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 (Sep 2026). This Phase 2 trial studies multiple treatments for breast cancer.
Treatment: L-Ornithine L-Aspartate · CDK4/6 inhibitor · Fulvestrant · N-Acetylcysteine (NAC) Treatment · Pioglitazone (PIO) · PARP inhibitor — This is a prospective, Phase II, open-label, two-arm parallel study evaluating the efficacy and safety of combined treatment (L-Ornithine L-Aspartate, N-Acetylcysteine) with CDK4/6 inhibitors and Fulvestrant 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 expression (>10% tumor cell positivity by immunohistochemistry)
ER > 10% tumor cell positivity by immunohistochemistry is defined as ER positive
Required: PR (PGR) expression (>10% tumor cell positivity by immunohistochemistry)
PR > 10% tumor cell positivity is defined as PR positive
Required: HER2 (ERBB2) wild-type (0-1+ by IHC or 2+ but negative by FISH without amplification)
HER2 0 - 1+ or HER2 ++ but negative by FISH without amplification is defined as HER2 negative
Excluded: BRCA1 pathogenic germline mutation
patients with pathogenic germline BRCA1/2 mutations
Excluded: BRCA2 pathogenic germline mutation
patients with pathogenic germline BRCA1/2 mutations
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
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.
Is prior treatment required for enrollment?
Yes. Patients must have previously received CDK4/6 inhibitor and endocrine therapy.
Does this trial require ESR1?
Yes, ESR1 expression is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR expression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
Are patients with BRCA1 alterations eligible?
No. BRCA1 pathogenic germline mutation is an exclusion criterion.
Are patients with BRCA2 alterations eligible?
No. BRCA2 pathogenic germline mutation is an exclusion criterion.
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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