Study of pembrolizumab, capecitabine, or olaparib in patients with early-stage triple negative breast cancer and remaining disease after initial treatment

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What is this study about?

This study focuses on individuals with early-stage Triple Negative Breast Cancer who still have residual disease, which means some cancer cells remain in the body, after receiving initial treatment. The initial treatment involves neoadjuvant therapy, which is medicine given before surgery to shrink a tumor. The purpose of this study is to evaluate the benefit of adding pembrolizumab to standard follow-up treatments.

Participants in this study will receive different combinations of medications as part of their adjuvant therapy, which is treatment given after the main treatment to lower the risk of the cancer returning. Some individuals will receive pembrolizumab along with capecitabine or olaparib. Other participants may receive tegafur, gimeracil, and oteracil. These medications are administered either through an intravenous infusion, which is medicine delivered directly into a vein, or by taking pills at home.

Who Can Join the Study?

  • Both men and women who are 18 years of age or older can participate.
  • You must be willing to sign a written informed consent form, which is a document that explains all the details of the study before you agree to join.
  • You must have Stage II or III triple negative breast cancer, which is a specific type of breast cancer that does not have certain common receptors (proteins) on the cancer cells.
  • Your cancer must have been tested and shown to have estrogen receptor (ER) and progesterone receptor (PR) levels of less than 10%, and it must be HER2-negative, meaning it lacks a specific protein that helps cancer grow.
  • You must have already completed neoadjuvant treatment, which is medical treatment given before the main surgery to shrink a tumor.
  • This previous treatment must have included chemotherapy (drugs used to kill cancer cells) and pembrolizumab (an immunotherapy drug that helps the immune system fight cancer).
  • Your surgery to remove the breast must have happened within the last 12 weeks.
  • Your previous treatment must have resulted in non-pCR, meaning there was still some cancer remaining in the body after the initial treatment.
  • You are expected to start a standard of care adjuvant treatment, which is the regular treatment given after surgery to prevent the cancer from returning. This includes drugs called capecitabine or olaparib.
  • You must have a WHO performance status of 0 to 2, which is a scale used by doctors to measure how well you can perform daily activities and how much your illness affects your lifestyle.
  • You must have adequate organ function, meaning your vital organs like the liver and kidneys are working well.
  • Your absolute neutrophil count (ANC), which is a measure of certain white blood cells that fight infection, must be at least 1,000/mm3.
  • Your platelet count, which helps your blood clot, must be at least 50,000/mm3.
  • Your estimated creatinine clearance, a test used to check how well your kidneys are filtering your blood, must be at least 30 mL/min.
  • Your total serum bilirubin levels, a substance made when red blood cells break down, must be within a safe range.
  • Your AST and ALT levels, which are enzymes found in the liver, must be within a safe range to ensure your liver is healthy.
  • People who are able to become pregnant must agree to use effective contraception (methods to prevent pregnancy) during the study and for 6 months after the last dose of medicine.
  • You must be able and willing to follow the study schedule, including all doctor visits, treatments, and medical tests.

Who Cannot Join the Study?

  • You cannot take any of the study drugs, which are the specific medications being tested in this research.
  • You have another type of invasive malignancy, which means a cancer that has spread into nearby tissues, unless it was treated with the goal of a complete cure more than 5 years ago and did not require chemotherapy (a type of drug treatment used to kill cancer cells) at that time.
  • You have any psychological, family, social, or living situation issues that might make it difficult for you to follow the study rules or attend all your scheduled medical appointments.
  • You have any other serious short-term or long-term medical or psychiatric condition (a mental health issue) that could increase your risk during the study or make it hard for doctors to understand how the study treatment is working.
  • You have any laboratory abnormality, which means your blood tests or other medical tests show results that are outside of the normal healthy range.
  • The investigator (the main doctor in charge of the study) decides that your health or situation makes it unsafe or unsuitable for you to join the trial.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Stichting OLVG Amsterdam The Netherlands
Zuyderland Medisch Centrum Stichting Geleen The Netherlands
Frisius Heerenveen The Netherlands
University Hospital Maastricht Maastricht The Netherlands

Other Sites

Site Name City Country Status
Ziekenhuis Gelderse Vallei Stichting Ede The Netherlands
Haga Hospital Hague The Netherlands
Noordwest Ziekenhuisgroep Stichting Alkmaar The Netherlands
Isala Klinieken Stichting Zwolle The Netherlands
Groene Hart Ziekenhuis Gouda The Netherlands
Jeroen Bosch Ziekenhuis Stichting s-Hertogenbosch The Netherlands
Canisius Wilhelmina Ziekenhuis Nijmegen The Netherlands
Amphia Hospital Breda The Netherlands
Tergooiziekenhuizen Hilversum The Netherlands
Albert Schweitzer Ziekenhuis Dordrecht The Netherlands
Stichting Viecuri Medisch Centrum voor Noord-Limburg Venlo The Netherlands
Medisch Spectrum Twente Enschede The Netherlands
Diakonessenhuis Stichting Utrecht The Netherlands
Ziekenhuisgroep Twente Stichting Almelo The Netherlands
ZorgSaam Ziekenhuis Terneuzen The Netherlands
Ziekenhuis St Jansdal Harderwijk The Netherlands
Ikazia Ziekenhuis Rotterdam The Netherlands
Het Van Weel-Bethesda Ziekenhuis Dirksland The Netherlands
Rode Kruis Ziekenhuis B.V. Beverwijk The Netherlands
Ziekenhuis Amstelland Amstelveen The Netherlands
Ziekenhuis Nij Smellinghe Drachten The Netherlands
Maxima Medisch Centrum Veldhoven The Netherlands
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Maasstad Ziekenhuis Stichting Rotterdam The Netherlands
Catharina Ziekenhuis Stichting Eindhoven The Netherlands
Stichting Radboud University Medical Center Nijmegen The Netherlands
St. Antonius Ziekenhuis Nieuwegein The Netherlands
Meander Medical Center Amersfoort The Netherlands
Sint Franciscus Vlietland Groep Stichting Rotterdam The Netherlands
Deventer Ziekenhuis Deventer The Netherlands
Reinier de Graaf Groep Delft The Netherlands
Medical Center Haaglanden Leidschendam The Netherlands
Stichting Treant Ziekenhuiszorg Emmen The Netherlands
Zaans Medisch Centrum Stichting Zaandam The Netherlands
Bravis Ziekenhuis Roosendaal The Netherlands
Slingeland Ziekenhuis Doetinchem The Netherlands
Wilhelmina Ziekenhuis Assen Assen The Netherlands
Gelre Hospitals Zutphen The Netherlands
Netherlands Cancer Institute Amsterdam The Netherlands
Spaarne Gasthuis Hoofddorp The Netherlands
Dijklander Ziekenhuis Hoorn The Netherlands
Redhwmqge Zrnttgxbph Swrxlahyc Arnhem The Netherlands
Uowdspopshez Mvcpinm Cnrsjts Geyobbery Groningen The Netherlands
Sigqgwyja Mpfoosj Zicpkrstah Groningen The Netherlands
Ahpxidwd Dc Rxylud Zuuhwszmzg Bntn Goes The Netherlands
Oudbynrexo Znorxbxkan Gmeebczhw Bpls Scheemda The Netherlands
Lnjwvqdenq Zpzdfkxwdc Rqphxaps Roermond The Netherlands
Sgqmbrtvk Byowdiz Amsterdam The Netherlands
Bqvxosg Zlqvkjrqai Gorinchem The Netherlands
Smc Juec Gtsovhnp Wuquh Weert The Netherlands
Siebprgbfsrqnepg Knjzxbnj Bujzelv Winterswijk The Netherlands
Ihmvyufdcg Zyjigxczsg Capelle Aan Den Ijssel The Netherlands
Sosfxjg Geldrop The Netherlands
Audnrcgk zqhjdjoauw Sxjhu Sneek The Netherlands
Arhfrxxil Umi Amsterdam The Netherlands
Ernshar Upipfpcjgngu Mxaynms Cigcvhk Rhxluatio (sjbapjv Mwt Rotterdam The Netherlands
Smr Euqaiifcf Hqnghesd Tqagmfy Tilburg The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Not yet recruiting
30.04.2026

Trial locations

Pembrolizumab is a type of immunotherapy that helps the body’s immune system recognize and attack cancer cells. In this study, it is being tested to see if adding it to standard treatments can help prevent the cancer from coming back in patients who have early-stage triple-negative breast cancer.

Capecitabine is a chemotherapy medication taken by mouth. It works by interfering with the growth of cancer cells and is used as a standard treatment to help control or reduce cancer.

Olaparib is a type of targeted therapy that works by blocking specific proteins that cancer cells need to grow and divide. It is used as a standard treatment option to help prevent cancer from returning.

Tegafur, gimeracil, and oteracil are medications combined into one capsule used as a form of chemotherapy. This combination works to deliver and enhance the effectiveness of the cancer-fighting drug within the body.

Investigated diseases:

Triple negative breast cancer – This is a specific type of breast cancer characterized by the absence of estrogen receptors, progesterone receptors, and human epidermal growth factor receptor 2 on the surface of the cancer cells. Because these cells lack these three common markers, the cancer does not respond to hormone therapies or targeted drugs that focus on these specific receptors. The disease typically involves aggressive cell growth. It can begin in the breast tissue and may progress to other parts of the body.

Trial ID:
2025-524229-41-00
Trial Phase:
Therapeutic confirmatory (Phase III)

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