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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

NCT05656079 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2022-12-19

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • CSPC Ouyi Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Shanghai Pudong Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2024-09-30
Completion
2025-09-30

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05656079 on ClinicalTrials.gov