This clinical trial is focused on studying a type of breast cancer known as HER2-positive early breast cancer. The study is comparing two different treatment approaches. One group of patients will receive a medication called trastuzumab deruxtecan, which is given as an injection into a vein. The other group will receive a combination of medications that include paclitaxel or docetaxel, carboplatin, trastuzumab, and pertuzumab. These medications are also given as injections and are part of the standard treatment for this type of cancer.
The purpose of the study is to see how well these treatments work in helping patients achieve a complete response, meaning no signs of cancer, after 12 or 18 weeks of treatment. The study will also look at whether patients treated with trastuzumab deruxtecan have a high chance of being free from distant cancer spread for three years. Patients will be monitored throughout the study to see how their cancer responds to the treatment and to check their overall health and quality of life.
Participants in the study will receive their assigned treatment and will have regular check-ups to monitor their progress. The study aims to provide valuable information on the effectiveness of these treatments in managing HER2-positive early breast cancer and to help guide future treatment options for patients with this condition.
1joining the study
Upon joining the study, you will be assigned to one of two treatment groups. This assignment is based on your specific health condition and risk factors.
2treatment group assignment
You will be placed in either the group receiving trastuzumab deruxtecan or the group receiving a combination of paclitaxel, docetaxel, carboplatin, trastuzumab, and pertuzumab. The decision is made by the study team based on your health profile.
3treatment administration
If you are in the trastuzumab deruxtecan group, you will receive the medication through an intravenous infusion. This means the medication is given directly into your vein. The treatment will last for either 12 or 18 weeks, depending on your specific treatment plan.
If you are in the combination therapy group, you will receive paclitaxel or docetaxel with carboplatin, trastuzumab, and pertuzumab through intravenous infusion. The duration of this treatment is also 12 or 18 weeks, as determined by the study team.
4monitoring and assessments
Throughout the treatment period, your health will be closely monitored. This includes regular check-ups and assessments to evaluate your response to the treatment.
You will undergo clinical evaluations at 6, 12, and 18 weeks to assess the effectiveness of the treatment and any side effects you may experience.
5post-treatment follow-up
After completing the treatment, you will continue to be monitored for a period of time to assess your long-term health outcomes.
The study aims to evaluate the 3-year distant disease-free survival rate, which means checking if the cancer has not spread to other parts of your body during this time.
Who Can Join the Study?
Must be a female patient with untreated HER2+ breast cancer, confirmed by a local pathology test within 6 weeks before joining the study.
Must be at least 18 years old.
Must not donate or retrieve eggs for personal use from the time of joining the study until at least 7 months after the last study drug is given.
Must belong to one of the following groups:
Cohort 1: Low to intermediate risk of cancer coming back, as decided by the study doctor. Recommended tumor size is between 1 and 3 cm, with no cancer in the lymph nodes.
Cohort 2: Intermediate to high risk of cancer coming back, as decided by the study doctor. Recommended tumor size is between 3 and 5 cm, with no cancer in the lymph nodes.
Elderly patients (65 years or older) can be assigned to any group as decided by the study doctor.
Must provide written informed consent to participate in the study.
Must have a Left Ventricular Ejection Fraction (LVEF) of at least 50% within 28 days before joining the study. LVEF is a measure of how well the heart is pumping blood.
Must have an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1, which means being fully active or restricted in physically strenuous activity but able to carry out light work.
Must have adequate bone marrow and organ function within 14 days before joining the study, as shown by specific blood test results:
Absolute neutrophil count of at least 1.5 x 109/L
Platelets of at least 100 x 109/L
Hemoglobin of at least 9.0 g/dL
Estimated glomerular filtration rate (eGFR) of at least 30 mL/min, which measures kidney function
INR of 1.5 or less, which measures blood clotting
Serum creatinine less than 1.5 mg/dL, which measures kidney function
Total bilirubin less than 1.5 times the upper limit of normal (ULN), except for patients with Gilbert’s Syndrome who may have up to 3.0 times ULN or direct bilirubin 1.5 times ULN
Aspartate transaminase (AST) less than 2.5 times ULN, which measures liver function
Alanine transaminase (ALT) less than 2.5 times ULN, which measures liver function
Must have an adequate treatment washout period before joining the study, meaning enough time has passed since any previous treatments.
Must show evidence of post-menopausal status or have a negative serum pregnancy test if of childbearing potential. Post-menopausal status can be confirmed if:
Had both ovaries removed
Are 60 years or older
Are under 60 years old and have not had a menstrual period for 12 or more months without other causes like chemotherapy or hormone treatments
Have blood test results showing post-menopausal hormone levels
Who Cannot Join the Study?
Patients who do not have HER2+ early breast cancer cannot participate. HER2+ refers to a specific protein that promotes the growth of cancer cells.
Only female patients are eligible to participate.
Patients who are considered part of a vulnerable population are not eligible. This term generally refers to groups who may have limited ability to give informed consent or are at higher risk of being harmed.
Trastuzumab-deruxtecan is a medication used in this trial to treat HER2-positive early breast cancer. It is a combination of two components: trastuzumab, which targets and attaches to the HER2 protein on cancer cells, and deruxtecan, a chemotherapy drug that helps kill these cancer cells. This combination allows the medication to deliver chemotherapy directly to the cancer cells, potentially reducing the growth of the tumor.
Paclitaxel is a chemotherapy drug used in this trial to treat breast cancer. It works by stopping cancer cells from dividing and growing, which can help to shrink tumors and slow down the progression of the disease. It is often used in combination with other medications to enhance its effectiveness.
Docetaxel is another chemotherapy drug included in the trial. Similar to paclitaxel, it works by interfering with the growth and division of cancer cells. It is used to treat various types of cancer, including breast cancer, and is often part of a combination therapy to improve treatment outcomes.
Carboplatin is a chemotherapy medication that is used to treat cancer by damaging the DNA of cancer cells, which prevents them from growing and dividing. It is often used in combination with other drugs to increase its effectiveness in treating breast cancer.
Trastuzumab is a targeted therapy used in this trial for HER2-positive breast cancer. It works by attaching to the HER2 protein on the surface of cancer cells, which can help slow or stop the growth of the tumor. It is often used in combination with other treatments to improve outcomes for patients.
Pertuzumab is another targeted therapy used in the trial for HER2-positive breast cancer. It works by blocking the HER2 protein, similar to trastuzumab, but it attaches to a different part of the protein. This can help prevent the cancer cells from growing and dividing. Pertuzumab is often used in combination with trastuzumab and chemotherapy to enhance the treatment’s effectiveness.
HER2-positive early breast cancer – This is a type of breast cancer characterized by the overexpression of the human epidermal growth factor receptor 2 (HER2) protein. It typically begins in the cells of the breast tissue and can grow rapidly due to the presence of excess HER2 proteins, which promote cell division. The disease often starts as a small tumor in the breast and can progress to involve nearby lymph nodes. If not managed, it may spread to other parts of the body. The progression of this cancer can vary, with some cases remaining localized while others may become more aggressive. The growth and spread of the cancer depend on various factors, including the biology of the tumor and the patient’s overall health.
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