Clinical trial · Interventional
Docetaxel Plus Imatinib Mesylate in Metastatic Breast Cancer
Phase II Trial of Docetaxel Plus Imatinib Mesylate in Metastatic Breast Cancer
NCT00193180CI-TRIAL-00022403completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention
- 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.
- interventionNames
- Drug: Imatinib
- Drug: Docetaxel
Primary outcomes (1)
- measure
- Overall Response Rate (ORR)
- timeFrame
- 18 months
- description
- 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.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTYardley 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. PMID 19933079