Recruiting

Study of Capecitabine and Pembrolizumab for Patients with Triple Negative Breast Cancer After Chemoimmunotherapy and Surgery

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What is this trial about?

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

This clinical trial is focused on studying Triple Negative Breast Cancer, a type of breast cancer that does not have any of the three common receptors known to fuel most breast cancer growth. The study is specifically for patients who have residual disease after receiving initial treatment with chemotherapy and immunotherapy before surgery. The treatment being tested in this study involves the use of two medications: capecitabine and pembrolizumab. Capecitabine is a type of chemotherapy that is taken in the form of film-coated tablets, while pembrolizumab is an immunotherapy given as an infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of this study is to evaluate how effective the combination of capecitabine and pembrolizumab is in preventing the return of cancer after surgery. Participants in the study will receive these medications after they have undergone surgery to remove the breast tumor. The study will monitor the participants over a period of time to see how well the treatment works in keeping the cancer from coming back. The study will also look at the overall survival of participants, which means the length of time they live after starting the study, and any side effects they may experience from the treatment.

Participants will be closely followed by the study team, and their health will be monitored regularly to ensure their safety and to gather information about the treatment's effectiveness. The study aims to provide valuable insights into whether adding capecitabine to pembrolizumab can improve outcomes for patients with Triple Negative Breast Cancer who have residual disease after initial treatment. The study is expected to continue until 2028, with recruitment starting in 2024.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient must have signed a written informed consent. If unable to do so, a trusted person can confirm the consent in writing.
The patient must have completed surgery for breast tumor removal and any affected lymph nodes.
Step 2
Initial assessment
The patient undergoes an assessment to ensure no complete pathological response to previous treatments, defined as RCB Class I, II, or III.
A tumor sample from the surgery is required for analysis.
Step 3
Pre-treatment requirements
The patient must have adequate organ and bone marrow function, confirmed by lab tests within 28 days before starting the trial.
Women of child-bearing potential must have a negative pregnancy test within 7 days before starting treatment.
Step 4
Treatment initiation
The treatment involves the administration of capecitabine and pembrolizumab.
Capecitabine is administered through infusion. The specific dosage and frequency are determined by the study protocol.
Step 5
Treatment duration
The treatment continues for a specified duration as outlined in the study protocol.
Regular monitoring and assessments are conducted to evaluate the patient's response to the treatment.
Step 6
Follow-up and monitoring
The patient's health and response to treatment are monitored throughout the study.
Safety and tolerability are assessed by tracking any adverse events.
Step 7
Study completion
The study aims to evaluate the efficacy of the treatment in improving invasive disease-free survival.
The study is expected to conclude by April 2028.

Who can join the trial?

16 criteria

The patient must have signed a written informed consent before any trial-specific procedures. If the patient cannot physically sign, a trusted person can confirm the patient's consent in writing.
The patient must have Triple Negative Breast Cancer (TNBC) and have been treated with at least 6 cycles of standard neoadjuvant chemotherapy, including pembrolizumab, anthracyclines, and/or taxanes. Other drugs may be allowed after discussion, except capecitabine.
The patient must have had complete removal of the breast tumor(s) and any affected lymph nodes.
The patient must not have a complete pathological response, which means the cancer is classified as RCB Class I, II, or III based on local assessment.
A sample of the tumor from surgery, preserved in a specific way (formalin-fixed paraffin-embedded), must be available along with its histological report.
The patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 or less. This is a scale that measures the patient's ability to perform daily activities.
The patient must have adequate organ and bone marrow function, confirmed by lab tests done within 28 days before starting the trial.
The patient must be at least 18 years old.
The patient must have TNBC confirmed by tests showing HER2 negativity and less than 10% of cells stained for ER and PgR.
The patient must have recovered to at least grade 1 from any side effects of previous treatments, except for hair loss and certain hormone-related conditions that are controlled by medication.
The patient must have received at least one injection of pembrolizumab after surgery, either with or after radiotherapy.
The patient must have had breast surgery at least 2 weeks before starting the trial, and the surgical wound must be healed. The last pembrolizumab injection must have been at least 3 weeks before starting the trial.
Women who can become pregnant must have a negative pregnancy test within 7 days before starting the trial.
Women who can become pregnant and male patients must agree to use effective contraception from the time of the negative pregnancy test until 4 months after the last dose of study drugs.
The patient must be able and willing to attend study visits and follow procedures as outlined in the study protocol.
The patient must be affiliated with a Social Security System or equivalent.

Who cannot join the trial?

10 criteria

Patients who have not been diagnosed with Triple Negative Breast Cancer with remaining disease after receiving treatment before surgery.
Patients who have not received a combination of chemotherapy and immunotherapy before surgery.
Patients who are not within the specified age range for the study.
Patients who are not willing or able to follow the study procedures.
Patients who have other medical conditions that might interfere with the study treatment.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients who have allergies to the study medications.
Patients who have a history of other cancers that might affect the study results.
Patients who have serious infections or other health issues that could be worsened by the study treatment.

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Verified sites

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

Verified
Besancon University Hospital Center
Besançon, France
Verified
CHU Grenoble Alpes
La Tronche, France
Responsive
Institut De Cancerologie De Lorraine
Vandoeuvre Les Nancy, France

Trial locations

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Investigated drugs

Capecitabine
is a medication used in this trial as a post-operative treatment. It is a type of chemotherapy that works by interfering with the growth of cancer cells, slowing their spread in the body. In this study, it is being evaluated for its effectiveness in improving survival rates in patients with Triple Negative Breast Cancer who have residual disease after initial treatment.
Pembrolizumab
is an immunotherapy drug used in this trial. It helps the immune system recognize and attack cancer cells more effectively. In this study, it is combined with capecitabine to see if it can improve outcomes for patients with Triple Negative Breast Cancer who still have cancer remaining after initial treatments.

What is already known about the treatment

Capecitabine
Capecitabine is an oral medication used in the treatment of certain types of cancer, including breast cancer. It is currently being studied in clinical trials as an adjuvant therapy for Triple Negative Breast Cancer with residual disease after neoadjuvant chemo-immunotherapy. The main therapeutic indication is to improve invasive disease-free survival in these patients. Capecitabine works by interfering with the DNA synthesis of cancer cells, thereby inhibiting their growth and proliferation. It belongs to the pharmacological class of antimetabolites.
Pembrolizumab
Pembrolizumab is administered as an intravenous infusion and is used in the treatment of various cancers, including breast cancer. It is being evaluated in clinical trials for its effectiveness as part of a combination therapy with capecitabine for Triple Negative Breast Cancer with residual disease after neoadjuvant chemo-immunotherapy. The primary therapeutic indication is to enhance invasive disease-free survival. Pembrolizumab functions by blocking a specific protein on immune cells, allowing the immune system to better detect and attack cancer cells. It is classified as an immune checkpoint inhibitor.

Investigated diseases

Triple Negative Breast Cancer – This is a type of breast cancer that does not have any of the three common receptors known to fuel most breast cancer growth: estrogen, progesterone, and the HER-2/neu gene. It is considered more aggressive and difficult to treat than other types of breast cancer. The disease often progresses quickly and is more likely to spread and recur. It is typically diagnosed in younger women and is more common in African American women. After initial treatment, such as chemotherapy, some patients may still have residual disease, which means that cancer cells remain in the body. This residual disease can lead to further progression if not managed effectively.