Metastatic Breast CancerPhase 2NCT01380808
Capecitabine and Pseudomonas Aeruginosa Combination in Metastatic Breast Cancer (MBC)
A Phase 2 study testing capecitabine and pseudomonas aeruginosa combination in people with Metastatic Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
The progression free survival could be prolonged adding pseudomonas aeruginosa to monotherapy capecitabine. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- capecitabine and pseudomonas aeruginosa combination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- May 2011to Jul 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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；
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of Capecitabine and Pseudomonas Aeruginosa Combination in the Salvage Treatment of Metastatic Breast Cancer
The progression free survival could be prolonged adding pseudomonas aeruginosa to monotherapy capecitabine.
Read the detailed description
the efficacy of the combination is much better than monotherapy
- Conditions
- Metastatic Breast Cancer
- Being tested
- capecitabine and pseudomonas aeruginosa combination
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capecitabine and pseudomonas aeruginosa combinationDrug
Also called capecitabine, pseudonomas aeruginosa
capecitabine 1000mg/m2 bid, po. pseudomonas aeruginosa 0.5ml loading dose,1ml qod ih.
| Study group | Role | What they receive |
|---|---|---|
| experimental arm | Experimental | capecitabine and pseudomonas aeruginosa combination Receives: Drug: capecitabine and pseudomonas aeruginosa combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
Measured: 1 year
Secondary outcomes (1)
overall response rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xichun Hu, Fudan University
- Investigators
- Xichun Hu, MD,PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01380808
- Sponsor's protocol ID
- Fudan BR2011-05
- Status last verified
- Jul 2013
- First submitted
- 10 May 2011
- Last updated
- 26 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25768439
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Capecitabine and Pseudomonas Aeruginosa Combination in the Salvage Treatment of Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT01380808
- Acronym / sponsor ID
- Fudan BR2011-05
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 27 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The progression free survival could be prolonged adding pseudomonas aeruginosa to monotherapy capecitabine.
Detailed description
the efficacy of the combination is much better than monotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental arm | Experimental | Drug: capecitabine and pseudomonas aeruginosa combinationcapecitabine and pseudomonas aeruginosa combination |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| capecitabine and pseudomonas aeruginosa combinationAlso: capecitabine, pseudonomas aeruginosacapecitabine 1000mg/m2 bid, po. pseudomonas aeruginosa 0.5ml loading dose,1ml qod ih. | Drug | experimental arm |
Primary outcome
progression free survival
Time frame: 1 year
1 secondary outcome
overall response rate
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2013.
- Derived from this study: PubMed 25768439Lv 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xichun Hu, MD,PhD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing capecitabine and pseudomonas aeruginosa combination in people with Metastatic Breast Cancer, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free survival (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01380808, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2013.