence of progressive disease (PD), whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| OS, defined as the time from the date of randomization to the date of death due to any cause., Objective Response (OR) by BICR per RECIST v1.1, DoR by BICR per RECIST v1.1, Clinical Benefit Response (CBR: complete response [CR], partial response [PR], or stable disease [SD] /non-CR/non-progression [non-PD] ≥24 weeks) by BICR per RECIST v1.1, Type, incidence, severity (as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE v5.0]), seriousness of adverse events (AEs), any laboratory test or electrocardiogram (ECG) abnormalities, and characterization PF-07248144 effect on corrected QT interval (QTc) from baseline., Ctrough (lowest plasma concentration before scheduled dose) of PF-07248144 | — |
Countries
Belgium, Bulgaria, Czechia, Finland, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Slovakia, Spain, Sweden