breast cancer
Conditions
Interventions
Endocrine group:endocrine therapy
Sponsors
Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Adult female (aged 18-75 years old, including 18 and 75 years old); 2. Eastern Cooperative Oncology Group performance status (ECOG PS) score 0-1; 3. The expected survival time is not less than 3 months; 4. Pathologically confirmed hormone receptor (ER - and PR-positive) and HER2-negative advanced breast cancer (ER-positive: >1% tumor cells stained immunohistochemically; PR positive expression: immunohistochemical staining >1% of tumor cells; HER2 negative: immunohistochemistry 0,1 +, or FISH/CISH negative); HR+HER2 ? breast cancer was defined as the final subtype based on the molecular subtype results of the last biopsy if there were multiple pathological findings. 5. Pathologically confirmed metastatic breast cancer that is not suitable for local surgical; 6. No treatment for recurrence and metastasis; 7. mIHC4 value was calculated according to the formula: mIHC4=94.7*{-0.100*ER%/10-0.079*PgR%/10+0.586*Her2 +0.240*ln(1+10*Ki67)}, and the mIHC4 value of the patient should be >39.8. 8. Blood routine examination within 1 week before enrollment was basically normal: a. White blood cell count (WBC) =3.0×10^9 / L, b. Neutrophil count (ANC) =1.5×10^9 / L, c. Platelet count (PLT) =75×10^9 / L; 9. Liver and kidney function tests within 1 week before enrollment were basically normal (based on the normal values of the participating laboratory) : a. Total bilirubin (TBIL) =1.5× upper limit of normal value (ULN), b. alanine aminotransferase and aspartate aminotransferase (ALT/AST) =2.5×ULN (=5×ULN in patients with liver metastases), c. Serum creatinine =1.5×ULN or creatinine clearance (Ccr) =60 ml/min; 10.Informed consent was obtained.
Exclusion criteria
Exclusion criteria: 1. Central nervous system metastasis (including brain parenchyma, leptomeningeal and spinal meningeal metastasis). 2. Concomitant diseases or conditions that may interfere with study participation, or any serious medical disorder that may affect the safety of the subjects (e.g., uncontrolled heart disease, hypertension, active or uncontrolled infection, active hepatitis B virus infection); 3. Pregnant or lactating patients; 4. Received more than one cycle of systemic therapy (including chemotherapy and endocrine therapy) for recurrent and metastatic lesions. 5. Plan to receive chemotherapy combined with endocrine therapy (endocrine therapy refers to SERM, AI, CDK4/6 inhibitors, fulvestrant, siddamide, everolimus and other drugs, excluding ovarian function suppression); 6. Patients with recurrence and metastasis without evaluable lesions after surgical resection; 7, mIHC4=39.8;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survive(OS);Objective response rate (ORR, CR+PR);Clinical benefit rate (CBR, CR+PR+SD); | — |
Countries
China
Contacts
Public ContactLiang Jin
Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Outcome results
None listed