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Trial record 18 of 509 for:    MOXIFLOXACIN

Routine Therapy Plus Moxifloxacin in Advanced Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03405168
Recruitment Status : Completed
First Posted : January 19, 2018
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Zhong-yu Yuan, 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.

Condition or disease Intervention/treatment Phase
Advanced Breast Cancer Antibiotic Stable Disease With a Trend of Progression Drug: Moxifloxacin Hydrochloride 400mg Tablet Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Routine Therapy Plus Moxifloxacin in Advanced Breast Cancer
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : July 30, 2018
Actual Study Completion Date : July 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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.




Primary Outcome Measures :
  1. progression-free survival (PFS) [ Time Frame: 1years ]
    the time from the beginning of treatment for metastatic breast cancer to disease progression or death from any cause


Secondary Outcome Measures :
  1. objective response rate (ORR) [ Time Frame: 6 months ]
    the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period

  2. clinical benefit rate (CBR) [ Time Frame: 6 months ]
    the proportion of patients with tumors complete response, partial response, and stable disease

  3. overal survival(OS) [ Time Frame: 3 years ]
    the time from the beginning of treatment for metastatic breast cancer to death from any cause



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03405168


Locations
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China, Guangdong
Zhongyu Yuan
Guangzhou, Guangdong, China, 510000
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Study Director: jiajia huang Sun-yatsen University Cancer center

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Responsible Party: Zhong-yu Yuan, MD, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03405168     History of Changes
Other Study ID Numbers: SYSUCC-008
First Posted: January 19, 2018    Key Record Dates
Last Update Posted: November 16, 2018
Last Verified: November 2018

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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
Additional relevant MeSH terms:
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Moxifloxacin
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs