Breast cancer
Conditions
Interventions
Treatment group:Pyrotinib + Trastuzumab (HLX02) + AI
Control group:Trastuzumab (HLX02) + AI
Sponsors
Hunan Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be included in this study: 1) Local recurrence or metastasis confirmed by histological examination and patients with stage IV breast cancer who are newly diagnosed. 2) Premenopausal or perimenopausal patients (if they are such patients, they need to be combined with OFS, which includes bilateral oophorectomy or GnRHa drugs), or postmenopausal patients. 3) Patients with bilateral breast cancer need to have metastatic lesions that are pathologically ER-positive and HER2-positive. 4) HER2 and ER-positive invasive breast cancer, follow the 2018 version of the ASCO/CAP breast cancer HER2 detection guidelines and the 2010 version of the ASCO/CAP breast cancer ER/PR detection guidelines interpretation standards. HER2 positivity is defined as the confirmation by the pathology laboratory that the immunohistochemistry (IHC) score is HER2 3+ or 2+ and the in situ hybridization (ISH) test is positive, and ER positivity is defined as the percentage of cells that are positive for ER expression by immunohistochemistry =10%. 5) Age =18 years old, and =70 years old female. 6) ECOG score 0~1. 7) The estimated survival period is not less than 12 weeks. 8) According to the RECIST 1.1 standard, at least one measurable lesion exists. 9) It is allowed for patients who have used trastuzumab, partuzumab and chemotherapy in the past adjuvant/neoadjuvant trastuzumab and partuzumab in the last adjuvant/neoadjuvant trastuzumab and partuzumab treatment to the end of the tumor. The disease-free period is =12 months. 10) Patients who have used endocrine therapy in the past adjuvant/neoadjuvant, adjuvant aromatase inhibitors, and the disease-free period =12 months from the end of the last treatment to the tumor's progress are allowed. 11) Patients with postoperative disease-free survival (DFS) =12 months. 12) The functional level of the organ must meet the following requirements: i) Blood routine • ANC=1.5×109/L; • PLT=90×109/L; • Hb=90 g/L; ii) Blood biochemistry • TBIL=1.5×ULN; * ALT and AST=3×ULN (ALT andAST=5×ULN for those with liver metastases); •BUN and Cr=1.5×ULN and creatinine clearance=50 mL/min (Cockcroft-Gault formula); iii) Cardiac color ultrasound • LVEF=50%; vi) 12-lead electrocardiogram • The QT interval (QTcF) corrected by the Fridericia method is <480 ms for women 13. Patients with known hormone receptor status. 14. Voluntarily join this study, sign informed consent, have good compliance and are willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria cannot be included in this study: 1) Patients with central nervous system metastasis; 2) Patients with visceral crisis, definition of visceral crisis: abnormal function of several organs confirmed by symptoms, signs, laboratory examinations, and rapid progress of the disease.Visceral crisis is not simply the existence of visceral metastasis, but refers to critical visceral conditions that require rapid and effective treatment to control the progress of the disease, especially when the opportunity for chemotherapy is lost after the progress. 3) Inability to swallow, chronic diarrhea and intestinal obstruction, there are many factors that affect the administration and absorption of drugs. 4) Those who have received radiotherapy, endocrine therapy, chemotherapy, surgical treatment (excluding local puncture or biopsy) or molecular targeted therapy in the recurrence/metastasis stage. 5) Those who have received radiotherapy, chemotherapy, surgical treatment (excluding local puncture or biopsy) or molecular targeted therapy within 4 weeks before entering the group. 6) Those who received endocrine therapy within 2 weeks before entering the group. 7) Participated in clinical trials of other drugs within 4 weeks before entering the group. 8) Tyrosine kinase inhibitors (lapatinib, lenatinib and pyrrotinib, etc.) that target HER2 have been used or are being used in the past. 9) Have suffered from other malignant tumors in the past 5 years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma. 10) Receive any other anti-tumor treatment at the same time. 11) Those who are known to have a history of allergies to the drug components of this program; have a history of immunodeficiency, including HIV testing positive, HCV, active viral hepatitis B or suffering from other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation. 12) Have suffered from any heart disease, including: (1) arrhythmias that require drug treatment or are of clinical significance; (2) myocardial infarction; (3) heart failure; (4) Any other heart disease judged by the researcher to be unfit to participate in this trial, etc. 13) Female patients during pregnancy and lactation, female patients with fertility and positive baseline pregnancy test. 14) According to the judgment of the researchers, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of the study (including but not limited to severe hypertension, severe diabetes, active infections, etc. that cannot be controlled by drugs). 15) Have a clear history of neurological or mental disorders in the past, including epilepsy or dementia. 16) The researcher determined that the patient was not suitable for any other situation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Clinical benefit rate; | — |
Countries
China
Contacts
Public ContactOuyang Quchang
Hunan Cancer Hospital
Outcome results
None listed