Pyrotinib, Trastuzumab And Abraxane in HER2-positive MBC With Brain Metastasis
A Single-arm, Open-label Study Of Pyrotinib Combined WithTrastuzumab And Abraxane in Patients With Brain Metastases From HER2-positive Metastatic Breast Cancer
1 other identifier
interventional
100
1 country
1
Brief Summary
The purpose of this study is to assess the efficacy and safety of pyrotinib combined with trastuzumab and abraxane in HER2-positive MBC with brain metastasis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 breast-cancer
Started Jan 2021
Shorter than P25 for phase_2 breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2020
CompletedFirst Posted
Study publicly available on registry
November 20, 2020
CompletedStudy Start
First participant enrolled
January 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2022
CompletedNovember 20, 2020
November 1, 2020
1 year
November 19, 2020
November 19, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Objective Response Rate (ORR) of Intracranial Lesion
Refers to the proportion of patients whose Intracranial Lesion have shrunk to a certain proportion and maintained for a certain period of time, including cases of CR and PR, RECIST 1.1 were used to assess objective tumor remission
Estimated up to 1 year
Progression Free Survival(PFS) of Intracranial Lesion
the date from the first dose to the first occurrence of Intracranial Lesion progression or death from any cause, whichever occurs first
Estimated up to 1 year
Secondary Outcomes (3)
Progression Free Survival(PFS)
Estimated up to 1 year
Objective Response Rate (ORR)
Estimated up to 1 year
disease control rate(DCR)
Estimated up to 1 year
Study Arms (1)
Pyrotinib Plus Trastuzumab And Abraxane
EXPERIMENTALPyrotinib Plus Trastuzumab And Abraxane
Interventions
8 mg/kg intravenously (IV) on Day 1 of Cycle 1, followed by 6 mg/kg on Day1 of each 21-day cycle
Eligibility Criteria
You may qualify if:
- Aged \>18 years.
- ECOG performance status ≤2.
- Histologically or cytologic confirmed HER2 positive advanced breast cancer.
- MRI confirmed brain metastases. According to RECIST 1.1, at least one measurable lesion exists.
- No limit of previous chemotherapy lines.
- Previously have not reveived capecitabine or disease progression of capecitabine after 6 months, or progression of capecitabine adjuvant therapy after one year;
- Life expectancy of more than 3 months.
- Required laboratory values including following parameters: ANC: ≥ 1.5 x 10\^9/L;Platelet count: ≥ 100 x 10\^9/L;Hemoglobin: ≥ 9.0 g/dL;Total bilirubin: ≤ 1.5 x upper limit of normal (ULN);ALT and AST: ≤ 1.5 x ULN (or ≤ 5×ULN in patients with liver metastases);BUN and creatine clearance rate: ≥ 50 mL/min;LVEF: ≥ 50%;QTcF: \< 470 ms for female and \< 450 ms for male.
- Signed the informed consent form prior to patient entry.
You may not qualify if:
- Patients with brain metastases who have extensive meningeal metastases and are treated with hormone dehydration.
- Subjects with third space fluid(such as a large amount of pleural effusion and ascites) that can not be controled by drainage or other methods. (such as pleural effusion and ascites).
- Received whole brain radiotherapy, chemotherapy, surgery or target therapy within 2 weeks prior to randomization. Received hormone therapy within 1 weeks prior to randomization, Received the nitrosoureas or mitomycin chemotherapy within 6 weeks prior to randomization.
- Participated in other clinical trial within 4 weeks prior to randomization.
- Treated or treating with HER2 tyrosine kinase inhibitors (TKIs) (including Lapatinib, Neratinib and Pyrotinib).
- Second malignancies within 5 years, except for cured carcinoma in-situ of uterine cervix, skin basal cell carcinomaand squamous-cell carcinoma.
- Receiving any other anti-tumor therapies at time of study screening visit.
- There are no other serious and/or uncontrolled diseases that may affect research participation, including any of the following: (1) unable to swallow, chronic diarrhea and intestinal obstruction and factors influencing the usage of oral administration; (2) has allergies or a known history of hypersensitivity to the drug components of this program; History of Immunodeficiency, acquired or congenital immunodeficiency (HIV positive) ,history of organ transplantation; (3) History of any kind of Heart disease, including 1) Myocardial infarction; 2) Heart failure; 3) Any other heart disease judged by researcher as not suitable for participating in this study, etc; (4) Infection.
- All female patients in breastfeeding period or in child-bearing period or with positive pregnancy test result or refusing to take a reliable method of birth control during the study.
- Any other situations judged by investigator as not suitable for participating in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zhiyong Yu
Jinan, Shandong, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
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
November 19, 2020
First Posted
November 20, 2020
Study Start
January 1, 2021
Primary Completion
January 1, 2022
Study Completion
March 1, 2022
Last Updated
November 20, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share