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OncoMatch/Clinical Trials/NCT04215003

A Clinical Trial of Breast Cancer Neo-adjuvant Therapy Based on Molecular Pathway in FUSCC

Is NCT04215003 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including A and B for breast cancer.

Phase 1/2RecruitingFudan UniversityNCT04215003Data as of May 2026

Treatment: A · B · CL4This is a Phase Ib/II, prospective , open-label, single center, Bayesian adaptive design, umbrella study evaluating the efficacy and safety of neo-adjuvant therapy in patients with breast cancer.

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Disease stage

Required: Stage IIB, IIIC

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: chemotherapy

Naïve to chemotherapy or hormonal treatments

Cannot have received: hormonal therapy

Naïve to chemotherapy or hormonal treatments

Cannot have received: radiotherapy

Previous regional or systemic treatment for breast cancer (include but not limited to chemotherapy, radiotherapy, targeted therapy, other clinical trials)

Cannot have received: targeted therapy

Previous regional or systemic treatment for breast cancer (include but not limited to chemotherapy, radiotherapy, targeted therapy, other clinical trials)

Cannot have received: other clinical trials

Previous regional or systemic treatment for breast cancer (include but not limited to chemotherapy, radiotherapy, targeted therapy, other clinical trials)

Lab requirements

Blood counts

neutrophil count ≥ 1.5x10^9/L, hemoglobin level ≥ 100 g/L, Platelets ≥ 100 x 10^9/L

Kidney function

serum creatinine ≤110μmol/L, urea nitrogen ≤7.1mmol/L

Liver function

serum aminotransferase (AST) ≤ 60U/L, serum total bilirubin ≤ 2.5 times ULN

Cardiac function

Normal heart function, with normal ECG and LVEF ≥ 55%

Adequate bone marrow function, blood routine examination shows neutrophil count ≥ 1.5x109/L, hemoglobin level ≥ 100 g/L, Platelets ≥ 100 x 109/L Adequate liver and kidney function, serum aminotransferase (AST) ≤ 60U/L, serum total bilirubin ≤ 2.5 times ULN, serum creatinine ≤110μmol/L, urea nitrogen ≤7.1mmol/L ... Normal heart function, with normal ECG and LVEF ≥ 55%

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

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