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Trial Title:
Pyrotinib Combined With Trastuzumab Subcutaneously Compared Intravenous Administration in the Treatment of HER2-positive Early Breast Cancer
NCT ID:
NCT06537674
Condition:
HER2+ Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Trastuzumab
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Trastuzumab intravenous drip/Trastuzumab Subcutaneous Injection
Description:
Group A is Trastuzumab intravenous drip,Group B is Trastuzumab Subcutaneous Injection
Arm group label:
Group A
Arm group label:
Group B
Summary:
This study evaluated the clinical benefits of intravenous administration of pyrotinib
combined with trastuzumab subcutaneous preparation by comparing the efficacy and quality
of life of intravenous administration in the treatment of HER2-positive early breast
cancer
Criteria for eligibility:
Study pop:
HER2-positive early stage breast cancer patients
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Women aged ≥18 years and ≤75 years who are newly treated for breast cancer;
2. Pathological examination confirmed HER2 positive (immunohistochemical staining
ICH+++ or ICH++ and FISH positive);
3. Patients with invasive breast cancer diagnosed histologically plus imaging as early
(T1c-3, N0-1, M0) or locally advanced (T2-3, N2, or N3, M0);
4. ECOG score 0-1;
5. Plan to undergo the final surgical removal of breast cancer, i.e. breast-conserving
surgery or total mastectomy, sentinel lymph node (SN) biopsy or axillary lymph node
dissection (ALND);
6. If the major organs function normally, the following criteria are met:
(1) The standard of blood routine examination should meet: ANC ≥1.5×109/L; PLT ≥90×109/L;
Hb ≥90g/L; (2) Biochemical examination should meet the following criteria: TBIL≤ upper
limit of normal value (ULN); ALT and AST≤1.5 times the upper limit of normal (ULN);
Alkaline phosphatase ≤2.5 times the upper limit of normal (ULN); BUN and Cr≤1.5×ULN and
creatinine clearance ≥50 mL/min (Cockcroft-Gault formula); (3) Color Doppler
ultrasonography and echocardiography: left ventricular ejection fraction (LVEF≥55%); (4)
Fridericia calibrated QT interval (QTcF) for 18-lead ECG <470 ms; 7. For female patients
who are not menopausal or have not been surgically sterilized, they should consent to
abstinence or use an effective contraceptive method during treatment and for at least 7
months after the last dose in the study treatment.
8. Volunteer to join the study and sign the informed consent.
Exclusion Criteria:
1. Known allergic history of the drug components of this protocol;
2. Previously received antitumor therapy or radiation therapy for any malignant tumor
(except for cured cervical carcinoma in situ and basal cell carcinoma);
3. Has undergone major non-breast cancer related surgery within 4 weeks, or has not
fully recovered from such surgery;
4. Stage IV (metastatic) breast cancer patients;
5. Inability to swallow, intestinal obstruction, or other factors affecting the
administration and absorption of the drug;
6. Serious heart disease or discomfort that cannot be treated;
7. Suffering from mental illness or psychotropic substance abuse, unable to cooperate;
8. Pregnant or lactating women;
9. Patients with severe liver and kidney function diseases and blood system diseases;
10. Those who were not considered suitable for inclusion by the researchers included:
history of drug abuse, history of use of blood products, anticoagulant drugs and
immunological drugs within the past year; Poor compliance and refusal to cooperate
with treatment
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Start date:
August 15, 2024
Completion date:
December 30, 2026
Lead sponsor:
Agency:
Jiangsu Famous Medical Technology Co., Ltd.
Agency class:
Industry
Source:
Jiangsu Famous Medical Technology Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06537674
