Lapatinib for Brain Metastases In ErbB2-Positive Breast Cancer

Novartis

Status and phase: Completed; Phase 2

Conditions: Neoplasms, Breast

Treatments: Drug: lapatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00263588

EGF105084

CLAP016A2202 (Other Identifier)

2005-003944-68 (EudraCT Number)

Details and patient eligibility

About

Determine how safe and effective lapatinib is when used to treat patients with ErbB2 overexpressing breast cancer that has spread to the brain and is still progressing there even after radiation treatment using WBRT (whole brain radiotherapy) or SRS (stereotactic radiosurgery) to the brain. Lapatinib is an oral drug that will be taken every day. Tests for safety and efficacy will be performed every 4 weeks or 8 weeks (depending on the test) during the course of the study.

Enrollment: 242 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed Informed Consent
• ErbB2(HER2)overexpressing breast cancer.
• Brain lesion(s) which are progressing.
• Prior treatment of brain metastases with Whole Brain Radiotherapy (WBR)and/or Stereotactic Radiosurgery (SRS).
• Prior treatment with trastuzumab (Herceptin), either alone or in combination with chemotherapy.
• Cardiac ejection fraction(LVEF)within the institutional range of normal as measured by Echocardiogram.
• Able to swallow an oral medication.
• Adequate kidney and liver function.
• Adequate bone marrow function.

Exclusion criteria

• Pregnant or lactating females.
• Conditions that would effect the absorption of an oral drug.
• History of immediate or delayed hypersensitivity reaction to gadolinium contrast agents.
• Pre-existing severe cerebral vascular disease, such as stroke involving a major vessel.
• Serious medical or psychiatric disorder that would interfere with the patient's safety or informed consent.

Trial design

242 participants in 1 patient group

single arm

Experimental group

Description:

750 mg lapatinib administered orally twice daily

Treatment:

Drug: lapatinib