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

• Status: Recruiting
• Trial end date: 2025-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

To evaluate the safety and efficacy of pegylated liposomal doxorubicin/cyclophosphamide/trastuzumab/pertuzumab followed by docetaxel/ trastuzumab/pertuzumab compared with epirubicin/cyclophosphamide followed by docetaxel/trastuzumab/pertuzumab in the adjuvant treatment of early breast cancer.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Pudong Hospital
• Collaborator: CSPC Ouyi Pharmaceutical Co., Ltd.
• Treatments: Cyclophosphamide; Docetaxel; Doxorubicin; Epirubicin; Liposomal doxorubicin; Pertuzumab; Trastuzumab

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.