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Completed

NCT Number: NCT01380808

Capecitabine and Pseudomonas Aeruginosa Combination in Metastatic Breast Cancer (MBC)

The progression free survival could be prolonged adding pseudomonas aeruginosa to monotherapy capecitabine.

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Fudan University Cancer Hospital

Shanghai, 200032, China

About this study

the efficacy of the combination is much better than monotherapy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female between 18 and 70 years old
  • Patients with histologic proved metastatic breast cancer, unsuitable to be treated locally.
  • Patients with Her-2 negative breast cancer(HER-2 negative or one plus by IHC test , if HER-2 two plus by IHC,FISH result should be negative)
  • Disease progression after anthracycline and/or taxane regimen therapy and candidate for capecitabine monotherapy
  • Patients previously treated by capecitabine containing regimen should response to the chemotherapy containing capecitabine and progressed at least 4 months after the last capecitabine treatment
  • Karnofsky score more than 70;ECOG 0~2;
  • Normal functions with heart, liver,renal and bone marrow
  • WBC≥4×109/L;Hb≥90 g/L;plt≥100×109/L
  • Got ICF before enrollment

Exclusion criteria

  • Pregnant or breast-feeding women or positive serum pregnancy test
  • Uncontrolled brain metastases. Patients with brain metastases must be locally treated and the disease must be stable for at least one month at the time of enrolling
  • Participation in any investigational drug study within 4 weeks preceding treatment start.
  • Concurrent other malignancy at other sites or previous other cancer within the last 5 years, with the exception of adequately treated in situ carcinoma of cervix uteri or basal or squamous cell carcinoma of the skin or a contralateral breast cancer.
  • Serious uncontrolled intercurrent infections
  • Poor compliance

Treatment and study plan

capecitabine and pseudomonas aeruginosa combination

Drug

capecitabine 1000mg/m2 bid, po. pseudomonas aeruginosa 0.5ml loading dose,1ml qod ih.

Other names: capecitabine, pseudonomas aeruginosa

Primary outcomes

  1. progression free survival

    Time frame: 1 year

Secondary outcomes

  1. overall response rate

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

A Phase II Study of Capecitabine and Pseudomonas Aeruginosa Combination in the Salvage Treatment of Metastatic Breast Cancer

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jun 27, 2011
Registry last updated
Jul 26, 2013

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.

Published trials that share one or more normalized conditions with this study.