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Phase II Trial of Trastuzumab Followed by Weekly Paclitaxel/Carboplatin as First-Line Treatment for Patients with Metastatic Breast Cancer Burris H III, Yardley D, Jones S, Houston G, Broome C, Thompson D, Greco F, White M and Hainsworth J. J Clin Oncol 2004;22(9):1621-29. Study Objectives Schema: Arm 1 — Response to Weekly Trastuzumab Schema: Arm 2 — Stable Disease with Weekly Trastuzumab Schema: Arm 3 — Disease Progression on Weekly Trastuzumab Patient Characteristics 61 patients enrolled Assessable for response (n=52) Median age: 51 ER/PR-positive (n=34) HER2-positive IHC 3+ (n=41) IHC 2+ (n=20) Results: Overall Response, Progression and Survival Results: Disease Response after 8 or 16 Weeks of Single-Agent Trastuzumab (H) Results: Response to CT and TCH Toxicity Hematologic toxicity Grade III/IV neutropenia = 28% Grade III thrombocytopenia = 3% Grade III/IV anemia = 5% No Grade IV nonhematologic toxicities Weakness and fatigue most common Carboplatin hypersensitivity = 7 patients Grade III neuropathy = 3 patients Cardiotoxicity LVEF decline 20% = 5/61 (8.2%) LVEF in 3 patients 20% but asymptomatic and continued trastuzumab Two patients discontinued therapy due to declines in LVEF One patient exhibited symptoms of CHF One patient was asymptomatic but had a 40% decline in LVEF Conclusions Single-agent H is safe and effective initial therapy in patients with HER2-positive metastatic disease The addition of CT to weekly H increases the response rate Weekly CT is a highly active, well-tolerated regimen in metastatic breast cancer Lack of response to H did not interfere with sensitivity to weekly CT American Society of Clinical Oncology Technology Assessment on the Use of Aromatase Inhibitors as Adjuvant Therapy for Postmenopausal Women with Hormone Receptor-Positive Breast Cancer: Status Report 2004 Winer EP, Hudis C, Burstein HJ, Wolff AC, Pritchard KI, Ingle JN, Chlebowski RT, Gelber R, Edge SB, Gralow J, Cobleigh MA, Mamounas EP, Goldstein LJ, Whelan TJ