OncoMatch/Clinical Trials/NCT06555068
A Trial of HRS-6209 in Combination With Fulvestrant, Letrozole, HRS-8080, or HRS-1358 in Breast Cancer Patients
Is NCT06555068 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments for advanced unresectable or metastatic breast cancer.
Treatment: HRS-6209 in Combination with Fulvestrant · HRS-6209 in Combination with HRS-1358 · HRS-6209 in Combination with Letrozole · HRS-6209 in Combination with HRS-8080 · HRS-6209 in Combination with HRS-1358 — The study is being conducted to evaluate the safety, PK and efficacy of HRS-6209 in Combination with Fulvestrant, Letrozole, HRS-8080, or HRS-1358 for advanced unresectable or metastatic breast cancer
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 overexpression (positive)
histopathologically confirmed ER-positive
Required: PR (PGR) overexpression (positive)
histopathologically confirmed PR-positive
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1.5 × 10^9/L; Platelet count ≥ 90 × 10^9/L; Hemoglobin ≥ 10 g/dL
Kidney function
Normal blood creatinine or creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula)
Liver function
Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN, or ≤ 5.0 × ULN for patients with liver metastasis
Cardiac function
LVEF ≥ 50%; QTcF ≤ 470 msec; PT and APTT ≤ 1.5 × ULN
Absolute neutrophil count ≥ 1.5 × 10^9/L; Platelet count ≥ 90 × 10^9/L; Hemoglobin ≥ 10 g/dL; Normal blood creatinine or creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula); Serum albumin ≥ 3.0 g/dL; Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN, or ≤ 5.0 × ULN for patients with liver metastasis; PT and APTT ≤ 1.5 × ULN; Urine protein < 2+ or 24-h urine protein < 1 g; LVEF ≥ 50%; QTcF ≤ 470 msec.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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