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

NCT ID: NCT03933319

Last Updated: 2020-07-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-11
• Study Completion Date: 2022-05-01

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 .

Conditions

HER2-positive Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

pegylated liposomal doxorubicin

Intervention Type: DRUG

Eligible patients will be treated with the PLD+trastuzumab regimen until the disease progresses or intolerable toxicity

Interventions

pegylated liposomal doxorubicin

Eligible patients will be treated with the PLD+trastuzumab regimen until the disease progresses or intolerable toxicity

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

CSPC Ouyi Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Peng Yuan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

peng yuan

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Locations

Peng Yuan

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

peng yuan, Prof

Role: CONTACT

yuanpeng01@hotmail.com

13501270834 ext. 13501270834

Facility Contacts

peng yuan, Prof

Role: primary

yuanpeng01@hotmail.com

13501270834 ext. 13501270834

xue wang, Dr

Role: backup

wxyxuki@163.com

13811967690 ext. 13501270834

Other Identifiers

CSPC-DMS-BC-11

Identifier Type: -

Identifier Source: org_study_id