drugset / Trial / NCT07486687
Pembrolizumab Adjuvant in Patients With Early-stage Triple Negative Breast Cancer With Residual Disease After Neoadjuvant Pembrolizumab Plus Chemotherapy
Phase 3
Not yet recruiting
1000 enrolled
The Netherlands Cancer Institute
BOOG Study Center · collabIntegraal Kankercentrum Nederland (IKNL) · collabStichting Treatmeds · collabZorgevaluatie en Gepast Gebruik (ZE&GG) · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The phase III, multicenter, pragmatic PLANET trial aims to evaluate the benefit and safety of pembrolizumab as an addition to standard of care adjuvant treatment (capecitabine or olaparib) in triple negative breast cancer (TNBC) patients with residual disease (non-pCR) after neoadjuvant chemotherapy and pembrolizumab. All study procedures resemble routine clinical practice as much as possible (i.e., pragmatic clinical trial). In addition to the randomized trial, a registry will be set up, in which patients who reach pCR (and therefore, do not receive adjuvant treatment) will be registered and followed.
Timeline
- Start
- 2026-04
- Primary completion
- 2032-04
- Completion
- 2036-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pembrolizumab | Monoclonal antibody | — | — |
| Comparator | Capecitabine | Small molecule | — | — |
| Comparator | Olaparib | Small molecule | — | — |