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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Xichun Hu, Fudan University
ClinicalTrials.gov Identifier:
NCT01380808
First received: May 10, 2011
Last updated: July 25, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention Phase
Metastatic Breast Cancer
Drug: capecitabine and pseudomonas aeruginosa combination
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • progression free survival [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • overall response rate [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: May 2011
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

the efficacy of the combination is much better than monotherapy

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01380808

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

No publications provided

Responsible Party: Xichun Hu, Dr, Fudan University
ClinicalTrials.gov Identifier: NCT01380808     History of Changes
Other Study ID Numbers: Fudan BR2011-05
Study First Received: May 10, 2011
Last Updated: July 25, 2013
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Capecitabine
Fluorouracil
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014