To Evaluate the Cardiac Safety of Pegylated Liposomal Doxorubicin Concurrently Plus Trastuzumab and Pertuzumab in the Adjuvant Setting for Early-stage HER-2-positive Breast Cancer: a Multicenter, Randomized Controlled Clinical Study

Launched by SHANGHAI PUDONG HOSPITAL · Dec 11, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a combination of medications for treating early-stage HER2-positive breast cancer. Specifically, it looks at whether pegylated liposomal doxorubicin used with trastuzumab and pertuzumab is safer compared to another treatment involving epirubicin, with both groups receiving additional therapies after surgery. This trial is currently recruiting female participants between the ages of 18 and 70 who have been diagnosed with invasive HER2-positive breast cancer but do not have any cancer that has spread to distant parts of the body.

To be eligible for this trial, participants should have completed surgery and begun chemotherapy within eight weeks. They should also have a certain level of heart function before and after treatment. It’s important for potential participants to know that those with certain health issues, such as severe heart disease or previous cancer treatments, may not qualify. Throughout the trial, participants will closely monitor their health and receive regular check-ups to ensure their safety while being treated.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. 18-70 years old, Female;
• • 2. Subjects with histopathologically confirmed invasive breast cancer;
• • 3. HER2-positive breast cancer (Immunohistochemistry score of 3+ or fluorescence in situ hybridization positivity);
• • 4. No distant metastasis;
• • 5. Lymph node positive or negative, primary tumour≥2cm;
• • 6. Lymph node negative，primary tumour≤2cm and any of the following factors; 1) Histological grade 3; 2) ER negative (\<10%) and PR negative (\<20%); 3) Age\<35 years old; 4) Pathological hint: vascular invasion or intravascular cancer thrombus;
• • 7. Surgery was completed and chemotherapy was started within 8 weeks after surgery;
• • 8. Before and after chemotherapy LVEF≥55%;
• • 9. ECOG performance status of 0-1;
• • 10. Signed the informed consent.
• Exclusion Criteria:
• • 1. Subjects who are known to be allergic or intolerant to chemotherapy drugs or their excipients;
• • 2. Previously suffered from invasive breast cancer, and other malignant tumors within 5 years (excluding carcinoma in situ of the cervix, carcinoma in situ of the rectum, carcinoma in situ of melanoma, basal cell carcinoma of the skin, and squamous cell carcinoma);
• • 3. For breast cancer, have received any anti-tumor therapy before randomization (except surgical treatment before enrollment);
• • 4. Hematopoietic function, renal function and liver function meet one of the following conditions: 1) Neutrophil count ≤1.5×109/L; 2) Platelet count ≤ 50×109/L; 3) Hemoglobin ≤ 8.0g/dL; 4) Creatinine clearance rate ≤30ml/min; 5) AST and ALT ≥ 2.5 times the upper limit of normal in subjects without liver metastases; 6) Bilirubin ≥ 2 times the upper limit of normal; 7) APTT/PT≥1.5 times the upper limit of normal;
• • 5. Have a history of cardiovascular disease or associated with severe cardiovascular disease, lung disease;
• • 6. Active hypertension: systolic blood pressure ≥ 180mmHg, diastolic blood pressure ≥ 90mmHg;
• • 7. NYHA cardiac insufficiency grading ≥ Ⅲ grade;
• • 8. Severe, uncontrollable systemic disease;
• • 9. Subjects who are pregnant or breastfeeding, or subjects who cannot ensure effective contraceptive measures during the study treatment;
• • 10. Subjects who participated in other clinical trials at the same time;
• • 11. Subjects determined by the investigator to be inappropriate to participate in this study.