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Study on Preoperative Treatment for HER2 Positive Breast Cancer Using Docetaxel, Pertuzumab, and Trastuzumab in Patients with Primary Breast Cancer

Fast replyRegistered 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 HER2-positive breast cancer, a type of breast cancer characterized by the overexpression of the HER2 protein. The study aims to evaluate the impact of a treatment approach that is guided by the patient's response to therapy. The medications being used in this study include Docetaxel, Perjeta (pertuzumab), Herceptin (trastuzumab), and Kadcyla (trastuzumab emtansine). These treatments are administered to see how well they work in shrinking the cancer before surgery.

Participants in the study will receive these medications through infusions or injections over a period of time. The study will monitor how the cancer responds to these treatments and assess the long-term outcomes for the patients. The goal is to determine the effectiveness of the treatment in reducing the size of the tumor and improving the chances of successful surgery. The study will also look at the safety of the treatments and their impact on the quality of life of the participants.

Throughout the study, various aspects such as the clinical and radiological response of the cancer, the characteristics of the tumors, and the survival rates of the patients will be evaluated. The study will also consider the frequency of breast-conserving surgeries and the overall safety of the treatment regimen. This research is part of a larger effort to improve treatment strategies for patients with HER2-positive breast cancer.

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
Initial treatment phase
The treatment begins with the administration of docetaxel and pertuzumab. These medications are given through an intravenous infusion. The dosage and frequency will be determined by the medical team based on individual patient needs.
During this phase, the patient will also receive trastuzumab, which is administered as a subcutaneous injection. The medical team will provide specific instructions regarding the dosage and schedule.
Step 2
Response evaluation
After the initial treatment phase, the patient's response to the medications will be evaluated. This involves clinical and radiological assessments to determine the effectiveness of the treatment.
The evaluation will help in deciding the next steps in the treatment plan, which may include adjustments to the medication regimen.
Step 3
Adjusted treatment phase
Based on the response evaluation, the treatment may be adjusted. This could involve continuing with the same medications or introducing trastuzumab emtansine, which is administered through an intravenous infusion.
The medical team will provide detailed instructions on the dosage and frequency of the adjusted treatment.
Step 4
Ongoing monitoring
Throughout the trial, regular monitoring of the patient's health and response to treatment will be conducted. This includes blood tests, imaging studies, and assessments of heart function.
The goal is to ensure the safety and effectiveness of the treatment while managing any side effects that may occur.
Step 5
Final assessment
At the end of the treatment period, a comprehensive assessment will be conducted to evaluate the overall response to the treatment.
This assessment will include clinical, radiological, and pathological evaluations to determine the impact of the treatment on the cancer.

Who can join the trial?

9 criteria

Provide written informed consent, which means you agree to participate in the study after being fully informed about it.
Have breast cancer confirmed by a test called histology, which examines tissue under a microscope. The cancer should be characterized by tests for ER (estrogen receptor), PR (progesterone receptor), HER2 (a protein that can affect the growth of cancer cells), and a proliferation marker that shows how quickly cancer cells are growing.
Have tumor and blood samples available. The HER2 type should be confirmed by a detailed genetic test called Next-Generation Sequencing.
Be 18 years or older. Elderly patients should be in a condition suitable for the planned treatment.
Have primary breast cancer that is larger than 20mm in diameter or have confirmed cancer spread to the lymph nodes.
Have adequate bone marrow, kidney (renal), liver (hepatic), and heart (cardiac) functions, and no other uncontrolled medical or mental health disorders.
Have a Left Ventricular Ejection Fraction (LVEF) greater than 55%, which is a measure of how well your heart is pumping blood.
Have an ECOG performance status of 0-1, which means you are fully active or have some symptoms but can carry out light work.
Have primary breast cancer as described above, plus at most two well-defined distant metastases (cancer spread to other parts of the body) that can be treated with a precise type of radiation therapy called stereotactic radiotherapy, if this treatment is available.

Who cannot join the trial?

5 criteria

Patients with any other type of cancer besides primary breast cancer cannot participate. Primary breast cancer means the cancer started in the breast and has not spread to other parts of the body.
Individuals who are not within the specified age range for the study are excluded. The age range is not specified here, but it means that only people of certain ages can join.
Participants who are not part of the specified clinical trial groups are excluded. This means that only certain groups of people, based on specific characteristics, can join the study.
People who are not female or male subjects are excluded. This means the study is open to both women and men.
Individuals who are considered part of a vulnerable population are excluded. A vulnerable population includes people who might need special protection or care, like children or people with certain disabilities.

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Verified sites

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

Karolinska University Hospital
Verified
Solna, Sweden
Region Vaesterbotten
Responsive
Umea, Sweden
Soedersjukhuset AB
Responsive
Stockholm, Sweden

Trial locations

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Investigated drugs

Trastuzumab
is a medication used in the treatment of HER2-positive breast cancer. It works by targeting the HER2 protein on the surface of cancer cells, helping to stop their growth and spread.
Pertuzumab
is another medication used for HER2-positive breast cancer. It is often used in combination with trastuzumab to enhance the treatment effect by blocking the HER2 protein in a different way.
Docetaxel
is a chemotherapy drug that helps to kill cancer cells by interfering with their ability to divide and grow. It is commonly used in combination with other medications for breast cancer treatment.
Paclitaxel
is a chemotherapy medication that works by stopping cancer cells from dividing. It is used to treat various types of cancer, including breast cancer, and is often part of a combination therapy.
Carboplatin
is a chemotherapy drug that damages the DNA of cancer cells, preventing them from multiplying. It is used in combination with other treatments for breast cancer to improve outcomes.

What is already known about the treatment

Trastuzumab – This medication is administered intravenously and is used primarily for treating HER2-positive breast cancer. It is currently well-established in medical practice and literature as an effective treatment for this type of cancer. Trastuzumab works by targeting the HER2 protein on cancer cells, blocking them from receiving growth signals, which helps to slow or stop the growth of the cancer. It is classified as a monoclonal antibody, a type of targeted cancer therapy.

Investigated diseases

Primary Breast Cancer – This is a type of cancer that originates in the breast tissue, typically in the ducts or lobules. It is characterized by the uncontrolled growth of abnormal cells in the breast, which can form a tumor. As the disease progresses, the tumor may grow larger and can potentially spread to nearby lymph nodes or other parts of the body. The progression of primary breast cancer can vary, with some tumors growing slowly and others more rapidly. The disease may present with symptoms such as a lump in the breast, changes in breast shape, or skin dimpling. Early detection and monitoring are crucial for understanding the progression of the disease.