Recruiting

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

Verified siteRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Participation in the study
After joining the study, one of several treatment paths is assigned through a process called randomization, which is a method used to assign participants to different groups by chance.
Step 2
Treatment with pembrolizumab and capecitabine
One possible path involves receiving pembrolizumab, which is an intravenous medication (delivered through a vein) at a dose of 400 mg.
This is combined with capecitabine, which is an oral medication taken in the form of film-coated tablets at a dose of 2500 mg/m² (milligrams based on body surface area).
Step 3
Treatment with pembrolizumab and olaparib
Another possible path involves receiving pembrolizumab via intravenous infusion at a dose of 400 mg.
This is combined with olaparib, which is an oral medication taken as film-coated tablets at a dose of 600 mg.
Step 4
Treatment with pembrolizumab and teysuno
A third possible path involves receiving pembrolizumab via intravenous infusion at a dose of 400 mg.
This is combined with teysuno, which is an oral medication taken as hard capsules at a dose of 60 mg/m² (milligrams based on body surface area).

Who can join the trial?

18 criteria

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 trial?

6 criteria

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.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, The Netherlands
Responsive
Sint Franciscus Vlietland Groep Stichting
Rotterdam, The Netherlands
Responsive
Universitair Medisch Centrum Utrecht
Utrecht, The Netherlands

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

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.

What is already known about the treatment

Pembrolizumab
This medication is an immunotherapy administered as a solution through an intravenous infusion into a vein. It is an established treatment used to help the immune system recognize and attack various types of cancer. At the molecular level, it works by blocking a specific protein on immune cells that prevents them from attacking cancer cells, effectively releasing the brakes on the body's natural defenses. It belongs to a class of drugs known as checkpoint inhibitors.
Capecitabine
This drug is an oral chemotherapy medication taken in the form of film-coated tablets. It is widely used in medical practice to treat several types of solid tumors, including certain breast cancers. Once inside the body, it is converted into a powerful substance that interferes with the DNA production of cancer cells, preventing them from multiplying. It is classified as an antimetabolite.
Olaparib
This medication is taken orally in the form of film-coated tablets and is an approved treatment for specific genetic types of cancer. It is used to target tumors that have difficulty repairing their own DNA. By blocking specific enzymes that help cancer cells fix broken DNA, the drug causes the cancer cells to accumulate damage and eventually die. This drug is classified as a PARP inhibitor.
Tegafur, gimeracil, oteracil
This combination medication is administered orally using hard capsules. It is a well-known treatment used to manage various digestive and breast cancers. The tegafur component works by interfering with the DNA of cancer cells, while the gimeracil and oteracil components help ensure the drug stays active in the body longer by preventing its breakdown. This combination is classified as an antimetabolite therapy.

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.