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

• Status: Terminated
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Trastuzumab

Criteria

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