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Cardiac Safety and Efficacy for Early-stage Breast Cancer Patients Treated With Pegylated Liposomal Doxorubicin（PLD)

NCT03949634 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 272

Last updated 2019-05-14

No results posted yet for this study

Summary

This is a randomized, multicenter, open, controlled Post-Marketing Study. 272 early stage female breast cancer patients who were histopathology confirmed with adjuvant chemotherapy indications were enrolled in this study .The subjects will be randomly assigned to one of the two treatment groups at a 1: 1 ratio, and stratified by trastuzumab,age,baseline cardiac risk factors.

Conditions

  • Early Breast Cancer

Interventions

DRUG

PLD

pegylated liposomal doxorubicin is 35 mg/m2 intravenously on Days 1 of each 21-day cycle followed by cyclophosphamide.

DRUG

CTX

cyclophosphamide is 600 mg/m2 intravenously on Days 1 of each 21-day cycle, followed by docetaxel or paclitaxel.

DRUG

Docetaxel

docetaxel is 100 mg/m2 intravenously on Days 1 of each 21-day cycle.

DRUG

Paclitaxel

paclitaxel is 80mg/m2 intravenously on Days 1, 8 and 15 of each 21-day cycle.

DRUG

Doxorubicin

doxorubicin is 60 mg/m2 intravenously on Days 1 of each 21-day cycle followed by cyclophosphamide.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • zhimin shao, doctor · Fudan University affiliated cancer hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-09-01
Primary Completion
2019-10-31
Completion
2020-10-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT03949634 on ClinicalTrials.gov