LUX-Breast 3 Clinical Trial Infographic

Boehringer Ingelheim

An open label, Phase II randomised study of afatinib* alone or in combination with vinorelbine vs. investigator’s choice of treatment in patients with HER2+ breast cancer with progressive brain metastases after trastuzumab or lapatinib based therapy.

Inclusion Criteria

• Female patients aged 18 years or older
• Patients with HER2+ breast cancer with a documented central nervous system (CNS) recurrence/progression (by imaging) during or after a HER2 (ErbB2) inhibitor (trastuzumab or lapatinib) based therapy
• At least one measurable and progressive lesion in the brain
• Previous treatment with HER2 inhibitors to be discontinued at least 14 days prior to first study treatment administration
• Prior chemotherapy must have been discontinued at least 14 days for trastuzumab and 7 days for lapatinib and hormonal therapy at least 7 days prior to first study treatment
• Patients must have recovered to baseline condition or to Common Terminology Criteria for Adverse Events (CTCAE)
• Prior surgery, whole brain radiotherapy or stereotactic radiosurgery allowed, provided that there is unequivocal evidence of one or more new and/or progressive brain metastases after completion of whole brain radiotherapy or stereotactic radiosurgery

If you are an investigator interested in becoming involved in the study and have potentially eligible patients, please visit http://clinicaltrials.gov/ct2/show/NCT01441596?term=lux+breast+3&rank=1 for more information about LUX-Breast 3

*Afatinib is an investigational compound. Its safety and efficacy have not yet been fully established.