Breast CancerPhase 3NCT00080301
Novel Epothilone Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer
A Phase 3 study testing Ixabepilone + Capecitabine and Capecitabine in people with Breast Cancer and Metastases, run by R-Pharm at 127 sites in 22 countries.
Trial summary
The purpose of this clinical research study is to learn if BMS-247550 added to the approved therapy of capecitabine is better than capecitabine alone in shrinking or slowing the growth of the cancer in women with metastatic breast cancer who are resistant to taxane and received anthracycline chemotherapy. 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 + Capecitabine and Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 752 participants
- Where
- 127 sitesin 22 countries
- Study dates
- Sep 2003to Mar 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients must have received either 2 or 3 prior chemotherapy regimens including adjuvant or neoadjuvant therapy.
- Prior treatment must have included both an anthracycline (i.e., doxorubicin or epirubicin) and a taxane (i.e., paclitaxel or docetaxel).
- Patients must have received a minimum cumulative dose of anthracycline or must be resistant to an anthracycline.
- Patients must be resistant to taxane therapy.
- Patients may not have any history of brain and/or leptomeningeal metastases.
- Patients may not have CTC Grade 2 or greater neuropathy (motor or sensory).
- Patients may have not have had prior treatment with an epothilone and/or capecitabine (i.e., Xeloda)
Trial locations and contacts
127 sites in 22 countries.
127 sites in 22 countries
United States32 sites
Local Institution
Albuquerque, New Mexico
Local Institution
Austin, Texas
Local Institution
Baltimore, Maryland
Local Institution
Burlington, Massachusetts
Local Institution
Burlington, Vermont
Local Institution
Columbia, Missouri
Local Institution
Columbia, South Carolina
Local Institution
Columbus, Ohio
Local Institution
Denver, Colorado
Local Institution
Greenville, South Carolina
Local Institution
Hartford, Connecticut
Local Institution
Houston, Texas
Local Institution
Jackson, Mississippi
Local Institution
Kansas City, Missouri
Local Institution
Knoxville, Tennessee
Local Institution
Little Rock, Arkansas
Local Institution
Livingston, New Jersey
Local Institution
Morgantown, West Virginia
Local Institution
Nashville, Tennessee
Local Institution
New Brunswick, New Jersey
Local Institution
New York, New York
Local Institution
Ogden, Utah
Local Institution
Oklahoma City, Oklahoma
Local Institution
Omaha, Nebraska
Local Institution
Orlando, Florida
Local Institution
Pittsburgh, Pennsylvania
Local Institution
San Francisco, California
Local Institution
St Louis, Missouri
Local Institution
Tacoma, Washington
Local Institution
Tulsa, Oklahoma
Local Institution
Vallejo, California
Local Institution
Washington D.C., District of Columbia
France15 sites
Local Institution
Angers
Local Institution
Avignon
Local Institution
Bayonne
Local Institution
Besançon
Local Institution
Bobigny
Local Institution
Bordeaux
Local Institution
Clermont-Ferrand
Local Institution
Lyon
Local Institution
Nantes
Local Institution
Nice
Local Institution
Saint-Brieuc
Local Institution
Saint-Cloud
Local Institution
Saint-Herblain
Local Institution
Strasbourg
Local Institution
Toulouse
Argentina11 sites
Local Institution
Capital Federal, Buenos Aires
Local Institution
Córdoba
Local Institution
Haedo, Buenos Aires
Local Institution
La Plata, Buenos Aires
Local Institution
Lanus, BuenosAires
Local Institution
Mar del Plata, Buenos Aires
Local Institution
Neuquén
Local Institution
Pilar, Buenos Aires
Local Institution
Quilmes, Buenos Aires
Local Institution
Rosario, Santa Fe Province
Local Institution
Santa Fe
Brazil8 sites
Local Institution
Belo Horizonte, Mina Gerais
Local Institution
Curitiba, Paraná
Local Institution
Fortaleza, Ceará
Local Institution
Jaú, São Paulo
Local Institution
Porto Alegre, Rio Grande do Sul
Local Institution
Santo André, São Paulo
Local Institution
São Paulo
Local Institution
Sao Paulo - Sp, São Paulo
China8 sites
Local Institution
Beijing, Beijing Municipality
Local Institution
Beijing, Shanghai Municipality
Local Institution
Beijing
Local Institution
Guangzhou, Guangdong
Local Institution
Jinan, Shandong
Local Institution
Nanjing, Jiangsu
Local Institution
Shanghai
Local Institution
Xi’an, Shanxi
United Kingdom7 sites
Local Institution
Bristol, Avon
Local Institution
Chelmsford, Essex
Local Institution
Guildford, Surrey
Local Institution
London, Greater London
Local Institution
Manchester, Greater Manchester
Local Institution
Newcastle upon Tyne, Tyne and Wear
Local Institution
Sheffield, South Yorkshire
Mexico5 sites
Local Institution
Acapulco de Juárez, Guerrero
Local Institution
Chihuahua City
Local Institution
Distrito Federal
Local Institution
Mérida, Yucatán
Local Institution
San Luis Potosí City
Spain5 sites
Local Institution
Barcelona
Local Institution
Girona
Local Institution
Madrid
Local Institution
Valencia
Local Institution
Zaragoza
Belgium4 sites
Local Institution
Edegem
Local Institution
Ghent
Local Institution
Leuven
Local Institution
Liège
Canada4 sites
Local Institution
Montreal, Quebec
Local Institution
Oshawa, Ontario
Local Institution
Toronto, Ontario
Local Institution
Vancouver, British Columbia
Hungary4 sites
Local Institution
Budapest
Local Institution
Debrecen
Local Institution
Győr
Local Institution
Pécs
Italy4 sites
Local Institution
Brescia
Local Institution
Candiolo (To)
Local Institution
Forlì
Local Institution
San Giovanni Rotondo
Germany3 sites
Local Institution
Berlin
Local Institution
Duisburg
Local Institution
Erlangen
Philippines3 sites
Local Institution
Manila
Local Institution
Quezon
Local Institution
Quezon City
Malaysia2 sites
Local Institution
Kampung Baharu Nilai, Negeri Sembilan
Local Institution
Kuala Lumpur
About this study
Official title: A Phase III Trial of Novel Epothilone BMS-247550 Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer Previously Treated With or Resistant to an Anthracycline and Who Are Taxane Resistant
The purpose of this clinical research study is to learn if BMS-247550 added to the approved therapy of capecitabine is better than capecitabine alone in shrinking or slowing the growth of the cancer in women with metastatic breast cancer who are resistant to taxane and received anthracycline chemotherapy. The safety of this treatment will also be studied.
- Conditions
- Breast Cancer, Metastases
- Being tested
- Ixabepilone + Capecitabine, Capecitabine
- 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.
Ixabepilone + CapecitabineDrug
Also called BMS-247550, IXEMPRA, Epothilone
Ixabepilone - Intravenous Solution, IV 40mg/m², Day 1 every 21 days, Until progression/unacceptable toxicity
Capecitabine (Active Comparator) - Tablet, Oral, 2000 mg/m², Bid Days 1-14 every 21 days, Until progression/unacceptable toxicity
CapecitabineDrug
Tablet, Oral, 2500 mg/m², Bid Days 1-14 every 21 days, Until progression/unacceptable toxicity
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Ixabepilone + Capecitabine |
| B | Active comparator | Not described Receives: Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS) Per Independent Radiology Review Committee (IRRC)
PFS defined as the time in months from randomization to date of progression. Patients who died without a reported prior progression were considered to have progressed on date of death; those who didn't progress or die were censored on date of last tumor assessment. Median PFS time with 95% CI estimated using the Kaplan Meier product limit method.
Measured: based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity
Secondary outcomes (6)
Overall Response Rate (ORR) Per IRRC
Participants with best response of "Complete" or "Partial" according to Response Evaluation Criteria in Solid Tumors (RECIST) a 4-item scale wherein complete response=disappearance of all target lesions and partial response=30% decrease in the sum of the longest diameter of target lesions
Measured: based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity
Duration of Response Per IRRC
Computed for all patients with a best response of "Partial" or "Complete" per RECIST (a 4-item scale as described in previous outcome measure), calculated from the time when these criteria were first met until the first date of documented progression or death.
Measured: based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity
Time to Response Per IRRC
Time to response was summarized using descriptive statistics and was defined as the time from first dose of study treatment until measurement criteria were first met for Partial Response or Complete Response.
Measured: based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity
Overall Survival (OS)
OS was defined as the time from randomization to death. Participants who did not die at the time of the analysis were censored at the latest follow-up date. Median OS with 95% CI was estimated using the Kaplan Meier product limit method.
Measured: from date of randomization until death
Treatment-related Safety Summary
Laboratory values, adverse events, and other symptoms were graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTC) Version 3.0
Measured: safety was assessed on a continual basis every cycle while on-treatment and every 4 weeks post treatment until toxicities resolved or were deemed irreversible.
Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI)
Quality of life, as measured by the FBSI, an 8-item, participant-reported instrument to measure symptoms. Each item has 5 possible responses ranging from 0 (not at all) to 4 (very much). The scoring was conducted according to the Functional Assessment of Chronic Illness Therapy manual, Version 4; higher scores reflect fewer symptoms.
Measured: Baseline and prior to each 21-day cycle of treatment, and at first posttreatment follow-up assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2004 (estimated)
- Study startSep 2003
- Primary completionNov 2006
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 752 participants (actual)
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
- NCT00080301
- Sponsor's protocol ID
- CA163-046
- Status last verified
- Oct 2020
- First submitted
- 26 Mar 2004
- Last updated
- 2 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Thomas ES, Gomez HL, Li RK, Chung HC, Fein LE, Chan VF, Jassem J, Pivot XB, Klimovsky JV, de Mendoza FH, Xu B, Campone M, Lerzo GL, Peck RA, Mukhopadhyay P, Vahdat LT, Roche HH. Ixabepilone plus capecitabine for metastatic breast cancer progressing after anthracycline and taxane treatment. J Clin Oncol. 2007 Nov 20;25(33):5210-7. doi: 10.1200/JCO.2007.12.6557. Epub 2007 Oct 29.
PubMed 17968020Vahdat LT, Vrdoljak E, Gomez H, Li RK, Bosserman L, Sparano JA, Baselga J, Mukhopadhyay P, Valero V. Efficacy and safety of ixabepilone plus capecitabine in elderly patients with anthracycline- and taxane-pretreated metastatic breast cancer. J Geriatr Oncol. 2013 Oct;4(4):346-52. doi: 10.1016/j.jgo.2013.07.006. Epub 2013 Aug 23.
PubMed 24472478Jassem J, Fein L, Karwal M, Campone M, Peck R, Poulart V, Vahdat L. Ixabepilone plus capecitabine in advanced breast cancer patients with early relapse after adjuvant anthracyclines and taxanes: a pooled subset analysis of two phase III studies. Breast. 2012 Feb;21(1):89-94. doi: 10.1016/j.breast.2011.09.003. Epub 2011 Sep 21.
PubMed 21937232Roche H, Conte P, Perez EA, Sparano JA, Xu B, Jassem J, Peck R, Kelleher T, Hortobagyi GN. Ixabepilone plus capecitabine in metastatic breast cancer patients with reduced performance status previously treated with anthracyclines and taxanes: a pooled analysis by performance status of efficacy and safety data from 2 phase III studies. Breast Cancer Res Treat. 2011 Feb;125(3):755-65. doi: 10.1007/s10549-010-1251-y. Epub 2010 Dec 3.
PubMed 21128114
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Trial of Novel Epothilone BMS-247550 Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer Previously Treated With or Resistant to an Anthracycline and Who Are Taxane Resistant
- ClinicalTrials.gov ID
- NCT00080301
- Acronym / sponsor ID
- CA163-046
- Conditions
- Breast Cancer, Metastases
- Keywords
- Metastatic Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 752 participants (actual)
- Lead sponsor
- R-PharmIndustry (pharma, biotech, devices)
- Study start
- Sep 2003
- Primary completion
- Nov 2006 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 30 Mar 2004 (estimated)
- Results
- Posted 17 Aug 2009
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 clinical research study is to learn if BMS-247550 added to the approved therapy of capecitabine is better than capecitabine alone in shrinking or slowing the growth of the cancer in women with metastatic breast cancer who are resistant to taxane and received anthracycline chemotherapy. The safety of this treatment will also be studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Ixabepilone + Capecitabine |
| B | Active comparator | Drug: Capecitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Ixabepilone + CapecitabineAlso: BMS-247550, IXEMPRA, EpothiloneIxabepilone - Intravenous Solution, IV 40mg/m², Day 1 every 21 days, Until progression/unacceptable toxicity Capecitabine (Active Comparator) - Tablet, Oral, 2000 mg/m², Bid Days 1-14 every 21 days, Until progression/unacceptable toxicity | Drug | A |
| CapecitabineTablet, Oral, 2500 mg/m², Bid Days 1-14 every 21 days, Until progression/unacceptable toxicity | Drug | B |
Primary outcome
Progression-free Survival (PFS) Per Independent Radiology Review Committee (IRRC)
Time frame: based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity
PFS defined as the time in months from randomization to date of progression. Patients who died without a reported prior progression were considered to have progressed on date of death; those who didn't progress or die were censored on date of last tumor assessment. Median PFS time with 95% CI estimated using the Kaplan Meier product limit method.
6 secondary outcomes
Overall Response Rate (ORR) Per IRRC
Time frame: based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity
Duration of Response Per IRRC
Time frame: based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity
Time to Response Per IRRC
Time frame: based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity
Overall Survival (OS)
Time frame: from date of randomization until death
Treatment-related Safety Summary
Time frame: safety was assessed on a continual basis every cycle while on-treatment and every 4 weeks post treatment until toxicities resolved or were deemed irreversible.
Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI)
Time frame: Baseline and prior to each 21-day cycle of treatment, and at first posttreatment follow-up assessment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 17968020Thomas ES, Gomez HL, Li RK, Chung HC, Fein LE, Chan VF, Jassem J, Pivot XB, Klimovsky JV, de Mendoza FH, Xu B, Campone M, Lerzo GL, Peck RA, Mukhopadhyay P, Vahdat LT, Roche HH. Ixabepilone plus capecitabine for metastatic breast cancer progressing after anthracycline and taxane treatment. J Clin Oncol. 2007 Nov 20;25(33):5210-7. doi: 10.1200/JCO.2007.12.6557. Epub 2007 Oct 29.
- Derived from this study: PubMed 24472478Vahdat LT, Vrdoljak E, Gomez H, Li RK, Bosserman L, Sparano JA, Baselga J, Mukhopadhyay P, Valero V. Efficacy and safety of ixabepilone plus capecitabine in elderly patients with anthracycline- and taxane-pretreated metastatic breast cancer. J Geriatr Oncol. 2013 Oct;4(4):346-52. doi: 10.1016/j.jgo.2013.07.006. Epub 2013 Aug 23.
- Derived from this study: PubMed 21937232Jassem J, Fein L, Karwal M, Campone M, Peck R, Poulart V, Vahdat L. Ixabepilone plus capecitabine in advanced breast cancer patients with early relapse after adjuvant anthracyclines and taxanes: a pooled subset analysis of two phase III studies. Breast. 2012 Feb;21(1):89-94. doi: 10.1016/j.breast.2011.09.003. Epub 2011 Sep 21.
- Derived from this study: PubMed 21128114Roche H, Conte P, Perez EA, Sparano JA, Xu B, Jassem J, Peck R, Kelleher T, Hortobagyi GN. Ixabepilone plus capecitabine in metastatic breast cancer patients with reduced performance status previously treated with anthracyclines and taxanes: a pooled analysis by performance status of efficacy and safety data from 2 phase III studies. Breast Cancer Res Treat. 2011 Feb;125(3):755-65. doi: 10.1007/s10549-010-1251-y. Epub 2010 Dec 3.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
127 sites in 22 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ixabepilone + Capecitabine and Capecitabine in people with Breast Cancer and Metastases, run by R-Pharm at 127 sites in 22 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 2 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 127 sites in United States, France, Argentina, Brazil, China and 17 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (PFS) Per Independent Radiology Review Committee (IRRC) (time frame: based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity). 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 NCT00080301, which also lists 4 linked publications.
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 2 Nov 2020.