Clinical trial · Interventional
Moxifloxacin in Adjuvant Treatment of Patients With Operable Breast Cancer
A Multicenter, Placebo-Controlled, Phase III Trial of Standard Adjuvant Chemotherapy Plus Moxifloxacin in Operable Breast Cancer
NCT05114720CI-TRIAL-00099089completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objective of this study is to compare disease-free survival (DFS) of patients with operable breast cancer randomised to treatment with standard adjuvant chemotherapy plus moxifloxacin or placebo.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| standard adjuvant chemotherapy plus moxifloxacin | Drug | — | UNRESOLVED |
| standard adjuvant chemotherapy plus placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- standard adjuvant chemotherapy plus moxifloxacin
- description
- Standard adjuvant chemotherapy (Taxanes combined with cyclophosphamide or doxorubicin combined with cyclophosphamide followed by taxanes) plus antibiotic (moxifloxacin) Other Name: docetaxel 75mg/m\^2, or nab-paclitaxel 260mg/m\^2, IV, days 1, cycled every 21 days cyclophosphamide 1000 mg/m\^2, IV, days 1, cycled every 21 days; or doxorubicin 60mg/m\^2, IV, days 1, combined with cyclophosphamide 600 mg/m\^2, IV, days 1, followed by docetaxel 75mg/m\^2, or nab-paclitaxel 260mg/m\^2, IV, days 1; plus Moxifloxacin 0.4 PO once daily days 1-5; cycled every 21 days
- interventionNames
- Drug: standard adjuvant chemotherapy plus moxifloxacin
- type
- PLACEBO_COMPARATOR
- label
- standard adjuvant chemotherapy plus placebo
- description
- Standard adjuvant chemotherapy (Docetaxel combined with cyclophosphamide or doxorubicin combined with cyclophosphamide followed by docetaxel) plus placebo Other Name: docetaxel 75mg/m\^2, or nab-paclitaxel 260mg/m\^2, IV, days 1 cyclophosphamide 1000 mg/m\^2, IV, days 1, cycled every 21 days; or doxorubicin 60mg/m\^2, IV, days 1, combined with cyclophosphamide 600 mg/m\^2, IV, days 1, followed by docetaxel 75mg/m\^2, or nab-paclitaxel 260mg/m\^2, IV, days 1; plus Placebo 0.4 PO once daily days 1-5; cycled every 21 days
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Have provided written and signed informed consent; 2. Histologically confirmed invasive ductal carcinoma; 3. Planned to received (neo)/adjuvant chemotherapy; 4. Eastern Cooperative Oncology Group (ECOG) score of 0 to 1; 5. Normal blood routine, liver and kidney functions within 1 week before enrollment in this study; 6. Women of childbearing age have a negative serum or urinary pregnancy tests prior to enrollment in this study; Pre-menopause women are contracepted with medically acceptable methods during the study period. 7. Compliance with the study protocol. Exclusion Criteria: 1. Pregnant or breast feeding; 2. Eastern Cooperative Oncology Group (ECOG) score ≥ 2; 3. Hypersensitivity to moxifloxacin or quinolones compounds; 4. Concomitant with other antitumor therapies or participating in other clinical trials; 5. Have a history of heart disease, such as arrhythmia, conduction block, S-T segment elevation, ischemic heart disease, or congenital heart disease; 6. Severe uncontrolled co-infection, or severe metabolic disorders; 7. A clear past history of neurological or psychiatric disorders, including epilepsy or dementia; 8. Poor compliance, unwillingness or inability to follow protocol to continue the study; 9. Any circumstances in which the investigator deemed the subject unsuitable for enrollment in this study.
References
Publications (0)
Data not yet available
No reference posted for this study.