Ignite Creation Date:
2024-07-17 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06483386
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-12
Brief Title:
Pyrotinib and Subcutaneous Preparation of Trastuzumab Combined With Capecitabine Neoadjuvant Therapy for HER2 Study of Breast Cancer
Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Organization:
Tianjin Medical University Cancer Institute and Hospital
Study Overview
Official Title:
Pyrotinib and Subcutaneous Preparation of Trastuzumab Combined With Capecitabine Neoadjuvant Therapy for HER2Single Arm Phase II Multicenter Study of Breast Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objective To explore the efficacy and safety of Pyrotinib trastuzumab subcutaneous preparation and capecitabine neoadjuvant therapy for early HER2breast cancer
Administration method 6 cycles throughout the entire process
Pyrotinib Maleate Tablets Continuously administered from the first day of the first course of treatment 400 Mgday orally administered within 30 minutes after breakfast Trastuzumab Subcutaneous injection 600mg d1 q3w Capecitabine oral 1000 mgm2 bid d1-14 q3w Premenopausal goserelin 36mg once every 28 days
Administration method 6 cycles throughout the entire process
Pyrotinib Maleate Tablets Continuously administered from the first day of the first course of treatment 400 Mgday orally administered within 30 minutes after breakfast Trastuzumab Subcutaneous injection 600mg d1 q3w Capecitabine oral 1000 mgm2 bid d1-14 q3w Premenopausal goserelin 36mg once every 28 days
Detailed Description:
Inclusion Criteria 1 Age Female first-time patients aged 18 and above 2 Pathological examination confirmed HER2 positive invasive breast cancer HER2 positive definition Further application of in situ hybridization ISH for immunohistochemistry IHC 3or IHC 2 HER2 gene amplification regardless of hormone receptor status ER and PR According to the eighth edition of AJCC the staging is T1c-2N0-1M0 and according to Recipe 11 there are At least one measurable lesion 4 ECOG PS 0-1 points 5 The main organ function is normal which meets the following standards
1 The standard for blood routine examination must comply with no blood transfusion or blood products within 14 days no use of G-CSF
Correction of other hematopoietic stimulating factors
Hb100gL ANC 15 10 9L PLT 100 10 9L
2 Biochemical examination must meet the following standards
TBIL 1 ULN ALT AST 15 ULN ALP 25 ULN BUN and Cr 15 ULN
3 Cardiac ultrasound
Left ventricular ejection fraction LVEF 55 6 Women of childbearing age must undergo a pregnancy test serum within 7 days before enrollment and the result is negative Sexual and willing to use appropriate medication during the trial period and within 8 weeks after the last administration of the investigational drug The method of contraception 7 The subjects voluntarily joined this study signed an informed consent form had good compliance and cooperated with follow-up
Exclusion criteria
Those who are unable to participate in the clinical study under any of the following circumstances
1 Have received any form of anti-tumor treatment in the past chemotherapy radiotherapy molecular targeted therapy Endocrine therapy etc
2 Simultaneously receiving any other anti-tumor treatment
3 Bilateral breast cancer inflammatory breast cancer or occult breast cancer
4 breast cancer not confirmed by histopathology
5 Other malignant tumors have appeared within the past 5 years except for cured cervical cancer in situ
6 Severe dysfunction of important organs such as heart liver and kidney
7 Unable to swallow chronic diarrhea and intestinal obstruction there are various factors that affect medication administration and absorption Factors
8 Participated in clinical trials of other drugs within 4 weeks prior to enrollment
9 Individuals with a known history of allergies to the drug components of this protocol History of immunodeficiency including HIV Test positive HCV active hepatitis B or other acquired diseases Natural immunodeficiency disease or a history of organ transplantation
10 Have ever suffered from any heart disease including 1 those that require medication or have clinical significance Arrhythmias 2 Myocardial infarction 3 Heart failure 4 Any researcher Other heart diseases deemed unsuitable for participation in this trial
11 Pregnant and lactating female patients with fertility and positive baseline pregnancy test results Female patients of childbearing age who are unwilling to take effective contraceptive measures throughout the entire trial period Female patients
12 According to the researcher39s judgment there is a serious threat to patient safety or an impact on patient completion of the study The accompanying diseases studied including but not limited to severe hypertension that cannot be controlled by medication severe Diabetes active infection etc
13 Have a clear history of neurological or psychiatric disorders including epilepsy or dementia Researchers believe that Any other circumstances in which the patient is not suitable to participate in this study
Termination of study standard
1 Completed treatment according to regulations
2 Imaging evidence indicates progression of the disease
3 After dose adjustment the subjects still cannot tolerate toxicity During the research process pregnancy events occurred in the subjects
5 The subject withdraws their informed consent and requests withdrawal 6 Other situations where the researcher deems it necessary to withdraw from the study
efficacy indicators
Main efficacy indicators
tpCR
Secondary efficacy indicators
1 pCRypT0yp0
2 BCS
3 ORR
4 iDFS
5 EFS
6 Security
7 Biomarker detection
Research object T1c-2N0-1M0 HER2 expression positive in newly treated female patients
1 The standard for blood routine examination must comply with no blood transfusion or blood products within 14 days no use of G-CSF
Correction of other hematopoietic stimulating factors
Hb100gL ANC 15 10 9L PLT 100 10 9L
2 Biochemical examination must meet the following standards
TBIL 1 ULN ALT AST 15 ULN ALP 25 ULN BUN and Cr 15 ULN
3 Cardiac ultrasound
Left ventricular ejection fraction LVEF 55 6 Women of childbearing age must undergo a pregnancy test serum within 7 days before enrollment and the result is negative Sexual and willing to use appropriate medication during the trial period and within 8 weeks after the last administration of the investigational drug The method of contraception 7 The subjects voluntarily joined this study signed an informed consent form had good compliance and cooperated with follow-up
Exclusion criteria
Those who are unable to participate in the clinical study under any of the following circumstances
1 Have received any form of anti-tumor treatment in the past chemotherapy radiotherapy molecular targeted therapy Endocrine therapy etc
2 Simultaneously receiving any other anti-tumor treatment
3 Bilateral breast cancer inflammatory breast cancer or occult breast cancer
4 breast cancer not confirmed by histopathology
5 Other malignant tumors have appeared within the past 5 years except for cured cervical cancer in situ
6 Severe dysfunction of important organs such as heart liver and kidney
7 Unable to swallow chronic diarrhea and intestinal obstruction there are various factors that affect medication administration and absorption Factors
8 Participated in clinical trials of other drugs within 4 weeks prior to enrollment
9 Individuals with a known history of allergies to the drug components of this protocol History of immunodeficiency including HIV Test positive HCV active hepatitis B or other acquired diseases Natural immunodeficiency disease or a history of organ transplantation
10 Have ever suffered from any heart disease including 1 those that require medication or have clinical significance Arrhythmias 2 Myocardial infarction 3 Heart failure 4 Any researcher Other heart diseases deemed unsuitable for participation in this trial
11 Pregnant and lactating female patients with fertility and positive baseline pregnancy test results Female patients of childbearing age who are unwilling to take effective contraceptive measures throughout the entire trial period Female patients
12 According to the researcher39s judgment there is a serious threat to patient safety or an impact on patient completion of the study The accompanying diseases studied including but not limited to severe hypertension that cannot be controlled by medication severe Diabetes active infection etc
13 Have a clear history of neurological or psychiatric disorders including epilepsy or dementia Researchers believe that Any other circumstances in which the patient is not suitable to participate in this study
Termination of study standard
1 Completed treatment according to regulations
2 Imaging evidence indicates progression of the disease
3 After dose adjustment the subjects still cannot tolerate toxicity During the research process pregnancy events occurred in the subjects
5 The subject withdraws their informed consent and requests withdrawal 6 Other situations where the researcher deems it necessary to withdraw from the study
efficacy indicators
Main efficacy indicators
tpCR
Secondary efficacy indicators
1 pCRypT0yp0
2 BCS
3 ORR
4 iDFS
5 EFS
6 Security
7 Biomarker detection
Research object T1c-2N0-1M0 HER2 expression positive in newly treated female patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None