Predicted Biomarkers of CDK4/6 Inhibitors (Palbociclib) in ER-positive Metastasis Breast Cancer

Exclusion Criteria

• •no prior treatment
• •receiving treatment other than the trial 4 weeks prior to the study, or participating in another clinical study
• •unwilling to provide tissue and blood for genetic testing
• •non-resistant on endocrine therapy before treating with palbociclib
• •progress of ≥ 2nd line endocrine therapy
• •patients with advanced disease, symptoms, visceral spread, and life-threatening complications in the short term (including large uncontrollable spills \[thoracic, pericardium, abdominal cavity\], pulmonary lymphangitis, and liver involvement\>50%)
• •patients with active, uncontrolled or symptomatic central nervous system metastases, cancerous meningitis or clinical signs suggesting pia mater disease, brain edema and/or tumor growth. Patients with a history of central nervous system metastasis or spinal cord compression, if they have received local treatment (such as radiation therapy, stereotactic surgery) and are clinically stable, they need to stop convulsions and steroids for at least 4 weeks before randomization.
• •patients received major surgery, chemotherapy, radiation therapy, or other anticancer treatments within 2 weeks prior to enrollment
• •diagnosis of any other malignant tumor, within 3 years prior to the enrollment, except adequately treated basal/squamous cell skin cancer or cervical carcinoma
• •infused whole blood without leukocytes removing within 120 days prior to sampling
• •during lactation or with positive blood or urine pregnancy test