Abstract
1062 Background: Preclinical and clinical data suggest that docetaxel, trastuzumab and platinum compounds act synergistically. Studies in the metastatic disease are conflicting. In this phase II study the activity of this regimen was assessed and correlated with changes in circulating biomarkers. Methods: Patients with locally advanced, FISH+ HER2 amplified, breast cancer were treated in this protocol with TCH as initial neo-adjuvant treatment. Patients received Docetaxel 75 mg/sqm, carboplatinum AUC 6mg/mL.min and trastuzumab 6 mg/kg (with a loading dose in cycle 1). Six cycles were intended provided no progression occured. No prophylactic G-CSF or antibiotics were administered. Measurement of circulating ECD HER2, CTC (RT-PCR mammaglobin and CK-19), and total plasma DNA was performed prior to the start of therapy, after cycle 1 and after 3 and 6 cycles. A cardiac MUGA exam was performed every three cycles. All patients were intented to undego mastectomy and axillary clearance after the end of chemotherapy. Results: 40 patients have been treated with a median age of 56 year. No patient suffered from progression of disease while on THC. All patients received 6 cycles, 4 patients received respectively 7, 7, 8 and 9 cycles. In total 247 cycles were administered. No cases of CHF were observed. 5 patients suffered from a asymptomatic decline > 10% in LVEF. A clinical CR and PR was obtained in 32 (80%). A pathological CR both in breast axilla was obtained in 16/39 (41%). Tumor response was predicted by changes in both CTC and ECD HER-2. Conclusions: THC was confirmed to be a very active and safe regimen in patients with HER-2 amplified breast cancer. Changes in biomarkers rapidly predicted response. No significant financial relationships to disclose.
Published Version
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