Neoadjuvant Therapy With Trastuzumab and Docetaxel Followed by Trastuzumab, Caelyx (Liposomal Doxorubicin) and Cyclophosphamide in Operable or Locally Advanced Her-2 Positive Breast Cancer
Chemotherapy in association with trastuzumab, a monoclonal antibody, given before surgery,
has been shown to reduce tumor size and permit better resection of HER-2 positive breast
cancers. This study will evaluate the activity of a neoadjuvant treatment with docetaxel
and trastuzumab given every 3 weeks for 4 cycles, followed by the combination of caelyx,
cyclophosphamide and trastuzumab every 3 weeks for 4 cycles. Patients will undergo breast
cancer surgery 2-5 weeks after the completion of neoadjuvant therapy. Adjuvant therapy
after surgery will be given according to existing guidelines, and will include an
additional 10 cycles of trastuzumab.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
complete pathologic response rate
Andrea De Matteis, M.D.
NCI Naples, Division of Medical Oncology C
Italy: Ethics Committee