Metastatic Breast CancerPhase 2NCT00593827
Phase II Trial of Weekly or Every 3-week Ixabepilone for Patients With Metastatic Breast Cancer
A Phase 2 study testing Ixabepilone in people with Metastatic Breast Cancer, run by R-Pharm at 57 sites in United States.
Trial summary
The purpose of this study was to determine the effects of the weekly regimen of ixabepilone dosing compared to the once every 3 week dosing regimen in participants with metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- 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
- 176 participants
- Where
- 57 sitesUnited States
- Study dates
- May 2008to Aug 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has MBC that is measurable by RECIST or has nonmeasurable disease with serum CA27.29 (or CA15.3) ≥ 50
- Has Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer
- Prior chemotherapy is permitted with no limit on the number of prior regimens
- Two weeks or more have elapsed since last chemotherapy or radiation treatment
- Has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-2
- Is female, ≥ 18 yrs of age
Show all 9Show fewer
- Protocol defined appropriate laboratory values
- Negative pregnancy test within 7 calendar days prior to registration
- Has signed a patient informed consent
Who cannot join
- Had prior treatment with ixabepilone or other epothilones
- Has HER2+ disease
- Has a known, prior, severe (National Cancer Institute Common Terminology Criteria Adverse Events [NCI CTCAE] Grade 3-4) history of hypersensitivity reaction to a drug formulated in Cremophor ® EL (polyoxyethylated castor oil)
- Is receiving concurrent immunotherapy, hormonal therapy or radiation therapy
- Is receiving concurrent investigational therapy or has received such therapy within the past 30 days
- Has peripheral neuropathy > Grade 1
- Has evidence of central nervous system (CNS) involvement requiring radiation or steroid treatment. Participants with stable brain metastases who are off steroids at least 2 weeks are eligible
- Is pregnant or breast feeding
Trial locations and contacts
57 sites in 1 country.
57 sites in 1 country
United States57 sites
New York Oncology Hematology, P.C.
Amsterdam, New York, 12010
Texas Cancer Center
Arlington, Texas, 76014
Texas Oncology-Central Austin Cancer Center
Austin, Texas, 78731
Mamie Mcfaddin Ward Cancer Center Texas Oncology
Beaumont, Texas, 77702
Texas Oncology
Bedord, Texas, 76022
Birmingham Hematology & Oncology Associates Llc
Birmingham, Alabama, 35205
Central Indiana Cancer Centers
Carmel, Indiana, 46032
Maryland Oncology Hematology, P.A.
Columbia, Maryland, 21044
Missouri Cancer Associates
Columbia, Missouri, 65201
Texas Cancer Center At Medical City
Dallas, Texas, 75230
Texas Oncology
Dallas, Texas, 75231
Texas Oncology/Methodist Charlton Cancer Ctr
Dallas, Texas, 75237
Baylor Sammons Cancer Ctr
Dallas, Texas, 75246
Texas Oncology Sammons Cancer Center
Dallas, Texas, 75246
Texas Cancer Center
Denton, Texas, 76210
Regional Cancer Care
Durham, North Carolina, 27704
Puget Sound Cancer Centers
Edmonds, Washington, 98026
Texas Oncology
Fort Worth, Texas, 76104
Texas Oncology
Garland, Texas, 75942
Cancer Centers Of The Carolinas
Greenville, South Carolina, 29605
Comprehensive Cancer Center Of Nevada
Henderson, Nevada, 89074
Texas Oncology
Houston, Texas, 77024
Florida Cancer Institute
Hudson, Florida, 34667
Kansas City Cancer Center, Llc
Kansas City, Missouri, 64131
Texas Oncology - Lake Vista Cancer Center
Lewisville, Texas, 75067
Longview Cancer Center
Longview, Texas, 75601
South Texas Cancer Center
McAllen, Texas, 78503
Texas Cancer Center Of Mesquite
Mesquite, Texas, 75150
Texas Oncology, Pa
Midland, Texas, 78701
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, 55404
Hematology-Oncology Assoc. Of Northern Nj, Pa
Morristown, New Jersey, NJ
Southwest Cancer Care
Murrieta, California, 92562
Cancer Care & Hematology Specialists Of Chicagoland
Niles, Illinois, 60714
Ocala Oncology Center
Ocala, Florida, 34471
Cancer Centers Of Florida, P.A
Ocoee, Florida, 34761
Texas Oncology - Odessa
Odessa, Texas, 79761
Paris Regional Cancer Center Lab
Paris, Texas, 75460
Hematology Oncology Associates
Phoenix, Arizona, 85012
Raleigh Hematology Oncology Associates
Raleigh, North Carolina, 27607
Interlakes Oncology & Hematology, P.C.
Rochester, New York, 14623
Oncology & Hematology Associates Of Southwest Virginia, Inc.
Salem, Virginia, 24153
New Mexico Cancer Care Associates
Santa Fe, New Mexico, 87505
Puget Sound Cancer Centers
Seattle, Washington, 98133
Northern Arizona Hematology & Oncology Associates
Sedona, Arizona, 86336
Texas Cancer Center - Sherman
Sherman, Texas, 75090
Cancer Care Northwest
Spokane, Washington, 99202
Evergreen Hematology And Oncology
Spokane, Washington, 99218
Arch Medical Services, Inc.
St Louis, Missouri, 63141
Texas Oncology Cancer Center - Sugar Land
Sugar Land, Texas, 77479
Hope Center
Terre Haute, Indiana, 47802
Arizona Oncology Associates D.B.A. Hematology Oncology
Tucson, Arizona, 85704
Tyler Cancer Center
Tyler, Texas, 75702
Northwest Cancer Specialists, Pc
Vancouver, Washington, 98684
Texas Oncology Cancer Care And Research Center
Waco, Texas, 76712
Deke Slayton Cancer Center
Webster, Texas, 77598
Alliance Hematology Oncology, Pa
Westminster, Maryland, 21157
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, 98902
About this study
Official title: Phase II Randomized Trial of Weekly and Every 3-week Ixabepilone in Metastatic Breast Cancer (MBC) Patients
The purpose of this study was to determine the effects of the weekly regimen of ixabepilone dosing compared to the once every 3 week dosing regimen in participants with metastatic breast cancer.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Ixabepilone
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IxabepiloneDrug
Also called IXEMPRA, BMS-247550
Injection, IV, Until progressive disease or intolerable toxicity Ixabepilone 16 mg/m^2 was administered as a 1-hour IV continuous infusion on Days 1, 8, and 15 in a 28-day cycle until progressive disease or intolerable toxicity.
IxabepiloneDrug
Also called IXEMPRA, BMS-247550
Injection, IV, Until progressive disease or intolerable toxicity Ixabepilone 40 mg/m^2 was administered as a 3-hour IV infusion on Day 1 of each 21-day cycle provided the subject met the retreatment criteria.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest Receives: Drug: Ixabepilone |
| Arm 2 | Active comparator | ixabepilone 40 mg/m^2 every 3 weeks Receives: Drug: Ixabepilone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS) at 6 Months (6-month PFS Rate): Proportion of Participants Progression Free at 6 Months
PFS at 6 months was defined as proportion of participants who neither progressed nor died before 6 months. Computed using Kaplan-Meier estimates.
Measured: From the date of randomization to 6-months on study
Secondary outcomes (7)
Median Progression Free Survival
PFS is defined as time interval from the date of randomization to the date of (first) progression or date of death. Participants who progressed or died were counted as events. Participants lost to follow-up were censored as of the last date of contact. Participants who started a new treatment before they progressed were censored as of the date of start of the new treatment. Participants who had not progressed or died were censored at the date of last follow-up. PFS (months) = (End date - date of randomization + 1)/30.4375.
Measured: From the date of randomization to date of progression, death, or last tumor assessment (maximum participant PFS of 25.7 months)
Overall Response Rate (ORR) Based on Response Criteria in Solid Tumors [RECIST]
ORR is defined as the proportion of responders (complete response [CR] + partial response [PR] in participants with measurable disease) in that arm among all randomized participants.
CR: Disappearance of all evidence of target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions.
Measurable disease: Lesions that can be accurately measured in at least one dimension (LD to be recorded) as ≥20 mm with conventional techniques (computed tomography [CT], magnetic resonance imaging [MRI], X-ray) or as ≥10 mm with spiral CT scan.
Measured: Assessed at 12-week intervals until disease progression (to a maximum follow-up for tumor response of 26.3 months)
Best Response as Assessed With RECIST
Determined based on the sequence of disease status with corresponding best response. PD=At least a 20% increase in the sum of LD of target lesions in reference to the smallest sum LD recorded or the appearance of 1 or more new lesions; SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD in reference to the smallest sum LD. NE=Participants who discontinued treatment secondary to toxicity or died (either before completion of 1 treatment cycle). Please refer outcome measure 3 for explanation of CR and PR. CR+PR+SD=overall disease control.
Measured: Assessed at 12-week intervals until disease progression (to a maximum follow-up for tumor response of 26.3 months)
Overall Survival (OS)
Survival was measured as the date of randomization to the date of death. Participants who were alive at the time of the database lock or lost to follow-up were censored at the last known alive date. The distribution of overall survival was analyzed via the Kaplan Meier method in each arm.
Survival time (months) = (End date - date of randomization + 1)/30.4375
Measured: From the date of randomization to date of death (maximum participant OS of 26.3 months)
Time to Response
Time to response is defined as the time from the start of treatment until the first (confirmed) CR or PR was recorded. Time to response was computed only for participants whose best response was PR or CR.
CR: Disappearance of all target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions with reference to the baseline sum LD.
Measured: From the date of first dose to date of first PR or CR assessment ( maximum participant time to response of 8.3 months)
Duration of Response
Duration of overall response was defined as the period from the time first PR or CR was recorded until the first date of documented PD or death. Duration of response was computed for participants whose best response was either PR or CR. Participants who neither relapsed nor died were censored on the date of their last tumor assessment. Kaplan-Meier method was used to estimate the duration of response. Refer to outcome measures 3 and 4 for CR, PR, and PD.
Measured: From the date of first PR or CR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 17.4 months)
Incidence of All Grades of Peripheral Neuropathy
All events of peripheral neuropathy were assessed and graded per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3. CTC Grade (GR) 1=Mild; GR2=Moderate; GR3=Severe or medically significant, not immediately life-threatening; and GR4=Life-threatening. All treatment-related and not related Neuropathy and Peripheral Neuropathy were included; serious adverse events (SAEs) were not included.
Measured: Assessed from the date of first study dose until at least 30 days after the last dose of study drug. Median time on study therapy was 12 weeks (range: 4-60 weeks for 16 mg/m^2 arm; 3-87 weeks for 40 mg/m^2 arm).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2008 (estimated)
- Study startMay 2008
- Primary completionAug 2010
- Study completionAug 2010
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 Metastatic 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- R-Pharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- US Oncology Research
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00593827
- Sponsor's protocol ID
- CA163-132
- Other IDs
- USOR 06-106
- Status last verified
- Feb 2016
- First submitted
- 4 Jan 2008
- 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
- Phase II Randomized Trial of Weekly and Every 3-week Ixabepilone in Metastatic Breast Cancer (MBC) Patients
- ClinicalTrials.gov ID
- NCT00593827
- Acronym / sponsor ID
- CA163-132
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- R-PharmIndustry (pharma, biotech, devices)
- Collaborators
- US Oncology Research
- Study start
- May 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 15 Jan 2008 (estimated)
- Results
- Posted 25 May 2012
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 was to determine the effects of the weekly regimen of ixabepilone dosing compared to the once every 3 week dosing regimen in participants with metastatic breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: Ixabepiloneixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest |
| Arm 2 | Active comparator | Drug: Ixabepiloneixabepilone 40 mg/m^2 every 3 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Has MBC that is measurable by RECIST or has nonmeasurable disease with serum CA27.29 (or CA15.3) ≥ 50
- Has Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer
- Prior chemotherapy is permitted with no limit on the number of prior regimens
- Two weeks or more have elapsed since last chemotherapy or radiation treatment
- Has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-2
Key exclusion criteria (8 listed)
- Had prior treatment with ixabepilone or other epothilones
- Has HER2+ disease
- Has a known, prior, severe (National Cancer Institute Common Terminology Criteria Adverse Events [NCI CTCAE] Grade 3-4) history of hypersensitivity reaction to a drug formulated in Cremophor ® EL (polyoxyethylated castor oil)
- Is receiving concurrent immunotherapy, hormonal therapy or radiation therapy
- Is receiving concurrent investigational therapy or has received such therapy within the past 30 days
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: IXEMPRA, BMS-247550Injection, IV, Until progressive disease or intolerable toxicity Ixabepilone 16 mg/m^2 was administered as a 1-hour IV continuous infusion on Days 1, 8, and 15 in a 28-day cycle until progressive disease or intolerable toxicity. | Drug | Arm 1 |
| IxabepiloneAlso: IXEMPRA, BMS-247550Injection, IV, Until progressive disease or intolerable toxicity Ixabepilone 40 mg/m^2 was administered as a 3-hour IV infusion on Day 1 of each 21-day cycle provided the subject met the retreatment criteria. | Drug | Arm 2 |
Primary outcome
Progression-Free Survival (PFS) at 6 Months (6-month PFS Rate): Proportion of Participants Progression Free at 6 Months
Time frame: From the date of randomization to 6-months on study
PFS at 6 months was defined as proportion of participants who neither progressed nor died before 6 months. Computed using Kaplan-Meier estimates.
7 secondary outcomes
Median Progression Free Survival
Time frame: From the date of randomization to date of progression, death, or last tumor assessment (maximum participant PFS of 25.7 months)
Overall Response Rate (ORR) Based on Response Criteria in Solid Tumors [RECIST]
Time frame: Assessed at 12-week intervals until disease progression (to a maximum follow-up for tumor response of 26.3 months)
Best Response as Assessed With RECIST
Time frame: Assessed at 12-week intervals until disease progression (to a maximum follow-up for tumor response of 26.3 months)
Overall Survival (OS)
Time frame: From the date of randomization to date of death (maximum participant OS of 26.3 months)
Time to Response
Time frame: From the date of first dose to date of first PR or CR assessment ( maximum participant time to response of 8.3 months)
Duration of Response
Time frame: From the date of first PR or CR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 17.4 months)
Incidence of All Grades of Peripheral Neuropathy
Time frame: Assessed from the date of first study dose until at least 30 days after the last dose of study drug. Median time on study therapy was 12 weeks (range: 4-60 weeks for 16 mg/m^2 arm; 3-87 weeks for 40 mg/m^2 arm).
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
57 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 in people with Metastatic Breast Cancer, run by R-Pharm at 57 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 9 inclusion and 8 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 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 57 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 25 May 2012). 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) at 6 Months (6-month PFS Rate): Proportion of Participants Progression Free at 6 Months (time frame: From the date of randomization to 6-months on study). 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.