OncoMatch/Clinical Trials/NCT05594095
SNF Platform Study of HR+/ HER2-advanced Breast Cancer
Is NCT05594095 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Targeted therapy
Endocrine / hormonal
Other
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)
Demographics
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.
Frequently asked questions
Is NCT05594095 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior radiotherapy, molecular targeted therapy, surgery disqualifies patients from enrollment.
Does this trial require ESR1?
Yes, ESR1 overexpression is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR overexpression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 negative (HER2 0-1+ or HER2+ but negative by FISH without amplification) is a required biomarker for enrollment.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify