Not Yet RecruitingPhase 3

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

1,000 participantsStarted 2026-04

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Male or female, ≥18 years of age on day of signing informed consent
✓. Stage II or III TNBC prior to the start of neoadjuvant treatment
✓. Locally assessed stage II or III TNBC according to the primary tumor (T) and regional lymph node (N) staging as per the American Joint Committee on Cancer (AJCC) for breast cancer staging criteria version 8
✓. Locally assessed estrogen receptor (ER) and/or progesterone receptor (PR) expression \<10% and HER2-negative according to the ASCO-CAP guideline1
✓. The patient has received neoadjuvant treatment with chemotherapy (containing at least anthracyclines and taxanes) and pembrolizumab, with a minimum of two 6-weekly (or four 3-weekly) cycles of pembrolizumab
✓. The patient underwent breast surgery ≤12 weeks prior to inclusion in the study
✓. The patient is scheduled to start standard of care adjuvant treatment with capecitabine or olaparib (pending reimbursement), based on non-pCR after neoadjuvant treatment, defined as RCB score \>02
✓. World Health Organization (WHO) performance status 0-2

Exclusion criteria

What they're measuring

Invasive disease free survival (IDFS)

Timeframe: Up to 10 years after inclusion of the last patient

Trial details

NCT IDNCT07486687

SponsorThe Netherlands Cancer Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2032-04

Contact for this trial

Robin van den Borg, MD

+31205129111 planet@nki.nl

View on ClinicalTrials.gov More Triple Negative Breast Cancer (TNBC), Early Setting trials