Breast cancer
Conditions
Interventions
Experimental group:Dalpiciclib Puls Pyrotinib Plus Endocrine therapy
Sponsors
The Fist Affiliated Hospital of Jinzhou Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The patients voluntarily joined this study, signed an informed consent form, and had good compliance. 2. Women aged = 18 years and = 75 years old. 3. Patients with locally recurrent or metastatic breast cancer confirmed by histological examination. 4. Premenopausal or perimenopausal patients (if such patients, combined with OFS, including bilateral ovariectomy or during the study period receiving GnRHa class drugs), or postmenopausal patients. 5. Patients with bilateral breast cancer should confirm that both breast lesions and metastatic lesions are pathologically HER2 and HR positive. 6. HER2 and HR positive invasive breast cancer, follow the 2018 ASCO/CAP breast cancer HER2 detection guidelines and 2010 ASCO/CAP breast cancer ER/PR detection guidelines interpretation standards (Increase the timeliness of pathological reports) HER2 positivity is defined as the percentage of tumor cells with confirmed immunohistochemical (IHC) scores of HER2 3+or 2+and positive in situ hybridization (ISH) detection confirmed by the pathological laboratory, and ER positivity is defined as the percentage of tumor cells with positive ER expression detected by immunohistochemistry = 10%. 7. ECOG score is 0-1. 8. The expected survival period is not less than 12 weeks. 9. According to RECIST 1.1 standard, at least one measurable lesion is present. 10. Received = 1 line anti HER2 treatment in the recurrence or late stage; Patients with a disease-free interval of = 6 months from the end of the last treatment to tumor progression are allowed to use trastuzumab as a previous adjuvant/new adjuvant. 11. The functional level of organs must meet the following requirements: 1) Blood routine: ANC = 1.5 × 109/L; PLT = 90 × 109/L; Hb = 90 g/L; 2) Blood biochemistry: TBIL = 1.5 × ULN;; ALT and AST = 3 × ULN (ALT and AST = 5 × ULN in patients with liver metastasis); BUN and Cr = 1.5 × ULN with creatinine clearance rate = 50 mL/min (Cockcroft Gault formula); 3) Cardiac ultrasound: LVEF = 50%; 4) 12 lead electrocardiogram: QT interval (QTcF) corrected by Fridericia method for females<480 ms; 12. Patients with known hormone receptor status.
Exclusion criteria
Exclusion criteria: 1. Diffuse liver metastasis, extensive lymphangitis caused by lung cancer, and extensive bone marrow metastasis. 2. Unable to swallow, chronic diarrhea, and intestinal obstruction, there are multiple factors that affect medication administration and absorption. 3. During the active phase, there may be leptomeningeal metastasis, brain metastasis, or spinal cord compression. Unless the patient's disease is stable (asymptomatic; there is no evidence of new or emerging brain metastases), steroid therapy should be stopped for at least 14 days before treatment begins. Patients with brain metastases who receive radiotherapy and/or surgery must wait for 28 days after intervention and confirm disease stability through pre randomized imaging evaluation. Asymptomatic CNS detected during the screening period must wait for 28 days after surgical and/or radiation intervention, and disease stability must be confirmed through pre randomization imaging. 4. Individuals who have received radiation therapy, chemotherapy, surgical treatment (excluding local puncture or biopsy) or molecular targeted immunotherapy within 4 weeks prior to enrollment. 5. Individuals who have received endocrine therapy within 2 weeks prior to enrollment. 6. Individuals who have used aromatase inhibitors (i.e. anastrozole/letrozole/exemestan) for less than 24 months as a previous adjuvant/neoadjuvant therapy, have no disease progression during advanced treatment, and have no disease interval less than 12 months after discontinuation. 7. Previously used or currently using tyrosine kinase inhibitors targeting HER2 (such as Lapatinib, Neratinib, and Pyrotinib) or CDK4/6 inhibitors (such as Palbociclib, Abemaciclib, and Dalpiciclib). 8. Those who have previously used Fulvestrant. 9. Individuals who have previously used HDAC/PAM pathway inhibitors (such as Chidamide and Everolimus). 10. Other malignant tumors within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin. 11. Simultaneously receive any other anti-tumor treatment. 12. Uncontrollable pleural effusion (pleural effusion/abdominal effusion/pericardial effusion, etc.) excluding those who do not require further drainage within 28 days after intervention. 13. Individuals with a known history of allergies to the drug components of this protocol; Have a history of immunodeficiency, including HIV testing, HCV, positive syphilis antibodies, active hepatitis B with HBV = ULN, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation. 14. Pregnant and lactating female patients, female patients with fertility and positive baseline pregnancy test results. 15. According to the investigator's judgment, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study (including but not limited to severe hypertension beyond drug control, severe diabetes, active infection, etc.). 16. Hypertension with poor drug control (systolic blood pressure = 150mmHg or diastolic blood pressure = 100mmHg) 17. A history of severe heart disease, such as symptomatic congestive heart failure (CHF), New York Heart Association (NYHA) cardiac function classification = 2, and a history of myocardial infarction or unstable angina within the first 6 months of the screening period. Arrhythmias that require medication treatment or have clinical significance; Any other heart disease determin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Clinical Benefit Rate;Progression Free Survival;Overall Survival;Adverse Events and Serious Adverse Events; | — |
Countries
China
Contacts
Public ContactZhenhua Zhai
The Fist Affiliated Hospital of Jinzhou Medical University
Outcome results
None listed