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NCT03949634

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

Status unknown Phase 3 Last updated 14 May 2019
What this trial tests

Phase 3 trial testing PLD in Early Breast Cancer in 272 participants. Status unknown.

Timeline
1 September 2017
Primary endpoint
31 October 2019
31 October 2020

Quick facts

Lead sponsorFudan University
PhasePhase 3
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment272
Start date1 September 2017
Primary completion31 October 2019
Estimated completion31 October 2020
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Fudan University

Who can join

Adults 18 to 75, female only, with Early Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Cardiac Cachexia: Unaddressed Aspect in Cancer Patients.
    Saha S, Singh PK, Roy P, Kakar SS. · · 2022 · cited 20× · PMID 35326441 · DOI 10.3390/cells11060990
  2. Pegylated liposomal doxorubicin + cyclophosphamide followed by taxane as adjuvant therapy for early-stage breast cancer: a randomized controlled trial.
    Tang L, He M, Geng C, Fan Z, et al · · 2025 · PMID 40504550 · DOI 10.1093/oncolo/oyaf101

Verify or expand the search:

Other trials of PLD

Trials testing the same drug.

Other recruiting trials for Early Breast Cancer

Currently open trials in the same condition.

Other Fudan University trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03949634.

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