- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04903652
Pyrotinib Maleate Combined With Vinorelbine in the Treatment of HER2-positive Advanced Breast Cancer
A Prospective Phase Ⅱ Clinical Study of Pyrotinib Maleate Combined With Vinorelbine in the Treatment of HER2-positive Advanced Breast Cancer That Has Failed Trastuzumab Therapy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Tianjin, China
- Tianjin cancer hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Female patients between 18 and 75 years old;
- ECOG physical status score 0-2 points;
- The expected overall survival period is not less than 12 weeks;
- Pathologically confirmed HER2 expression-positive recurrent/metastatic breast cancer patients; the standard for HER2 expression positive is immunohistochemical staining (IHC) detection of HER2 3+ and/or fluorescent in situ hybridization (FISH) positive The researcher of the test center reviews and confirms).
- The disease progresses during or after treatment with trastuzumab (stopping the drug for less than 12 months);
- The number of chemotherapy lines used in the recurrence/metastasis stage is less than or equal to 2 lines;
- Patients who have at least one measurable lesion [spiral CT scan ≥10 mm (CT scan thickness not greater than 5mm)] and who have progressed after or during the last anti-tumor treatment (RECIST version 1.1);
- The main organs are functioning normally, that is, they meet the following standards:
1) The standard of routine blood examination should meet: Hb≥100 g/L (no blood transfusion within 14 days); ANC≥1.5×109 /L; PLT≥75×109 /L; 2) The biochemical inspection shall meet the following standards: TBIL≤1.5×ULN (upper limit of normal value); ALT and AST≤2.5×ULN; if there is liver metastasis, ALT and AST≤5×ULN; Serum creatinine ≤1.5×ULN, creatinine clearance ≥50ml/min (based on Cockroft and Gault formula); 3) Heart color Doppler ultrasound Left ventricular ejection fraction (LVEF) ≥50%; 9. For female patients who have not undergone menopause or have not undergone surgical sterilization: during treatment and at least 7 months after the last dose in the study treatment, agree to abstain from sex or use an effective method of contraception. 10. Patients voluntarily join this study, have good compliance with the planned treatment, understand the research process of this study, and sign written informed consent.
Exclusion Criteria:
- There is fluid in the third space that cannot be controlled by drainage or other methods, such as pleural fluid and ascites;
- There are many factors that affect the oral and absorption of drugs (such as inability to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.);
Severe heart disease or discomfort, including but not limited to the following diseases:
- Confirmed history of heart failure or systolic dysfunction (LVEF <50%)
- High-risk uncontrolled arrhythmia, such as atrial tachycardia, resting heart rate> 100 bpm, significant ventricular arrhythmia (such as ventricular tachycardia) or higher grade atrioventricular block (ie Mobitz II second degree atrioventricular block or third degree atrioventricular block)
- Angina pectoris that requires anti-angina pectoris medication
- Clinically significant heart valve disease
- ECG shows transmural myocardial infarction -Poor hypertension control (systolic blood pressure> 180 mmHg and/or diastolic blood pressure> 100 mmHg).
- Those who have been confirmed to be allergic to the drug components of this program; have a history of immunodeficiency, including positive HIV testing, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation.
- Patients who are known to be pregnant or planning to become pregnant, or patients of gestational age who are unwilling to take effective contraceptive measures during the entire trial period;
- Suffer from serious concomitant diseases, such as infectious diseases.
- Other malignant tumors have occurred in the past 5 years, except for cured cervical carcinoma in situ and non-melanoma skin cancer;
- Patients who have participated in other experimental studies within 30 days before the first dose of study drug is administered;
- Patients judged by the investigator to be unsuitable to participate in this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pyrotinib plus Vinorelbine
|
Pyrotinib p.o. 400 mg once daily
Vinorelbine p.o. 40 mg once every other day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival (PFS)
Time Frame: Estimated 24 months
|
From enrollment to progression or death (for any reason)
|
Estimated 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective response rate (ORR)
Time Frame: Estimated 24 months
|
Ratio of CR and PR in all subjects
|
Estimated 24 months
|
Disease Control Rate (DCR)
Time Frame: Estimated 24 months
|
Ratio of CR ,PR and SD in all subjects
|
Estimated 24 months
|
Overall survival (OS)
Time Frame: Estimated 36 months
|
From enrollment to death (for any reason)
|
Estimated 36 months
|
Security (CTCAE 5.0)
Time Frame: From informed consent through 28 days following treatment completion
|
Adverse events are described in terms of CTCAE 5.0
|
From informed consent through 28 days following treatment completion
|
Collaborators and Investigators
Investigators
- Principal Investigator: Chunfang Hao, PhD, Department of Breast Cancer Medical Oncology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BC-Pyrotinib-NVB
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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