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

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ClinicalTrials.gov Identifier: NCT03949634
Recruitment Status : Recruiting
First Posted : May 14, 2019
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Zhimin Shao, Fudan University

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.

Condition or disease Intervention/treatment Phase
Early Breast Cancer Drug: PLD Drug: CTX Drug: Docetaxel Drug: Paclitaxel Drug: Doxorubicin Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 272 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: 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.
Drug: PLD
pegylated liposomal doxorubicin is 35 mg/m2 intravenously on Days 1 of each 21-day cycle followed by cyclophosphamide.
Other Name: duomeisu

Drug: CTX
cyclophosphamide is 600 mg/m2 intravenously on Days 1 of each 21-day cycle, followed by docetaxel or paclitaxel.
Other Name: huanlinxianan

Drug: Docetaxel
docetaxel is 100 mg/m2 intravenously on Days 1 of each 21-day cycle.
Other Name: taisudi

Drug: Paclitaxel
paclitaxel is 80mg/m2 intravenously on Days 1, 8 and 15 of each 21-day cycle.
Other Name: taisu

Active Comparator: 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.
Drug: CTX
cyclophosphamide is 600 mg/m2 intravenously on Days 1 of each 21-day cycle, followed by docetaxel or paclitaxel.
Other Name: huanlinxianan

Drug: Docetaxel
docetaxel is 100 mg/m2 intravenously on Days 1 of each 21-day cycle.
Other Name: taisudi

Drug: Paclitaxel
paclitaxel is 80mg/m2 intravenously on Days 1, 8 and 15 of each 21-day cycle.
Other Name: taisu

Drug: Doxorubicin
doxorubicin is 60 mg/m2 intravenously on Days 1 of each 21-day cycle followed by cyclophosphamide.
Other Name: ameisu




Primary Outcome Measures :
  1. cardiotoxity [ Time Frame: 2 years. ]
    Congestive heart failure with clinical symptoms, or no symptoms but an abnormal LVEF


Secondary Outcome Measures :
  1. 5-year DFS [ Time Frame: 5 years ]
    5-year disease-free survival rate

  2. 5-year OS [ Time Frame: 5 years ]
    5-year overall survival rate

  3. Adverse events (AE) [ Time Frame: 5 years ]
    Incidence and Severity of adverse events according to the CTC AE V4.03



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03949634


Contacts
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Contact: jiandong nie, doctor 0311-66575708 niejd@mail.ecspc.com

Locations
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China
Fudan University affiliated cancer hospital Recruiting
Shanghai, China
Contact: lichen tang, doctor         
Sponsors and Collaborators
Fudan University
Investigators
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Principal Investigator: zhimin shao, doctor Fudan University affiliated cancer hospital

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Responsible Party: Zhimin Shao, chief physician, Fudan University
ClinicalTrials.gov Identifier: NCT03949634     History of Changes
Other Study ID Numbers: CSPC -DMS- BC-08
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Docetaxel
Albumin-Bound Paclitaxel
Cyclophosphamide
Doxorubicin
Liposomal doxorubicin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors