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Study on Adding Capecitabine to Carboplatin-Based Chemotherapy for Patients with Early Triple Negative Breast Cancer

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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 the effects of adding a medication called capecitabine to a type of chemotherapy that includes carboplatin for treating early-stage triple-negative breast cancer. Triple-negative breast cancer is a type of breast cancer that does not have three common receptors known to fuel most breast cancer growth: estrogen, progesterone, and HER2/neu. The purpose of the study is to see if adding capecitabine to the treatment can improve the response to chemotherapy before surgery.

Participants in the study will receive treatments over a period of time, with some receiving the combination of capecitabine and carboplatin, while others will receive carboplatin-based chemotherapy alone. The study will compare the effects of these treatments to see if the addition of capecitabine leads to better outcomes. The treatments are given through an infusion, which means they are delivered directly into the bloodstream through a vein.

The study will monitor the participants' response to the treatment, focusing on how well the cancer responds to the chemotherapy. The main goal is to see if the cancer is completely gone from the breast and lymph nodes after the treatment, which is known as a pathologic complete response. The study will also look at other important outcomes, such as how long participants live without the cancer coming back and overall survival rates. This research aims to provide more information on the potential benefits of adding capecitabine to the treatment plan for patients with early triple-negative breast cancer.

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
Initial treatment phase
The treatment begins with the administration of cyclophosphamide and epirubicin. These medications are given through a vein, known as intravenous use. The specific dosage and frequency will be determined by the healthcare provider based on individual needs and response to treatment.
Step 2
Introduction of pembrolizumab
Pembrolizumab, also administered intravenously, is added to the treatment regimen. This medication is a type of immunotherapy that helps the immune system fight cancer cells. The healthcare provider will provide details on the dosage and schedule.
Step 3
Paclitaxel and carboplatin administration
The treatment continues with the addition of paclitaxel and carboplatin, both given intravenously. These are chemotherapy drugs that work by stopping the growth of cancer cells. The healthcare provider will determine the appropriate dosage and frequency.
Step 4
Addition of capecitabine
Capecitabine is introduced as an oral medication. This drug is taken by mouth and is designed to interfere with the growth of cancer cells. The healthcare provider will provide instructions on how to take this medication, including the dosage and duration.
Step 5
Monitoring and evaluation
Throughout the treatment, regular monitoring and evaluation will occur to assess the response to the medications. This may include physical exams, imaging tests, and laboratory tests. The healthcare provider will discuss the results and any necessary adjustments to the treatment plan.
Step 6
Surgery
Following the completion of the chemotherapy regimen, surgery is planned to remove any remaining cancer. The type of surgery will depend on the individual case and will be discussed with the healthcare provider.
Step 7
Post-surgery follow-up
After surgery, follow-up appointments will be scheduled to monitor recovery and check for any signs of cancer recurrence. The healthcare provider will provide guidance on any additional treatments or lifestyle changes that may be necessary.

Who can join the trial?

11 criteria

Sign a written informed consent form that has been approved by the Ethical Review Board.
Be willing to use an effective form of birth control during the treatment period and for at least 6 months after, if you are a woman who can have children, a man, or a sexual partner of a participant.
Agree to undergo treatment and study-related procedures as outlined in the study plan.
Be between the ages of 18 and 75 years old.
Have a confirmed diagnosis of cancer in one breast, where chemotherapy before surgery is planned.
Have cancer that has spread to the lymph nodes (N1-3) or, if not, have a tumor larger than 20 mm.
Have a tumor that is **ER negative**, meaning it has less than 1% or 10% of cells showing estrogen receptors, as determined by specific tests.
Have a tumor that is **HER2-normal**, according to national guidelines.
Agree to genetic testing for mutations in **BRCA1**, **BRCA2**, and other genes linked to breast cancer.
Have a **WHO performance status** of 0 or 1, which means you are fully active or have some symptoms but do not need to stay in bed.
Have a negative pregnancy test if you are a woman who can have children, meaning you are premenopausal or have not had a period for less than 12 months after menopause and have not had surgery to prevent pregnancy.

Who cannot join the trial?

5 criteria

Patients who have a different type of breast cancer that is not early triple negative breast cancer.
Patients who are not within the specified age range for the study.
Patients who are not part of the specified clinical trial groups.
Patients who are not female or male, as the study includes both genders.
Patients who are considered part of a vulnerable population, which means they might need special protection or care.

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Verified sites

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

Aalborg University Hospital
Verified
Aalborg, Denmark
Region Vaesterbotten
Responsive
Umea, Sweden
Soedersjukhuset AB
Responsive
Stockholm, Sweden

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Investigated drugs

Capecitabine
is a medication used in this trial to see if it can improve the treatment of early-stage breast cancer that is negative for estrogen receptors (ER) and human epidermal growth factor receptor 2 (HER2). It is being tested to find out if adding it to the standard chemotherapy can help eliminate cancer cells more effectively before surgery.
Carboplatin
is a chemotherapy drug that is part of the standard treatment for certain types of breast cancer. In this trial, it is used as a base treatment to which capecitabine is added. The goal is to determine if the combination of carboplatin and capecitabine can increase the chances of completely removing the cancer before surgery.

What is already known about the treatment

Capecitabine
Capecitabine is an oral medication used in the treatment of certain types of cancer, including early triple-negative breast cancer. It is currently being studied in clinical trials to assess its effectiveness when added to carboplatin-based chemotherapy. The main therapeutic indication for capecitabine is to improve the pathologic complete response rate in patients with early ER-negative and HER2-negative breast cancer. At the molecular level, capecitabine is a prodrug that is converted into 5-fluorouracil (5-FU) in the body, which then interferes with DNA synthesis in cancer cells, inhibiting their growth. It is classified as an antimetabolite in pharmacology.
Carboplatin
Carboplatin is administered intravenously and is used in chemotherapy to treat various cancers, including early triple-negative breast cancer. It is part of ongoing clinical trials to evaluate its efficacy in combination with capecitabine. The primary therapeutic indication for carboplatin is to enhance the treatment response in patients with early ER-negative and HER2-negative breast cancer. Its mechanism of action involves binding to DNA in cancer cells, causing cross-linking and ultimately leading to cell death. Carboplatin is classified as a platinum-based chemotherapy drug.

Investigated diseases

Early Triple Negative Breast Cancer – This is a type of breast cancer characterized by the absence of estrogen receptors, progesterone receptors, and excess HER2 protein. It is considered more aggressive than other types of breast cancer due to its rapid growth and higher likelihood of spreading. The disease typically affects younger women and is more common in those with a BRCA1 gene mutation. It progresses quickly, often leading to larger tumors at the time of diagnosis. Unlike other breast cancers, it does not respond to hormonal therapy or medicines that target HER2 receptors. Treatment usually involves a combination of surgery, chemotherapy, and radiation therapy.