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

Not Applicable

Conditions: -C509 Breast, unspecified
Breast, unspecified
C509

Registration Number: PER-077-04

Lead Sponsor: ALLOS THERAPEUTICS, INC.,

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

• Histologically or cytologically confirmed breast cancer in women with brain metastases confirmed radiographically.
• Must be at least 18 years of age.
• KPS> 70.
• Adequate renal, hepatic and hematological function.
• Proper pulmonary function tests.
• Saturation of arterial O2 at rest measured by means of cutaneous pulse oximetry (Sp02)> 90% when breathing ambient air.
• Sp02 in activity (for example, uninterrupted walk for approximately 50 feet [15 m] on a flat surface)> 90% when breathing ambient air.
• Women with a capacity to procreate should practice a medically acceptable contraceptive regimen and must obtain a negative serum pregnancy test within 14 days prior to the first day of WRBT. Postmenopausal patients for at least 1 year (> 12 months since the last menstrual period) or who are surgically sterilized should not undergo this test.
• The patient must be available to repeat the dose and to receive follow-up.
• The patient must give her informed consent in writing.

Exclusion Criteria

• Active concurrent malignant disease (except non-melanoma skin cancer or cervical carcinoma in-situ). If there is a history of previous malignancy, the patient should not have been exposed to the disease for> 5 years.
• The patient is likely to undergo surgical removal and / or stereotactic radiosurgery as an initial therapy for brain metastasis.
• Planned concurrent systemic treatment (cytotoxic and / or cytostatic) for breast cancer and / or extracranial metastasis during WBRT, with the exception of hormonal therapy, with trastuzumab and / or with corticosteroids.
• Previous treatment for brain metastasis (includes external beam radiotherapy, brachytherapy, stereotactic radiography, surgery, chemotherapy and treatments with drugs, biological substances or devices under investigation).
• Presence of leptomeningeal metastasis.
• Use of any drug, biological substance or device under investigation within 28 days prior to day 1 of WBRT.
• Previous exposure to efaproxiral.
• Pregnant or lactating women.
• Active infection or any serious pre-existing medical condition, which could affect the patient´s ability to receive the protocol treatment.
• Dementia or mental state significantly altered that would hinder understanding and the granting of informed consent.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:The overall survival between the treatment groups will be compared by means of the stratified registry classification test. The strata that are used in this test will coincide with the strata that had been defined at the moment of the random assignment of the patients. Survival will be measured from the random assignment date.<br>Measure:Survival<br>Timepoints:After treatment<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:The response rate in the brain at 3 months will be evaluated through a blind central review based on the criteria proposed by the RECIST Committee<br>Measure:Response rate in the brain at 3 months<br>Timepoints:3 months<br>;<br>Outcome name:The KPS of each patient will be analyzed in the initial visit and in the follow-up visits of month 1, month 3 and month 6. The percentage of patients with stable KPS classifications or improvement (relative to the initial visit) will be compared. between one and another treatment groups.<br>Measure:KPS and evaluation of neurological signs and symptoms<br>Timepoints:month 1, month 3 and month 6<br>

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