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

Sponsor
The Netherlands Cancer Institute
Study ID
NCT07486687
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Breast Cancer Stage II
  • Breast Cancer Stage III
  • Early Stage Triple-Negative Breast Carcinoma
  • Triple -Negative Breast Cancer
  • Triple Negative Breast Cancer (TNBC), Early Setting

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
Mar 2026
Primary completion
Apr 30, 2032
Completion
Apr 30, 2036

Study Design

Enrollment
1,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Standard of care plus pembrolizumab
    Patients randomized to the investigational arm of the trial will receive standard of care adjuvant treatment (capecitabine or, in case of BRCA germline mutation, olaparib (if reimbursed)) plus pembrolizumab.
  • Active Comparator: Standard of care
    Patients randomized to the control arm of the trial will receive standard of care adjuvant treatment (capecitabine or, in case of BRCA germline mutation, olaparib (if reimbursed)).

Primary Outcome Measure

Invasive disease free survival (IDFS) [ Time Frame: Up to 10 years after inclusion of the last patient ]

Central Contacts

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