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Marched Pair Study Conventional Doxorubicin(DOX) Versus Pegylated Liposomal Doxorubicin(PLD) Neoadjuvant Chemotherapy

NCT02953184 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2017-12-29

No results posted yet for this study

Summary

The regimen PLD plus cyclophosphamide 4 cycles followed by paclitaxel or docetaxel 4 cycles(noted in phase II CAPRICE) will be used as experimental group. The regimen will be compared to the standard treatment of doxorubicin plus cyclophosphamide(AC) 4 cycles followed by paclitaxel or docetaxel 4 cycles\[noted in National Comprehensive Cancer Network (NCCN) guideline\].

Conditions

  • Antineoplastic Combined Chemotherapy Protocols

Interventions

DRUG

Pegylated Liposomal Doxorubicin

35mg/m2 iv drop during the first 4 cycles every three week

DRUG

Cyclophosphamide

600mg/m2 IV drop during the first 4 cycles every three week

DRUG

Taxotere

100mg/m2 IV drop during the last 4 cycles every three week

DRUG

Dexrazoxane (DZR)

DZR will be administrated for protecting Cardiac toxicity in the group of Active comparator.

DRUG

vitamin B

Vitamin B will be administrated for protecting HFS in PLD group

DRUG

Doxorubicin

60mg/m2 Doxorubicin IV drop during the first 4 cycles every three week

PROCEDURE

Breast Conserved Surgery

Patients will undergo Breast Conserved Surgery if the tumor/breast ratio is proper and she demands to conserve the breast after 8 cycles of chemotherapy

PROCEDURE

Modified Radical Mastectomy

Patients will undergo Modified Radical Mastectomy if she does not keep her breast after 8 cycles of chemotherapy

PROCEDURE

Sentinel Lymph Node Biopsy（SLNB）

Patients will undergo Sentinel Lymph Node Biopsy（SLNB） if the evaluation of lymph node are negative after 8 cycles of chemotherapy

Sponsors & Collaborators

  • Jilin University

    lead OTHER

Principal Investigators

  • Aiping Shi, Doctor · The First Hospital of Jilin University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2019-11-30
Completion
2020-11-30

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 NCT02953184 on ClinicalTrials.gov