breast cancer
Conditions
Interventions
Experimental group A:Fulvestrant + Dalpiciclib + Pyrotinib
Experimental group B:Trastuzumab + Dalpiciclib + Pyrotinib
Sponsors
He'nan Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Premenopausal/perimenopausal/postmenopausal women aged >=18 years; 2. Patients with unresectable locally advanced recurrent or metastatic breast cancer; 3. Type of patient: (1) Cohort A: All patients were diagnosed with estrogen receptor (ER) positive (>10%) and/or progesterone receptor (PR) positive (>1%), HER2 receptor positive invasive breast cancer. Follow the 2018 ASCO-CAP HER2 positive Interpretation guidelines. Immunohistochemical (IHC) scores of 3+, or 2+ and in situ hybridization (ISH) positive (ISH amplification rate >=2.0) were confirmed by pathology laboratory. (new) Adjuvant treatment stage trastuzumab > 12 months after the end of treatment, or no trastuzumab treatment in the early stage; No adjuvant endocrine therapy or postoperative adjuvant endocrine therapy > 24 months of recurrence and progression; Premenopausal or perimenopausal patients should be combined with OFS (OFS include bilateral oophorectomy or GnRHa drugs); (2) Cohort B: All patients were diagnosed with estrogen receptor (ER), progesterone receptor (PR) negative (=2.0) were confirmed by pathology laboratory. (new) Adjuvant treatment stage trastuzumab > 12 months after the end of treatment, or no trastuzumab treatment in the early stage; 4. No systematic treatment for advanced diseases in the past; 5. At least one measurable lesion or bone metastasis according to RECIST 1.1; 6. ECOG 0-1.
Exclusion criteria
Exclusion criteria: 1. Patients with brain metastases; 2. Inability to swallow, chronic diarrhea and intestinal obstruction, with multiple factors affecting drug administration and absorption; 3. Received radiotherapy, chemotherapy and surgery (excluding local puncture) within 4 weeks before enrollment; Those who received antitumor endocrine therapy after the screening period; 4. Participated in clinical trials of other drugs within 4 weeks before enrollment; 5. Have used or are using tyrosine kinase inhibitors targeting HER2 (Lapatinib, neratinib, pyrrotinib, etc.); 6. Previous treatment with any CDK4/6 inhibitors; 7. Patients have had other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix) within 5 years or at the same time; 8. Known allergic history of drug components of the program; A history of immunodeficiency, including HIV positive, HCV, active viral hepatitis B, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation; 9. Any history of heart disease, including: (1) Medically treatable or clinically significant arrhythmias; (2) Myocardial infarction; (3) Heart failure; (4) Any other heart disease that the investigator has determined is not suitable for participation in the study; 10. Pregnant and lactating patients, fertile patients who tested positive for baseline pregnancy tests or patients of childbearing age who did not want to take effective contraceptive measures during the whole test period; 11. Concomitant diseases (including but not limited to severe hypertension, severe diabetes, active infection, etc. that cannot be controlled by drugs) that, in the judgment of the researcher, seriously endanger the safety of the patient or affect the completion of the study; 12. Moderate infection (e.g., intravenous antibiotic, antifungal, or antiviral medication is required according to clinical guidelines) occurring within 4 weeks prior to initial administration, or unexplained fever > 38.5? occurring during screening/prior to initial administration; 13. A clear history of neurological or psychiatric disorders, including epilepsy or dementia; 14. The investigator did not consider the patient suitable for any other conditions in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;objective response rate; | — |
Countries
China
Contacts
Public ContactYan Min
He'nan Cancer Hospital
Outcome results
None listed