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Study on the Effectiveness of Trastuzumab, Pertuzumab, and Docetaxel for Patients with Early HER2-Positive Breast Cancer

Verified siteRegistered drugNo placebo

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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 breast cancer, specifically a type known as HER2-positive early breast cancer. The study is investigating a treatment that includes a combination of medications: trastuzumab, pertuzumab, and docetaxel. These medications are used together to see if they can improve the outcomes for patients with this type of breast cancer.

The purpose of the study is to determine if adding pertuzumab to the existing treatment regimen, which already includes trastuzumab and chemotherapy, can help patients live longer without the cancer coming back. The study will compare this new combination treatment to the current standard treatment to see which is more effective.

Participants in the study will receive the treatment through an intravenous infusion, which means the medication is given directly into a vein. The study will follow participants over a period of time to monitor their health and any side effects they may experience. Some participants may receive a placebo as part of the study. The main goal is to see if the new treatment combination can improve the chances of staying cancer-free after treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after meeting the criteria: being a woman over 18 years old with confirmed invasive HER2-positive breast cancer.
Step 2
Initial treatment phase
Receive a combination of trastuzumab, pertuzumab, and docetaxel. These medications are administered intravenously, meaning they are given through a vein.
This phase involves several cycles of treatment. Each cycle includes receiving the medications on a specific schedule, followed by a rest period.
Step 3
Subsequent chemotherapy cycles
After the initial treatment phase, continue with three additional cycles of chemotherapy. The specific medications and schedule will be determined by the study protocol.
Step 4
Monitoring and follow-up
Throughout the study, regular monitoring of health status is conducted. This includes checking heart function, as well as tracking any side effects or changes in quality of life.
The primary goal is to assess invasive disease-free survival, which means the length of time after treatment that the patient remains free of invasive breast cancer.
Step 5
Study completion
The study is expected to conclude by June 2025. At this point, final assessments will be made regarding overall survival, disease-free survival, and any long-term effects of the treatment.

Who can join the trial?

3 criteria

You must be a woman.
You need to be older than 18 years.
You must have a confirmed diagnosis of **invasive HER2-positive breast cancer**. This means that your breast cancer has a specific protein called HER2 that helps it grow.

Who cannot join the trial?

4 criteria

Patients who are not female cannot participate.
Patients who do not have **HER2-positive early breast cancer** cannot participate. **HER2-positive** means that the cancer has a protein that promotes the growth of cancer cells.
Patients who are not within the specified age range cannot participate. The age range is typically defined by the study, but it is not specified here.
Patients who are part of a vulnerable population cannot participate. A **vulnerable population** includes groups like children, pregnant women, or those unable to give consent.

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Verified sites

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

Helsinki University Central Hospital
Verified
Helsinki, Finland
Kuopio University Hospital
Verified
Kuopio, Finland
Oulu University Hospital
Verified
Oulu, Finland

Trial locations

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Investigated drugs

Trastuzumab
is a medication used to treat HER2-positive breast cancer. It works by targeting and blocking the function of the HER2 protein, which can promote the growth of cancer cells. This helps to slow down or stop the growth of the cancer.
Pertuzumab
is another medication used in the treatment of HER2-positive breast cancer. It works in a similar way to trastuzumab by targeting the HER2 protein, but it binds to a different part of the protein. This can enhance the effectiveness of trastuzumab when used together.
Docetaxel
is a type of chemotherapy drug that is used to treat various types of cancer, including breast cancer. It works by interfering with the growth and division of cancer cells, which can help to reduce the size of tumors and slow the progression of the disease.

Pertuzumab

What is already known about the treatment

Trastuzumab
This medication is administered intravenously and is used primarily in the treatment of HER2-positive breast cancer. It is well-established in medical literature and is commonly used in combination with other drugs to improve treatment outcomes. Trastuzumab works by targeting the HER2 protein on cancer cells, blocking their growth and survival. It is classified as a monoclonal antibody.
Pertuzumab
Administered intravenously, pertuzumab is used in combination with trastuzumab and chemotherapy for treating HER2-positive breast cancer. It is currently being studied to determine its effectiveness in improving disease-free survival. Pertuzumab works by binding to the HER2 receptor, preventing cancer cell growth. It is also classified as a monoclonal antibody.
Docetaxel
This medication is given intravenously and is used as part of a chemotherapy regimen for breast cancer. It is a well-known chemotherapy agent that disrupts cell division by stabilizing microtubules, leading to cancer cell death. Docetaxel is classified as a taxane, a type of chemotherapy drug.

Investigated diseases

Breast Cancer – Breast cancer is a disease where cells in the breast grow uncontrollably, forming a tumor that can often be felt as a lump. It typically begins in the ducts or lobules of the breast and can spread to other parts of the body if not treated. The progression of breast cancer can vary, with some types growing slowly and others more rapidly. It is classified into stages based on the size of the tumor and whether it has spread to lymph nodes or other areas. Early detection and understanding of the specific type of breast cancer are crucial for managing its progression.