Routine Therapy Plus Moxifloxacin in Advanced Breast Cancer

NCT03405168 | Completed Phase 2 DMC

• 1 other identifier: SYSUCC-008
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Breast Cancer; Antibiotic; Stable Disease With a Trend of Progression

Outcome Measures

Primary Outcomes (1)

• progression-free survival (PFS)

  the time from the beginning of treatment for metastatic breast cancer to disease progression or death from any cause

  1years

Secondary Outcomes (3)

• objective response rate (ORR)

  6 months

• clinical benefit rate (CBR)

  6 months

• overal survival(OS)

  3 years

Study Arms (1)

routine therapy plus moxifloxacin

EXPERIMENTAL

Routine therapy (chemotherapy, endocrine therapy or target therapy) is according to physician's choice.

Drug: Moxifloxacin Hydrochloride 400mg Tablet

Interventions

Moxifloxacin Hydrochloride 400mg Tablet DRUG

Moxifloxacin is oral administration, 400 mg once a day, D1 to D7, 28 days as one cycle.

routine therapy plus moxifloxacin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Zhongyu Yuan

Guangzhou, Guangdong, 510000, China

Location

Related Publications (1)

• Wang X, Li J, Shi W, Huang Z, Xia W, Huang J, Su Y, Wang S, Shi Y, Bi X, Yuan Z. Efficacy of Moxifloxacin plus Treatment of Physician's Choice in Patients with Metastatic Breast Cancer. Oncologist. 2020 Oct;25(10):e1439-e1445. doi: 10.1634/theoncologist.2020-0364. Epub 2020 Jun 1.

  PMID: 32390277 DERIVED

MeSH Terms

Interventions

Moxifloxacin; Tablets

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Officials

• jiajia huang

  Sun-yatsen University Cancer center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 14, 2018
• First Posted: January 19, 2018
• Study Start: January 1, 2018
• Primary Completion: July 30, 2018
• Study Completion: July 30, 2018
• Last Updated: November 16, 2018

Record last verified: 2018-11

Locations

CN (1)