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A Phase 2 Study of ZK219477 (ZK-EPO) in Patients With Breast Cancer and Brain Metastases

Phase 2
18 Years
Not Enrolling
Breast Cancer, CNS Disease

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Trial Information

A Phase 2 Study of ZK219477 (ZK-EPO) in Patients With Breast Cancer and Brain Metastases

- Participants will be given ZK219477 intravenously over approximately 30 minutes every
three weeks.

- During all treatment cycles a physical exam and questions about the participants
general health and specific questions about any problems they may be having will be

- At least every three weeks blood tests will be done to assess the effect of ZK219477 on
the body.

- After every 2 cycles of treatment, participants will have additional scans to assess
the effect of ZK219477 on their cancer. This will include a CT scan of the abdomen,
chest, and pelvis, and an MRI of the brain.

- At the time of the standard MRI, participants will be asked to undergo an additional
MRI sequence, which means they will be in the MRI machine for approximately 15-20 more

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.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response Rate in the Central Nervous System (CNS)

Outcome Description:

Objective response rate is defined as at least a 50 percent reduction in the Central Nervous system target lesion volume compared to the lesion volume at baseline.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Nancy Lin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

July 2007

Completion Date:

January 2012

Related Keywords:

  • Breast Cancer
  • CNS Disease
  • metastatic breast cancer
  • invasive breast cancer
  • brain metastases
  • ZK-EPO
  • Breast Neoplasms
  • Central Nervous System Diseases
  • Neoplasm Metastasis
  • Brain Neoplasms



Dana-Farber Cancer Institute Boston, Massachusetts  02115