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C4551002 - An Interventional, Open-Label, Randomized, Multicenter, Phase 3 Study of PF-07248144 Plus Fulvestrant Compared to Investigator’s Choice of Therapy in Adult Participants with Hormone Receptor-Positive, HER2-Negative Advanced/Metastatic Breast Cancer Whose Disease Progressed After Prior CDK4/6 Inhibitor-based Therapy

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-520566-22-00
Acronym
C4551002
Enrollment
153
Registered
2025-10-20
Start date
2025-11-10
Completion date
Unknown
Last updated
2026-01-27

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 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

DRUGEXEMESTANE
DRUGFULVESTRANT
DRUGEVEROLIMUS

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 RECIST v1.1, or death due to any cause in the absence of progressive 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., 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

Outcome results

None listed

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