Clinical trial NCT03933319: Phase Ⅱ Study of Pegylated Liposomal Doxorubicin（PLD）Plus Trastuzumab in HER-2 Positive Metastatic Breast Cancer
Official title: Phase Ⅱ Study of Pegylated Liposomal Doxorubicin（PLD）Plus Trastuzumab in HER-2 Positive Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: HER2-positive Breast Cancer
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
Collaborators: name: CSPC Ouyi Pharmaceutical Co., Ltd.
First posted: 2019-05-01
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 .


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.

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: approximately 6 months
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: approximately 1.5 years
measure: Incidence and Severity of adverse events
timeFrame: approximately 1.5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peng Yuan
state: Beijing
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: peng yuan
role: PRINCIPAL_INVESTIGATOR
References: