Breast Cancer
Conditions
Interventions
Experimental group:Abemaciclib Combined with Fulvestrant and Pyrotinib
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. The patients voluntarily join the research, sign the informed consent form, and have good compliance; 2. Adult female patients (aged between 18-80 years old, including 18 and 80 years old); 3. Recurrent or metastatic breast cancer confirmed by pathology or imaging, not suitable for surgical resection or radiotherapy for the purpose of cure; 4. Pathological examination confirmed ER and/or PR positive, HER2 positive (ER expression: immunohistochemical staining of tumor cells >= 10%; PR expression: immunohistochemical staining of tumor cells >= 10%; HER-2 positive: immunohistochemical staining 3+ or FISH positive); 5. Within 2 weeks before enrollment, at least one measurable lesion determined by imaging examination (the short diameter of lymph node >=15mm), including normal CT scan >=20mm, spiral CT scan diameter >=10mm; 6. Postmenopausal patients (for premenopausal patients, including bilateral oophorectomy and GnRHa drugs); 7. Recurrence and metastasis occur during adjuvant endocrine therapy or within 12 months after the end of treatment; or progress during rescue therapy phase using endocrine therapy; 8. In the previous neoadjuvant therapy stage, progressed during the treatment with the trastuzumab regimen; or in the adjuvant therapy stage, recurrence and metastasis occurred during the treatment with the trastuzumab regimen or within 1 year after the end; or progress during the rescue treatment phase using a regimen including trastuzumab; 9. Have not used anti-HER2-TKI drugs before, or have used such drugs but have not proved ineffective; 10. WHO's physical condition is 0-2 points, and the expected survival time is not less than 3 months; 11. Previous treatment-related toxicity should be reduced to NCI CTCAE (version 5.0) = 3.0 x 10 ^ 9 / L; neutrophil count (ANC) >= 1.5 x 10 ^ 9 / L; platelet count (PLT) >= 100 x 10^9/L; 13. Liver, kidney and heart function tests were basically normal within one week before enrollment (based on the normal values of each research center laboratory): (1) Total bilirubin (TBIL) = 60 ml/min; (4) Left ventricular ejection fraction (LVEF) >= 55%; (5) QTcF (Fridericia correction) <= 470 ms.
Exclusion criteria
Exclusion criteria: 1. Subject has untreated central nervous system (CNS) metastases. 2. Received systemic therapy within 4 weeks before enrollment, such as chemotherapy, molecular targeted therapy or other clinical trial drugs; received endocrine therapy within 4 weeks before enrollment. 3. There are uncontrollable factors affecting the administration and absorption of the drug, such as dysphagia, chronic diarrhea and intestinal obstruction. 4. Previously received CDK4/6 inhibitor or fulvestrant treatment. 5. Other malignancies in the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin or squamous cell carcinoma of the skin. 6. Has undergone major surgery or major trauma within 4 weeks prior to randomization, or is expected to undergo major surgery. 7. Pregnant subjects, lactating subjects or subjects of childbearing age who are unwilling to take effective contraceptive measures. 8. Subjects with a known history of hypersensitivity to the drug components of the course. 9. Have a history of immunodeficiency, including HIV positive, HCV, active hepatitis B or other acquired and congenital immunodeficiency diseases, or a history of organ transplantation. 10. History of cardiac dysfunction, including: (1) angina pectoris; (2) clinically significant arrhythmia or requiring drug intervention; (3) myocardial infarction; (4) heart failure; (5) other cardiac dysfunction (as judged by the doctor); (6) any cardiac or renal abnormality >= grade 2 found during screening. 11. According to the judgment of the researchers, there are some concomitant diseases that seriously endanger the safety of subjects or affect the completion of the study. 12. A clear history of neurological or psychiatric disorders, including epilepsy or dementia. 13. Any other condition in which the researcher believes that the subject is unsuitable for the study, may interfere with an accompanying disease or research condition, or there is any serious medical impediment that may affect the safety of the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Countries
China
Contacts
Public ContactWang Hao
Sichuan Cancer Hospital
Outcome results
None listed