PembroLizumab Adjuvant in patients with early-stage Triple NEgaTive breast cancer with residual disease after neoadjuvant pembrolizumab plus chemotherapy – the multicenter, randomized phase III, pragmatic PLANET trial

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-524229-41-00

Enrollment

1000

Registered

2026-04-01

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-01

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

Conditions

Triple negative breast cancer

Brief summary

Invasive disease-free survival (IDFS)

Detailed description

Distant disease-free survival (DDFS), Overall survival (OS), Safety/adverse events, Global health/QoL and physical functioning (assessed via EQ-5D, EORTC QLQ C30 and EORTC QLQ-BR42), Cost-effectiveness, IDFS, DDFS and OS in the PLANET registry

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion.

DRUGCapecitabine Accord 500 mg film-coated tablets

DRUGLynparza 150 mg film-coated tablets

DRUGTeysuno 15 mg/4.35 mg/11.8 mg hard capsules

DRUGCapecitabine Accord 150 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Invasive disease-free survival (IDFS)	—

Secondary

Measure	Time frame
Distant disease-free survival (DDFS), Overall survival (OS), Safety/adverse events, Global health/QoL and physical functioning (assessed via EQ-5D, EORTC QLQ C30 and EORTC QLQ-BR42), Cost-effectiveness, IDFS, DDFS and OS in the PLANET registry	—

Outcome results

None listed

Source: EU CTIS · Data processed: Apr 2, 2026