Screening Plasma HER2 Amplication by Digital PCR in Advanced Breast Cancer Patients Treated With Trastuzumab and Pyrotinib
Primary Purpose
Advanced Breast Cancer
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Trastuzumab and Pyrotinib
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Patients with recurrent or distant metastatic breast cancer whose primary tissue was negative for HER2 amplification, and newly diagnosed patients with stage IV breast cancer who were negative for HER2 amplification; All enrolled patients had previously received ≥ second-line therapy; Note: ① negative expression of HER2 refers to the primary tissue tested by IHC/FISH (clinical report), and the cell immunohistochemical staining intensity is 0,1 + or 2+, but negative by fluorescence in situ hybridization (FISH).
- Age range 18-75, female;
- Good physical strength: ECOG score 0-1;
- Expected survival of more than 3 months;
- The patient had no major organ dysfunction;Include: Routine blood The ANC acuity 1.5 x 109 / L;PLT acuity 90 x 109 / L;Hb 90 g/L or higher; Blood biochemical 1.5 x ULN TBIL or less;ALT and AST 2 x ULN or less;ALT and AST≤5×ULN in patients with liver metastases;BUN and Cr≤1.5×ULN and creatinine clearance ≥50 mL/min (Cockcroft-Gault formula); Heart colour to exceed LVEF 50% or higher;Fridericia adjusted QT interval (QTcF) for 12-lead electrocardiogram in men < 450 ms and in women < 470 ms.
- Evaluable tumor lesions according to RECIST 1.1 criteria;
- Voluntarily join the group, agree and sign the written informed consent.
Exclusion Criteria:
- Patients who have previously received anti-HER2 therapy, or who have received a study drug or preparation/treatment (i.e., participating in another trial) within 4 weeks prior to enrollment;
- Patients who are allergic to study drugs or unable to take them orally;Patients who refuse the medication regimen;
- Serious dysfunction of vital organs (heart, liver, kidney);Clinically significant heart disease, i.e., New York Heart Association (NYHA) grade ⅲ - ⅳ heart failure or more severe congestive heart failure or severe arrhythmias requiring pharmacological intervention;Uncontrollable angina pectoris, uncontrolled arrhythmia or uncontrolled hypertension, myocardial infarction within 6 months as confirmed by electrocardiogram (ECG);Previous history of organ transplantation, splenectomy;
- Patients with other malignancies, except for cured non-melanoma skin cancers, cervical carcinoma in situ and other tumors that have been cured for at least 5 years;
- Pregnant and lactating women (women of childbearing age are subject to pregnancy tests), fertile women with positive baseline pregnancy tests, or women of childbearing age who are unwilling to use effective contraception throughout the study period.;
- In the active period of other acute infectious diseases or chronic infectious diseases;
- A history of uncontrolled epilepsy, central nervous system disease or mental disorder;
- Persons with disabilities of consciousness and other legal capacity or legal capacity limited;
- A known history of human immunodeficiency virus;
- Other conditions that the investigator considers inappropriate for the patient to participate in the study.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental Arm
Arm Description
Trastuzumab and Pyrotinib
Outcomes
Primary Outcome Measures
objective response rate(ORR)
The ORR will be defined as the proportion of patients in the Efficacy Evaluable patient Set who achieve complete response (CR) and partial response (PR)
Secondary Outcome Measures
Progression free survival(PFS)
PFS will be defined as the time from first dose of study drug until documentation of disease progression or death from any cause
Incidence and Severity of adverse events
hematologic, hepatotoxicity, Incidence of hypertension, Incidence of proteinuria
Full Information
NCT ID
NCT05020964
First Posted
August 19, 2021
Last Updated
August 24, 2021
Sponsor
Chinese Academy of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05020964
Brief Title
Screening Plasma HER2 Amplication by Digital PCR in Advanced Breast Cancer Patients Treated With Trastuzumab and Pyrotinib
Official Title
Screening Plasma HER2 Amplication by Digital PCR in Advanced Breast Cancer Patients Treated With Trastuzumab and Pyrotinib
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 20, 2021 (Anticipated)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The hypothesis of this study is to discover the efficacy and safety of trastuzumab combined with pyrotinib in treating advanced breast cancer with HER2 positive, which is detected by digital PCR. It is a single-arm, multicenter phase II clinical study.
The purpose of this study is:
To explore the Response rate (RR) and progression-free survival(PFS) and safety of patients with recurrent metastatic breast cancer who received trastuzumab combined with pyrotinib in positive plasma HER2 amplification detected by digital PCR.
To explore the potential using of digital PCR in recurrent and metastatic breast cancer.
Detailed Description
The purpose of this study is:
To explore the Response rate (RR) and progression-free survival(PFS) and safety of patients with recurrent metastatic breast cancer who received trastuzumab combined with pyrotinib in positive plasma HER2 amplification detected by digital PCR.
To explore the potential using of digital PCR in recurrent and metastatic breast cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Arm
Arm Type
Experimental
Arm Description
Trastuzumab and Pyrotinib
Intervention Type
Drug
Intervention Name(s)
Trastuzumab and Pyrotinib
Intervention Description
Trastuzumab: 3-week dosing regimen, The initial load dose was 8 mg/kg. Pyrotinib: 400 mg orally once daily, take it continuously, every 21 days as a cycle.
Use until intolerable toxicity or disease progression occurs.
Primary Outcome Measure Information:
Title
objective response rate(ORR)
Description
The ORR will be defined as the proportion of patients in the Efficacy Evaluable patient Set who achieve complete response (CR) and partial response (PR)
Time Frame
up to 1 year after the last patient enrolled
Secondary Outcome Measure Information:
Title
Progression free survival(PFS)
Description
PFS will be defined as the time from first dose of study drug until documentation of disease progression or death from any cause
Time Frame
up to 1 year after the last patient enrolled
Title
Incidence and Severity of adverse events
Description
hematologic, hepatotoxicity, Incidence of hypertension, Incidence of proteinuria
Time Frame
approximately 1.5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with recurrent or distant metastatic breast cancer whose primary tissue was negative for HER2 amplification, and newly diagnosed patients with stage IV breast cancer who were negative for HER2 amplification; All enrolled patients had previously received ≥ second-line therapy; Note: ① negative expression of HER2 refers to the primary tissue tested by IHC/FISH (clinical report), and the cell immunohistochemical staining intensity is 0,1 + or 2+, but negative by fluorescence in situ hybridization (FISH).
Age range 18-75, female;
Good physical strength: ECOG score 0-1;
Expected survival of more than 3 months;
The patient had no major organ dysfunction;Include: Routine blood The ANC acuity 1.5 x 109 / L;PLT acuity 90 x 109 / L;Hb 90 g/L or higher; Blood biochemical 1.5 x ULN TBIL or less;ALT and AST 2 x ULN or less;ALT and AST≤5×ULN in patients with liver metastases;BUN and Cr≤1.5×ULN and creatinine clearance ≥50 mL/min (Cockcroft-Gault formula); Heart colour to exceed LVEF 50% or higher;Fridericia adjusted QT interval (QTcF) for 12-lead electrocardiogram in men < 450 ms and in women < 470 ms.
Evaluable tumor lesions according to RECIST 1.1 criteria;
Voluntarily join the group, agree and sign the written informed consent.
Exclusion Criteria:
Patients who have previously received anti-HER2 therapy, or who have received a study drug or preparation/treatment (i.e., participating in another trial) within 4 weeks prior to enrollment;
Patients who are allergic to study drugs or unable to take them orally;Patients who refuse the medication regimen;
Serious dysfunction of vital organs (heart, liver, kidney);Clinically significant heart disease, i.e., New York Heart Association (NYHA) grade ⅲ - ⅳ heart failure or more severe congestive heart failure or severe arrhythmias requiring pharmacological intervention;Uncontrollable angina pectoris, uncontrolled arrhythmia or uncontrolled hypertension, myocardial infarction within 6 months as confirmed by electrocardiogram (ECG);Previous history of organ transplantation, splenectomy;
Patients with other malignancies, except for cured non-melanoma skin cancers, cervical carcinoma in situ and other tumors that have been cured for at least 5 years;
Pregnant and lactating women (women of childbearing age are subject to pregnancy tests), fertile women with positive baseline pregnancy tests, or women of childbearing age who are unwilling to use effective contraception throughout the study period.;
In the active period of other acute infectious diseases or chronic infectious diseases;
A history of uncontrolled epilepsy, central nervous system disease or mental disorder;
Persons with disabilities of consciousness and other legal capacity or legal capacity limited;
A known history of human immunodeficiency virus;
Other conditions that the investigator considers inappropriate for the patient to participate in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuan Peng
Phone
01087787245
Email
yuanpeng01@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yi-Kun Kang
Phone
18911611553
Email
345890335@qqq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuan Peng
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Screening Plasma HER2 Amplication by Digital PCR in Advanced Breast Cancer Patients Treated With Trastuzumab and Pyrotinib
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