Breast CancerPhase 2NCT00080262
Novel Epothilone (BMS-247550) in Patients With Metastatic Breast Cancer (MBC)
A Phase 2 study testing Ixabepilone in people with Breast Cancer and Metastases, run by R-Pharm at 45 sites in 10 countries.
Trial summary
The purpose of this research study is to assess the response rate of the investigational drug BMS-247550 (Ixabepilone) in women with metastatic breast cancer who are refractory to an anthracycline, a taxane, and capecitabine. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Metastases
- What is being tested?
- Ixabepilone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 45 sitesin 10 countries
- Study dates
- Feb 2004to Dec 2006
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have received all 3 drugs- an anthracycline, taxane, and capecitabine (alone or in combination) and be resistant
- No more than 3 prior chemotherapy regimens in the metastatic setting
- Must have at least one target lesion that is radiographically measurable
- Good performance status
- No history of or current brain or leptomeningeal disease
Who cannot join
None listed.
Trial locations and contacts
45 sites in 10 countries.
45 sites in 10 countries
United States17 sites
Local Institution
Asheville, North Carolina
Local Institution
Baltimore, Maryland
Local Institution
Boston, Massachusetts
Local Institution
Charlotte, North Carolina
Local Institution
Chattanooga, Tennessee
Local Institution
Houston, Texas
Local Institution
Jackson, Tennessee
Local Institution
Jacksonville, Florida
Local Institution
Knoxville, Tennessee
Local Institution
La Verne, California
Local Institution
Meriden, Connecticut
Local Institution
Nashville, Tennessee
Local Institution
New York, New York
Local Institution
Pittsburgh, Pennsylvania
Local Institution
Providence, Rhode Island
Local Institution
Salt Lake City, Utah
Local Institution
San Antonio, Texas
France7 sites
Local Institution
Besançon
Local Institution
Bobigny
Local Institution
Clermont-Ferrand
Local Institution
Dijon
Local Institution
Lyon
Local Institution
Marseille
Local Institution
Vandœuvre-lès-Nancy
South Africa5 sites
Local Institution
Fichardtpark, Free State
Local Institution
Overport, KwaZulu-Natal
Local Institution
Panorama, Western Cape
Local Institution
Port Elizabeth, Eastern Cape
Local Institution
Pretoria, Gauteng
Sweden4 sites
Local Institution
Helsingborg
Local Institution
Lund
Local Institution
Malmö
Local Institution
Stockholm
Mexico3 sites
Local Institution
Chihuahua City
Local Institution
Distrito Federal
Local Institution
Mérida, Yucatán
About this study
Official title: Phase II Study of Novel Epothilone (BMS-247550) in Patients With MBC Who Are Refractory to an Anthracycline, a Taxane, and Capecitabine
The purpose of this research study is to assess the response rate of the investigational drug BMS-247550 (Ixabepilone) in women with metastatic breast cancer who are refractory to an anthracycline, a taxane, and capecitabine.
- Conditions
- Breast Cancer, Metastases
- Being tested
- Ixabepilone
- Keywords
- Metastatic Breast Cancer
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IxabepiloneDrug
Also called BMS-247550
Solution, IV, 40 mg/m2, every 21 days, extended, until PD or discontinued for other reasons.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Ixabepilone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate as determined by the IRRC
Secondary outcomes (1)
Time to progression, duration of response, overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2004 (estimated)
- Study startFeb 2004
- Primary completionDec 2006
- Study completionDec 2006
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 Breast CancerStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 participants
Sponsor and investigators
- Lead sponsor
- R-Pharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00080262
- Sponsor's protocol ID
- CA163-081
- Status last verified
- Jan 2017
- First submitted
- 25 Mar 2004
- Last updated
- 30 Jan 2017
- Results posted
- No
Publications
Perez EA, Lerzo G, Pivot X, Thomas E, Vahdat L, Bosserman L, Viens P, Cai C, Mullaney B, Peck R, Hortobagyi GN. Efficacy and safety of ixabepilone (BMS-247550) in a phase II study of patients with advanced breast cancer resistant to an anthracycline, a taxane, and capecitabine. J Clin Oncol. 2007 Aug 10;25(23):3407-14. doi: 10.1200/JCO.2006.09.3849. Epub 2007 Jul 2.
PubMed 17606974
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Novel Epothilone (BMS-247550) in Patients With MBC Who Are Refractory to an Anthracycline, a Taxane, and Capecitabine
- ClinicalTrials.gov ID
- NCT00080262
- Acronym / sponsor ID
- CA163-081
- Conditions
- Breast Cancer, Metastases
- Keywords
- Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants
- Lead sponsor
- R-PharmIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 26 Mar 2004 (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 purpose of this research study is to assess the response rate of the investigational drug BMS-247550 (Ixabepilone) in women with metastatic breast cancer who are refractory to an anthracycline, a taxane, and capecitabine.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Ixabepilone |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients must have received all 3 drugs- an anthracycline, taxane, and capecitabine (alone or in combination) and be resistant
- No more than 3 prior chemotherapy regimens in the metastatic setting
- Must have at least one target lesion that is radiographically measurable
- Good performance status
- No history of or current brain or leptomeningeal disease
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| IxabepiloneAlso: BMS-247550Solution, IV, 40 mg/m2, every 21 days, extended, until PD or discontinued for other reasons. | Drug | 1 |
Primary outcome
Response rate as determined by the IRRC
1 secondary outcome
Time to progression, duration of response, overall survival
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 30 Jan 2017.
- Background: PubMed 17606974Perez EA, Lerzo G, Pivot X, Thomas E, Vahdat L, Bosserman L, Viens P, Cai C, Mullaney B, Peck R, Hortobagyi GN. Efficacy and safety of ixabepilone (BMS-247550) in a phase II study of patients with advanced breast cancer resistant to an anthracycline, a taxane, and capecitabine. J Clin Oncol. 2007 Aug 10;25(23):3407-14. doi: 10.1200/JCO.2006.09.3849. Epub 2007 Jul 2.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
45 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ixabepilone in people with Breast Cancer and Metastases, run by R-Pharm at 45 sites in 10 countries.
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 5 inclusion and 0 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 30 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States, France, South Africa, Sweden, Mexico and 5 more countries. 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?
Response rate as determined by the IRRC. 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 NCT00080262, 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 30 Jan 2017.