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Phase Ⅱ Study of Pegylated Liposomal Doxorubicin(PLD)Plus Trastuzumab in HER-2 Positive Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03933319
Recruitment Status : Unknown
Verified July 2020 by Peng Yuan, Chinese Academy of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : May 1, 2019
Last Update Posted : July 8, 2020
CSPC Ouyi Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Peng Yuan, Chinese Academy of Medical Sciences

Brief Summary:
This is a single-center phase Ⅱ study designed to evaluated the efficacy and safety of pegylated liposomal doxorubicin(PLD)in combination with trastuzumab in HER-2 positive metastatic breast cancer .

Condition or disease Intervention/treatment Phase
HER2-positive Breast Cancer Drug: pegylated liposomal doxorubicin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase Ⅱ Study of Pegylated Liposomal Doxorubicin(PLD)Plus Trastuzumab in HER-2 Positive Metastatic Breast Cancer
Actual Study Start Date : March 11, 2019
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : May 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: PLD in combination with trastuzumab

Trastuzumab: administered at a loading dose of 8 mg/kg IV followed by 6 mg/kg once every 21 days.

pegylated liposomal doxorubicin(PLD):administered at dose of 35mg/m2 IV once every 21 days.

Drug: pegylated liposomal doxorubicin
Eligible patients will be treated with the PLD+trastuzumab regimen until the disease progresses or intolerable toxicity

Primary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: approximately 6 months ]
    The ORR will be calculated as the proportion of patients in the Efficacy Evaluable Patient Set who achieve complete response (CR) and partial response (PR)

Secondary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: approximately 1.5 years ]
    PFS will be defined as the time from first dose of study drug until documentation of disease progression or death from any cause

  2. Incidence and Severity of adverse events [ Time Frame: approximately 1.5 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Ability to understand and voluntarily receive the research procedures according to protocol,willingness to sign the written informed consent document;
  • Female patients aged from 18 to 70 years old;
  • Histologically confirmed as invasive breast cancer;
  • HER-2 Positive(defined by: IHC 3+ or ISH positive), regardless of HR status;
  • Recurrence after adjuvant therapy or metastatic breast cancer,and chemotherapy naïve in the metastatic setting or had one prior regimen for metastatic breast cancer;
  • Patients must have measurable disease according to RECIST criteria Version 1.1(Brain metastases lesions and bone metastases lesions were excluded);
  • The adverse event caused by prior therapy has recovered, or stabilized, or does not affect the study administration according to the investigator's judgment;
  • Performance status 0-1;
  • Life expectancy of at least 3 months;
  • Left ventricular ejection fraction (LVEF)≥55%;
  • Brain natriuretic peptide (BNP) and cardiac troponin T (cTnT) were in the normal range;
  • Patients must have normal ECG;
  • Bone marrow function: absolute neutrophil count (ANC)≥1.5×109/L,platelets≥100×109/L,hemoglobin ≥90g/L;
  • Hepatic function:alanine aminotransferase(ALT) and aspartate aminotransferase(AST) ≤2.5×ULN,serum total bilirubin≤ 1.5×ULN,or ≤2.5×ULN who has Gilbert's syndrome;
  • Renal function:serum creatinine≤1.5×ULN;
  • Coagulation function:the international standardized ratio (INR) ≤1.5×ULN, prothrombin time (PT) or the activated partial thrombin time (APTT) ≤1.5×ULN.

Exclusion Criteria:

  • Patients with symptomatic brain metastases.
  • Patients who are known or suspected to be allergic to the active ingredient or excipients of the investigational drug.
  • Prior cumulative dose of 240 mg/m2 for doxorubicin and 400 mg/m2 for epirubicin.
  • Prior treatment with anthracyclines has caused cardiotoxicity, or failed (disease progression during therapy or recurrence and metastasis within 12 months after adjuvant therapy).
  • Prior mediastinal radiotherapy.
  • Participation in other clinical trials within 4 weeks before enrollment.
  • Severe cardiovascular disease, including history of congestive heart failure, acute myocardial infarction within 6 months before enrollment, transmural myocardial infarction measured by ECG, uncontrolled arrhythmia, angina requiring therapy, clinically significant valvular heart disease, uncontrolled hypertension.
  • Severe or uncontrolled infection.
  • Positivity for HIV, Hepatitis B or C.
  • Active malignancy in the past 5 years (other than carcinoma in situ of the cervix or basal cell carcinoma of the skin).
  • Patients who are pregnant , breastfeeding ,or refuse to use adequate contraception during the course of participation.
  • Need to concurrent other cancer therapy(other than palliative care for non-target lesions).
  • Other ineligible conditions according to the researcher's judgment.

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 identifier (NCT number): NCT03933319

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Contact: peng yuan, Prof 13501270834 ext 13501270834

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China, Beijing
Peng Yuan Recruiting
Beijing, Beijing, China, 100021
Contact: peng yuan, Prof    13501270834 ext 13501270834   
Contact: xue wang, Dr    13811967690 ext 13501270834   
Sponsors and Collaborators
Chinese Academy of Medical Sciences
CSPC Ouyi Pharmaceutical Co., Ltd.
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Principal Investigator: peng yuan Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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Responsible Party: Peng Yuan, Principal Investigator, Chinese Academy of Medical Sciences Identifier: NCT03933319    
Other Study ID Numbers: CSPC-DMS-BC-11
First Posted: May 1, 2019    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: July 2020

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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
Breast Diseases
Skin Diseases
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action