breast cancer
Conditions
Interventions
Group 1:pyrotinib, dalpiciclib and endocrine drugs
Sponsors
Affiliated Cancer Hospital of Shantou University Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Male patients aged >= 18 years, postmenopausal or premenopausal/perimenopausal female patients with breast cancer, meet one of the following conditions: (1) Previous bilateral oophorectomy, or age >= 60 years; (2) Age = 6 months; 5. <= 1 line chemotherapy in advanced stage; 6. ECOG <= 2; 7. There are measurable lesions or only bone metastases (including osteolytic lesions or mixed osteolytic/osteogenic lesions) that meet the RECIST 1.1 standard; 8. It has sufficient organ and bone marrow functions; 9. For female patients who have not undergone surgical sterilization: the pregnancy test results before the first administration were negative. During the treatment period and within 90 days after the last administration in the study treatment, they agreed to take effective non-hormonal contraceptive measures; 10. All acute toxic reactions of previous anti-tumor treatment were relieved to 0-1 degree or to the level specified in the inclusion/exclusion criteria. Hair loss and other toxicities that the researchers believe do not pose a safety risk to patients are excluded; 11. With my consent and signed informed consent, I am willing and able to follow the planned visit, research treatment plan, laboratory examination and other test procedures.
Exclusion criteria
Exclusion criteria: 1. The previous pathological diagnosis was HER2 positive (HER2 IHC3+or IHC2+/ISH+) breast cancer; 2. Patients with brain metastasis with persistent symptoms; 3. The researcher judged that it was not suitable for patients who were treated with darsilli+ET combined with pyrrolidine and chemotherapy selected by doctors; 4. Having undergone major surgery, chemotherapy, radiotherapy, any investigational drug or other anti-cancer treatment within 2 weeks before entering the study; 5. Diagnosed with any other malignant tumor within 3 years before entering the study, except for non-melanoma skin cancer, basal cell or squamous cell skin cancer or cervical carcinoma in situ after radical treatment; 6. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA >= 1000 IU/mL), hepatitis C (hepatitis C antibody positive, HCV-RNA higher than the detection limit of the analytical method) or co-infection with hepatitis B and hepatitis C; 7. Within 6 months before entering the study, the following conditions occurred: myocardial infarction, severe/unstable angina pectoris, NYHA grade 2 or above cardiac insufficiency, persistent arrhythmia >= grade 2, atrial fibrillation of any grade, coronary/peripheral artery bypass surgery, symptomatic congestive heart failure, cerebrovascular accident (including transient cerebral ischemia attack or symptomatic pulmonary embolism); 8. Severe infection (such as intravenous drip of antibiotics, antifungal or antiviral drugs according to clinical diagnosis and treatment specifications) occurred within 4 weeks before the first administration, or fever > 38.5? of unknown cause occurred during screening/before the first administration; 9. Inability to swallow, intestinal obstruction or other factors affecting drug administration and absorption; 10. Known abnormal anticoagulation function; or use of anticoagulant therapy before intramuscular injection of fluvastatin or LHRH agonist (Goserelin); 11. Known to be allergic to darsilide, pyrrolidine or any excipients; 12. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 13. Known history of abuse or drug abuse of psychotropic substances; 14. There are other serious physical or mental diseases or laboratory abnormalities that may increase the risk of participating in the study, or interfere with the results of the study, as well as patients who are not suitable for participating in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival;Overall Survival;Duration of Response;Time to Progression;Relationship between HER4 and efficacy;Safety;Tolerance;adverse event, AE;Serious adverse events, SAE;Disease control rate, DCR; | — |
Countries
China
Contacts
Public ContactZeng De
Affiliated Cancer Hospital of Shantou University Medical College
Outcome results
None listed