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

NCT01380808 | Completed Phase 2 DMC

• 1 other identifier: Fudan BR2011-05
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• progression free survival

  1 year

Secondary Outcomes (1)

• overall response rate

  1 year

Study Arms (1)

experimental arm

EXPERIMENTAL

capecitabine and pseudomonas aeruginosa combination

Drug: capecitabine and pseudomonas aeruginosa combination

Interventions

capecitabine and pseudomonas aeruginosa combination DRUG

capecitabine 1000mg/m2 bid, po. pseudomonas aeruginosa 0.5ml loading dose,1ml qod ih.

Also known as: capecitabine, pseudonomas aeruginosa

experimental arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female between 18 and 70 years old
• Patients with histologic proved metastatic breast cancer, unsuitable to be treated locally.
• 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)
• Disease progression after anthracycline and/or taxane regimen therapy and candidate for capecitabine monotherapy
• 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
• Karnofsky score more than 70；ECOG 0\~2；
• Normal functions with heart, liver,renal and bone marrow
• WBC≥4×109/L；Hb≥90 g/L；plt≥100×109/L
• Got ICF before enrollment

You may not qualify if:

• Pregnant or breast-feeding women or positive serum pregnancy test
• 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
• Participation in any investigational drug study within 4 weeks preceding treatment start.
• 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.
• Serious uncontrolled intercurrent infections
• Poor compliance

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, 200032, China

Location

Related Publications (1)

• 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.

  PMID: 25768439 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Xichun Hu, MD,PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: May 10, 2011
• First Posted: June 27, 2011
• Study Start: May 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: July 26, 2013

Record last verified: 2013-07

Locations

CN (1)