First Report of the European Cooperative Trial in Operable Breast Cancer Ii (ecto Ii): Effects of Primary Chemo-Endocrine Therapy on Local-Regional Disease in Er-Positive Breast Cancer
Journal of clinical oncology(2008)
Abstract
588 Background: To improve the pathologic complete remission rate documented in the ECTO trial (ASCO 2002), in June 2005 we activated a randomized phase II two stage-type protocol with concomitant chemo-endocrine therapy in ER-positive breast cancer > 2 cm at diagnosis. Methods: 182 patients were enrolled by end of June 2007. Patients were randomly allocated to 3 chemotherapy regimens: A (AT, doxo 60 mg/m2 + paclitaxel 200 mg/m2, q 3 w x 4 followed by CMF d1+8 q 4 w x 4); B (AT as above followed by CM d1+8 + capecitabine 1,850 mg/m2 for 14 days q 4 w x 4); C (AC, doxo 60 mg/m2 + cyclophosphamide 600 mg/m2 q 3 w x 4 followed by paclitaxel 100 mg/m2 d1+8 + capecitabine as above q 3 w x 4). Exemestane (25 mg/day) was given from the start of chemotherapy till surgery in all 3 regimens, along with LH-RH analogues in all premenopausal women. Results: At the cut-off date of August 31, 2007, 102 patients were assessed for the first step of the analysis plan. Baseline characteristics (age, menopause, PgR and HER2)...
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