Routine Therapy Plus Moxifloxacin in Advanced Breast Cancer

Phase 2

Completed

• Conditions: Advanced Breast Cancer; Antibiotic; Stable Disease With a Trend of Progression
• Interventions: Drug: Moxifloxacin Hydrochloride 400mg Tablet

• Registration Number: NCT03405168
• Lead Sponsor: Sun Yat-sen University

Brief Summary

This is a phase II,single center,prospective, single arm clinical trial. The objective is to evaluate the efficacy and safety of routine therapy plus moxifloxacin in Advanced Breast Cancer whose evaluation is stable disease with a trend of progression.

Detailed Description

This is a phase II,single center,prospective, single arm clinical trial. A lot of in vitro and in vivo study demonstrate that quinolones antibiotics can increase anti-tumor effect. The objective is to evaluate the efficacy and safety of routine therapy plus moxifloxacin in Advanced Breast Cancer whose evaluation is stable disease with a trend of progression.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-01-14
• Study First Submitted QC: 2018-01-14
• Study First Posted: 2018-01-19
• Primary Completion: 2018-07-30
• Study Completion: 2018-07-30
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-14
• Last Update Posted: 2018-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 35

Inclusion Criteria

• Female ≥ 18 years, ≤70 years.
• Has measurable metastatic MBC, with at least 1 measurable lesion per RECIST criteria.
• Fail first-line or above anti-tumor treatment
• Evaluation is stable disease with a trend of progression.
• Minimum life expectancy 16 weeks
• Histological confirmation of breast cancer on primary tumour at diagnosis/on biopsy of metastasis
• ECOG Performance Status (PS) 0-2 with no deterioration over previous 2 weeks
• Normal organ function.
• Has signed a Patient Informed Consent Form

Exclusion Criteria

• Hypersensitivity to moxifloxacin or other quinolones.
• Tendon damage,peripheral neuropathy,myasthenia gravis.
• Rapidly progressive visceral disease not suitable for further therapy.
• Evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, or active infection including hepatitis B, hepatitis C and HIV
• With the exception of alopecia, any unresolved toxicities from previous therapy greater than CTCAE grade 1 before study treatment
• Evidence of dementia, altered mental status or any psychiatric condition that would prohibit understanding or rendering of informed consent
• Inability or unwillingness to comply with study procedures, including inability to take regular oral medication
• Researchers consider it is not suitable for participation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
routine therapy plus moxifloxacin	Moxifloxacin Hydrochloride 400mg Tablet	Routine therapy (chemotherapy, endocrine therapy or target therapy) is according to physician's choice.

Primary Outcome Measures

Name	Time	Method
progression-free survival (PFS)	1years	the time from the beginning of treatment for metastatic breast cancer to disease progression or death from any cause

Secondary Outcome Measures

Name	Time	Method
objective response rate (ORR)	6 months	the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period
clinical benefit rate (CBR)	6 months	the proportion of patients with tumors complete response, partial response, and stable disease
overal survival(OS)	3 years	the time from the beginning of treatment for metastatic breast cancer to death from any cause

Trial Locations

Locations (1)

Zhongyu Yuan; 🇨🇳 Guangzhou, Guangdong, China