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C4391025_AN INTERVENTIONAL, OPEN-LABEL, RANDOMIZED, MULTICENTER, PHASE 2 STUDY OF PF-07220060 PLUS LETROZOLE COMPARED TO LETROZOLE ALONE IN POSTMENOPAUSAL WOMEN 18 YEARS OR OLDER WITH HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE BREAST CANCER IN THE NEOADJUVANT SETTING

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512848-30-00
Acronym
C4391025
Enrollment
76
Registered
2024-10-17
Start date
2024-11-12
Completion date
2025-07-10
Last updated
2025-08-26

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 BREAST CANCER

Brief summary

CCCA (Ki-67 ≤2.7%) rates at Day 14 (centrally assessed biopsy).

Detailed description

Incidence of all AEs, SAEs, and AEs leading to study drug discontinuation., ctDNA measurements at baseline and Day 14., Ctrough and peri-biopsy plasma concentrations of PF-07220060., Ki-67 staining.

Interventions

DRUGLetrozole SanoSwiss 2
DRUG5 mg plėvele dengtos tabletės

Sponsors

Pfizer Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
CCCA (Ki-67 ≤2.7%) rates at Day 14 (centrally assessed biopsy).—

Secondary

MeasureTime frame
Incidence of all AEs, SAEs, and AEs leading to study drug discontinuation., ctDNA measurements at baseline and Day 14., Ctrough and peri-biopsy plasma concentrations of PF-07220060., Ki-67 staining.—

Countries

Belgium, France, Germany, Italy, Poland, Slovakia, Spain, Sweden

Outcome results

None listed

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