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C4891002: A Phase 3, Randomized, Open-Label, Multicenter Study Of ARV-471 (PF-07850327) Plus Palbociclib Versus Letrozole Plus Palbociclib For The Treatment Of Participants With Estrogen Receptor Positive, HER2-Negative Breast Cancer Who Have Not Received Any Prior Systemic Anti-Cancer Treatment For Advanced Disease (VERITAC-3)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-500545-24-00
Acronym
C4891002
Enrollment
17
Registered
2023-09-19
Start date
2023-10-04
Completion date
Unknown
Last updated
2025-08-22

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

Conditions

ER + /HER 2 - Advanced Breast Cancer

Brief summary

Study Lead-in: •Incidence of Grade 4 neutropenia AE (as graded by NCI CTCAE v5.0) with onset within the first 4 cycles. •Incidence of dose reduction or drug discontinuation within the first 4 cycles., Phase 3: •Progression-free survival (PFS), defined as the time from the date of randomization to the date of first documented disease progression, as determined by BICR assessment per RECIST v1.1, or death due to any cause, whichever occurs first.

Detailed description

Study Lead-in: •Incidence of AEs and SAEs •Incidence of laboratory abnormalities. •Incidence of ECG abnormalities., Study Lead-in: •Objective Response, Clinical Benefit Response, Duration of response as determined by investigator assessment per RECIST v1.1, Study Lead-in: •Plasma concentrations of ARV-471 and ARV-473., Study Lead-in: •Plasma concentrations of palbociclib., Phase 3: •Overall Survival (OS), defined as the time from the date of randomization to the date of death due to any cause., Phase 3: •Objective Response, clinical Benefit Response, duration of response as determined by BICR assessment per RECIST v 1.1, Phase 3: •Incidence of AEs and SAEs • Incidence of laboratory abnormalities. •Incidence of ECG abnormalities., Phase 3: •Plasma concentrations of ARV-471 and its epimer ARV-473., Phase 3: •Plasma concentrations of palbociclib., Phase 3: • EuroQol EQ-5D-5L •EORTC QLQ-C30 •EORTC QLQ-BR23, Phase 3: •ctDNA plasma quantitative changes from pretreatment to evaluate potential predictability of their associations with clinical outcomes.

Interventions

Sponsors

Pfizer Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Study Lead-in: •Incidence of Grade 4 neutropenia AE (as graded by NCI CTCAE v5.0) with onset within the first 4 cycles. •Incidence of dose reduction or drug discontinuation within the first 4 cycles., Phase 3: •Progression-free survival (PFS), defined as the time from the date of randomization to the date of first documented disease progression, as determined by BICR assessment per RECIST v1.1, or death due to any cause, whichever occurs first.

Secondary

MeasureTime frame
Study Lead-in: •Incidence of AEs and SAEs •Incidence of laboratory abnormalities. •Incidence of ECG abnormalities., Study Lead-in: •Objective Response, Clinical Benefit Response, Duration of response as determined by investigator assessment per RECIST v1.1, Study Lead-in: •Plasma concentrations of ARV-471 and ARV-473., Study Lead-in: •Plasma concentrations of palbociclib., Phase 3: •Overall Survival (OS), defined as the time from the date of randomization to the date of death due to any cause., Phase 3: •Objective Response, clinical Benefit Response, duration of response as determined by BICR assessment per RECIST v 1.1, Phase 3: •Incidence of AEs and SAEs • Incidence of laboratory abnormalities. •Incidence of ECG abnormalities., Phase 3: •Plasma concentrations of ARV-471 and its epimer ARV-473., Phase 3: •Plasma concentrations of palbociclib., Phase 3: • EuroQol EQ-5D-5L •EORTC QLQ-C30 •EORTC QLQ-BR23, Phase 3: •ctDNA plasma quantitative changes from pretreatment to evaluate potential

Countries

Hungary, Italy, Slovakia, Spain

Outcome results

None listed

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