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Completed

NCT Number: NCT03405168

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.

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Zhongyu Yuan

Guangzhou, Guangdong, 510000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Moxifloxacin Hydrochloride 400mg Tablet

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 19, 2018
Registry last updated
Nov 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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