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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 (easy laugh)

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Pegylated liposomal doxorubicin
Epirubicin
Cyclophosphamid
Trastuzumab
Pertuzumab
Docetaxel
Sponsored by
Shanghai Pudong Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 18-70 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. Exclusion Criteria: 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.

Sites / Locations

  • Shanghai Pudong HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

pegylated liposomal doxorubicin;cyclophosphamide;trastuzumab;pertuzumab ;docetaxel

Epirubicin;cyclophosphamide f;docetaxel;trastuzumab;pertuzumab

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

1-year incidence of cardiotoxicity

Secondary Outcome Measures

Full Information

First Posted
December 11, 2022
Last Updated
December 11, 2022
Sponsor
Shanghai Pudong Hospital
Collaborators
CSPC Ouyi Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05656079
Brief 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
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Pudong Hospital
Collaborators
CSPC Ouyi Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
204 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
pegylated liposomal doxorubicin;cyclophosphamide;trastuzumab;pertuzumab ;docetaxel
Arm Type
Experimental
Arm Description
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.
Arm Title
Epirubicin;cyclophosphamide f;docetaxel;trastuzumab;pertuzumab
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Pegylated liposomal doxorubicin
Other Intervention Name(s)
duomeisu, Doxorubicin Hydrochloride Liposome Injection
Intervention Description
Drug: Pegylated liposomal doxorubicin (35 mg/m2) will be administered by an intravenous infusion on day 1 of each21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Epirubicin
Other Intervention Name(s)
biaoroubixing
Intervention Description
Drug: Epirubicin (90 mg/m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamid
Other Intervention Name(s)
huanlinxianan
Intervention Description
Drug: Cyclophosphamide (600 mg/m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Trastuzumab
Other Intervention Name(s)
qutuozhudankang
Intervention Description
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
Intervention Name(s)
Pertuzumab
Other Intervention Name(s)
patuozhudankang
Intervention Description
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
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
duoxitasai
Intervention Description
Drug: Docetaxel (75mg/m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle.
Primary Outcome Measure Information:
Title
1-year incidence of cardiotoxicity
Time Frame
1-year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-70 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yongping Li
Phone
021 68035102
Email
liyongpingdt@sina.com
Facility Information:
Facility Name
Shanghai Pudong Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongping Li
Email
liyongpingdt@sina.com

12. IPD Sharing Statement

Learn more about this trial

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

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