Pembrolizumab Adjuvant in Patients With Early-stage Triple Negative Breast Cancer With Residual Disease After Neoadjuvant Pembrolizumab Plus Chemotherapy

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.

NCT Number	NCT07486687
Lead Sponsor	The Netherlands Cancer Institute Collaborators: BOOG Study Center, Stichting Treatmeds, Zorgevaluatie en Gepast Gebruik (ZE&GG), Integraal Kankercentrum Nederland (IKNL)
Conditions	Triple Negative Breast Cancer (TNBC), Early Setting, Early Stage Triple-Negative Breast Carcinoma, Triple -Negative Breast Cancer, Breast Cancer Stage II, Breast Cancer Stage III
Enrollment	1,000 participants
Start Date	2026-04
Primary Completion	2032-04 (estimated)
Study Completion	2036-04 (estimated)
Updated on ClinicalTrials.gov	2026-03-20