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

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What is this study about?

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.

1 joining the study

Participation begins after meeting the criteria: being a woman over 18 years old with confirmed invasive HER2-positive breast cancer.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Kuopio University Hospital	Kuopio	Finland

Other Sites

Site Name	City	Country
Oulu University Hospital	Oulu	Finland
Turku University Hospital	Turku	Finland
Pirkanmaan hyvinvointialue	Tampere	Finland
Uerrvfg Uladthfoya Hixsmwmf	Uppsala	Sweden
Hzuchiwh Uztzoltksm Ccakdyi Hdqkvayt	Helsinki	Finland

Trial status

Country	Status	Recruitment Start
Finland	Not yet recruiting	07.12.2015
Sweden	Not yet recruiting	07.12.2015

Trial locations

Investigated drugs:

Pertuzumab

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.

Investigated diseases:

Breast cancer

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.

Trial ID:

2024-512884-30-00

Protocol code:

FBCSG-01-2007

NCT ID:

NCT02625441

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?