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OncoMatch/Clinical Trials/NCT06268652

Patient Derived Organoid-guided Personalized Treatment Versus Treatment of Physician's Choice in Breast Cancer

Is NCT06268652 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Gemcitabine and Capecitabine for breast cancer.

Phase 3RecruitingSun Yat-sen UniversityNCT06268652Data as of May 2026

Treatment: Gemcitabine · Capecitabine · Vinorelbine · EribulinThis multicenter, open-label, randomized phase III trial is designed to study the efficacy and safety of organoid-guided personalized treatment (OGPT)versus treatment of physician's choice (TPC) in previously treated refractory breast cancer.

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 2 prior lines

Lab requirements

Blood counts

WBC ≥3 × 10^9/L; ANC ≥1.5 × 10^9/L; PLT ≥100 × 10^9/L; Hgb ≥8g/dL

Kidney function

serum creatinine clearance (CG formula) > 30 mL/min

Liver function

AST (SGOT), ALT (SGPT) ≤ 2.5 × ULN (no liver invasion) or ≤ 5 × ULN (with liver invasion); total bilirubin (TBIL) ≤ ULN

Cardiac function

No serious organ (main organ: heart, lung, liver, kidney) functional abnormalities (refer to respective standards); Exclude NYHA Class III or IV heart failure, poorly controlled coronary artery disease or arrhythmia, or history of myocardial infarction within 6 months

No serious organ (main organ: heart, lung, liver, kidney) functional abnormalities (refer to respective standards); Routine blood test: white blood cells (WBC) ≥3 × 10^9/L; absolute neutrophil count (ANC) ≥1.5 × 10^9/L; platelets (PLT) ≥100 × 10^9/L; hemoglobin (Hgb) ≥8g /dL; Blood biochemical indicators: AST (SGOT), ALT (SGPT) ≤ 2.5 × ULN (no liver invasion) or ≤ 5 × ULN (with liver invasion); total bilirubin (TBIL) ≤ ULN; serum creatinine clearance (CG formula) > 30 mL/min; Coagulation function: PT, INR ≤ 1.5 × ULN (unless warfarin is being used for anticoagulation)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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