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OncoMatch/Clinical Trials/NCT04722978

Standard Chemotherapy Plus Moxifloxacin as First-line Treatment for Metastatic Triple-negative Breast Cancer

Is NCT04722978 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Gemcitabine and carboplatin plus antibiotic (moxifloxacin) for triple negative breast cancer.

Phase 3RecruitingSun Yat-Sen University Cancer CenterNCT04722978Data as of May 2026

Treatment: Gemcitabine and carboplatin plus antibiotic (moxifloxacin) — The primary objective of this study is to compare progression-free survival (PFS) of patients with metastatic triple-negative breast cancer randomised to treatment with standard chemotherapy plus moxifloxacin or placebo.

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Extracted eligibility criteria

Cancer type

Triple-Negative Breast Cancer

Breast Carcinoma

Biomarker criteria

Required: ESR1 wild-type (< 1% positive cells by IHC)

ER negative (defined as < 1% positive cells by IHC)

Required: PR (PGR) wild-type (< 1% positive cells by IHC)

progesterone receptor (PR) negative (defined as < 1% positive cells by IHC)

Required: HER2 (ERBB2) wild-type (IHC 0-1 or FISH negative)

HER2 negative (defined as IHC 0-1 staining or fluorescent in situ hybridization (FISH) negative)

Excluded: BRCA1 pathogenic mutation

Definitive breast cancer susceptibility gene (BRCA) mutation

Excluded: BRCA2 pathogenic mutation

Definitive breast cancer susceptibility gene (BRCA) mutation

Excluded: PD-L1 (CD274) positive

Programmed Cell Death-Ligand 1 (PD-L1) positive

Excluded: MSH2 deficient

mismatch repair deficient (dMMR)

Excluded: MSH6 deficient

mismatch repair deficient (dMMR)

Excluded: MLH1 deficient

mismatch repair deficient (dMMR)

Excluded: PMS2 deficient

mismatch repair deficient (dMMR)

Excluded: MSI high

microsatellite instability-high (MSI-H)

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

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

Lab requirements

Blood counts

adequate bone marrow function

Kidney function

adequate renal function

Liver function

adequate hepatic function

Cardiac function

left ventricular ejection fraction (lvef) by echocardiogram ≥45%

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

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