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

Phase 2
18 Years
70 Years
Open (Enrolling)
Metastatic Breast Cancer

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Trial Information

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

the efficacy of the combination is much better than monotherapy

Inclusion Criteria:

1. Female between 18 and 70 years old

2. Patients with histologic proved metastatic breast cancer, unsuitable to be treated

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

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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

progression free survival

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Xichun Hu, MD,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University


China: Ethics Committee

Study ID:

Fudan BR2011-05



Start Date:

May 2011

Completion Date:

December 2013

Related Keywords:

  • Metastatic Breast Cancer
  • Breast Neoplasms
  • Pseudomonas Infections