title: A phase I study of combination therapy with nanoparticle albumin-bound paclitaxel and cyclophosphamide in patients with metastatic or recurrent breast cancer.
abstract: 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 600 mg/m(2), while the dose of nab-PTX was increased from 180 mg/m(2) (Level 1) to 220 mg/m(2) (Level 2) and then to 260 mg/m(2) (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.
  
  
  CONCLUSIONS
  The RD of combination therapy with nab-PTX and CPA was 220 mg/m(2) and 600 mg/m(2), respectively, in patients with metastatic or recurrent breast cancer.
authors: Department of Surgery, Surgical Oncology and Science, School of Medicine, Sapporo Medical University, Minami 1-Jo, Nishi 17-Chome, Chuo-ku, Sapporo, Hokkaido, 060-8556, Japan, kutomi@sapmed.ac.jp.
authors: Goro
authors: G
authors: Kutomi
authors: Tousei
authors: T
authors: Ohmura
authors: Fukino
authors: F
authors: Satomi
authors: Hideki
authors: H
authors: Maeda
authors: Hiroaki
authors: H
authors: Shima
authors: Hidekazu
authors: H
authors: Kameshima
authors: Minoru
authors: M
authors: Okazaki
authors: Hideji
authors: H
authors: Masuoka
authors: Kenichi
authors: K
authors: Sasaki
authors: Koichi
authors: K
authors: Hirata
mesh_terms: D000368:Aged; D000068196:Albumin-Bound Paclitaxel / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000556:secondary; D003520:Cyclophosphamide / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D053758:Nanoparticles; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*
chemical_list: D000068196:Albumin-Bound Paclitaxel; D003520:Cyclophosphamide