TY - JOUR T1 - Phase II Study of S-1 in Combination with Trastuzumab for HER2-positive Metastatic Breast Cancer JF - Anticancer Research JO - Anticancer Res SP - 3583 LP - 3588 VL - 34 IS - 7 AU - TSUTOMU TAKASHIMA AU - TAKAHIRO NAKAYAMA AU - KATSUHIDE YOSHIDOME AU - HIDEMI KAWAJIRI AU - SHUNJI KAMIGAKI AU - JUNJI TSURUTANI AU - TAKASHI ARAI AU - TOSHIKAZU ITO AU - YOSHIHUMI KOMOIKE AU - TAKAKO DOI AU - NORIKAZU MASUDA AU - KEISUKE MIYAUCHI AU - YASUO MIYOSHI AU - JUNICHI SAKAMOTO AU - SATOSHI MORITA AU - TETSUYA TAGUCHI Y1 - 2014/07/01 UR - http://ar.iiarjournals.org/content/34/7/3583.abstract N2 - Aim: We undertook a prospective phase II study to evaluate the efficacy of S-1 plus trastuzumab combination regimen for human epidermal-growth factor receptor-2 (HER2)-positive metastatic breast cancer (MBC). Patients and Methods: HER2-positive MBC patients received oral administration of S-1 (80 mg/m2/day, days 1 to 28, every 6 weeks) and intravenous weekly trastuzumab (2 mg/kg), according to the results of a prior Phase I trial of our group. Results: A total of 28 patients were enrolled and received a median of 3.5 (range 1-10) cycles of treatment. Overall response rate and clinical benefit rate were 53.6% and 75.0%, respectively. Progression-free survival was 30 weeks. With regard to grade 3 and 4 adverse effects, leucopenia, neutropenia, increase in serum alanine aminotransferase, and diarrhea were observed. Conclusion: Combination of S-1 and trastuzumab was tolerable and had excellent efficacy with good response and disease control in this trial. ER -