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Tykerb EAP Trials
Hi Joe,
GSK has answered some questions about the EAP program.
Prior to putting a patient on the EAP, the oncologist is asked to evaluate the patient's eligibility for one of our ongoing trials - 104900, a study of Lapatinib in combination with trastuzumab versus lapatinib monotherapy in patients with metastatic breast cancer whose disease has progressed on trastuzumab-containing regimens, 105084 (brain mets) and 103009, the inflammatory breast cancer study. If the patient is eligible for one of them, we ask that they be put on the ongoing study. If they are not eligible for one of these studies, then they of course could come on the EAP as long as they are eligible for that. If it turns out that the patient is eligible for one of the ongoing studies, but does not have reasonable access to an open study site (defined as about a 3 hour drive), they could go on the EAP in that instance, also.
If the site (oncologist) has been attempting to call someone at GSK and not getting a response, please have them contact me so I can put them in touch with the right person.
Thanks so much.
Cathy
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