Phase I/II Trial of Primary Chemotherapy With Non-pegylated Liposomal Doxorubicin, Paclitaxel and Lapatinib in Patients With HER2-positive Early
Breast cancer is the most common malignancy affecting females in northern Europe and North
America, corresponding to an age-corrected annual incidence of 100 to 120 per 100000
females. Approximately 30-40% of all patients treated with curative intent will develop
metastatic disease. Perioperative systemic treatment has made a major impact on relapse-free
and overall survival of women with early-stage breast cancer [ , ] with therapeutic
strategies being based on the endocrine responsiveness and the estimated risk of relapse
defined by tumor size, axillary lymph node involvement, histologic and nuclear grade,
lymphatic and/or vascular invasion, HER2/neu-overexpression and age [ ]. Perioperative
therapy has traditionally been administered postoperatively, but chemotherapy is
increasingly utilized in the preoperative setting as it can significantly improve the rate
of breast conserving surgery, and new regimens can be evaluated rapidly and more precisely.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the optimal doses for NPLD, paclitaxel and lapatinib (phase I)
every 3 weeks
Yes
Dirk Elling
Principal Investigator
Sana Klinikum Lichtenberg, Berlin
Germany: Federal Institute for Drugs and Medical Devices
LAPADO-Study
NCT01172223
September 2007
September 2016
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