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

NAUnknownINTERVENTIONAL
Enrollment

204

Participants

Timeline

Start Date

July 1, 2021

Primary Completion Date

September 30, 2024

Study Completion Date

September 30, 2025

Conditions
Breast Cancer
Interventions
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.

DRUG

Epirubicin

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

DRUG

Cyclophosphamid

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

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.

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.

DRUG

Docetaxel

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

Trial Locations (1)

Unknown

RECRUITING

Shanghai Pudong Hospital, Shanghai

Sponsors
All Listed Sponsors
collaborator

CSPC Ouyi Pharmaceutical Co., Ltd.

INDUSTRY

lead

Shanghai Pudong Hospital

OTHER

NCT05656079 - 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 | Biotech Hunter | Biotech Hunter