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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



Johns Hopkins Oncology Center Baltimore, Maryland  21287
University of Minnesota Cancer Center Minneapolis, Minnesota  55455
Washington University School of Medicine Saint Louis, Missouri  63110
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Henry Ford Hospital Detroit, Michigan  48202
Franklin Square Hospital Center Baltimore, Maryland  21237
SUNY Downstate Medical Center Brooklyn, New York  11203
Siouxland Regional Cancer Center Sioux City, Iowa  51101-1733
Wenatchee Valley Clinic Wenatchee, Washington  98801
Alta Bates Comprehensive Cancer Center Berkeley, California  94704
Duke University Medical Center Durham, North Carolina  27710
Northwestern University Chicago, Illinois  60611
Thomas Jefferson University Philadelphia, Pennsylvania  19107-6541
Ohio State University Columbus, Ohio  43210
Texas Oncology Dallas, Texas  
Eastchester Center for Cancer Care Bronx, New York  10469
Yale University School Of Medicine New Haven, Connecticut  06520
Center for Cancer and Blood Disorders Bethesda, Maryland  20817
Boca Raton Community Hospital Boca Raton, Florida  33486
University of Wisconsin Madison,, Wisconsin  53792-5666
Virginia G. Piper Cancer Center, Arizona Oncology Services Phoenix, Arizona  85013
Arizona Cancer Center, University of Arizona Tucson, Arizona  85724-5081
The University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
University of California at Los Angeles Los Angeles, California  90095
Radiological Associates of Sacramento Sacramento, California  95816
UCSF - Comprehensive Cancer Center San Francisco, California  94115
University of Miami Medical Miami, Florida  33136
University of South Florida - H. Lee Moffitt Cancer Center Tampa, Florida  33612
Emory University Winship Cancer Institute Atlanta, Georgia  30322
Parkview Research Center Ft. Wayne, Indiana  46805
Indiana University School of Medicine Indianapolis, Indiana  46204
Maryland Hematology Oncology Baltimore, Maryland  21236
Dent Neurologic Institute Amherst, New York  14226
University of North Carolina Breast Center Chapel Hill, North Carolina  27599
University of Cincinnati Division of Hematology-Oncology Cincinnati, Ohio  45267
Cleveland Clinic Hospital Cleveland, Ohio  44195
Virginia Mason Cancer Center Seattle, Washington  98101