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

HER2-positive Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03933319
• Other study ID #: CSPC-DMS-BC-11
• Status: Recruiting
• Phase: Phase 2
• Start date: March 11, 2019
• Est. completion date: May 1, 2022

Study information

• Verified date: July 2020
• Source: Chinese Academy of Medical Sciences
• Contact: peng yuan, Prof
• Phone: 13501270834
• Email: yuanpeng01[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 1, 2022
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• HER2-positive Breast Cancer

Intervention

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

Locations

Country	Name	City	State
China	Peng Yuan	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences	CSPC Ouyi Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (ORR)	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)	approximately 6 months
Secondary	Progression-free survival (PFS)	PFS will be defined as the time from first dose of study drug until documentation of disease progression or death from any cause	approximately 1.5 years
Secondary	Incidence and Severity of adverse events		approximately 1.5 years