breast cancer
Conditions
Interventions
single arm: Pyrrottinib tablets: 400mg, QD, P.O., Q3W, a total of 6 cycles. Trastuzumab: load dose of 8mg/kg for the first cycle and 6mg/kg for the subsequent cycle , IVGTT, D1, Q3W, a total of 6 cycl
Sponsors
Breast Oncology Center, Chongqing Key Laboratory of Translational Research for Cancer Metastasis and Individualized Treatment, Chongqing University Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Female patients >= 18 years old and = 1.5 x 10^9/L;Platelet count (PLT) >= 90 x 10^9/L;Hemoglobin (Hb) >= 90 g/L; 2) Blood biochemistry: total bilirubin (TBIL) = 55%; 4) 12-lead electrocardiogram: QT interval (QTCF) < 470 msec corrected by Fridericia method. (7) For women who are premenopausal or have not undergone surgical sterilization: consent to abstinence or use of effective contraceptives during the treatment period and for at least 7 months after the last dosing in the study treatment (8) Volunteered to participate in this study, signed the informed consent, had good compliance and was willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: (1) Stage IV (metastatic) breast cancer; (2) inflammatory breast cancer; (3) prior antitumor therapy or radiation therapy for any malignancy, not including cured cervical orthotopic lesions Carcinoma, basal cell carcinoma or squamous cell carcinoma; (4) Concurrently receiving anti-tumor therapy in other clinical trials, including endocrine therapy, bisphosphonates or Immunotherapy; (5) Had undergone a major non-breast cancer-related surgical procedure within 4 weeks prior to randomization, or had not yet received such surgery Completely recovered during operation. (6) Serious heart disease or discomfort, including but not limited to the following: -- Diagnosis of heart failure or systolic dysfunction (LVEF 100 BPM, significant ventricular Arrhythmias (such as ventricular tachycardia) or a higher level of atrioventricular block (Mobitz II second degree atrioventricular block)Conduction block or third degree atrioventricular block); -- angina that requires anti-angina medication; -- Valvular heart disease with clinical significance; -- ECG showed a transmural myocardial infarction; -- Poor control of hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure BBB>0 mmHg). (7) Inability to swallow, intestinal obstruction or other factors that affect the taking and absorption of drugs; (8) People who are known to have allergies to the drug components of this regimen;A history of immunodeficiency, including HIV positive,Or other acquired or congenital immune deficiency diseases, or a history of organ transplantation; (9) Pregnant and lactating female patients, women with fertility and positive baseline pregnancy test, Or patients of child-bearing age who were unwilling to use effective contraception throughout the trial; (10) Has a serious comorbidity or other comorbidity that may interfere with planned treatment, or is considered by the investigator any other circumstances that are not suitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| tpCR; | — |
Countries
China
Contacts
Public ContactXiaohua Zeng/Mei Liu
Breast Oncology Center, Chongqing Key Laboratory of Translational Research for Cancer Metastasis and Individualized Treatment, Chongqing University Cancer Hospital
Outcome results
None listed