Routine Therapy Plus Moxifloxacin in Advanced Breast Cancer

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.

Study Overview

• Status: Completed
• Conditions: Advanced Breast Cancer; Antibiotic; Stable Disease With a Trend of Progression
• Intervention / Treatment: Drug: Moxifloxacin Hydrochloride 400mg Tablet

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 Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Zhongyu Yuan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: routine therapy plus moxifloxacin; Routine therapy (chemotherapy, endocrine therapy or target therapy) is according to physician's choice.	Drug: Moxifloxacin Hydrochloride 400mg Tablet; Moxifloxacin is oral administration, 400 mg once a day, D1 to D7, 28 days as one cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Study Director: jiajia huang, Sun-yatsen University Cancer center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2018
• Primary Completion (ACTUAL): July 30, 2018
• Study Completion (ACTUAL): July 30, 2018

Study Registration Dates

• First Submitted: January 14, 2018
• First Submitted That Met QC Criteria: January 14, 2018
• First Posted (ACTUAL): January 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 16, 2018
• Last Update Submitted That Met QC Criteria: November 14, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral, Combined; Contraceptives, Oral; Contraceptive Agents, Female; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
• Other Study ID Numbers: SYSUCC-008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No