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

Roche

Status and phase: Terminated; Phase 2

Conditions: Breast Cancer

Treatments: Drug: trastuzumab [Herceptin]

Study type: Interventional

Funder types: Industry

Identifiers

NCT01363986

ML25432

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Trastuzumab Monotherapy

Experimental group

Description:

Participants received an initial loading dose of 4 milligrams per kilogram (mg/kg) trastuzumab intravenous (i.v.), followed by weekly doses of 2 mg/kg i.v. for up to 18 weeks.

Treatment:

Drug: trastuzumab [Herceptin]