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 (Jun 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
Treatments studied
Endocrine / hormonal
Other
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)
Demographics
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.
Frequently asked questions
Is NCT06555068 currently recruiting?
Yes, this trial is currently recruiting patients.
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.
Is there an age limit?
Yes. Patients must be 75 years or younger.
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