OncoMatch/Clinical Trials/NCT05594095
SNF Platform Study of HR+/ HER2-advanced Breast Cancer
Is NCT05594095 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for breast neoplasm.
Treatment: PIK3CA inhibitor · AKT inhibitor · Carrelizumab · Famitinib · Fluzoparib · Dalpiciclib · SHR-A1811 · Everolimus · Aromatase Inhibitors or Fulvestrant · Goserelin · TPC · Sorafenib · Apatinib · SHR-A1921 · SHR-A2102 · SHR-A2009 · SHR-1167 · SHR-6209 · bevacizumab — The purpose of this study is to establish a prospective, multi-center platform research based on clinical subtypes to explore precision therapy in patients hormone-receptor-positive HER2-negative advanced breast cancer who had previously used CDK4/6 inhibitors.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 overexpression (ER >10% positive tumor cells by immunohistochemistry)
ER >10% positive tumor cells by immunohistochemistry is defined as ER positive
Required: PR (PGR) overexpression (PR >10% positive tumor cells by immunohistochemistry)
PR >10% positive tumor cells is defined as PR positive
Required: HER2 (ERBB2) negative (HER2 0-1+ or HER2+ but negative by FISH without amplification)
HER2 0-1+ or HER2 + but negative by FISH without amplification was defined as HER2 negative
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: CDK4/6 inhibitor
HR+/HER2- advanced breast cancer patients who had previously received CDK4/6 inhibitor therapy
Cannot have received: radiotherapy
Exception: not within 3 weeks before the start of the study
They have not received radiotherapy, molecular targeted therapy, or surgery within 3 weeks before the start of the study
Cannot have received: molecular targeted therapy
Exception: not within 3 weeks before the start of the study
They have not received radiotherapy, molecular targeted therapy, or surgery within 3 weeks before the start of the study
Cannot have received: surgery
Exception: not within 3 weeks before the start of the study
They have not received radiotherapy, molecular targeted therapy, or surgery within 3 weeks before the start of the study
Cannot have received: chemotherapy
Exception: not within 3 weeks before the start of the study
Radiotherapy (except for palliative causes), chemotherapy, and immunotherapy were used in the first 3 weeks of treatment, except bisphosphonate (which can be used for bone metastasis)
Cannot have received: immunotherapy
Exception: not within 3 weeks before the start of the study
Radiotherapy (except for palliative causes), chemotherapy, and immunotherapy were used in the first 3 weeks of treatment, except bisphosphonate (which can be used for bone metastasis)
Lab requirements
Blood counts
HB ≥90 g/L (no blood transfusion within 14 days); ANC ≥1.5 x 10^9 / L; PLT ≥75 x 10^9 / L
Kidney function
Serum Cr ≤1×ULN, endogenous creatinine clearance > 50 ml/min (Cockcroft-Gault formula)
Liver function
TBIL ≤1.5×ULN; ALT and AST ≤3×ULN; If liver metastases were present, ALT and AST≤ 5×ULN
The functions of the main organs are basically normal and meet the following conditions: ... see above
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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