patients in clinical trial overwhelmingly prefer subcutaneous herceptin administratn

['lizbeth]

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.

[AlaskaAngel]

Hi 'lizbeth,


I pulled up the study on clinicaltrials.gov and the actual table description of the arms is poorly done (it shows one arm noted to be HER2 positive patients receiving lapatinib and trastuzumab only, with the other arm being ER/PR positive and receiving letrozole only, and does not show any patients in the trial who happen to be both HR positive and HER2 positive) while the initial description indicates the trial is designed

1. To establish the safety and tolerability of an extended regimen of lapatinib + trastuzumab, with or without endocrine therapy

It is also described as being an "extension" study, in which the patients chosen are from an earlier study (I'm not sure what the treatment in the arms were for that earlier study, but it sounds like these were patients who have already completed some lapatinib and trastuzumab but I don't know if that earlier study required any administration of chemotherapy?)

A.A.