Immunogenicity Profile of Neoadjuvant Keytruda in Combination with Anthracycline versus Carboplatin/PAclitaxel Containing Chemotherapy Regimen for The Treatment of Early-stage, TILs-Positive, Triple-Negative Breast CanceR (KeyPARTNER)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-507008-30-00

Enrollment

Registered

2024-03-13

Start date

2024-04-17

Completion date

Unknown

Last updated

2025-06-27

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

Conditions

High risk (TILs-positive) HR-/HER2- (triple negative) breast cancer

Brief summary

Primary efficacy endpoint: Pathological complete response;, Primary translational endpoint: Fate bifurcation is defined as the proportion of TILs with the phenotype T-bet(hi) PD1(mid) CD8+. Quantification of number of T cells per mm2 with different phenotypes will be performed, and averages will be calculated per disease sampling (i.e., pre-treatment and C2D1), per arm and by pCR status.

Interventions

DRUGCARBOPLATIN

DRUGEPIRUBICIN

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGPEGFILGRASTIM

DRUGPACLITAXEL

DRUGDOXORUBICIN

DRUGCYCLOPHOSPHAMIDE

DRUGFILGRASTIM

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Primary efficacy endpoint: Pathological complete response;, Primary translational endpoint: Fate bifurcation is defined as the proportion of TILs with the phenotype T-bet(hi) PD1(mid) CD8+. Quantification of number of T cells per mm2 with different phenotypes will be performed, and averages will be calculated per disease sampling (i.e., pre-treatment and C2D1), per arm and by pCR status.	—

Countries

Portugal

Outcome results

None listed

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