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

Fudan University

Status and phase: Completed; Phase 2

Conditions: Metastatic Breast Cancer

Treatments: Drug: capecitabine and pseudomonas aeruginosa combination

Study type: Interventional

Funder types: Other

Identifiers

NCT01380808

Fudan BR2011-05

Details and patient eligibility

About

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

Full description

the efficacy of the combination is much better than monotherapy

Enrollment: 100 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

experimental arm

Experimental group

Description:

capecitabine and pseudomonas aeruginosa combination

Treatment:

Drug: capecitabine and pseudomonas aeruginosa combination