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

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What is this study about?

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.

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.

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Region Vaestmanland	Vasteras	Sweden

Other Sites

Site Name	City	Country
Region Oerebro Laen	Orebro	Sweden
Næstved Hospital	Næstved	Denmark
Region Vaesternorrland	Sundsvall	Sweden
Soedra Aelvsborg Hospital Vaestra Goetalandsregionen	Boras	Sweden
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Sygehus Lillebaelt Vejle Sygehus	Vejle	Denmark
Aalborg University Hospital	Aalborg	Denmark
Region Skane Kristianstad Central Hospital	Kristianstad	Sweden
Sankt Gorans Sjukhus	Stockholm	Sweden
Region Joenkoepings Laen	Jönköping	Sweden
Region Kronoberg	Vaxjo	Sweden
Rigshospitalet	Copenhagen	Denmark
Sygehus Soenderjylland Soenderborg	Aabenraa	Denmark
Region Vaesterbotten	Umea	Sweden
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
Region Halland	Varberg	Sweden
Soedersjukhuset AB	Stockholm	Sweden
Ugsrjtc Utgmnxswoe Httzgdre	Uppsala	Sweden
Rxvuvf Vnepylzyv	Karlstad	Sweden
Hxoppvtv Hmzzwygg	Hillerød	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	02.09.2019
Sweden	Not recruiting	02.09.2019

Trial locations

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.

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.

Trial ID:

2022-501102-35-00

Protocol code:

NordicTrip

NCT ID:

NCT04335669

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?