OncoMatch/Clinical Trials/NCT04722978
Standard Chemotherapy Plus Moxifloxacin as First-line Treatment for Metastatic Triple-negative Breast Cancer
Is NCT04722978 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies Gemcitabine and carboplatin plus antibiotic (moxifloxacin) for triple negative breast cancer.
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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
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)
Demographics
Prior therapy
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.
Frequently asked questions
Is NCT04722978 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.
Does this trial require ESR1?
Yes, ESR1 wild-type is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR wild-type 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 mutation is an exclusion criterion.
Are patients with BRCA2 alterations eligible?
No. BRCA2 pathogenic mutation is an exclusion criterion.
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.
Check if I qualify