Breast CancerPhase 2NCT00063102
A Study of ABT-751 in Patients With Recurrent Breast Cancer After Taxane (Taxol or Taxotere) Therapy.
A Phase 2 study testing ABT-751 in people with Breast Cancer, run by Abbott at 8 sites in United States.
Trial summary
The purpose of the study is to determine if ABT-751 will decrease tumors, and determine how long the tumor shrinkage can be maintained in patients with breast cancer after having had taxol or taxotere. Patients will receive ABT-751 by mouth daily for 21 days. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- ABT-751
- How many people
- 40 participants
- Where
- 8 sitesUnited States
- Study dates
- Nov 2002to Aug 2004
- 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
- Stage IIIB or IV breast cancer.
- Recurrent tumor after or while on taxane therapy (taxol or taxotere).
- Able to tolerate normal activities of daily living.
- Adequate bone marrow, kidney and liver function.
Who cannot join
- Pregnant or breast feeding.
- No anti-tumor therapy (including hormonal therapy or Herceptin) within 4 weeks of the start of ABT-751 administration.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Georgia Cancer Specialists
Atlanta, Georgia
Northwestern University Medical School Division of Hematology/Oncology
Chicago, Illinois, 60611
Texas Oncology
Dallas, Texas
Indiana University Cancer Center Section of of Hemtology/Oncology Indiana Cancer Pavilion
Indianapolis, Indiana, 46202
Oncology & Hemotology Associates of Kansas City, PA
Kansas City, Missouri, 64111
Oncology-Hematology Group of South Florida
Miami, Florida, 33176
Clinical Research Network, Inc.
Plantation, Florida, 33324
Northern Indiana Cancer Research Consortium
South Bend, Indiana
About this study
Official title: A Phase II Study of ABT-751 in Patients With Breast Cancer Refractory to Taxane Regimens
The purpose of the study is to determine if ABT-751 will decrease tumors, and determine how long the tumor shrinkage can be maintained in patients with breast cancer after having had taxol or taxotere. Patients will receive ABT-751 by mouth daily for 21 days. Patients will be off drug for 7 days before starting the next cycle of drug.
- Conditions
- Breast Cancer
- Being tested
- ABT-751
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-751Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate in subjects with Breast cancer
Measured: 1 year
Secondary outcomes (3)
Time to Tumor Progression (TTP)
Measured: 1 year
Survival
Measured: 2 years
Toxicities associated with treatment administration
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 posted23 Jun 2003 (estimated)
- Study startNov 2002
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 40 participants
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Helen Eliopoulos, MD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00063102
- Sponsor's protocol ID
- M02-447
- Status last verified
- Nov 2007
- First submitted
- 19 Jun 2003
- Last updated
- 29 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of ABT-751 in Patients With Breast Cancer Refractory to Taxane Regimens
- ClinicalTrials.gov ID
- NCT00063102
- Acronym / sponsor ID
- M02-447
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Nov 2002
- Study completion
- Aug 2004 (actual)
- First posted
- 23 Jun 2003 (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 the study is to determine if ABT-751 will decrease tumors, and determine how long the tumor shrinkage can be maintained in patients with breast cancer after having had taxol or taxotere. Patients will receive ABT-751 by mouth daily for 21 days. Patients will be off drug for 7 days before starting the next cycle of drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Stage IIIB or IV breast cancer.
- Recurrent tumor after or while on taxane therapy (taxol or taxotere).
- Able to tolerate normal activities of daily living.
- Adequate bone marrow, kidney and liver function.
Key exclusion criteria (2 listed)
- Pregnant or breast feeding.
- No anti-tumor therapy (including hormonal therapy or Herceptin) within 4 weeks of the start of ABT-751 administration.
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 |
|---|---|---|
| ABT-751 | Drug | – |
Primary outcome
Objective Response Rate in subjects with Breast cancer
Time frame: 1 year
3 secondary outcomes
Time to Tumor Progression (TTP)
Time frame: 1 year
Survival
Time frame: 2 years
Toxicities associated with treatment administration
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 29 Nov 2007.
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.
Helen Eliopoulos, MD study director
Abbott
8 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 ABT-751 in people with Breast Cancer, run by Abbott at 8 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 4 inclusion and 2 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 29 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
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?
Objective Response Rate in subjects with Breast cancer (time frame: 1 year). 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 29 Nov 2007.