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

• Status: Recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: Female

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 .

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Medical Sciences
• Collaborator: CSPC Ouyi Pharmaceutical Co., Ltd.
• Treatments: Doxorubicin; Liposomal doxorubicin; Trastuzumab

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.