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

NCT07486687 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2026-03-20

No results posted yet for this study

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.

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

Interventions

DRUG

Standard of care plus pembrolizumab

Standard of care adjuvant treatment (capecitabine or olaparib) plus pembrolizumab

DRUG

Standard of care (capecitabine or olaparib)

Standard of care adjuvant treatment (capecitabine or olaparib)

Sponsors & Collaborators

  • BOOG Study Center

    collaborator OTHER

  • Stichting Treatmeds

    collaborator UNKNOWN

  • Zorgevaluatie en Gepast Gebruik (ZE&GG)

    collaborator UNKNOWN

  • Integraal Kankercentrum Nederland (IKNL)

    collaborator UNKNOWN

  • The Netherlands Cancer Institute

    lead OTHER

Principal Investigators

  • Gabe Sonke, MD, PhD · Netherlands Cancer Institute - Antoni van Leeuwenhoek

  • Marleen Kok, MD, PhD · Netherlands Cancer Institute - Antoni van Leeuwenhoek

  • Agnes Jager, MD, PhD · Erasmus MC Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2032-04-30
Completion
2036-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07486687 on ClinicalTrials.gov