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 (Jun 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
Treatments studied
Endocrine / hormonal
Other
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)
Demographics
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.
Frequently asked questions
Is NCT07117630 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior radiotherapy, chemotherapy, immunotherapy disqualifies patients from enrollment.
Does this trial require ESR1?
Yes, ESR1 overexpression (ER > 10% tumor cell positivity by immunohistochemistry) is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR overexpression (PR > 10% tumor cell positivity by immunohistochemistry) is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 HER2 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.
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