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

ALLOS THERAPEUTICS, INC.,0 个研究点目标入组 0 人开始时间: 2005年1月19日最近更新: 2023年9月4日

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•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.

•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.

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