Clinical trial · Interventional
Imatinib Mesylate in Treating Patients With Metastatic Breast Cancer
Phase II Trial of STI571 in Metastatic Breast Cancer
NCT00045188CI-TRIAL-00009033completedPhase 2ClinicalTrials.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)
Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have metastatic breast cancer. Imatinib mesylate may stop the growth of cancer by blocking the enzymes necessary for tumor cell growth
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Male Breast Cancer | Male Breast Carcinoma | ALIAS | 0.90 |
| Recurrent Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| imatinib mesylate | Drug | Imatinib Mesylate | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (imatinib mesylate)
- description
- Patients receive oral imatinib mesylate twice daily. Treatment continues for at least 8 weeks in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: imatinib mesylate
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Objective tumor response (CR + PR), as determined by the RECIST criteria
- timeFrame
- Up to 2 years
Secondary outcomes (3)
- measure
- Incidence of adverse events
- timeFrame
- Up to 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed metastatic breast cancer * Documented expression of CD117 (c-kit) or platelet-derived growth factor receptor * Adequate tumor tissue from either the primary tumor and/or metastatic disease available for evaluation * Must have received prior chemotherapy with an anthracycline (doxorubicin or epirubicin) and/or taxane (paclitaxel or docetaxel) as adjuvant or for advanced disease * At least 1 unidimensionally measurable lesion * At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan * Bone disease may not be only source of measurable disease * Pleural or peritoneal ascites are not considered measurable disease * No known brain metastases * Hormone receptor status: * Not specified * Female or male * Not specified * Performance status - ECOG 0-2 * Performance status - Karnofsky 60-100% * More than 12 weeks * Absolute neutrophil count at least 1,500/mm\^3 * WBC at least 3,000/mm\^3 * Platelet count at least 100,000/mm\^3 * Bilirubin normal * AST or ALT no greater than 2.5 times upper limit of normal * Creatinine normal * Creatinine clearance at least 60 mL/min * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * No other uncontrolled concurrent illness * No ongoing or active infection * No prior allergic reaction attributed to compounds of similar chemical or biologic composition to imatinib mesylate * No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix * No psychiatric illness or social situation that would preclude study compliance * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception during and for 1 week after study * No concurrent biologic agents * No more than 2 prior chemotherapy regimens for metastatic disease * Therapy with high-dose regimens or bone marrow transplantation considered 1 regimen * At least 4 weeks since prior chemotherapy (6 weeks for carmustine or mitomycin) and recovered * No concurrent chemotherapy * Prior hormonal therapy for stage IV disease and/or as adjuvant therapy allowed * At least 4 weeks since prior radiotherapy and recovered * Prior localized radiotherapy that does not influence the signal of the evaluable lesion is allowed * At least 2 weeks since prior minor surgery * At least 4 weeks since prior major surgery * Recovered from prior surgery * Low-molecular weight heparin or heparin allowed for anticoagulation * No concurrent warfarin * No concurrent combination antiretroviral therapy for HIV-positive patients * No concurrent investigational therapies or agents * No other concurrent anticancer therapy * No concurrent intake of cola, orange juice, grapefruit, or orange or grapefruit sections
References
Publications (0)
Data not yet available
No reference posted for this study.