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C4391022 - AN INTERVENTIONAL, OPEN-LABEL, RANDOMIZED, MULTICENTER PHASE 3 STUDY OF PF-07220060 PLUS FULVESTRANT COMPARED TO INVESTIGATOR’S CHOICE OF THERAPY IN PARTICIPANTS OVER 18 YEARS OF AGE WITH HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED/METASTATIC BREAST CANCER WHOSE DISEASE PROGRESSED AFTER PRIOR CDK 4/6 INHIBITOR-BASED THERAPY

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506487-13-00
Acronym
C4391022
Enrollment
174
Registered
2024-07-16
Start date
Unknown
Completion date
2025-02-13
Last updated
2024-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hormone receptor-positive, her2-negative advanced/metastatic breast cancer

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

Pfizer Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026