A Study of Herceptin (Trastuzumab) in Combination With Whole Brain Radiotherapy in Patients With HER-2 Positive Breast Cancer

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)

This single-arm, multicenter, open-label study will evaluate the efficacy and safety of Herceptin (trastuzumab) in combination with whole brain radiotherapy on brain metastases in patients with HER-2 positive breast cancer. The patients will receive Herceptin 4 mg/kg (loading dose) followed by 2 mg/kg for a maximum of 18 weekly cycles. The anticipated time on study treatment is 18 weeks.

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) </=2
• 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