Clinical trial · Interventional
BMS-247550 Plus Capecitabine in Treating Patients With Metastatic Breast Cancer
A Phase I Study of BMS-247550 in Combination With Capecitabine in Patients With Metastatic Breast Cancer Previously Treated With a Taxane and an Anthracycline
NCT00049244CI-TRIAL-00025696unknownPhase 1ClinicalTrials.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 use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining BMS-247550 with capecitabine in treating patients who have metastatic breast cancer that has not responded to previous chemotherapy with a taxane and an anthracycline.
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)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
| ixabepilone | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed breast cancer * Metastatic disease by radiography or histology * Must have received prior chemotherapy with a taxane and an anthracycline in the adjuvant or metastatic setting * No more than 2 prior chemotherapy regimens in the metastatic setting * Measurable or evaluable disease * Bone lesions not measurable * Primary breast lesions not measurable if assessed only by physical exam * No active brain metastasis * No cerebral edema by CT scan or MRI * No progression since prior imaging studies * No requirement for steroids * No clinical symptoms of brain metastasis * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 18 and over Sex * Not specified Menopausal status * Not specified Performance status * ECOG 0-1 Life expectancy * At least 3 months Hematopoietic * Absolute neutrophil count at least 2,000/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 9.0 g/dL Hepatic * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * ALT no greater than 2.5 times ULN Renal * Creatinine less than 1.5 times ULN Cardiovascular * No uncontrolled or significant cardiovascular disease * No myocardial infarction within the past year * No uncontrolled angina within the past year * No history of congestive heart failure * No history of atrial or ventricular arrhythmias * No history of second- or third-degree heart block * No uncontrolled hypertension Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No hypersensitivity to Cremophor EL or fluorouracil * No prior intolerance to fluoropyrimidines * No other serious uncontrolled medical disorder or active infection that would preclude study * No dementia or altered mental status that would preclude study * No grade 2 or greater neuropathy (neuromotor or neurosensory) PRIOR CONCURRENT THERAPY: Biologic therapy * See Chemotherapy * Prior immunotherapy allowed * No concurrent trastuzumab (Herceptin) * No concurrent immunotherapy Chemotherapy * See Disease Characteristics * At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, or doxorubicin HCl liposome) * At least 2 years since prior high-dose chemotherapy with bone marrow transplantation or peripheral blood stem cell support * No prior epothilone, capecitabine, or continuous-infusion fluorouracil * No other concurrent chemotherapy Endocrine therapy * Prior hormonal therapy allowed * No concurrent hormonal therapy * Concurrent hormone replacement therapy allowed Radiotherapy * At least 3 weeks since prior radiotherapy * No prior radiotherapy to more than 25% of the bone marrow * No concurrent therapeutic radiotherapy Surgery * Not specified Other * At least 3 weeks since prior investigational cytotoxic agents * No concurrent warfarin for therapeutic anticoagulation * Low-dose warfarin allowed for implanted ports or indwelling catheters * No other concurrent experimental anticancer medications * No other concurrent antitumor therapy * Concurrent bisphosphonates for palliation of bone metastases allowed if initiated before study
References
Publications (0)
Data not yet available
No reference posted for this study.