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

Primary Purpose

Early Breast Cancer

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

PLD

CTX

Docetaxel

Paclitaxel

Doxorubicin

About this trial

This is an interventional treatment trial for Early Breast Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Fudan University affiliated cancer hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PLD plus CTX sequential docetaxel or PTX

DOX plus CTX sequential docetaxel or PTX

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

cardiotoxity

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

Secondary Outcome Measures

5-year DFS

5-year disease-free survival rate

5-year OS

5-year overall survival rate

Adverse events (AE)

Incidence and Severity of adverse events according to the CTC AE V4.03

Full Information

NCT ID

NCT03949634

First Posted

April 16, 2019

Last Updated

May 13, 2019

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT03949634

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Unknown status

Study Start Date

September 1, 2017 (Actual)

Primary Completion Date

October 31, 2019 (Anticipated)

Study Completion Date

October 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Early Breast Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

272 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PLD plus CTX sequential docetaxel or PTX

Arm Type

Experimental

Arm Description

Arm Title

DOX plus CTX sequential docetaxel or PTX

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

PLD

Other Intervention Name(s)

duomeisu

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

CTX

Other Intervention Name(s)

huanlinxianan

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Other Intervention Name(s)

taisudi

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Other Intervention Name(s)

taisu

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Doxorubicin

Other Intervention Name(s)

ameisu

Intervention Description

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

Primary Outcome Measure Information:

Title

cardiotoxity

Description

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

Time Frame

2 years.

Secondary Outcome Measure Information:

Title

5-year DFS

Description

5-year disease-free survival rate

Time Frame

5 years

Title

5-year OS

Description

5-year overall survival rate

Time Frame

5 years

Title

Adverse events (AE)

Description

Incidence and Severity of adverse events according to the CTC AE V4.03

Time Frame

5 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

jiandong nie, doctor

Phone

0311-66575708

niejd@mail.ecspc.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

zhimin shao, doctor

Organizational Affiliation

Fudan University affiliated cancer hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fudan University affiliated cancer hospital

City

Shanghai

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

lichen tang, doctor

12. IPD Sharing Statement

Learn more about this trial

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

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