NCT03933319UnknownPhase 2
Phase Ⅱ Study of Pegylated Liposomal Doxorubicin（PLD）Plus Trastuzumab in HER-2 Positive Metastatic Breast Cancer
Chinese Academy of Medical Sciences1 site in 1 country30 target enrollmentStarted: March 11, 2019Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Objective response rate (ORR)
Study Overview
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 .
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- 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.
Arms & Interventions
PLD in combination with trastuzumab
Experimental
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.
Intervention: pegylated liposomal doxorubicin (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- Progression-free survival (PFS)(approximately 1.5 years)
- Incidence and Severity of adverse events(approximately 1.5 years)
Investigators
Peng Yuan
Principal Investigator
Chinese Academy of Medical Sciences
Study Sites (1)
Loading locations...
Similar Trials
Unknown
Phase 2
Pegylated Liposomal Doxorubicin and Carboplatin as First Line Treatment for Patients With Advanced Non-small Cell Lung CancerNon-small Cell Lung CancerNCT01051362The First Affiliated Hospital of Guangzhou Medical University48
Completed
Phase 2
Pegylated Liposomal Doxorubicin, Bortezomib, Dexamethasone and Lenalidomide for Relapsed/Refractory Multiple MyelomaMultiple MyelomaNCT01160484Oncotherapeutics40
Unknown
Phase 2
Lipo-dox and Cyclophosphamide /5-Fluorouracil in Patients With Metastatic Breast CancerMetastatic Breast CancerNCT01451580TTY Biopharm47
Completed
Phase 2
Liposomal Doxorubicin and Docetaxel in Metastatic Breast CancerMetastatic Breast CancerNCT00524810ARCAGY/ GINECO GROUP67
Unknown
Phase 1
Pegylated Liposomal Doxorubicin Plus Albumin-Bound Paclitaxel and Trastuzumab in HER-2 Positive Breast CancerBreast CancerNCT03994107Peking Union Medical College40