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

NCT ID: NCT03949634

Last Updated: 2019-05-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 272 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2020-10-31

Brief 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.

Detailed 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.

Conditions

Early Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PLD plus CTX sequential docetaxel or PTX

pegylated liposomal doxorubicin 35 mg/m2,i.v.,d1, plus cyclophosphamide（CTX） 600 mg/m2,i.v.,d1, sequential docetaxel 100 mg/m2,i.v.,d1, or paclitaxel（PTX） 80mg/m2,i.v.,d1,8,15, once every 21days, for 4 cycles.

Group Type: EXPERIMENTAL

PLD

Intervention Type: DRUG

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

CTX

Intervention Type: DRUG

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

Docetaxel

Intervention Type: DRUG

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

Paclitaxel

Intervention Type: DRUG

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

DOX plus CTX sequential docetaxel or PTX

doxorubicin（DOX） 60 mg/m2,i.v.,d1, plus cyclophosphamide 600 mg/m2,i.v.,d1, sequential docetaxel 100 mg/m2,i.v.,d1, or paclitaxel 80mg/m2,i.v.,d1,8,15, once every 21days, for 4 cycles.

Group Type: ACTIVE_COMPARATOR

CTX

Intervention Type: DRUG

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

Docetaxel

Intervention Type: DRUG

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

Paclitaxel

Intervention Type: DRUG

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

Doxorubicin

Intervention Type: DRUG

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

Interventions

PLD

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

Intervention Type: DRUG

CTX

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

Intervention Type: DRUG

Docetaxel

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

Intervention Type: DRUG

Paclitaxel

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

Intervention Type: DRUG

Doxorubicin

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

Intervention Type: DRUG

Other Intervention Names

duomeisu; huanlinxianan; taisudi; taisu; ameisu

Eligibility Criteria

Inclusion Criteria

• 1.Subjects had histopathologically confirmed early stage breast cancer with adjuvant chemotherapy treatment evidence;
• 2.Age :18-75years old female;
• 3.High risk of recurrence: axillary lymph node-positive, or axillary lymph node negative with at least one of the following risk factors: triple negative breast cancer, histological grade III, the maximum tumor diameter> 5cm, Ki 67 ≥ 50%, vascular thrombosis positive;
• 4.ECOG score 0-1;
• 5.Expected survival time ≥ 12 months;
• 6.LVEF ≥ 55%;
• 7.Normal ECG, ST segment depression in patients such as coronary angiography, confirm <50% stenosis or incidental premature beats are acceptable;
• 8.Bone Marrow Function: ANC：≥1.5×109/L； PLT：≥100×109/L；Hb: ≥90g/L;
• 9.Liver and renal function:Serum creatinine ≤ normal upper limit (ULN) 1.5times; aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤ULN 2.5times; total bilirubin (TBil) level:≤ ULN 1.5 times, or ≤ ULN 2.5times if Gilbert's syndrome are present;
• 10.Subjects are well-behaved, able to undergo treatment and follow-up, and voluntarily comply with this study and understood the study's research process and signed the informed consent.

Exclusion Criteria

• 1.New York Heart Association (NYHA) Class II or greater heart failure;
• 2.Severe heart disease or discomfort, including but not limited to: High-risk uncontrolled arrhythmias, atrial tachycardia (heart rate>100/min at rest), significant ventricular arrhythmias (ventricular arrhythmias) or higher, atrioventricular block ([Mobitz 2] or third-degree atrioventricular block); Angina pectoris that needs to be treated with anti-anginal medicine; Valvular heart disease with clinical significance; Electrocardiogram shows transmural myocardial infarction; Uncontrolled high blood pressure(eg: Systolic blood pressure> 180 mmHg or diastolic blood pressure> 100 mmHg);
• 3.Prior received neoadjuvant chemotherapy;
• 4.Severe systemic infection or other serious disease;
• 5.Allergies to chemotherapeutic drugs or their excipients or intolerant patients;
• 6.Other malignant tumors have been found in the past 5 years,except for cured cervical carcinoma in situ, non melanoma of the skin;
• 7.Childbearing age patients who are pregnant or lactation and refusing to take effective contraceptive measures during the trial;
• 8.Received any other test drug treatment or participated in other clinical trials at the same time;
• 9.Other conditions considered to be inappropriate to be enrolled by the investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Zhimin Shao

chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

zhimin shao, doctor

Role: PRINCIPAL_INVESTIGATOR

Fudan University affiliated cancer hospital

Locations

Fudan University affiliated cancer hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

jiandong nie, doctor

Role: CONTACT

niejd@mail.ecspc.com

0311-66575708

Facility Contacts

lichen tang, doctor

Role: primary

References

Tang L, He M, Geng C, Fan Z, Ling R, Qiao G, Cai L, Luo T, Jin F, Wang H, Zhang A, Zhang H, Zeng X, Wang X, Jiang M, Wang Z, Shao Z. Pegylated liposomal doxorubicin + cyclophosphamide followed by taxane as adjuvant therapy for early-stage breast cancer: a randomized controlled trial. Oncologist. 2025 Jun 4;30(6):oyaf101. doi: 10.1093/oncolo/oyaf101.

Reference Type: DERIVED

PMID: 40504550 (View on PubMed)

Other Identifiers

CSPC -DMS- BC-08

Identifier Type: -

Identifier Source: org_study_id