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ZK219477 (Sagopilone) in Patients With Breast Cancer and Brain Metastases

Status: Recruiting
Phase: Phase 2
Diagnosis: Brain/Neuro Cancer: Other Non-Glioblastoma, Breast: Metastatic
NCT ID: NCT00496379 (View complete trial on
DFCI Protocol ID: 06-268


The purpose of this research study is to determine the effects (good and bad) of ZK219477(sagopilone) on participants and their cancer. ZK219477 is a chemotherapy drug that is thought to work by interfering with the ability of cancer cells to grow and divide. It is a part of a group of drugs called "epothilones" which appear to cause shrinkage of cancer in some patients with breast cancer. It is generally difficult for chemotherapy to enter the brain. However, it is believed that ZK219477 crosses into the brain. We are also studying whether an investigational MRI scan procedure may eventually help to predict which patients will benefit from ZK219477.


Conducting Institutions:
Dana-Farber Cancer Institute, Beth-Israel Deaconess Medical Center, Brigham and Women's Hospital

Overall PI:
Nancy Lin, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Steven Come, MD, Beth Israel Deaconess Medical Center

Dana-Farber Cancer Institute: Breast Cancer Nursing Team, 617-632-3478
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060

Eligibility Criteria

Inclusion Criteria: - Patients must have histologically or cytologically invasive breast cancer, with metastatic disease at the time of screening - Measurable Central Nervous System (CNS) disease, as defined as at least one lesion > or equal too 10mm in longest dimension - New or progressive CNS lesions after at least one prior standard CNS-directed therapy for treatment of brain metastases, which could include surgical resection, whole brain radiotherapy (WBRT), and/or stereotactic radiosurgery (SRS). Patients must have received prior WBRT, SRS or both. - Patient has been evaluated by a radiation oncologist, who feels that the plan to evaluate systemic chemotherapy in place of additional brain radiotherapy is an acceptable option - No increase in corticosteroid use in the week prior to study entry - Any number prior lines of chemotherapy for metastatic breast cancer - 18 years of age of older - Life expectancy of greater than 12 weeks - ECOG Performance Status 0-2 - Patients must have normal organ function as outlined in the protocol Exclusion Criteria: - Patients who have had chemotherapy within 3 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier - Patients who have had XRT within 3 weeks prior to entering the study or those who have not recovered from adverse events due to XRT - Patients may not be receiving any other investigational agent - Patients may not be receiving any cancer-directed therapy - Prior treatment with investigational chemotherapy for brain metastases - Prior treatment with epothilone for metastatic breast cancer - Leptomeningeal carcinomatosis as the only site of CNS involvement. - Concurrent treatment with an enzyme inducing antiepileptic drug, including phenytoin, carbamezepine, phenobarbital, or oxacarbazepine - More than 2 seizures over the last four weeks prior to study entry - Known contraindication to MRI or gadolinium contrast, such as cardiac pacemaker, ocular foreign body, or shrapnel - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements - Pregnant or breastfeeding women.
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