Breast CancerPhase 2NCT00193180
Docetaxel Plus Imatinib Mesylate in Metastatic Breast Cancer
A Phase 2 study testing Imatinib and Docetaxel in people with Breast Cancer, run by SCRI Development Innovations, LLC at 6 sites in United States.
Trial summary
This trial evaluates the novel combination of docetaxel with imatinib as first or second line therapy in advanced breast cancer with the aim of achieving higher effectiveness and potentially reducing side effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Imatinib and Docetaxel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 6 sitesUnited States
- Study dates
- May 2005to Jan 2009
- 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
- To be included in this study, you must meet the following criteria:
- Metastatic breast cancer confirmed by biopsy
- No more than one prior chemotherapy regimen for metastatic breast cancer
- Able to perform activities of daily living with minimal assistance
- Adequate bone marrow, liver and kidney function
- Age 18 years or older
- Give written informed consent
Who cannot join
- You cannot participate in this study if any of the following apply to you:
- Moderate to severe peripheral neuropathy
- Uncontrolled blood pressure or uncontrolled heart beat irregularities
- Diabetes Mellitus with fasting blood sugar greater than 200 mg %
- Significant heart disease within the prior 6 months
- Severe or uncontrolled medical disease
Show all 11Show fewer
- Active uncontrolled infection
- Known chronic liver disease
- Known diagnosis of HIV infection
- Pregnant or breast feeding females
- Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Baton Rouge General Medical Center
Baton Rouge, Louisiana, 70806
Oncology Hematology Care
Cincinnati, Ohio, 45242
Northeast Georgia Medical Center
Gainesville, Georgia, 30501
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, 40207
Tennessee Oncology
Nashville, Tennessee, 37203
Methodist Cancer Center
Omaha, Nebraska, 68114
About this study
Official title: Phase II Trial of Docetaxel Plus Imatinib Mesylate in Metastatic Breast Cancer
This trial evaluates the novel combination of docetaxel with imatinib as first or second line therapy in advanced breast cancer with the aim of achieving higher effectiveness and potentially reducing side effects.
Read the detailed description
All patients in this study received docetaxel 30 mg/m2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily
- Conditions
- Breast Cancer
- Being tested
- Imatinib, Docetaxel
- Keywords
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImatinibDrug
Also called Gleevec
Imatinib
DocetaxelDrug
Also called Taxotere
Docetaxel
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | All patients in this study received docetaxel 30 mg/m2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily. Receives: Drug: Imatinib; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
Defined as the proportion of patients with confirmed complete or partial response (CR or PR), recorded from date of treatment until date of recurrence or progressive disease, and assessed by RECIST v 1.1.
Measured: 18 months
Secondary outcomes (2)
Progression Free Survival (PFS)
PFS defined as the length of time, in months, that patients were alive from date of first protocol treatment until worsening of disease, assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Measured: 18 months
Overall Survival (OS)
Defined as the time from first protocol treatment to date of death due to any cause.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startMay 2005
- Primary completionMay 2008
- Study completionJan 2009
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 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- SCRI Development Innovations, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis, Aventis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Denise A. Yardley, MD, Principal investigator, SCRI Development Innovations, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00193180
- Sponsor's protocol ID
- SCRI BRE 74
- Status last verified
- Apr 2016
- First submitted
- 12 Sep 2005
- Last updated
- 27 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Yardley DA, Burris HA 3rd, Markus T, Spigel DR, Greco FA, Mainwaring M, Waterhouse DM, Webb CD, Hainsworth JD. Phase II trial of docetaxal plus imatinib mesylate in the treatment of patients with metastatic breast cancer. Clin Breast Cancer. 2009 Nov;9(4):237-42. doi: 10.3816/CBC.2009.n.040.
PubMed 19933079
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Docetaxel Plus Imatinib Mesylate in Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00193180
- Acronym / sponsor ID
- SCRI BRE 74
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- SCRI Development Innovations, LLCUniversity, hospital or other
- Collaborators
- Novartis, Aventis Pharmaceuticals
- Study start
- May 2005
- Primary completion
- May 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Posted 14 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial evaluates the novel combination of docetaxel with imatinib as first or second line therapy in advanced breast cancer with the aim of achieving higher effectiveness and potentially reducing side effects.
Detailed description
All patients in this study received docetaxel 30 mg/m2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Imatinib, Drug: DocetaxelAll patients in this study received docetaxel 30 mg/m2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Metastatic breast cancer confirmed by biopsy
- No more than one prior chemotherapy regimen for metastatic breast cancer
- Able to perform activities of daily living with minimal assistance
- Adequate bone marrow, liver and kidney function
- Age 18 years or older
Key exclusion criteria (11 listed)
- Moderate to severe peripheral neuropathy
- Uncontrolled blood pressure or uncontrolled heart beat irregularities
- Diabetes Mellitus with fasting blood sugar greater than 200 mg %
- Significant heart disease within the prior 6 months
- Severe or uncontrolled medical disease
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 |
|---|---|---|
| ImatinibAlso: GleevecImatinib | Drug | Intervention |
| DocetaxelAlso: TaxotereDocetaxel | Drug | Intervention |
Primary outcome
Overall Response Rate (ORR)
Time frame: 18 months
Defined as the proportion of patients with confirmed complete or partial response (CR or PR), recorded from date of treatment until date of recurrence or progressive disease, and assessed by RECIST v 1.1.
2 secondary outcomes
Progression Free Survival (PFS)
Time frame: 18 months
Overall Survival (OS)
Time frame: 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19933079Yardley DA, Burris HA 3rd, Markus T, Spigel DR, Greco FA, Mainwaring M, Waterhouse DM, Webb CD, Hainsworth JD. Phase II trial of docetaxal plus imatinib mesylate in the treatment of patients with metastatic breast cancer. Clin Breast Cancer. 2009 Nov;9(4):237-42. doi: 10.3816/CBC.2009.n.040.
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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.
Denise A. Yardley, MD principal investigator
SCRI Development Innovations, LLC
6 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 Imatinib and Docetaxel in people with Breast Cancer, run by SCRI Development Innovations, LLC at 6 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: finished, as of the sponsor's last update on 27 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 14 May 2013). 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?
Overall Response Rate (ORR) (time frame: 18 months). 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 NCT00193180, 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 27 May 2016; AzTrials last refreshed its copy on 8 Nov 2026.