HER2 Support Group Forums - View Single Post - patients in clinical trial overwhelmingly prefer subcutaneous herceptin administratn

'lizbeth · 09-18-2013, 12:14 PM

Alaska,

NCT00999804 - I think this trial does not have neoadjuvant chemo.
Extension Study of Lapatinib Plus Herceptin With or Without Endocrine Therapy (HELEX)

Primary Outcome Measures: To evaluate the rate of pathologic complete response, defined as no residual invasive cancer in the breast, after 12 or 24 weeks of lapatinib/trastuzumab with or without endocrine therapy. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]We propose a randomized multicenter neoadjuvant clinical trial in HER-2 overexpressing breast cancer patients with 12 vs. 24 weeks of lapatinib plus trastuzumab, with or without endocrine therapy, during which serial cancer tissue samples will be obtained for molecular studies in relation to tumor response. The patients will receive either 12 or 24 weeks of therapy to determine the pathologic complete response rate to this combined targeted therapy regimen, without the addition of any cytotoxic chemotherapy.

09-18-2013, 12:14 PM	#12
'lizbeth Senior Member Join Date: Apr 2008 Location: Sunny San Diego Posts: 2,214	Re: patients in clinical trial overwhelmingly prefer subcutaneous herceptin administr Alaska, NCT00999804 - I think this trial does not have neoadjuvant chemo. Extension Study of Lapatinib Plus Herceptin With or Without Endocrine Therapy (HELEX) Primary Outcome Measures: To evaluate the rate of pathologic complete response, defined as no residual invasive cancer in the breast, after 12 or 24 weeks of lapatinib/trastuzumab with or without endocrine therapy. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]We propose a randomized multicenter neoadjuvant clinical trial in HER-2 overexpressing breast cancer patients with 12 vs. 24 weeks of lapatinib plus trastuzumab, with or without endocrine therapy, during which serial cancer tissue samples will be obtained for molecular studies in relation to tumor response. The patients will receive either 12 or 24 weeks of therapy to determine the pathologic complete response rate to this combined targeted therapy regimen, without the addition of any cytotoxic chemotherapy.