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

NCT05656079 | Unknown

• 1 other identifier: kazuma
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 1-year incidence of cardiotoxicity

  1-year

Study Arms (2)

pegylated liposomal doxorubicin；cyclophosphamide；trastuzumab；pertuzumab ；docetaxel

EXPERIMENTAL

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.

Drug: Pegylated liposomal doxorubicin; Drug: Cyclophosphamid; Drug: Trastuzumab; Drug: Pertuzumab; Drug: Docetaxel

Epirubicin；cyclophosphamide f；docetaxel；trastuzumab；pertuzumab

ACTIVE COMPARATOR

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.

Drug: Epirubicin; Drug: Cyclophosphamid; Drug: Trastuzumab; Drug: Pertuzumab; Drug: Docetaxel

Interventions

Pegylated liposomal doxorubicin DRUG

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

Also known as: duomeisu, Doxorubicin Hydrochloride Liposome Injection

pegylated liposomal doxorubicin；cyclophosphamide；trastuzumab；pertuzumab ；docetaxel

Epirubicin DRUG

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

Also known as: biaoroubixing

Epirubicin；cyclophosphamide f；docetaxel；trastuzumab；pertuzumab

Cyclophosphamid DRUG

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

Also known as: huanlinxianan

Epirubicin；cyclophosphamide f；docetaxel；trastuzumab；pertuzumab; pegylated liposomal doxorubicin；cyclophosphamide；trastuzumab；pertuzumab ；docetaxel

Trastuzumab 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.

Also known as: qutuozhudankang

Epirubicin；cyclophosphamide f；docetaxel；trastuzumab；pertuzumab; pegylated liposomal doxorubicin；cyclophosphamide；trastuzumab；pertuzumab ；docetaxel

Pertuzumab 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.

Also known as: patuozhudankang

Epirubicin；cyclophosphamide f；docetaxel；trastuzumab；pertuzumab; pegylated liposomal doxorubicin；cyclophosphamide；trastuzumab；pertuzumab ；docetaxel

Docetaxel DRUG

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

Also known as: duoxitasai

Epirubicin；cyclophosphamide f；docetaxel；trastuzumab；pertuzumab; pegylated liposomal doxorubicin；cyclophosphamide；trastuzumab；pertuzumab ；docetaxel

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old, Female;
• Subjects with histopathologically confirmed invasive breast cancer;
• HER2-positive breast cancer (Immunohistochemistry score of 3+ or fluorescence in situ hybridization positivity);
• No distant metastasis;
• Lymph node positive or negative, primary tumour≥2cm;
• 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;
• Surgery was completed and chemotherapy was started within 8 weeks after surgery;
• Before and after chemotherapy LVEF≥55%;
• ECOG performance status of 0-1;
• Signed the informed consent.

You may not qualify if:

• Subjects who are known to be allergic or intolerant to chemotherapy drugs or their excipients;
• 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);
• For breast cancer, have received any anti-tumor therapy before randomization (except surgical treatment before enrollment);
• 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;
• Have a history of cardiovascular disease or associated with severe cardiovascular disease, lung disease;
• Active hypertension: systolic blood pressure ≥ 180mmHg, diastolic blood pressure ≥ 90mmHg;
• NYHA cardiac insufficiency grading ≥ Ⅲ grade;
• Severe, uncontrollable systemic disease;
• Subjects who are pregnant or breastfeeding, or subjects who cannot ensure effective contraceptive measures during the study treatment;
• Subjects who participated in other clinical trials at the same time;
• Subjects determined by the investigator to be inappropriate to participate in this study.

Sponsors & Collaborators

• Shanghai Pudong Hospital: lead
• CSPC Ouyi Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Shanghai Pudong Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

liposomal doxorubicin; Epirubicin; Cyclophosphamide; Trastuzumab; pertuzumab; Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes

Central Study Contacts

Yongping Li

CONTACT

021 68035102; liyongpingdt@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2022
• First Posted: December 19, 2022
• Study Start: July 1, 2021
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2025
• Last Updated: December 19, 2022

Record last verified: 2022-12

Locations

CN (1)