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A Phase 3 Randomized, Open-label Comparative Study of Standard Whole Brain Radiation Therapy With Supplemental Oxygen, With or Without Concurrent RSR13 (Efaproxiral), in Women With Brain Metastases From Breast Cancer

Phase 3
18 Years
Not Enrolling
Breast Cancer, Metastases

Thank you

Trial Information

A Phase 3 Randomized, Open-label Comparative Study of Standard Whole Brain Radiation Therapy With Supplemental Oxygen, With or Without Concurrent RSR13 (Efaproxiral), in Women With Brain Metastases From Breast Cancer

The screening process will include documentation of the cancer, which which will require a
brain scan and may include a liver scan. Other screening measurements will include a
Karnofsky Performance Status (KPS) assessment, measurement of the amount of oxygen in the
blood, using a non-invasive device most often placed on the finger, lung function tests that
will require blowing into a machine, and an electrocardiogram (ECG). About 2 teaspoons, or
10 mL, of blood will be taken for specific laboratory tests, and a pregnancy test will be
done on the blood of women of childbearing potential.

All study patients will receive supplemental oxygen and whole brain radiation therapy (WBRT)
(30 Gy, 3 Gy fractions) every weekday for 2 weeks. Half of the patients will be randomized
(assigned) to receive RSR13 prior to WBRT, and will need to have a central catheter placed
for treatment unless one is already in place. Patients who receive RSR13 will also need to
continue to receive oxygen in the clinic until the amount of oxygen in their blood is near
normal. This level has returned to near normal in most patients within 1 to 2 hours.

During treatment and follow-up visits, physical and neurological exam, KPS assessment,
weight, height, and vital sign measurements, and about 2 teaspoons of blood may be required.
Patients will need to return for follow-up visits 1 month after completion of treatment, 2
months later, and every 3 months thereafter until their doctor tells them otherwise.

Inclusion Criteria:

- Adult women with brain metastases from breast cancer

- Minimum KPS of 70

Exclusion Criteria:

- Previous treatment for brain metastases, including brain surgery and any form of
radiation to the brain

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Time Frame:

Measured from randomization until death due to any cause.

Safety Issue:


Principal Investigator

John Suh, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The Cleveland Clinic


United States: Food and Drug Administration

Study ID:




Start Date:

February 2004

Completion Date:

June 2007

Related Keywords:

  • Breast Cancer
  • Metastases
  • Breast
  • Brain
  • RSR13
  • efaproxiral
  • Whole Brain Radiation Therapy
  • Brain metastases
  • Metastatic breast cancer
  • Breast Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Brain Neoplasms



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