Clinical trial · Interventional
Epothilone B in Treating Patients With CNS Metastases From Breast Cancer
Phase II Trial of Patupilone in Patients With Brain Metastases From Breast Cancer
NCT00450866CI-TRIAL-00013906completedPhase 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)
RATIONALE: Drugs used in chemotherapy, such as epothilone B, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well epothilone B works in treating patients with CNS metastases from breast cancer.
Conditions
Conditions (2)
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 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| epothilone B | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Epothilone B
- interventionNames
- Biological: epothilone B
Primary outcomes (1)
- measure
- Central Nervous System (CNS) Progression-free Survival(PFS)
- timeFrame
- 3 months after treatment
- description
- The number of patients that are documented to have progression free survival at 3 months after treatment. Progression free is define as \<25% increase in tumor area. PFS will be measured from the date of entry into the trial to the date of documented progression of brain metastases or death.
Secondary outcomes (4)
- measure
- Toxicity as Measured by NCI CTCAE v3.0
- timeFrame
- 3 months after treatment
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed carcinoma of the breast
* CNS metastases (i.e., brain parenchymal lesions and/or leptomeningeal disease), meeting 1 of the following criteria:
* Recurrent or progressive CNS metastases after whole brain radiotherapy
* If only evaluable site of CNS progression has been previously treated with stereotactic radiosurgery, radiation necrosis must be excluded by radiographic (e.g., positron emission tomography scan or magnetic resonance spectroscopy) or histologic assessment
* Newly diagnosed, untreated, asymptomatic brain or leptomeningeal metastases
* Patient must be neurologically stable, as demonstrated by a stable dose of steroids and anticonvulsants for ≥ 1 week prior to obtaining baseline gadolinium-enhanced MRI of the brain and/or ≥ 1 week prior to beginning study treatment
* No CNS complications requiring urgent neurosurgical intervention (e.g., resection or shunt placement)
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
* Male or female
* Menopausal status not specified
* Karnofsky performance status 60-100%
* Life expectancy ≥ 3 months
* Absolute neutrophil count \> 1,500/mm\^3
* Hemoglobin \> 9.0 g/dL
* Platelet count \> 100,000/mm\^3 (red blood cell transfusion and repeat evaluation allowed)
* Bilirubin \< 1.5 times upper limit of normal (ULN)
* AST and ALT \< 2.5 times ULN
* Alkaline phosphatase \< 2.5 times ULN
* Creatinine \< 1.5 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after completion of study therapy
* No known hypersensitivity to epothilones
* No peripheral neuropathy \> grade 1
* No unresolved diarrhea within the past 7 days
* Grade 0 diarrhea required at study entry
* No concurrent serious medical illness (e.g., HIV positivity or active hepatitis B or C)
* No severe cardiac insufficiency (e.g., New York Heart Association class III-IV heart disease) with uncontrolled and/or unstable cardiac or coronary artery disease
* No active or suspected acute or chronic uncontrolled infection, including abscess or fistulae
* No other malignancy within the past 3 years except curatively treated nonmelanoma skin cancer, prostate cancer, or carcinoma in situ of the cervix
* No history of noncompliance to medical regimens or inability or unwillingness to return for all scheduled visits
* No contraindications to MRI, including any of the following:
* Pacemaker
* Ferromagnetic implants
* Claustrophobia
* Extreme obesity
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* More than 2 weeks since prior noncytotoxic drugs (e.g., small molecule-targeted drugs) and recovered
* More than 3 weeks since prior cytotoxic chemotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered
* More than 3 weeks since prior intracranial surgery and recovered
* More than 4 weeks since prior radiotherapy and recovered
* More than 4 weeks since prior major surgery
* More than 28 days since prior investigational compounds or drugs
* No prior epothilones
* No concurrent known diarrheagenic agents
* No other concurrent anticancer agents, including investigational agents, biological agents, or chemotherapy
* No other concurrent experimental therapies
* Concurrent hormone therapy and/or trastuzumab (Herceptin®) allowed
* No concurrent Coumadin® or other agents containing warfarin
* Low dose Coumadin® (≤ 1 mg) for prophylactic maintenance of indwelling lines or ports allowed
* No concurrent radiotherapy for central metastases (e.g., vertebral or mediastinal metastases)
* Concurrent radiotherapy for local peripheral metastases not being used as marker lesions allowed
* No concurrent prophylactic hematopoietic growth factors during course 1
* No concurrent herbal or nontraditional medicationsReferences
Publications (0)
Data not yet available
No reference posted for this study.