Phase 2
Completed N=37
Docetaxel Plus Imatinib Mesylate in Metastatic Breast Cancer
Source: ClinicalTrials.gov NCT00193180 ↗Enrolled (actual)
37
Serious AEs
48.7%
Results posted
May 2013
Primary outcomePrimary: Overall Response Rate (ORR) — 16 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate (ORR) |
16 | — |
| SECONDARY Progression Free Survival (PFS) |
9.3 | — |
| SECONDARY Overall Survival (OS) |
15.4 | — |
Eligibility Criteria
Inclusion Criteria
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
Exclusion Criteria
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
- 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.
Data sourced from ClinicalTrials.gov (NCT00193180). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.