Clinical trial · Interventional
Ixabepilone in Treating Patients With Locally Advanced or Metastatic Breast Cancer
A Phase II Clinical Trial Of BMS-247550 (NSC 710428), An Epothilone B Analog, In Patients With Breast Carcinoma
NCT00045097CI-TRIAL-00010902completedPhase 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)
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well ixabepilone works in treating patients with locally advanced or metastatic breast cancer.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ixabepilone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Anti-tumor activity as measured by CT scans and bone scans at baseline and every other course
- measure
- Ixabepilone toxicity as measured by lab studies at baseline and after every course
Secondary outcomes (2)
- measure
- Tumor tubulin polymerization and p53 expression from biopsy specimens and cDNA microarray testing at baseline and prior to course 2.
- measure
- Neurotoxicity assessment as measured by Semmes-Weinstein monofilament, sharpened Rombrog, one-legged stance, Jebsen Test of hand function, the grooved pef board , and subjective questionnaires at baseline and prior to every other course
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed\* adenocarcinoma of the breast * Incurable, locally advanced or metastatic disease * Primarily stage IV disease, but some inoperable stage III disease may be eligible (e.g., a patient with T4 and/or N2-3 disease who cannot receive doxorubicin or who has already received other therapy) NOTE: \*Patients with no available tissue for histologic confirmation but who have documentation of breast surgery and prior chemotherapy are eligible upon approval of the principal investigator * Measurable disease * No evidence of CNS metastases by brain MRI or contrast head CT scan * CNS metastases controlled by radiotherapy or surgical resection at least 6 months prior to study enrollment are allowed * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 18 and over Sex * Female or male Menopausal status * Not specified Performance status * ECOG 0-2 Life expectancy * At least 3 months Hematopoietic * Granulocyte count at least 1,200/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin no greater than 1.5 times upper limit of normal (ULN) (3 times ULN if there is clinical evidence of Gilbert's disease) * AST and ALT no greater than 2.5 times ULN Renal * Creatinine normal OR * Creatinine clearance greater than 40 mL/min Other * No poor medical risk due to other nonmalignant systemic disease * No active uncontrolled infection * No sensory, motor, or cranial neuropathy or neuropathic pain grade 2 or greater (unless neuropathy is clearly due to underlying breast cancer) * No other concurrent serious medical illness * No prior severe hypersensitivity reactions to agents containing Cremophor EL * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 2 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy * More than 4 weeks since prior filgrastim (G-CSF), pegfilgrastim, or thrombopoietin (or other platelet growth factors) * No concurrent immunotherapy Chemotherapy * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) * No other concurrent chemotherapy for breast cancer Endocrine therapy * More than 2 weeks since prior hormonal therapy * No concurrent hormonal therapy Radiotherapy * See Disease Characteristics * No prior craniospinal radiation * No prior total body irradiation * More than 4 weeks since prior radiotherapy Surgery * See Disease Characteristics Other * No other concurrent investigational drugs * No concurrent cytochrome p450 3A4 inhibitors, including any of the following: * Clarithromycin * Erythromycin * Troleandomycin * Delaviridine * Nelfinavir * Amprenavir * Ritonavir * Indinavir * Saquinavir * Lopinavir * Itraconazole * Ketoconazole * Fluconazole (\> 200 mg/day) * Voriconazole * Nefazodone * Fluvoxamine * Verapamil * Diltiazem * Amiodarone * Concurrent bisphosphonates for bone metastases allowed
References
Publications (2)
- RESULTDenduluri N, Low JA, Lee JJ, Berman AW, Walshe JM, Vatas U, Chow CK, Steinberg SM, Yang SX, Swain SM. Phase II trial of ixabepilone, an epothilone B analog, in patients with metastatic breast cancer previously untreated with taxanes. J Clin Oncol. 2007 Aug 10;25(23):3421-7. doi: 10.1200/JCO.2006.10.0784. Epub 2007 Jul 2. PMID 17606971
- RESULTLow J, Croarkin E, Parks R, et al.: Assessment of neurotoxicity in patients receiving BMS-247550 for metastatic breast cancer. [Abstract] Breast Cancer Research and Treatment 85.2: A-358, 2004. Also available online. Last accessed April 22, 2004.