A Multicenter, Open Label Study to Assess the Effect of Trastuzumab + Whole Brain Radiotherapy (WBRT) on Brain Metastases From HER-2 Positive Breast Cancer. (bHERt-2)
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Breast Cancer
Both
Breast Cancer
Trial Information
A Multicenter, Open Label Study to Assess the Effect of Trastuzumab + Whole Brain Radiotherapy (WBRT) on Brain Metastases From HER-2 Positive Breast Cancer. (bHERt-2)
Inclusion Criteria:
- Adult patients, >/=18 years of age
- Diagnosis of breast carcinoma with HER-2 overexpression
- At least one measurable brain metastasis
- Patients for whom, according to investigator assessment, whole brain radiotherapy is
the best therapeutic option
- Performance status (WHO)
- Life expectancy >/=3 months
Exclusion Criteria:
- Presence of neoplastic meningitis
- Any prior radiotherapy to the brain
- Patients for whom, according to investigator assessment, stereotactic radiotherapy is
the best therapeutic option
- Previous neoplasms, other than breast carcinoma, within 5 years since enrolment
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Brain response rate to trastuzumab and whole brain radiotherapy
Outcome Time Frame:
Week 7
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Italy: Ministry of Health
Study ID:
ML25432
NCT ID:
NCT01363986
Start Date:
September 2011
Completion Date:
June 2012
Related Keywords:
- Breast Cancer
- Breast Neoplasms
Name | Location |
|---|
