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 Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause in the absence of progression of 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, PFS by investigator Objective Response (OR) by BICR and by investigator per RECIST v1.1 Duration of Response (DoR) by BICR and by investigator per RECIST v1.1 Clinical Benefit Response (CBR: complete response [CR], partial response [PR], or stable disease [SD]/Non-CR/Non-progression of disease [non-PD] ≥24 weeks) by BICR and by investigator per RECIST v1.1., Type, incidence, severity (as graded by the National Cancer Institute Common Terminology for Adverse Events [NCI CTCAE v5.0]), seriousness and relationship to study interventions of adverse events (AEs), and any laboratory test and electrocardiogram (ECG) abnormalities, Patient reported outcomes (PROs) endpoints of global quality of life, symptoms, and functioning assessed using the European Quality of Life 5 Domain 5 Level Scale (EQ-5D-5L), European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30 and EORTC QLQ Breast Cancer Module 23 (BR23), C_trough of PF-07220060
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 Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause in the absence of progression of 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, PFS by investigator Objective Response (OR) by BICR and by investigator per RECIST v1.1 Duration of Response (DoR) by BICR and by investigator per RECIST v1.1 Clinical Benefit Response (CBR: complete response [CR], partial response [PR], or stable disease [SD]/Non-CR/Non-progression of disease [non-PD] ≥24 weeks) by BICR and by investigator per RECIST v1.1., Type, incidence, severity (as graded by the National Cancer Institute Common Terminology for Adverse Events [NCI CTCAE v5.0]), seriousness and relationship to study interventions of adverse events (AEs), and any laboratory test and electrocardiogram (ECG) abnormalities, Patient reported outcomes (PROs) endpoints of global quality of life, symptoms, and functioning assessed using the European Quality of Life 5 Domain 5 Level Scale (EQ-5D-5L), European Organization for the Research and Treatment of Cancer Quality of Life Questionnair | — |
Countries
Belgium, Bulgaria, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Poland, Slovakia, Spain, Sweden