Routine Therapy Plus Moxifloxacin in Advanced Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2018-07-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Advanced Breast Cancer Antibiotic Stable Disease With a Trend of Progression

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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routine therapy plus moxifloxacin

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

Group Type EXPERIMENTAL

Moxifloxacin Hydrochloride 400mg Tablet

Intervention Type DRUG

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

Interventions

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Moxifloxacin Hydrochloride 400mg Tablet

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No