OncoMatch/Clinical Trials/NCT07117630
An Open-Label, Bayesian Adaptive Phase II Clinical Study in HR+/HER2- Advanced Breast Cancer After Progression on Standard Therapy
Is NCT07117630 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including L-Ornithine L-Aspartate and CDK4/6 inhibitor for breast cancer.
Treatment: L-Ornithine L-Aspartate · CDK4/6 inhibitor · Fulvestrant — This is a prospective, open-label, Bayesian adaptive Phase 2 clinical trial evaluating the efficacy and safety of a novel triple-combination therapy (CDK4/6 inhibitors + Fulvestrant + L-Ornithine L-Aspartate) in patients with HR-positive/HER2-negative advanced breast cancer (ABC) who have progressed on prior standard therapy including CDK4/6 inhibitors and endocrine therapy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 overexpression (ER > 10% tumor cell positivity by immunohistochemistry) (ER > 10% tumor cell positivity by immunohistochemistry)
ER > 10% tumor cell positivity by immunohistochemistry is defined as ER positive
Required: PR (PGR) overexpression (PR > 10% tumor cell positivity by immunohistochemistry) (PR > 10% tumor cell positivity by immunohistochemistry)
PR > 10% tumor cell positivity is defined as PR positive
Required: HER2 (ERBB2) HER2 negative (HER2 0 - 1+ or HER2 ++ but negative by FISH without amplification) (HER2 0 - 1+ or HER2 ++ but negative by FISH without amplification)
HER2 0 - 1+ or HER2 ++ but negative by FISH without amplification is defined as HER2 negative
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: CDK4/6 inhibitor
disease progression after receiving systemic therapy including CDK4/6 inhibitors and endocrine therapy
Must have received: endocrine therapy
disease progression after receiving systemic therapy including CDK4/6 inhibitors and endocrine therapy
Cannot have received: radiotherapy
Exception: palliative reasons
Patients who have received radiotherapy (except for palliative reasons)...within 3 weeks prior to treatment.
Cannot have received: chemotherapy
Patients who have received...chemotherapy...within 3 weeks prior to treatment.
Cannot have received: immunotherapy
Patients who have received...immunotherapy...within 3 weeks prior to treatment.
Cannot have received: bisphosphonates
Exception: bone metastases
Patients who have received...bisphosphonates (except for bone metastases) within 3 weeks prior to treatment.
Cannot have received: molecular targeted therapy
Patients who have not received...molecular targeted therapy...within 3 weeks prior to the start of the study
Cannot have received: surgery
Exception: minor outpatient surgery, such as placement of vascular access
Patients who have undergone major surgery (except for minor outpatient surgery, such as placement of vascular access) within 3 weeks of the first course of study treatment.
Lab requirements
Blood counts
HB ≥ 90 g/L (no blood transfusion within 14 days); ANC ≥ 1.5 × 10^9/L; PLT ≥ 75 × 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 metastasis is present, then ALT and AST ≤ 5 × ULN
Patients whose main organs function normally by meeting the following requirements: Hematology criteria: HB ≥ 90 g/L (no blood transfusion within 14 days); ANC ≥ 1.5 × 10^9/L; PLT ≥ 75 × 10^9/L; Blood chemistry criteria: TBIL ≤ 1.5 × ULN (upper limit of normal); ALT and AST ≤ 3 × ULN; if liver metastasis is present, then ALT and AST ≤ 5 × ULN; serum Cr ≤ 1× ULN, endogenous creatinine clearance > 50 mL/min (Cockcroft-Gault formula);
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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