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

NCT03949634 | Unknown Phase 3

• 1 other identifier: CSPC -DMS- BC-08
• Study Type: interventional
• Target: 272
• Locations: 1 country
• Sites: 1

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.

Conditions

Early Breast Cancer

Outcome Measures

Primary Outcomes (1)

• cardiotoxity

  Congestive heart failure with clinical symptoms, or no symptoms but an abnormal LVEF

  2 years.

Secondary Outcomes (3)

• 5-year DFS

  5 years

• 5-year OS

  5 years

• Adverse events (AE)

  5 years

Study Arms (2)

PLD plus CTX sequential docetaxel or PTX

EXPERIMENTAL

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.

Drug: PLD; Drug: CTX; Drug: Docetaxel; Drug: Paclitaxel

DOX plus CTX sequential docetaxel or PTX

ACTIVE COMPARATOR

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.

Drug: CTX; Drug: Docetaxel; Drug: Paclitaxel; Drug: Doxorubicin

Interventions

PLD DRUG

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

Also known as: duomeisu

PLD plus CTX sequential docetaxel or PTX

CTX DRUG

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

Also known as: huanlinxianan

DOX plus CTX sequential docetaxel or PTX; PLD plus CTX sequential docetaxel or PTX

Docetaxel DRUG

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

Also known as: taisudi

DOX plus CTX sequential docetaxel or PTX; PLD plus CTX sequential docetaxel or PTX

Paclitaxel DRUG

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

Also known as: taisu

DOX plus CTX sequential docetaxel or PTX; PLD plus CTX sequential docetaxel or PTX

Doxorubicin DRUG

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

Also known as: ameisu

DOX plus CTX sequential docetaxel or PTX

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects had histopathologically confirmed early stage breast cancer with adjuvant chemotherapy treatment evidence;
• Age :18-75years old female;
• 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;
• ECOG score 0-1;
• Expected survival time ≥ 12 months;
• LVEF ≥ 55%;
• Normal ECG, ST segment depression in patients such as coronary angiography, confirm \<50% stenosis or incidental premature beats are acceptable;
• Bone Marrow Function: ANC：≥1.5×109/L； PLT：≥100×109/L；Hb: ≥90g/L;
• 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;
• 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.

You may not qualify if:

• New York Heart Association (NYHA) Class II or greater heart failure;
• 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);
• Prior received neoadjuvant chemotherapy;
• Severe systemic infection or other serious disease;
• Allergies to chemotherapeutic drugs or their excipients or intolerant patients;
• Other malignant tumors have been found in the past 5 years,except for cured cervical carcinoma in situ, non melanoma of the skin;
• Childbearing age patients who are pregnant or lactation and refusing to take effective contraceptive measures during the trial;
• Received any other test drug treatment or participated in other clinical trials at the same time;
• Other conditions considered to be inappropriate to be enrolled by the investigator.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University affiliated cancer hospital

Shanghai, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 40504550 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

1-dodecylpyridoxal; Docetaxel; Paclitaxel; Doxorubicin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• zhimin shao, doctor

  Fudan University affiliated cancer hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

jiandong nie, doctor

CONTACT

0311-66575708; niejd@mail.ecspc.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: May 14, 2019
• Study Start: September 1, 2017
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2020
• Last Updated: May 14, 2019

Record last verified: 2019-05

Locations

CN (1)