Clinical trial • Phase III • Oncology

PEMBROLIZUMAB for Triple negative breast cancer

Phase III trial of PEMBROLIZUMAB for Triple negative breast cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Triple negative breast cancer
Trial Stage
Phase III
Drug Modality
Monoclonal antibody|Small molecule

Key dates

Initial CTIS Submission Date
22-12-2025
First CTIS Authorization Date
01-04-2026

Trial design

Randomised, capecitabine accord 150 mg film-coated tablets (capecitabine) or capecitabine accord 500 mg film-coated tablets (capecitabine) or teysuno 15 mg/4.35 mg/11.8 mg hard capsules (tegafur/gimeracil/oteracil) or lynparza 150 mg film-coated tablets (olaparib); dose forms are listed in product names but trial dosing schedules not specified-controlled Phase III trial in Netherlands.

Randomised
Yes
Comparator
Capecitabine Accord 150 mg film-coated tablets (capecitabine) OR Capecitabine Accord 500 mg film-coated tablets (capecitabine) OR Teysuno 15 mg/4.35 mg/11.8 mg hard capsules (tegafur/gimeracil/oteracil) OR Lynparza 150 mg film-coated tablets (olaparib); dose forms are listed in product names but trial dosing schedules not specified
Real World Control
Yes
Target Sample Size
1000

Eligibility

Recruits 1000 No vulnerable population selected; participants must be ≥18 years and provide written informed consent. "Willingness to provide written informed consent, according to the Good Clinical Practice (GCP) and national/local regulations" is required; assent/other consent handling not specified..

Vulnerable Population
No vulnerable population selected; participants must be ≥18 years and provide written informed consent. "Willingness to provide written informed consent, according to the Good Clinical Practice (GCP) and national/local regulations" is required; assent/other consent handling not specified.

Inclusion criteria

  • {"criterion_text":"- Male or female, ≥18 years of age on day of signing informed consent\n- Willingness to provide written informed consent, according to the Good Clinical Practice (GCP) and national/local regulations\n- Stage II or III TNBC prior to the start of neoadjuvant treatment: a) 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; b) Locally assessed estrogen receptor (ER) and/or progesterone receptor (PR) expression <10% and HER2-negative according to the ASCO-CAP guideline\n- 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\n- The patient underwent breast surgery ≤12 weeks prior to inclusion in the study\n- 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 >0\n- World Health Organization (WHO) performance status 0-2\n- Adequate organ function, as assessed ≤30 days prior to the screening: a) Absolute neutrophil count (ANC) ≥1,000/mm3 (1.0 x 10e9 /L); b) Platelets ≥50,000/mm3 (50 x 10e9 /L); c) Estimated creatinine clearance ≥ 30 mL/min as calculated using the method standard for the institution; d) Total serum bilirubin ≤1.5 x upper limit of normal (ULN) (≤3.0 x ULN if Gilbert’s disease); e) Aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤3 x ULN\n- 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\n- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures"}

Exclusion criteria

  • {"criterion_text":"- Contra-indications for any of the study drugs\n- Other invasive malignancies, except when treated with curative intent without chemotherapy AND more than 5 years ago\n- The presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule\n- 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"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Invasive disease-free survival (IDFS)","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Distant disease-free survival (DDFS)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Overall survival (OS)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Safety/adverse events","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Global health/QoL and physical functioning (assessed via EQ-5D, EORTC QLQ C30 and EORTC QLQ-BR42)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Cost-effectiveness","definition_or_measurement_approach":""}
  • {"endpoint_text":"- IDFS, DDFS and OS in the PLANET registry","definition_or_measurement_approach":""}

Recruitment

Registry Or Advocacy Recruitment
Yes
Planned Sample Size
1000
Recruitment Window Months
120
Consent Approach
Written informed consent required from participants: "Willingness to provide written informed consent, according to the Good Clinical Practice (GCP) and national/local regulations". Participants must be ≥18. Details on assent, age-specific documents or available languages not specified.

Geography

Total Number Of Sites
61
Total Number Of Participants
1000

Netherlands

Earliest CTIS Part Ii Submission Date
26-02-2026
Latest Decision Or Authorization Date
01-04-2026
Processing Time Days
34
Number Of Sites
61
Number Of Participants
1000

Sites

Site Name
Canisius Wilhelmina Ziekenhuis
Department Name
Oncology
Contact Person Name
Johan Janssen
Site Name
Tergooiziekenhuizen
Department Name
Internal medicine
Contact Person Name
Annelieke Willemsen
Contact Person Email
research@tergooi.nl
Site Name
Treant Ziekenhuiszorg Stichting
Department Name
Oncology
Contact Person Name
Esther Klein Hesselink
Contact Person Email
oncologie@treant.nl
Site Name
Sint Franciscus Vlietland Groep Stichting
Department Name
Oncology
Contact Person Name
Hanneke Zuetenhorst
Contact Person Email
researchinterne@franciscus.nl
Site Name
Spaarne Gasthuis Stichting
Department Name
Internal medicine/Oncology
Contact Person Name
Bart de Valk
Site Name
Stichting Elisabeth-TweeSteden Ziekenhuis
Department Name
Oncology/Hematology
Contact Person Name
Anne-Marie van Riel
Contact Person Email
trialbureau-onco@etz.nl
Site Name
Maasstad Ziekenhuis Stichting
Department Name
Internal medicine/Oncology
Contact Person Name
Auke Huijben
Contact Person Email
reson@maasstadziekenhuis.nl
Site Name
Stichting OLVG
Department Name
Medical Oncology and Hematology
Contact Person Name
Roos Achterbergh
Contact Person Email
internegeneeskunde@olvg.nl
Site Name
Dijklander Ziekenhuis
Department Name
Center for Oncology
Contact Person Name
Firazia Rodjan
Site Name
Universitair Medisch Centrum Groningen
Department Name
Medical Oncology
Contact Person Name
Michel van Kruchten
Site Name
Rode Kruis Ziekenhuis B.V.
Department Name
Internal medicine
Contact Person Name
Astrid Lipplaa
Contact Person Email
alipplaa@rkz.nl
Site Name
Admiraal De Ruyter Ziekenhuis B.V.
Department Name
Internal medicine/Oncology
Contact Person Name
Ellen van Vliet
Contact Person Email
e.vanvliet@adrz.nl
Site Name
Ommelander Ziekenhuis Groningen B.V.
Department Name
Internal medicine
Contact Person Name
Thamara Osinga
Contact Person Email
t.osinga@ozg.nl
Site Name
Rijnstate Ziekenhuis Stichting
Department Name
Internal Medicine
Contact Person Name
Karin Beelen
Contact Person Email
kbeelen@rijnstate.nl
Site Name
Gelre Hospitals
Department Name
Internal medicine
Contact Person Name
Myrella Vlenterie
Contact Person Email
research_interne@gelre.nl
Site Name
Isala Klinieken Stichting
Department Name
Medical Oncology
Contact Person Name
Alet Jansen-Mager
Contact Person Email
rioc@isala.nl
Site Name
Stichting Viecuri Medisch Centrum voor Noord-Limburg
Department Name
Internal medicine/Oncology
Contact Person Name
Eline Boon
Contact Person Email
trialsoncologie@viecuri.nl
Site Name
Haga Hospital
Department Name
Internal medicine
Contact Person Name
Daniël Houtsma
Contact Person Email
d.houtsma@hagaziekenhuis.nl
Site Name
Albert Schweitzer Ziekenhuis
Department Name
Oncology
Contact Person Name
Esther Bouman
Contact Person Email
e.w.bouman@asz.nl
Site Name
Streekziekenhuis Koningin Beatrix
Department Name
Oncology
Contact Person Name
Marleen Duizer
Contact Person Email
m.duizer@skbwinterswijk.nl
Site Name
Radboud universitair medisch centrum Stichting
Department Name
Medical Oncology
Contact Person Name
Evelien Kuip
Contact Person Email
studies.onco@radboudumc.nl
Site Name
Meander Medisch Centrum
Department Name
Internal medicine
Contact Person Name
Jara Baas
Site Name
Groene Hart Ziekenhuis
Department Name
Internal medicine, Oncology/Hematology
Contact Person Name
Marit Suttorp
Contact Person Email
internegeneeskunde@ghz.nl
Site Name
Het Van Weel-Bethesda Ziekenhuis
Department Name
Internal medicine/Oncology
Contact Person Name
Anne-Marie Dietvorst
Contact Person Email
a.dietvorst@vanweelbethesda.nl
Site Name
Ziekenhuis Amstelland
Department Name
Oncology
Contact Person Name
Annette van Zweeden
Contact Person Email
a.vanzweeden@zha.nl
Site Name
Jeroen Bosch Ziekenhuis Stichting
Department Name
Oncology
Contact Person Name
Jolien Tol
Contact Person Email
j.tol@jbz.nl
Site Name
Ikazia Ziekenhuis
Department Name
Internal medicine
Contact Person Name
Jan Drooger
Contact Person Email
research-ig@ikazia.nl
Site Name
Haaglanden Medisch Centrum Stichting
Department Name
Oncology
Contact Person Name
Hendrika Maria Oosterkamp
Site Name
Ziekenhuis Gelderse Vallei Stichting
Department Name
Oncology Center
Contact Person Name
Maartje Verstappen
Contact Person Email
verstappenm@zgv.nl
Site Name
ZorgSaam Ziekenhuis
Department Name
Oncology
Contact Person Name
Marjan van Dijk
Contact Person Email
research@zzv.nl
Site Name
Zuyderland Medisch Centrum Stichting
Department Name
Oncology
Contact Person Name
Franchette van den Berkmortel
Site Name
Laurentius Ziekenhuis Roermond
Department Name
Internal medicine
Contact Person Name
Kirsten Aaldering
Contact Person Email
interne.geneeskunde@lzr.nl
Site Name
Noordwest Ziekenhuisgroep Stichting
Department Name
Internal medicine/Oncology
Contact Person Name
Suzan Vrijaldenhoven
Contact Person Email
s.vrijaldenhoven@nwz.nl
Site Name
Medisch Spectrum Twente
Department Name
Internal medicine
Contact Person Name
Machteld Wymenga
Contact Person Email
ResearchOC@mst.nl
Site Name
Wilhelmina Ziekenhuis Assen
Department Name
Internal medicine/Oncology
Contact Person Name
Peter Nieboer
Contact Person Email
peter.nieboer@wza.nl
Site Name
Reinier de Graaf Groep
Department Name
Oncology
Contact Person Name
Sophie Gerritse
Contact Person Email
oncologie-research@rdgg.nl
Site Name
Deventer Ziekenhuis
Department Name
Medical Oncology
Contact Person Name
Lonneke Kessels
Contact Person Email
l.kessels@dz.nl
Site Name
Bravis Ziekenhuis
Department Name
Internal medicine
Contact Person Name
Frederiek Terheggen
Site Name
Slingeland Ziekenhuis
Department Name
Internal medicine
Contact Person Name
Rune van de Wetering
Contact Person Email
research.onco@slingeland.nl
Site Name
Diakonessenhuis Stichting
Department Name
Oncology
Contact Person Name
Tanja Oostergo
Contact Person Email
researchoncologie@diakhuis.nl
Site Name
Ziekenhuisgroep Twente Stichting
Department Name
Oncology Center
Contact Person Name
Ester Siemerink
Contact Person Email
e.siemerink@zgt.nl
Site Name
Catharina Ziekenhuis Stichting
Department Name
Oncology
Contact Person Name
Birgit Vriens
Site Name
IJsselland Ziekenhuis
Department Name
Oncology
Contact Person Name
Mijntje Vastbinder
Contact Person Email
mvastbinder@ysl.nl
Site Name
Ziekenhuis St Jansdal
Department Name
Oncology
Contact Person Name
Asia Ropela
Site Name
Antonius Ziekenhuis Sneek
Department Name
Internal medicine
Contact Person Name
Hester van Cruijsen
Site Name
Stichting St. Anna Zorggroep
Department Name
Internal Medicine
Contact Person Name
Linda van de Winkel
Contact Person Email
l.vande.winkel@st-anna.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Oncology
Contact Person Name
Agnes Jager
Contact Person Email
a.jager@erasmusmc.nl
Site Name
Stichting BovenIJ
Department Name
Internal medicine/Oncology
Contact Person Name
Willemien van Leeuwen Breuk
Contact Person Email
oncologiestudies@bovenij.nl
Site Name
Stichting Martini Ziekenhuis
Department Name
Internal medicine
Contact Person Name
Annette van der Velden
Contact Person Email
a.vandervelden@mzh.nl
Site Name
Ziekenhuis Nij Smellinghe
Department Name
Internal medicine/Oncology
Contact Person Name
F.J. de Boer
Site Name
Sint Antonius Ziekenhuis Stichting
Department Name
Internal medicine
Contact Person Name
Mariëtte Agterof
Site Name
Amphia Hospital
Department Name
Oncology
Contact Person Name
Joan Heijns
Contact Person Email
JHeijns@amphia.nl
Site Name
Academisch Ziekenhuis Maastricht
Department Name
Medical Oncology
Contact Person Name
Maaike de Boer
Contact Person Email
maaike.deboer@mumc.nl
Site Name
Universitair Medisch Centrum Utrecht
Department Name
Medical oncology
Contact Person Name
Rhodé Bijlsma
Contact Person Email
oncostudies@umcutrecht.nl
Site Name
Frisius MC
Department Name
Oncology Center Leeuwarden
Contact Person Name
Lisanne Hamming
Contact Person Email
lisanne.hamming@frisiusmc.nl
Site Name
Zaans Medisch Centrum Stichting
Department Name
Internal medicine/Oncology
Contact Person Name
Sandra Bakker
Contact Person Email
bakker.sd@zaansmc.nl
Site Name
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Department Name
Internal Medicine
Contact Person Name
Marleen Kok
Contact Person Email
m.kok@nki.nl
Site Name
Beatrix Ziekenhuis
Department Name
Oncology
Contact Person Name
Marja Davidis-van Schoonhoven
Contact Person Email
InterneOncologie@rivas.nl
Site Name
Amsterdam UMC Stichting
Department Name
Medical Oncology
Contact Person Name
Inge Konings
Contact Person Email
medonc-mammae@amsterdamumc.nl
Site Name
Maxima Medisch Centrum
Department Name
Oncology
Contact Person Name
Marcus Dercksen
Contact Person Email
researchonco@mmc.nl
Site Name
St. Jans Gasthuis Weert
Department Name
Internal medicine
Contact Person Name
Myrte Zijlstra
Contact Person Email
m.zijlstra@sjgweert.nl

Sponsor

Primary sponsor

Full Name
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Netherlands

Investigational products

Investigational Product Name
KEYTRUDA 25 mg/mL concentrate for solution for infusion.
Active Substance
PEMBROLIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised
Investigational Product Name
Capecitabine Accord 500 mg film-coated tablets
Active Substance
CAPECITABINE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised
Investigational Product Name
Lynparza 150 mg film-coated tablets
Active Substance
OLAPARIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised
Investigational Product Name
Teysuno 15 mg/4.35 mg/11.8 mg hard capsules
Active Substance
TEGAFUR, GIMERACIL, OTERACIL
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised
Investigational Product Name
Capecitabine Accord 150 mg film-coated tablets
Active Substance
CAPECITABINE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised

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