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

NCT03933319 | Unknown Phase 2

• 1 other identifier: CSPC-DMS-BC-11
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Progression-free survival (PFS)

  approximately 1.5 years

• Incidence and Severity of adverse events

  approximately 1.5 years

Study Arms (1)

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.

Drug: pegylated liposomal doxorubicin

Interventions

pegylated liposomal doxorubicin DRUG

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

PLD in combination with trastuzumab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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；

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead
• CSPC Ouyi Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Peng Yuan

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Interventions

liposomal doxorubicin

Study Officials

• peng yuan

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

peng yuan, Prof

CONTACT

13501270834; yuanpeng01@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: May 1, 2019
• Study Start: March 11, 2019
• Primary Completion: March 31, 2021
• Study Completion: May 1, 2022
• Last Updated: July 8, 2020

Record last verified: 2020-07

Locations

CN (1)