Capecitabine and Pseudomonas Aeruginosa Combination in Metastatic Breast Cancer (MBC)
NCT ID: NCT01380808
Last Updated: 2013-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
100 participants
INTERVENTIONAL
2011-05-31
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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experimental arm
capecitabine and pseudomonas aeruginosa combination
capecitabine and pseudomonas aeruginosa combination
capecitabine 1000mg/m2 bid, po. pseudomonas aeruginosa 0.5ml loading dose,1ml qod ih.
Interventions
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capecitabine and pseudomonas aeruginosa combination
capecitabine 1000mg/m2 bid, po. pseudomonas aeruginosa 0.5ml loading dose,1ml qod ih.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
70 Years
FEMALE
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Xichun Hu
Dr
Principal Investigators
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Xichun Hu, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Fudan University Cancer Hospital
Shanghai, , China
Countries
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References
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Lv F, Cao J, Liu Z, Wang Z, Zhang J, Zhang S, Wang L, Zhao X, Shao Z, Wang B, Hu X. Phase II study of Pseudomonas aeruginosa-Mannose-Sensitive hemagglutinin in combination with capecitabine for Her-2-negative metastatic breast cancer pretreated with anthracycline and taxane. PLoS One. 2015 Mar 13;10(3):e0118607. doi: 10.1371/journal.pone.0118607. eCollection 2015.
Other Identifiers
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Fudan BR2011-05
Identifier Type: -
Identifier Source: org_study_id
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