caa a22 4500 605490880 CHVBK 20210128100507.0 cr unu---uuuuu 210128e20150601xx s 000 0 eng 10.1007/s10147-014-0725-z doi (NATIONALLICENCE)springer-10.1007/s10147-014-0725-z A phase I study of combination therapy with nanoparticle albumin-bound paclitaxel and cyclophosphamide in patients with metastatic or recurrent breast cancer [Elektronische Daten] [Goro Kutomi, Tousei Ohmura, Fukino Satomi, Hideki Maeda, Hiroaki Shima, Hidekazu Kameshima, Minoru Okazaki, Hideji Masuoka, Kenichi Sasaki, Koichi Hirata] Background: The objective of the present clinical study is to determine the maximum tolerated dose (MTD)/recommended dose (RD) of combination therapy with nanoparticle albumin-bound paclitaxel (nab-PTX) and cyclophosphamide (CPA) in patients with metastatic or recurrent breast cancer. Methods: nab-PTX and CPA were administered on the first day of each 21-day treatment cycle. The dose of CPA was fixed at 600mg/m2, while the dose of nab-PTX was increased from 180mg/m2 (Level 1) to 220mg/m2 (Level 2) and then to 260mg/m2 (Level 3). Results: A total of 11 patients from two institutions were enrolled in the present study. At Level 3, a dose-limiting toxicity (DLT) was observed in 1 patient. Considering treatment continuity and the risk of adverse events in Cycle 2 and thereafter at this level, further subject enrollment at Level 3 was discontinued after two patients had been enrolled. Since the doses used at Level 3 were considered the MTD of nab-PTX and CPA and the doses used at Level 2 were considered the RD of nab-PTX and CPA, three additional subjects were enrolled at Level 2. No DLTs were observed at Level 2. Conclusion: The RD of combination therapy with nab-PTX and CPA was 220mg/m2 and 600mg/m2, respectively, in patients with metastatic or recurrent breast cancer. Japan Society of Clinical Oncology, 2014 Breast cancer nationallicence nab-paclitaxel nationallicence Cyclophosphamide nationallicence Phase I nationallicence Kutomi Goro Department of Surgery, Surgical Oncology and Science, School of Medicine, Sapporo Medical University, Minami 1-Jo, Nishi 17-Chome, Chuo-ku, 060-8556, Sapporo, Hokkaido, Japan aut Ohmura Tousei Department of Surgery, Higashi-Sapporo Hospital, Sapporo, Japan aut Satomi Fukino Department of Surgery, Surgical Oncology and Science, School of Medicine, Sapporo Medical University, Minami 1-Jo, Nishi 17-Chome, Chuo-ku, 060-8556, Sapporo, Hokkaido, Japan aut Maeda Hideki Department of Surgery, Surgical Oncology and Science, School of Medicine, Sapporo Medical University, Minami 1-Jo, Nishi 17-Chome, Chuo-ku, 060-8556, Sapporo, Hokkaido, Japan aut Shima Hiroaki Department of Surgery, Surgical Oncology and Science, School of Medicine, Sapporo Medical University, Minami 1-Jo, Nishi 17-Chome, Chuo-ku, 060-8556, Sapporo, Hokkaido, Japan aut Kameshima Hidekazu Department of Surgery, Higashi-Sapporo Hospital, Sapporo, Japan aut Okazaki Minoru Sapporo Breast Surgical Clinic, Sapporo, Japan aut Masuoka Hideji Sapporo-Kotoni Breast Clinic, Sapporo, Japan aut Sasaki Kenichi Department of Surgery, Muroran City General Hospital, Muroran, Japan aut Hirata Koichi Department of Surgery, Surgical Oncology and Science, School of Medicine, Sapporo Medical University, Minami 1-Jo, Nishi 17-Chome, Chuo-ku, 060-8556, Sapporo, Hokkaido, Japan aut International Journal of Clinical Oncology Springer Japan 20/3(2015-06-01), 474-479 1341-9625 20:3<474 2015 20 10147 https://doi.org/10.1007/s10147-014-0725-z text/html Onlinezugriff via DOI BK010053 XK010053 XK010000 Metadata rights reserved Springer special CC-BY-NC licence nationallicence 1 research-article jats NATIONALLICENCE NATIONALLICENCE NL-springer NATIONALLICENCE 856 40 https://doi.org/10.1007/s10147-014-0725-z text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Kutomi Goro Department of Surgery, Surgical Oncology and Science, School of Medicine, Sapporo Medical University, Minami 1-Jo, Nishi 17-Chome, Chuo-ku, 060-8556, Sapporo, Hokkaido, Japan aut NATIONALLICENCE 700 1- Ohmura Tousei Department of Surgery, Higashi-Sapporo Hospital, Sapporo, Japan aut NATIONALLICENCE 700 1- Satomi Fukino Department of Surgery, Surgical Oncology and Science, School of Medicine, Sapporo Medical University, Minami 1-Jo, Nishi 17-Chome, Chuo-ku, 060-8556, Sapporo, Hokkaido, Japan aut NATIONALLICENCE 700 1- Maeda Hideki Department of Surgery, Surgical Oncology and Science, School of Medicine, Sapporo Medical University, Minami 1-Jo, Nishi 17-Chome, Chuo-ku, 060-8556, Sapporo, Hokkaido, Japan aut NATIONALLICENCE 700 1- Shima Hiroaki Department of Surgery, Surgical Oncology and Science, School of Medicine, Sapporo Medical University, Minami 1-Jo, Nishi 17-Chome, Chuo-ku, 060-8556, Sapporo, Hokkaido, Japan aut NATIONALLICENCE 700 1- Kameshima Hidekazu Department of Surgery, Higashi-Sapporo Hospital, Sapporo, Japan aut NATIONALLICENCE 700 1- Okazaki Minoru Sapporo Breast Surgical Clinic, Sapporo, Japan aut NATIONALLICENCE 700 1- Masuoka Hideji Sapporo-Kotoni Breast Clinic, Sapporo, Japan aut NATIONALLICENCE 700 1- Sasaki Kenichi Department of Surgery, Muroran City General Hospital, Muroran, Japan aut NATIONALLICENCE 700 1- Hirata Koichi Department of Surgery, Surgical Oncology and Science, School of Medicine, Sapporo Medical University, Minami 1-Jo, Nishi 17-Chome, Chuo-ku, 060-8556, Sapporo, Hokkaido, Japan aut NATIONALLICENCE 773 0- International Journal of Clinical Oncology Springer Japan 20/3(2015-06-01), 474-479 1341-9625 20:3<474 2015 20 10147