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

Metastatic Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01380808
• Other study ID #: Fudan BR2011-05
• Status: Completed
• Phase: Phase 2
• First received: May 10, 2011
• Last updated: July 25, 2013
• Start date: May 2011
• Est. completion date: July 2013

Study information

• Verified date: July 2013
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Description:

the efficacy of the combination is much better than monotherapy

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• capecitabine and pseudomonas aeruginosa combination
capecitabine 1000mg/m2 bid, po. pseudomonas aeruginosa 0.5ml loading dose,1ml qod ih.

Locations

Country	Name	City	State
China	Fudan University Cancer Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression free survival		1 year	Yes
Secondary	overall response rate		1 year	Yes