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 - ENRICH study
- Conditions
- MedDRA version: 4.0Level: 4Classification code 10027453Brain metastases from breast cancer
- Registration Number
- EUCTR2004-002109-58-AT
- Lead Sponsor
- ALLOS Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 360
1- Histologically or cytologically confirmed breast cancer in women with radiographically confirmed metastases to the brain
a. patient may have dural lesion(s) as the only site of disease in the brain, only if lesion(s) are pathologically confirmed to be malignant and proof of onset after primary diagnosis of breast cancer is available
b. patient may have extracranial metastases
c. patient may have received prior treatment for breast cancer and extracranial metastases
d. patient may receive concurrent trastuzumab, hormonal and/or corticosteroid therapy
2- At least 18 years of age
3- KPS>=70
4- Adequate hematologic, hepatic and renal function:
- hemoglobin >= 10 g/dL, white blood cell count >= 2.5*10^9 cells/L; absolute neutrophil count >= 1.5*10^9 cells/L; platelet count >= 100*10^9 cells/L;
- total bilirubin <= 1.5 time the Upper Limit of Normal (ULN); aspartate aminotransferase and alanine aminotransferase <= 3 times ULN
- serum creatinine <= 1.5 mg/dL;
5- Adequate pulmonary function tests by simple spirometry, as defined by forced vial capacity and forced expiratory volume in 1 second >+ 50% of normal for patient age, gender, height and race
6- Resting arterial O2 saturation (SpO2) measured by cutaneous pulse oximetry (SpO2)>=90% while breathing room air
7- Exercise (eg walking uninterrupted for approximately 15 metres on level ground) SpO2>=90% while breathing room air
8- (criterion removed in protocol version 2.2)
9- Women of childbearing potential must be practicing a medically acceptable contraceptive regimen and must have a negative serum pregnancy test within 14 days prior to first day of WBRT. Patients who are postmenopausal for at least 1 year (>12 months) or are surgically sterilized do not require this test
10- Patient must be accessible for repeat dosing and follow-up
11- Patient must give written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1- Active concurrent malignancy (except nonmelanoma skin cancer or in situ carcinoma of the cervix). If there is a history of prior malignancy, the patient must be disease-free for>=5 years
2- The patient is a candidate for surgical resection and/or stereotactic radiosurgery as initial therapy for brain metastases
3- Planned concurrent systemic (cytotoxic and/or cytostatic) treatment for breast cancer and/or extracranial metastases during WBRT, with the exception of trastuzumab, hormonal and/or corticosteroid therapy
4- Prior treatment for brain metastases (including external beam radiation therapy, brachytherapy, stereotactic radiosurgery, surgery, chemotherapy, and treatments with investigational drugs, biologics or devices)
5- Presence of leptomeningeal metastases
6- Use of any investigational drugs, biologics, or devices within 28 days prior to WBRT day 1
7- Previous exposure to efaproxiral
8- Women who are pregnant or lactating
9- Active infection or any serious underlying medical condition, which would impair the ability of the patient to receive protocol treatment
10- Dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Determine the effect of efaproxiral on primary and secondary efficacy endpoints in patients with brain metastases from breast cancer receiving daily intravenous (IV) efaproxiral with supplemental oxygen (O2) administered prior to standard whole brain radiation therapy (WBRT) compared to patients receiving standard WBRT with supplemental oxygen alone;Secondary Objective: Assess the safety of efaproxiral in this patient population;Primary end point(s): Survival, measured from the date of randomisation
- Secondary Outcome Measures
Name Time Method