Adding pembrolizumab after surgery in early triple negative breast cancer with leftover tumor
Tests pembrolizumab added to usual treatment in triple negative breast cancer with remaining disease.
Plain-language title generated from the registry record
Registry title: Pembrolizumab Adjuvant in Patients With Early-stage Triple Negative Breast Cancer With Residual Disease After Neoadjuvant Pembrolizumab Plus Chemotherapy
Key facts
- Where
- 's-Gravenhage, 'S-Hertogenbosch, Alkmaar, Almelo, Almere, Amersfoort, Amstelveen, Amsterdam, Apeldoorn, Arnhem, Assen, Beverwijk, Breda, Capelle aan den IJssel, Delft, Deventer, Dirksland, Doetinchem, Dordrecht, Drachten, Ede Gld, Eindhoven, Emmen, Enschede, Geldrop, Goes, Gorinchem, Gouda, Groningen, Harderwijk, Heerlen, Hilversum, Hoofddorp, Hoorn Nh, Leeuwarden, Leiderdorp, Leidschendam, Maastricht, Nieuwegein, Nijmegen, Roermond, Roosendaal, Rotterdam, Scheemda, Schiedam, Sneek, Terneuzen, Tilburg, Uden, Utrecht, Venlo, Weert, Winterswijk, Zaandam, and Zwolle, NetherlandsSee the 64 sites
- Phase
- Phase 3
Where in Netherlands
- Haga Hospital's-Gravenhage, NetherlandsTaking people
- Jeroen Bosch Ziekenhuis Stichting'S-Hertogenbosch, NetherlandsTaking people
- Noordwest Ziekenhuisgroep StichtingAlkmaar, NetherlandsTaking people
- Ziekenhuisgroep Twente StichtingAlmelo, NetherlandsTaking people
- Flevoziekenhuis StichtingAlmere, NetherlandsTaking people
- Meander Medisch CentrumAmersfoort, NetherlandsTaking people
- Ziekenhuis AmstellandAmstelveen, NetherlandsTaking people
- Amsterdam UMC StichtingAmsterdam, NetherlandsTaking people
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis StichtingAmsterdam, NetherlandsTaking people
- Stichting BovenIJAmsterdam, NetherlandsTaking people
- Stichting OLVGAmsterdam, NetherlandsTaking people
- Gelre HospitalsApeldoorn, NetherlandsTaking people
- Rijnstate Ziekenhuis StichtingArnhem, NetherlandsTaking people
- Wilhelmina Ziekenhuis AssenAssen, NetherlandsTaking people
- Rode Kruis Ziekenhuis B.V.Beverwijk, NetherlandsTaking people
- Amphia HospitalBreda, NetherlandsTaking people
- IJsselland ZiekenhuisCapelle aan den IJssel, NetherlandsTaking people
- Reinier de Graaf GroepDelft, NetherlandsTaking people
- Deventer ZiekenhuisDeventer, NetherlandsTaking people
- Het Van Weel-Bethesda ZiekenhuisDirksland, NetherlandsTaking people
- Slingeland ZiekenhuisDoetinchem, NetherlandsTaking people
- Albert Schweitzer ZiekenhuisDordrecht, NetherlandsTaking people
- Ziekenhuis Nij SmellingheDrachten, NetherlandsTaking people
- Ziekenhuis Gelderse Vallei StichtingEde Gld, NetherlandsTaking people
- Catharina Ziekenhuis StichtingEindhoven, NetherlandsTaking people
- Máxima Medisch CentrumEindhoven, NetherlandsTaking people
- Treant Ziekenhuiszorg StichtingEmmen, NetherlandsTaking people
- Medisch Spectrum TwenteEnschede, NetherlandsTaking people
- Stichting St. Anna ZorggroepGeldrop, NetherlandsTaking people
- Admiraal De Ruyter Ziekenhuis B.V.Goes, NetherlandsTaking people
- Beatrix ZiekenhuisGorinchem, NetherlandsTaking people
- Groene Hart ZiekenhuisGouda, NetherlandsTaking people
- Stichting Martini ZiekenhuisGroningen, NetherlandsTaking people
- Universitair Medisch Centrum GroningenGroningen, NetherlandsTaking people
- Ziekenhuis St JansdalHarderwijk, NetherlandsTaking people
- Zuyderland Medisch Centrum StichtingHeerlen, NetherlandsTaking people
- TergooiziekenhuizenHilversum, NetherlandsTaking people
- Spaarne Gasthuis StichtingHoofddorp, NetherlandsTaking people
- Dijklander ZiekenhuisHoorn Nh, NetherlandsTaking people
- Frisius MCLeeuwarden, NetherlandsTaking people
- Alrijne Zorggroep StichtingLeiderdorp, NetherlandsTaking people
- Haaglanden Medisch Centrum StichtingLeidschendam, NetherlandsTaking people
- Academisch Ziekenhuis MaastrichtMaastricht, NetherlandsTaking people
- Sint Antonius Ziekenhuis StichtingNieuwegein, NetherlandsTaking people
- Canisius Wilhelmina ZiekenhuisNijmegen, NetherlandsTaking people
- Radboud universitair medisch centrum StichtingNijmegen, NetherlandsTaking people
- Laurentius Ziekenhuis RoermondRoermond, NetherlandsTaking people
- Bravis ZiekenhuisRoosendaal, NetherlandsTaking people
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)Rotterdam, NetherlandsTaking people
- Ikazia ZiekenhuisRotterdam, NetherlandsTaking people
- Maasstad Ziekenhuis StichtingRotterdam, NetherlandsTaking people
- Ommelander Ziekenhuis Groningen B.V.Scheemda, NetherlandsTaking people
- Sint Franciscus Vlietland Groep StichtingSchiedam, NetherlandsTaking people
- Antonius Ziekenhuis SneekSneek, NetherlandsTaking people
- ZorgSaam ZiekenhuisTerneuzen, NetherlandsTaking people
- Stichting Elisabeth-TweeSteden ZiekenhuisTilburg, NetherlandsTaking people
- Bernhoven B.V.Uden, NetherlandsTaking people
- Diakonessenhuis StichtingUtrecht, NetherlandsTaking people
- Universitair Medisch Centrum UtrechtUtrecht, NetherlandsTaking people
- Stichting Viecuri Medisch Centrum voor Noord-LimburgVenlo, NetherlandsTaking people
- St. Jans Gasthuis WeertWeert, NetherlandsTaking people
- Streekziekenhuis Koningin BeatrixWinterswijk, NetherlandsTaking people
- Zaans Medisch Centrum StichtingZaandam, NetherlandsTaking people
- Isala Klinieken StichtingZwolle, NetherlandsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The Netherlands Cancer Institute
- Trial code
- NCT07486687EU 2025-524229-41-00
- Record updated
- 20 March 2026
- Original description
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.Read full original descriptionShow less
PembroLizumab Adjuvant in Patients With Early-stage Triple NEgaTive Breast Cancer With Residual Disease After Neoadjuvant Pembrolizumab Plus Chemotherapy - the Multicenter, Randomized Phase III, Pragmatic PLANET Trial
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.
Inclusion: 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; Adequate organ function, as assessed ≤30 days prior to the screening:; Absolute neutrophil count (ANC) ≥1,000/mm3 (1.0 x 10e9 /L); Platelets ≥50,000/mm3 (50 x 10e9 /L); Estimated creatinine clearance ≥ 30 mL/min as calculated using the method standard for the institution; Total serum bilirubin ≤1.5 x upper limit of normal (ULN) (≤3.0 x ULN if Gilbert's disease); Aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤3 x ULN; Participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 6 months after the last dose of study medication; Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures; Willingness to provide written informed consent, according to the Good Clinical Practice (GCP) and national/local regulations.
Exclusion: Contra-indications for any of the study drugs; Other invasive malignancies, except when treated with curative intent without chemotherapy AND more than 5 years ago; The presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.