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

NCT ID: NCT05656079

Last Updated: 2022-12-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2025-09-30

Brief 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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

pegylated liposomal doxorubicin；cyclophosphamide；trastuzumab；pertuzumab ；docetaxel

Pegylated liposomal doxorubicin 35 mg/m2, i.v. d1 +Cyclophosphamide 600 mg/m2 , i.v. d1 +Trastuzumab (8 mg/kg loading dose at first day only, then 6 mg/kg), i.v. d1+Pertuzumab (840 mg loading dose at first day only, then 420 mg), i.v. d1 ； q3w, for 4 cycles followed by Docetaxel 75mg/m2 , i.v. d1+ Pertuzumab 420 mg, i.v. d1+Trastuzumab 6 mg/kg, i.v. d1； q3w, for 4 cycles.

After the completion of adjuvant therapy, patients are required to receive a total of 1 year of treatment with trastuzumab combined with pertuzumab.

Group Type: EXPERIMENTAL

Pegylated liposomal doxorubicin

Intervention Type: DRUG

Drug: Pegylated liposomal doxorubicin (35 mg/m2) will be administered by an intravenous infusion on day 1 of each21-day cycle.

Cyclophosphamid

Intervention Type: DRUG

Drug: Cyclophosphamide (600 mg/m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle.

Trastuzumab

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Intervention Type: DRUG

Drug: Docetaxel (75mg/m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle.

Epirubicin；cyclophosphamide f；docetaxel；trastuzumab；pertuzumab

Epirubicin 90 mg/m2 , i.v. d1 +Cyclophosphamide 600 mg/m2 , i.v. d1； q3w, for 4 cycles followed by Docetaxel 75mg/m2 , i.v. d1+Trastuzumab (8 mg/kg loading dose at first day only, then 6 mg/kg), i.v. d1+Pertuzumab (840 mg loading dose at first day only, then 420 mg), i.v. d1； q3w, for 4 cycles.

After the completion of adjuvant therapy, patients are required to receive a total of 1 year of treatment with trastuzumab combined with pertuzumab.

Group Type: ACTIVE_COMPARATOR

Epirubicin

Intervention Type: DRUG

Drug: Epirubicin (90 mg/m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle.

Cyclophosphamid

Intervention Type: DRUG

Drug: Cyclophosphamide (600 mg/m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle.

Trastuzumab

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Intervention Type: DRUG

Drug: Docetaxel (75mg/m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle.

Interventions

Pegylated liposomal doxorubicin

Drug: Pegylated liposomal doxorubicin (35 mg/m2) will be administered by an intravenous infusion on day 1 of each21-day cycle.

Intervention Type: DRUG

Epirubicin

Drug: Epirubicin (90 mg/m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle.

Intervention Type: DRUG

Cyclophosphamid

Drug: Cyclophosphamide (600 mg/m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Docetaxel

Drug: Docetaxel (75mg/m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle.

Intervention Type: DRUG

Other Intervention Names

duomeisu; Doxorubicin Hydrochloride Liposome Injection; biaoroubixing; huanlinxianan; qutuozhudankang; patuozhudankang; duoxitasai

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

CSPC Ouyi Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Shanghai Pudong Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Pudong Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yongping Li

Role: CONTACT

Phone: 021 68035102

Email: liyongpingdt@sina.com

Facility Contacts

Yongping Li

Role: primary

Other Identifiers

kazuma

Identifier Type: -

Identifier Source: org_study_id