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

Breast Cancer Clinical Trial

— easy laugh  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05656079
• Other study ID #: kazuma
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: September 2025

Study information

• Verified date: December 2022
• Source: Shanghai Pudong Hospital
• Contact: Yongping Li
• Phone: 021 68035102
• Email: liyongpingdt[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 204
• Est. completion date: September 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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 = ? 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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Pegylated liposomal doxorubicin
Drug: Pegylated liposomal doxorubicin (35 mg/m2) will be administered by an intravenous infusion on day 1 of each21-day cycle.
• Epirubicin
Drug: Epirubicin (90 mg/m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle.
• Cyclophosphamid
Drug: Cyclophosphamide (600 mg/m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle.
• Trastuzumab
Drug: Trastuzumab (8 mg/kg loading dose at first day only, then 6 mg/kg) will be administered by an intravenous infusion on day 1 of each 21-day cycle.
• Pertuzumab
Drug: Pertuzumab (840 mg loading dose at first day only, then 420 mg) will be administered by an intravenous infusion on day 1 of each 21-day cycle.
• Docetaxel
Drug: Docetaxel (75mg/m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle.

Locations

Country	Name	City	State
China	Shanghai Pudong Hospital	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Pudong Hospital	CSPC Ouyi Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1-year incidence of cardiotoxicity		1-year