Breast CANCER
Conditions
Interventions
group A:X-based combination chemotherapy
group B:CDK4/6 inhibitors + endocrine therapy
Sponsors
Henan Cancer hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) age =18 years old; Invasive breast cancer with metastatic disease confirmed by histological or cytological examination; Patients without pathologically or cytologically confirmed metastatic disease should have clear evidence of metastasis by physical examination or radiological studies; (2) The most recent pathological report of biopsy confirmed HR low expression and HER2 negative. a) HR low expression was defined as 1-50% ER expression by immunohistochemistry (IHC); Or ER 12 weeks; (7) normal organ and bone marrow function; Routine blood tests performed within 1 week before enrollment were normal (according to the normal values of the participating laboratories). ? white blood cell count (WBC) =3.0×109/L; ? Neutrophil count (ANC) =1.5×109/L; ? hemoglobin (Hb) = 90 g/dL; ? platelet count (PLT) =100×109/L; Liver and kidney function tests were basically normal within 1 week before enrollment (based on the normal values of the participating laboratory). ? Total bilirubin (TBIL) =1.5× upper limit of normal value (ULN); ? alanine aminotransferase (SGPT/ALT) =2.5×ULN (=5xULN in patients with liver metastases); ? aspartate aminotransferase (SGOT/AST) =2.5× upper limit of normal value (ULN); ? Creatinine clearance (Ccr) =60 ml/min. (8) All adverse events recovered to grade 1 or less before enrollment (NCI CTCAE version 5.0); (9) patients without major organ dysfunction and heart disease; (10) Women and men of childbearing potential must agree to use appropriate contraception before and during study participation.
Exclusion criteria
Exclusion criteria: (1) symptomatic, uncontrolled brain or leptomeningeal metastases; Patients who had received previous systemic radical treatment for brain metastases (radiotherapy or surgery), if stable disease had been maintained for at least 1 month as confirmed by imaging, and if systemic hormone therapy (dose> 10mg/ day prednisone or other effective hormones) for more than 2 weeks without clinical symptoms. (2) patients received radiotherapy, chemotherapy, major surgery, targeted therapy or immunotherapy within 2 weeks before enrollment; Patients received endocrine therapy within 1 week before enrollment. Chemotherapy with nitrosourea or mitomycin was administered within 6 weeks before enrollment. (3) participated in other clinical trials of new drugs within 4 weeks before enrollment; (4) there can't be controlled by drainage or pneumatic methods third space effusion; (5) patients with other malignant tumors within the past 3 years, excluding radical cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma; (6) suffering from serious or uncontrolled diseases, including but not limited to: 1) active viral infection, such as HIV or HBV active (HbsAg positive and HBV-DNA=103, hepatitis C antibody positive); 2) history of severe cardiovascular disease: uncontrolled hypertension; Myocardial infarction, unstable arrhythmia, congestive heart failure, pericarditis, myocarditis, etc. Patients with NYHA class ?-? cardiac dysfunction, or left ventricular ejection fraction (LVEF) < 50% by echocardiography; 3) severe infection (e.g., intravenous antibiotic, antifungal, or antiviral therapy according to clinical practice) within 4 weeks prior to the first dose or unexplained fever during screening/before the first dose; 38.3°C (fever due to cancer, as judged by the investigator, was eligible); (7) patients with a history of psychotropic drug abuse and unable to abstain or with mental disorders; Or accompanied by swallowing and absorption dysfunction; (8) patients with other concomitant diseases that seriously endanger the safety of patients or affect the completion of the study according to the judgment of the investigators; (9) patients with known history of allergy to the components of this regimen; A history of immunodeficiency, including testing positive for HIV, HCV or other acquired or congenital immunodeficiency disorders, or a history of organ transplantation; (10) pregnant or lactating women; (11) Patients deemed unsuitable for inclusion by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| tPFS;OS;Clinical benefit rate;Disease control rate; | — |
Countries
CHIINA
Contacts
Public ContactYan Min
Henan Cancer hospital
Outcome results
None listed