This clinical trial is focused on studying treatments for triple-negative breast cancer, a type of breast cancer that does not have any of the three common receptors known to fuel most breast cancer growth. The study is testing the effectiveness of adding a medication called atezolizumab to standard chemotherapy. Atezolizumab is an immunotherapy drug that helps the immune system fight cancer. The chemotherapy regimen includes drugs such as paclitaxel, carboplatin, and either AC (doxorubicin and cyclophosphamide) or EC (epirubicin and cyclophosphamide). Some participants will receive a placebo instead of atezolizumab to compare the outcomes.
The purpose of the study is to determine if adding atezolizumab to chemotherapy improves the time patients remain free from cancer events, known as event-free survival. Participants will be randomly assigned to receive either atezolizumab or a placebo along with their chemotherapy. The study will follow participants through their treatment and for a period afterward to monitor their health and any recurrence of cancer. The treatment period can last up to 52 weeks, with regular follow-ups to assess the effectiveness and safety of the treatment.
Participants will undergo various assessments, including imaging tests like MRI to evaluate lymph nodes and other areas, as well as blood tests to ensure they meet the health criteria for the study. The trial aims to provide valuable information on whether atezolizumab can offer additional benefits to patients with triple-negative breast cancer when used alongside standard chemotherapy treatments.
1initial treatment phase
The treatment begins with a combination of paclitaxel and carboplatin. These medications are administered as an intravenous infusion. Paclitaxel is given weekly, while carboplatin is administered every three weeks.
During this phase, atezolizumab or a placebo is also given as an intravenous infusion. This is administered every three weeks.
2second treatment phase
Following the initial phase, the treatment continues with a combination of doxorubicin hydrochloride and cyclophosphamide or epirubicin hydrochloride and cyclophosphamide. These are administered as injectable solutions.
This phase involves cycles of treatment every two to three weeks, depending on the specific regimen.
3surgery
After completing the chemotherapy cycles, surgery is performed to remove any remaining cancerous tissue.
4adjuvant treatment phase
Post-surgery, the treatment continues with atezolizumab or a placebo. This is administered as an intravenous infusion every three weeks.
This phase aims to prevent cancer recurrence and is continued for up to one year.
5follow-up
Regular follow-up visits are scheduled to monitor health status and detect any signs of cancer recurrence.
These visits include physical examinations, imaging tests, and laboratory tests as needed.
Who Can Join the Study?
The patient must agree to participate and sign a consent form before starting any study procedures.
The lymph nodes in the armpit area must be checked using imaging tests like ultrasound or MRI within 42 days before joining the study. If the results are suspicious, a small sample may be taken for further testing.
Patients with certain types of breast cancer that are HER2-negative can join if the highest risk tumor is also negative for ER and PgR, which are specific proteins.
Blood tests done within 28 days before joining must show: enough white blood cells (ANC ≥ 1500/mm³), enough platelets (≥ 100,000/mm³), and enough hemoglobin (≥ 10 g/dL).
Liver function tests done within 28 days before joining must show: normal bilirubin levels unless the patient has a specific condition, and certain enzymes (alkaline phosphatase, AST, and ALT) must be within normal limits.
If certain liver enzymes are high, imaging tests must show no spread of cancer to the liver.
If alkaline phosphatase is high or there is unexplained bone pain, imaging tests must show no spread of cancer to the bones.
Patients with certain advanced nodal or tumor stages must have imaging tests to ensure no spread of cancer to the liver, bones, or chest.
Kidney function must be adequate, with creatinine clearance ≥ 50 mL/min, checked within 28 days before joining.
Blood clotting tests must be normal, and patients on blood thinners are not eligible.
Thyroid and cortisol levels must be checked within 28 days before joining. If abnormal, further evaluation is needed.
The breast cancer diagnosis must be confirmed by a specific type of biopsy.
The heart’s pumping ability (LVEF) must be checked and be at least 55% within 42 days before joining.
Women who can have children and men with partners who can have children must agree to use effective birth control during the study and for a period after the study ends.
The patient must be willing to follow the study schedule, including visits and tests.
Local testing must show the tumor is negative for ER, PgR, and HER2 proteins. If results are unclear, further testing may be needed.
Central testing will confirm the tumor is negative for ER, PgR, and HER2 proteins. A tissue sample must be sent for this testing.
The tumor sample will also be tested for PD-L1 status, which helps classify the cancer for study purposes.
Patients must be at least 18 years old.
Both female and male patients can participate.
The patient’s overall health status must be good, with an ECOG performance status of 0-1, which means they are fully active or have some symptoms but can still carry out light work.
The primary tumor must be at a specific stage, and if lymph nodes are involved, the tumor must meet certain size criteria.
Who Cannot Join the Study?
Patients who have a different type of cancer other than early breast cancer.
Patients who are not diagnosed with triple-negative breast cancer. This is a type of breast cancer that does not have three common receptors known to fuel most breast cancer growth.
Patients who are not within the specified age range for the study.
Patients who are not able to follow the study procedures or take the study medications.
Patients who have other serious health conditions that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have had another cancer in the past, unless it was treated and has not come back for a certain period.
Patients who have received certain treatments for cancer in the past that might affect the study results.
Patients who are participating in another clinical trial at the same time.
Patients who have allergies to the study medications or their ingredients.
Atezolizumab is an immunotherapy medication used in this trial. It works by helping the immune system recognize and attack cancer cells. In this study, it is being tested to see if it can improve the outcomes for patients with triple-negative breast cancer when added to standard chemotherapy.
Paclitaxel is a chemotherapy drug used in this trial. It works by stopping cancer cells from dividing and growing, which can help to shrink tumors and slow the progression of cancer.
Carboplatin is another chemotherapy medication included in the trial. It damages the DNA of cancer cells, which can prevent them from multiplying and lead to their death.
AC or EC refers to combinations of chemotherapy drugs used in this trial. AC stands for doxorubicin (also known as Adriamycin) and cyclophosphamide, while EC stands for epirubicin and cyclophosphamide. These combinations are used to kill cancer cells and reduce the size of tumors.
Triple-Negative Breast Cancer – Triple-negative breast cancer is a type of breast cancer that lacks three common receptors known to fuel most breast cancer growth: estrogen, progesterone, and the HER-2/neu gene. This form of cancer is more aggressive and tends to grow and spread more quickly than other types of breast cancer. It is more common in women under 40, African American women, and those with a BRCA1 mutation. The absence of these receptors means that common hormonal therapies are ineffective, making treatment options more limited. The cancer often presents as a lump in the breast and may be accompanied by changes in breast shape or skin texture. Early detection and treatment are crucial to managing the disease effectively.
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