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

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. Identifier: NCT01380808
Recruitment Status : Completed
First Posted : June 27, 2011
Last Update Posted : July 26, 2013
Information provided by (Responsible Party):
Xichun Hu, Fudan University

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

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: capecitabine and pseudomonas aeruginosa combination Phase 2

Detailed Description:
the efficacy of the combination is much better than monotherapy

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Capecitabine and Pseudomonas Aeruginosa Combination in the Salvage Treatment of Metastatic Breast Cancer
Study Start Date : May 2011
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: experimental arm
capecitabine and pseudomonas aeruginosa combination
Drug: capecitabine and pseudomonas aeruginosa combination
capecitabine 1000mg/m2 bid, po. pseudomonas aeruginosa 0.5ml loading dose,1ml qod ih.
Other Names:
  • capecitabine
  • pseudonomas aeruginosa

Primary Outcome Measures :
  1. progression free survival [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. overall response rate [ Time Frame: 1 year ]

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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

Inclusion Criteria:

  1. Female between 18 and 70 years old
  2. Patients with histologic proved metastatic breast cancer, unsuitable to be treated locally.
  3. 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)
  4. Disease progression after anthracycline and/or taxane regimen therapy and candidate for capecitabine monotherapy
  5. 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
  6. Karnofsky score more than 70;ECOG 0~2;
  7. Normal functions with heart, liver,renal and bone marrow
  8. WBC≥4×109/L;Hb≥90 g/L;plt≥100×109/L
  9. Got ICF before enrollment

Exclusion Criteria:

  1. Pregnant or breast-feeding women or positive serum pregnancy test
  2. 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
  3. Participation in any investigational drug study within 4 weeks preceding treatment start.
  4. 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.
  5. Serious uncontrolled intercurrent infections
  6. Poor compliance

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 identifier (NCT number): NCT01380808

Fudan University Cancer Hospital
Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
Principal Investigator: Xichun Hu, MD,PhD Fudan University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Xichun Hu, Dr, Fudan University Identifier: NCT01380808     History of Changes
Other Study ID Numbers: Fudan BR2011-05
First Posted: June 27, 2011    Key Record Dates
Last Update Posted: July 26, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
Breast Neoplasms
Pseudomonas Infections
Neoplasms by Site
Breast Diseases
Skin Diseases
Gram-Negative Bacterial Infections
Bacterial Infections
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents