Clinical Trials Logo
  1. Home
  2. Early Breast Cancer
  3. NCT03949634

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

Early Breast Cancer Clinical Trial

Official title:
Cardiac Safety and Efficacy for Early-stage Breast Cancer Patients Treated With Pegylated Liposomal Doxorubicin（PLD）：an Dynamic Randomized, Positive Control, Open, Multicenter Clinical Study

Clinical Trial 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.

Clinical Trial Description

Subjects will receive one of two treatment regimens:

Group A: intravenous infusion of pegylated liposomal doxorubicin（PLD） 35 mg/m2, d1; cyclophosphamide 600 mg/m2, intravenous infusion, d1; once every 21days, for 4 cycles. Sequential docetaxel 100 mg/m2, intravenous infusion, d1, or paclitaxel 80mg/m2,intravenous infusion, d1,8,15, once every 21 days, for 4 cycles.

Group B: intravenous infusion of doxorubicin 60 mg/m2, d1; cyclophosphamide 600 mg/m2, intravenous infusion, d1; sequential docetaxel 100 mg/m2, intravenous infusion, d1, or paclitaxel 80mg/m2,intravenous infusion, d1,8,15, once every 21days, for 4 cycles. The primary endpoint is cardiotoxity,the secondary endpoint is 5-year disease-free survival (DFS), 5-year overall survival (OS), and safety: hematology and non hematological toxicity. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03949634
Study type Interventional
Source Fudan University
Contact jiandong nie, doctor
Phone 0311-66575708
Email niejd@mail.ecspc.com
Status Recruiting
Phase Phase 3
Start date September 1, 2017
Completion date October 31, 2020
View Details
See also
  Status Clinical Trial Phase
Withdrawn NCT04538833 - GM1 in the Treatment of Neurotoxicity Induced by Albumin-bound Paclitaxel Phase 2
Completed NCT04436744 - A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Giredestrant Plus Palbociclib Compared With Anastrozole Plus Palbociclib for Postmenopausal Women With Estrogen Receptor-Positive and HER2-Negative Untreated Early Breast Cancer (coopERA Breast Cancer) Phase 2
Completed NCT02187744 - A Study Of PF-05280014 Or Trastuzumab Plus Taxotere® And Carboplatin In HER2 Positive Breast Cancer In The Neoadjuvant Setting (REFLECTIONS B327-04) Phase 3
Terminated NCT01155063 - Evaluating The Safety Of Exemestane Following 2-3 Years Of Adjuvant Tamoxifen Therapy In Postmenopausal Early Breast Cancer Patients N/A
Active, not recruiting NCT05730647 - Prospective Observational Study of Adjuvant Hormone Treatment in Estrogen-receptor Positive Premenopausal Early Breast Cancer Patients
Terminated NCT01919229 - A Pharmacodynamics Pre-surgical Study of LEE011 in Early Breast Cancer Patients (MONALEESA-1) Phase 2
Active, not recruiting NCT04293393 - Neoadjuvant Study Chemotherapy vs Letrozole + Abemaciclib in HR+/HER2- High/Intermediate Risk Breast Cancer Patients Phase 2
Completed NCT00713141 - Evaluation of Brain Function Before and After Standard Chemotherapy for Early Breast Cancer N/A
Recruiting NCT06341894 - Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in HR+/ HER2- Early Breast Cancer Phase 2
Not yet recruiting NCT06404736 - QL1706 Plus Chemotherapy as Neoadjuvant Therapy in Early High-Risk TNBC Breast Cancer Phase 2
Not yet recruiting NCT06404463 - QL1706 Plus Chemotherapy as Neoadjuvant Therapy in Early High-Risk ER+/HER2- Breast Cancer Phase 2
Not yet recruiting NCT06435104 - Aromatherapy in the Treatment of Early Breast Cancer Phase 2
Recruiting NCT03520894 - Radiotherapy in Preoperative Setting With CyberKnife for Breast Cancer N/A
Completed NCT03786198 - Activity Program During Aromatase Inhibitor Therapy N/A
Completed NCT01613352 - Feasibility of Ambulatory Surgery for Early Breast Cancer N/A
Completed NCT02738970 - A Dose-Finding Study of Pertuzumab (Perjeta) in Combination With Trastuzumab (Herceptin) in Healthy Male Participants and Women With Early Breast Cancer (EBC) Phase 1
Recruiting NCT01792726 - A Comparison of Intra-operative Radiotherapy Boost With External Beam Radiotherapy Boost in Early Breast Cancer. N/A
Completed NCT00323479 - Arthralgia During Anastrozole Therapy for Breast Cancer Phase 4
Completed NCT03493854 - A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Participants With HER2-Positive Early Breast Cancer Phase 3
Recruiting NCT04291378 - The DBCG Proton Trial: Photon Versus Proton Radiation Therapy for Early Breast Cancer N/A