Breast NeoplasmsPhase 2IXTENDNCT00546364
Randomized Study Evaluating Ixabepilone Plus Capecitabine or Docetaxel Plus Capecitabine in Metastatic Breast Cancer
A Phase 2 study testing Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2, Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 and Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 in people with Breast Neoplasms, run by R-Pharm at 60 sites in United States.
Trial summary
The purpose of this study is to assess the effect of ixabepilone plus capecitabine or docetaxel plus capecitabine on shrinking or slowing the growth of metastatic breast cancer in women. The safety of this combination therapy will also be evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2, Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 and Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 60 sitesUnited States
- Study dates
- Feb 2008to Mar 2010
- Phase
- Phase 2
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with metastatic breast cancer
- Measurable disease
- Up to 1 chemotherapy regimen is acceptable. Participants who have received paclitaxel in the neoadjuvant or adjuvant setting acceptable, only if the last dose of paclitaxel was received 12 months or less before the treatment. There is no timeframe for prior paclitaxel in the metastatic setting.
- Human epidermal growth factor receptor 2-positive participants allowed if they have progressed after receiving treatment with trastuzumab or lapatinib
- Eastern Cooperative Oncology Group Performance status of 0-1
- Age younger than 18 years
- Women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least 4 weeks after the last dose of investigational products
Who cannot join
- More than 1 chemotherapy regimen for the treatment of metastatic breast cancer
- Prior treatment with any epothilone, capecitabine, or docetaxel
- Prior radiation must not have included 30% or more of major bone marrow-containing areas (pelvis, lumbar spine). If prior radiation was less than 30%, a minimum interval of 2 weeks must be allowed between the last radiation treatment and administration of study medication. There must be at least 1 week between focal/palliative radiation and administration of study medication.
- Any current or previous history of brain and/or leptomeningeal metastases
- Neuropathy greater than Grade 2
- Any concurrent malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix
Show all 11Show fewer
- Uncontrolled diabetes mellitus
- Chronic hepatitis
- HIV-positive status
- Administration of trastuzumab, lapatinib, bevacizumab, or other systemic treatment for cancer must be discontinued 28 days prior to study medication. Hormonal anticancer agents must be discontinued at least 14 days prior to study medication. Hormonal replacement therapy is acceptable
- Biphosphonates for palliation of bone metastases allowed if initiated at least 7 days before study entry
Trial locations and contacts
60 sites in 1 country.
60 sites in 1 country
United States60 sites
Akron General Medical Center
Akron, Ohio, 44302
Summa Health System
Akron, Ohio, 44304
UNM Cancer Center
Albuquerque, New Mexico, 87106
Medical Oncology Associates of Augusta, PC
Augusta, Georgia, 30901
Austin Cancer Centers
Austin, Texas, 78759
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Hematology/Oncology Clinic
Baton Rouge, Louisiana, 70809
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809
Center for Cancer & Blood Disorders, PC
Bethesda, Maryland, 20817
Local Institution
Canton, Ohio, 44710
Charleston Cancer Center
Charleston, South Carolina, 29406
The Center for Cancer and Hematologic Disease
Cherry Hill, New Jersey, 08003
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
Mid Ohio Oncology/Hematology, Inc, dba The Mark H Zangmeister Center
Columbus, Ohio, 43219
Cancer Specialists of South Texas
Corpus Christi, Texas, 78412
Coastal Bend Cancer Center
Corpus Christi, Texas, 78463
Doylestown Hospital
Doylestown, Pennsylvania, 18901
Edward L Middleman, MD
Duncanville, Texas, 75137
Hematology & Oncology Associates of Nepa
Dunmore, Pennsylvania, 18512
Gaston Hematology and Oncology
Gastonia, North Carolina, 28054
Center for Cancer Care at Goshen Health System
Goshen, Indiana, 46526
The Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
Local Institution
Honolulu, Hawaii, 96813
Section Chief Medical Oncology
Houston, Texas, 77030
Howell Office Plaza
Howell Township, New Jersey, 07731
Jackson Oncology Associates, Pllc
Jackson, Mississippi, 39202
Local Institution
Jacksonville, Florida, 32209
Kingsport Hematology Oncology
Kingsport, Tennessee, 37660
The University of Tennessee Medical Center
Knoxville, Tennessee, 37920
Leah L Dietrich, MD
La Crosse, Wisconsin, 54601
Scripps Cancer Center
La Jolla, California, 92037
Arena Oncology Associates, PC
Lake Success, New York, 11042
Regional Hematology Oncology, PC
Langhorne, Pennsylvania, 19047
St Mary Medical Center
Langhorne, Pennsylvania, 19047
University of Kentucky
Lexington, Kentucky, 40536
University Medical Center, Inc
Louisville, Kentucky, 40202
Jose A Figueroa, MD
Lubbock, Texas, 79410
Local Institution
Miami, Florida, 33176
Lowcountry Hematology & Oncology, PA
Mt. Pleasant, South Carolina, 29464
Monroe Medical Associates
Munster, Indiana, 46321
Local Institution
Newark, Delaware, 19718
Local Institution
Newark, New Jersey, 07112
Peninsula Cancer Institute
Newport News, Virginia, 23601
Hematology Oncology Associates of Rockland
Nyack, New York, 10960
John W Kugler, MD
Peoria, Illinois, 61615
Local Institution
Philadelphia, Pennsylvania, 19140
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, 19141
New Mexico Cancer Care Associates (NMCCA)
Santa Fe, New Mexico, 87505
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104
Cancer Center of Central Connecticut
Southington, Connecticut, 06489
Southlake Oncology
Southlake, Texas, 76092
Providence Cancer Center
Spokane, Washington, 99204
Santee Hematology/Oncology
Sumter, South Carolina, 29150
Dch Cancer Treatment Center
Tuscaloosa, Alabama, 35401
Cooper Hospital, Division of Hematology/Oncology
Voorhees Township, New Jersey, 08043
Marion L Shepard Cancer Center
Washington, North Carolina, 27889
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
Cancer Center of Kansas
Wichita, Kansas, 67214
Local Institution
Woonsocket, Rhode Island, 02895
Midwestern Regional Medical Center
Zion, Illinois, 60099
About this study
Official title: IXTEND: A Randomized Phase 2 Study to Evaluate the Combination of Ixabepilone Plus Capecitabine or Capecitabine Plus Docetaxel in the Treatment of Metastatic Breast Cancer
The purpose of this study is to assess the effect of ixabepilone plus capecitabine or docetaxel plus capecitabine on shrinking or slowing the growth of metastatic breast cancer in women. The safety of this combination therapy will also be evaluated.
- Conditions
- Breast Neoplasms
- Being tested
- Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2, Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2, Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2Drug
Also called IXEMPRA®, BMS-247550
Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, self-administered on an outpatient basis twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle.
Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2Drug
Ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, self-administered on an outpatient basis twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle.
Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2Drug
Docetaxel 75 mg/m^2 administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, self-administered on an outpatient basis twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 | Experimental | Not described Receives: Drug: Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 |
| Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 | Experimental | Not described Receives: Drug: Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 |
| Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 | Active comparator | Not described Receives: Drug: Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Best Tumor Response as Assessed With Response Evaluation Criteria in Solid Tumors (RECIST)
RECIST definitions: Complete reponse (CR)=disappearance of all nontarget lesions; partial response (PR)=at least 30% reduction in the sum of the longest diameter (LD) of all target lesions in reference to the baseline sum LD; stable disease (SD)=neither PR nor progressive disease (PD) criteria were met; PD=at least 20% increase in the sum of the LD of all target lesions, taking as reference the smallest sum LD recorded at or following baseline. Tumor status assessed by investigator.
Measured: Baseline to 6 weeks (end of Cycle 2)
Percentage of Participants With Best Response to Treatment of Complete or Partial
The tumor response rate is defined as the number of participants with a best tumor response of CR or PR (as assessed by the investigator according to RECIST criteria), divided by the number of participants randomized in that arm.
Measured: Baseline to 6 weeks (end of Cycle 2)
Secondary outcomes (8)
Percentage of Triple-negative (TN) Participants With Best Response to Treatment of Complete or Partial
The tumor response rate is defined as the total number of participants whose best response is CR or PR, divided by the number of randomized participants. Participants not evaluable for response are considered to be nonresponders. TN participants are those with tumors that do not express estrogen or progesterone receptors and that do not over express human epidermal growth factor receptor 2 (HER2).
Measured: Baseline to 6 weeks (end of Cycle 2)
Percentage of Nontriple-negative (NTN) Participants With Best Response to Treatment of Complete or Partial Per Cohort
The tumor response rate is defined as the total number of participants whose best response is CR or PR, divided by the number of randomized participants. Participants not evaluable for response are considered to be nonresponders. NTN participants are who are not TN participants (TN participants are those with tumors that do not express estrogen or progesterone receptors and that do not overexpress HER2) and who received ixabepilone plus capecitabine or docetaxel plus capecitabine.
Measured: Baseline to 6 weeks (end of Cycle 2)
Number of Participants With Death, Adverse Events (AEs), Drug-related AEs, Serious AEs (SAEs), Drug-related SAEs, AEs Leading to Discontinuation (AEDs), Drug-related AEDs, and Drug-related Peripheral Neuropathy
An AE is any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=possibly, probably, or certainly related or of unknown relationship to study treatment. Grade 3=Severe, Grade 4=Life-threatening.
Measured: Baseline to end of Cycle 1 (21 days), continuously
Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade
CTC Grade 1=Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2=Moderate; minimal, local or noninvasive intervention indicated. Grade 3=Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling. Grade 4=Life-threatening consequences; urgent intervention indicated.
Measured: Baseline in Cycle 1 (21 days) and then prior to start of each 21-day cycle
Number of Participants With Abnormalities in Serum Chemistry Laboratory Results
ULN=Upper limit of normal among all laboratory ranges. Alanine aminotransferase (ALT) Grade 1:>ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. Aspartate aminotransferase (AST) Grade 1: >ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. Total bilirubin Grade 1: >ULN to 1.5*ULN; Grade 2: >1.5 to 3.0*ULN; Grade 3: >3.0 to 10.0*ULN; Grade 4: >10.0*ULN. Creatine Grade 1: >ULN to 1.5*ULN; Grade 2: 1.5 to 3.0*ULN; Grade 3: >3.0 to 6.0*ULN; Grade 4: >6.0*ULN.
Measured: Baseline in Cycle 1 (21 days) and then prior to start of each 21-day cycle
Time to Progression
Time to progression is defined as the time from date of randomization until the date that PD is first reported. Participants who die without a reported prior progression are considered to have progressed on the day of their death. Those who did not progress or die are censored at the day of their last tumor assessment.
Measured: Baseline to date progressive disease reported
Duration of Response
Duration of overall response is computed for participants whose best response is either PR or CR and is measured from the time measurement criteria are first met for CR or PR (whichever status is recorded first) until the first date of documented PD or death. Participants who did not relapse or die are censored on the date of their last tumor assessment.
Measured: Baseline (date of randomization) to date CR or PR criteria first met
Median Number of Treatment Cycles
The first dosing date is defined as the date of the first dose of chemotherapy or capecitabine, whichever was administered first. Cycles are defined as the time from Day 1 of the cycle until the day before the next cycle. The last cycle per participant is the 21-day period following Day 1 of that cycle.
Measured: Day 1 to end of Cycle 18, maximum (54 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2007 (estimated)
- Study startFeb 2008
- Primary completionMar 2010
- Study completionMar 2010
Why it stopped: Slow Accrual
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.
- Other trials for Breast NeoplasmsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- R-Pharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00546364
- Sponsor's protocol ID
- CA163-131
- Acronym
- IXTEND
- Status last verified
- Feb 2016
- First submitted
- 17 Oct 2007
- Last updated
- 10 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IXTEND: A Randomized Phase 2 Study to Evaluate the Combination of Ixabepilone Plus Capecitabine or Capecitabine Plus Docetaxel in the Treatment of Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00546364
- Acronym / sponsor ID
- IXTEND / CA163-131
- Conditions
- Breast Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow Accrual
- Enrolment
- 62 participants (actual)
- Lead sponsor
- R-PharmIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 18 Oct 2007 (estimated)
- Results
- Posted 1 Jun 2011
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 study is to assess the effect of ixabepilone plus capecitabine or docetaxel plus capecitabine on shrinking or slowing the growth of metastatic breast cancer in women. The safety of this combination therapy will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 | Experimental | Drug: Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 |
| Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 | Experimental | Drug: Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 |
| Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 | Active comparator | Drug: Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants with metastatic breast cancer
- Measurable disease
- Up to 1 chemotherapy regimen is acceptable. Participants who have received paclitaxel in the neoadjuvant or adjuvant setting acceptable, only if the last dose of paclitaxel was received 12 months or less before the treatment. There is no timeframe for prior paclitaxel in the metastatic setting.
- Human epidermal growth factor receptor 2-positive participants allowed if they have progressed after receiving treatment with trastuzumab or lapatinib
- Eastern Cooperative Oncology Group Performance status of 0-1
Key exclusion criteria (11 listed)
- More than 1 chemotherapy regimen for the treatment of metastatic breast cancer
- Prior treatment with any epothilone, capecitabine, or docetaxel
- Prior radiation must not have included 30% or more of major bone marrow-containing areas (pelvis, lumbar spine). If prior radiation was less than 30%, a minimum interval of 2 weeks must be allowed between the last radiation treatment and administration of study medication. There must be at least 1 week between focal/palliative radiation and administration of study medication.
- Any current or previous history of brain and/or leptomeningeal metastases
- Neuropathy greater than Grade 2
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, 40 mg/m^2 + Capecitabine, 1000 mg/m^2Also: IXEMPRA®, BMS-247550Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, self-administered on an outpatient basis twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle. | Drug | Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2 |
| Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2Ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, self-administered on an outpatient basis twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle. | Drug | Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 |
| Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2Docetaxel 75 mg/m^2 administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, self-administered on an outpatient basis twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle. | Drug | Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 |
Primary outcome
Number of Participants With Best Tumor Response as Assessed With Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: Baseline to 6 weeks (end of Cycle 2)
RECIST definitions: Complete reponse (CR)=disappearance of all nontarget lesions; partial response (PR)=at least 30% reduction in the sum of the longest diameter (LD) of all target lesions in reference to the baseline sum LD; stable disease (SD)=neither PR nor progressive disease (PD) criteria were met; PD=at least 20% increase in the sum of the LD of all target lesions, taking as reference the smallest sum LD recorded at or following baseline. Tumor status assessed by investigator.
Percentage of Participants With Best Response to Treatment of Complete or Partial
Time frame: Baseline to 6 weeks (end of Cycle 2)
The tumor response rate is defined as the number of participants with a best tumor response of CR or PR (as assessed by the investigator according to RECIST criteria), divided by the number of participants randomized in that arm.
8 secondary outcomes
Percentage of Triple-negative (TN) Participants With Best Response to Treatment of Complete or Partial
Time frame: Baseline to 6 weeks (end of Cycle 2)
Percentage of Nontriple-negative (NTN) Participants With Best Response to Treatment of Complete or Partial Per Cohort
Time frame: Baseline to 6 weeks (end of Cycle 2)
Number of Participants With Death, Adverse Events (AEs), Drug-related AEs, Serious AEs (SAEs), Drug-related SAEs, AEs Leading to Discontinuation (AEDs), Drug-related AEDs, and Drug-related Peripheral Neuropathy
Time frame: Baseline to end of Cycle 1 (21 days), continuously
Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade
Time frame: Baseline in Cycle 1 (21 days) and then prior to start of each 21-day cycle
Number of Participants With Abnormalities in Serum Chemistry Laboratory Results
Time frame: Baseline in Cycle 1 (21 days) and then prior to start of each 21-day cycle
Time to Progression
Time frame: Baseline to date progressive disease reported
Duration of Response
Time frame: Baseline (date of randomization) to date CR or PR criteria first met
Median Number of Treatment Cycles
Time frame: Day 1 to end of Cycle 18, maximum (54 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
60 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2, Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2 and Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2 in people with Breast Neoplasms, run by R-Pharm at 60 sites in United States.
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 7 inclusion and 11 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: stopped early, as of the sponsor's last update on 10 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in United States. 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?
Yes. Results are posted in the registry (first posted 1 Jun 2011). 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?
Number of Participants With Best Tumor Response as Assessed With Response Evaluation Criteria in Solid Tumors (RECIST) (time frame: Baseline to 6 weeks (end of Cycle 2)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2016.