Metastatic Breast Cancer
Conditions
Interventions
investigational material(s)
Generic name etc : Lapatinib
INN of investigational material :
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational materia
Sponsors
GlaxoSmithKline K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 18 Years and above - 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. - Adequate liver, kidney and bone marrow function. - 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.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the response to lapatinib in patients with progressive brain metastases from ErbB2-overexpressing breast cancer, and Safety. | — |
Outcome results
None listed