Capecitabine and Pseudomonas Aeruginosa Combination in Metastatic Breast Cancer (MBC)
This study is currently recruiting participants.
Verified October 2012 by Fudan University
Sponsor:
Fudan University
Information provided by (Responsible Party):
Xichun Hu, Fudan University
ClinicalTrials.gov Identifier:
NCT01380808
First received: May 10, 2011
Last updated: October 5, 2012
Last verified: October 2012
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Purpose
The progression free survival could be prolonged adding pseudomonas aeruginosa to monotherapy capecitabine.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Breast Cancer |
Drug: capecitabine and pseudomonas aeruginosa combination |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Capecitabine and Pseudomonas Aeruginosa Combination in the Salvage Treatment of Metastatic Breast Cancer |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Capecitabine
U.S. FDA Resources
Further study details as provided by Fudan University:
Primary Outcome Measures:
- progression free survival [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- overall response rate [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 96 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: experimental arm
capecitabine and pseudomonas aeruginosa combination
|
Drug: capecitabine and pseudomonas aeruginosa combination
capecitabine 1000mg/m2 bid, po. pseudomonas aeruginosa 0.5ml loading dose,1ml qod ih.
Other Names:
|
Detailed Description:
the efficacy of the combination is much better than monotherapy
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01380808
Contacts
| Contact: Biyun Wang, MD | 64175590 ext 5000 | wangbiyun@msn.com |
Locations
| China | |
| Fudan University Cancer Hospital | Recruiting |
| Shanghai, China, 200032 | |
| Contact: Biyun Wang, MD 64175590 ext 5000 wangbiyun@msn.com | |
Sponsors and Collaborators
Fudan University
Investigators
| Principal Investigator: | Xichun Hu, MD,PhD | Fudan University |
More Information
No publications provided
| Responsible Party: | Xichun Hu, Dr, Fudan University |
| ClinicalTrials.gov Identifier: | NCT01380808 History of Changes |
| Other Study ID Numbers: | Fudan BR2011-05 |
| Study First Received: | May 10, 2011 |
| Last Updated: | October 5, 2012 |
| Health Authority: | China: Ethics Committee |
Additional relevant MeSH terms:
|
Breast Neoplasms Pseudomonas Infections Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Gram-Negative Bacterial Infections Bacterial Infections Capecitabine Fluorouracil |
Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013