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Pyrotinib, Trastuzumab And Abraxane in HER2-positive MBC With Brain Metastasis

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ClinicalTrials.gov Identifier: NCT04639271
Recruitment Status : Not yet recruiting
First Posted : November 20, 2020
Last Update Posted : November 20, 2020
Sponsor:
Information provided by (Responsible Party):
Zhiyong Yu, Shandong Cancer Hospital and Institute

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.

Condition or disease Intervention/treatment Phase
Breast Cancer HER2-positive Breast Cancer Drug: Pyrotinib Plus And Drug: Trastuzumab Drug: Abraxane Phase 2

Detailed Description:

Overexpression of HER2 is associated with increased incidence of brain metastases in breast cancer, accounting for about 20-50% of HER2 positive breast cancer. Treatment strategy ranged from local therapies to systemic anti-HER2 therapies, prognosis of patients with brain metastases remains poor. Previous clinical trials had demonstrated the efficacy of trastuzumab and TKIs for brain metastasis.

Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. We designed the study to explore the efficacy and safety of pyrotinib combined with trastuzumab and abraxane in HER2-positive MBC with brain metastasis.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-arm, Open-label Study Of Pyrotinib Combined WithTrastuzumab And Abraxane in Patients With Brain Metastases From HER2-positive Metastatic Breast Cancer
Estimated Study Start Date : January 1, 2021
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : March 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pyrotinib Plus Trastuzumab And Abraxane
Pyrotinib Plus Trastuzumab And Abraxane
Drug: Pyrotinib Plus And
Pyrotinib::400mg/d,qd,po

Drug: Trastuzumab
8 mg/kg intravenously (IV) on Day 1 of Cycle 1, followed by 6 mg/kg on Day1 of each 21-day cycle

Drug: Abraxane
Abraxane 125mg/M2, qw iv




Primary Outcome Measures :
  1. Objective Response Rate (ORR) of Intracranial Lesion [ Time Frame: Estimated up to 1 year ]
    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

  2. Progression Free Survival(PFS) of Intracranial Lesion [ Time Frame: Estimated up to 1 year ]
    the date from the first dose to the first occurrence of Intracranial Lesion progression or death from any cause, whichever occurs first


Secondary Outcome Measures :
  1. Progression Free Survival(PFS) [ Time Frame: Estimated up to 1 year ]
    the date from the first dose to the first occurrence of disease progression or death from any cause, whichever occurs first

  2. Objective Response Rate (ORR) [ Time Frame: Estimated up to 1 year ]
    Refers to the proportion of patients whose 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

  3. disease control rate(DCR) [ Time Frame: Estimated up to 1 year ]
    Percentage of confirmed complete remission (CR), partial remission (PR), and disease stable (SD) cases in patients with evaluable efficacy



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04639271


Contacts
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Contact: Zhiyong Yu, PhD 86-13355312277 drzhiyongyu@aliyun.com
Contact: Chao Li, MD lichao19890305@126.com

Locations
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China, Shandong
Zhiyong Yu
Jinan, Shandong, China
Sponsors and Collaborators
Shandong Cancer Hospital and Institute
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Responsible Party: Zhiyong Yu, Principal Investigator, Shandong Cancer Hospital and Institute
ClinicalTrials.gov Identifier: NCT04639271    
Other Study ID Numbers: ShandongCHI-16
First Posted: November 20, 2020    Key Record Dates
Last Update Posted: November 20, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Breast Neoplasms
Brain Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Trastuzumab
Albumin-Bound Paclitaxel
Antineoplastic Agents, Immunological
Antineoplastic Agents