A Phase II Study of Neoadjuvant Treatment With Pegylated Liposomal Doxorubicin (Caelyx) and Cyclophosphamide +/- Trastuzumab Followed by Docetaxel in Patients With Locally Advanced Breast Cancer
Patients with locally advanced or inflammatory breast cancer have a very bad prognosis.
Several studies have shown that patients who receive a pathological complete response have
the best prognosis. Neoadjuvant chemotherapy including anthracyclines and taxanes has become
established as a standard option in the multidisciplinary management of this group of
patients. In HER2 positive patients, chemotherapy in combination with trastuzumab is
therapeutically attractive. Recent studies have also demonstrated that evaluation with
PET-CT scan can be used to stratify treatment and monitor early response to neoadjuvant
therapy.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
clinical response rate
evaluation of treatment efficacy every 2.cycle
24 weeks
No
Malgorzata K Tuxen, MD
Principal Investigator
Herlev Hospital, Department of Oncology
Denmark: Ethics Committee
PO5903, EudraCT 2008-007951-29
NCT01206881
March 2009
June 2011
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