Routine Therapy Plus Moxifloxacin in Advanced Breast Cancer

Advanced Breast Cancer Clinical Trial

Official title:

Routine Therapy Plus Moxifloxacin in Advanced Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03405168
• Other study ID #: SYSUCC-008
• Status: Completed
• Phase: Phase 2
• Start date: January 1, 2018
• Est. completion date: July 30, 2018

Study information

• Verified date: November 2018
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: July 30, 2018
• Est. primary completion date: July 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Breast Cancer
• Antibiotic
• Breast Neoplasms
• Stable Disease With a Trend of Progression

Intervention

Drug:
• Moxifloxacin Hydrochloride 400mg Tablet
Moxifloxacin is oral administration, 400 mg once a day, D1 to D7, 28 days as one cycle.

Locations

Country	Name	City	State
China	Zhongyu Yuan	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

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