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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 (Jun 2026). This Phase 1/2 trial studies multiple treatments including A and B for breast cancer.

Phase 1/2RecruitingFudan UniversityNCT04215003Data as of Jun 2026Location: China

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

Treatments studied

Other

ABCL4

Cancer type

Breast Carcinoma

Disease stage

Required: Stage IIB, IIIC

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 70
Female only

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.

Frequently asked questions

Is NCT04215003 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

What disease stage is eligible?

Stage IIB or IIIC is required.

Is there an age limit?

Yes. Patients must be 70 years or younger.

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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