Study of Sacituzumab Govitecan compared to standard therapy in HER2-negative breast cancer patients with high risk of relapse after neoadjuvant treatment
This study focuses on patients with HER2-negative breast cancer who still have residual disease after receiving standard neoadjuvant chemotherapy and are at high risk of cancer returning. The main treatment being investigated is sacituzumab govitecan, which is a specialized medication that combines an antibody with an anti-cancer drug, designed to target specific cancer cells.
The study compares two treatment approaches: patients will receive either sacituzumab govitecan or a standard treatment chosen by their doctor from several options including carboplatin, cisplatin, or capecitabine. The purpose is to determine if sacituzumab govitecan is more effective at preventing the cancer from returning compared to standard treatments.
Treatment will continue for up to 24 months. The medications are given either through an intravenous infusion directly into the bloodstream or as tablets taken by mouth, depending on which treatment the patient receives. All patients must have completed their previous treatments, including surgery and radiation therapy, before starting the study medication.
1Initial assessment
Your eligibility for the study will be confirmed through medical tests and examination after completing standard neoadjuvant treatment and surgery
Laboratory tests will check your blood counts, liver and kidney function
A heart function test will be performed according to standard procedures
2Treatment assignment
You will be randomly assigned to receive either sacituzumab govitecan or a standard treatment chosen by your doctor
The assignment must occur within 16 weeks after your final surgery or within 10 weeks after completing radiation therapy (whichever comes last)
3Treatment administration
If assigned to sacituzumab govitecan, you will receive the medication through an intravenous infusion
If assigned to standard treatment, you may receive one of the following:
– Carboplatin through intravenous infusion
– Cisplatin through intravenous infusion
– Capecitabine tablets taken by mouth
4Monitoring during treatment
Regular assessments will check for any side effects
Side effects will be measured using standardized criteria
Your quality of life will be evaluated using specific questionnaires
5Follow-up period
You will be monitored for signs of disease return or spread
Regular check-ups will continue until 2027
The main focus will be on tracking how long you remain free of invasive disease
Who Can Join the Study?
Must be at least 18 years old, both men and women can participate
Must agree to use effective birth control methods during treatment and for a period after the last dose if able to have children
Must have breast cancer confirmed by tissue examination that is HER2-negative (a specific type of breast cancer)
Must have remaining cancer tissue after initial chemotherapy treatment, with specific risk factors for cancer return
Must have undergone proper surgical removal of the cancer and lymph nodes
Must have completed at least 16 weeks of chemotherapy containing taxane (a type of cancer drug)
Must have no evidence of cancer spread during or after initial chemotherapy
Must start the study within 16 weeks after final surgery or within 10 weeks after completing radiation therapy
Must have completed radiation therapy before starting the study treatment
Must have good physical function (ECOG score 0 or 1, meaning able to perform daily activities)
Must have normal heart function
Must have acceptable blood test results, including:
Adequate blood cell counts
Normal liver function
Normal kidney function
Must have a negative pregnancy test if able to become pregnant
Must have recovered from side effects of previous treatments
Who Cannot Join the Study?
Previous diagnosis of HER2-positive breast cancer (HER2 is a protein that promotes cancer cell growth)
Age below 18 years old
Pregnant or breastfeeding women
Active or untreated brain metastases (cancer that has spread to the brain)
Severe heart conditions including heart failure or recent heart attack
Ongoing serious infections requiring treatment
Previous treatment with sacituzumab govitecan
Known allergies to the study medications
Participation in another clinical trial within the last 30 days
Significant liver or kidney dysfunction
Uncontrolled high blood pressure
Active autoimmune disease requiring systemic treatment (conditions where the immune system attacks healthy cells)
History of other cancers within the past 3 years (except for successfully treated non-melanoma skin cancer or cervical cancer in situ)
Any condition that, in the opinion of the study doctor, would make participation unsafe
Sacituzumab Govitecan is an antibody-drug conjugate medication used to treat breast cancer. It works by combining an antibody that targets cancer cells with a drug that can kill these cells. The antibody part helps the medication find and attach to specific proteins on cancer cells, while the drug part works to destroy the cancer cells. This medication is being studied as a treatment for patients with HER2-negative breast cancer who have completed standard neoadjuvant treatment (treatment given before surgery) but still have a high risk of cancer returning.
Treatment of Physician’s Choice refers to the standard treatment options that doctors typically prescribe for this type of cancer. This allows the doctor to select the most appropriate treatment for each patient based on their specific situation and medical history.
HER2-negative breast cancer – A type of breast cancer characterized by the absence of excess HER2 protein on the surface of cancer cells. This cancer begins in the breast tissue when cells start growing abnormally and uncontrollably. The disease can develop in different parts of the breast, including the ducts, lobules, or other breast tissues. The term “HER2-negative” indicates that the cancer cells don’t have high levels of a protein called human epidermal growth factor receptor 2, which distinguishes it from other types of breast cancer. This form of breast cancer typically develops gradually, with cancer cells potentially spreading to nearby tissues over time.
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