PT  - JOURNAL ARTICLE
AU  - OTA, DAISUKE
AU  - AKATSUKA, SOTARO
AU  - NISHI, TSUNEHIRO
AU  - KATO, TAKAO
AU  - TAKEUCHI, MASASHI
AU  - TSUJI, MUNECHIKA
AU  - FUKUUCHI, ATSUSHI
TI  - Phase I Study of Combination Therapy With Weekly Nanoparticle Albumin-bound Paclitaxel and Cyclophosphamide in Metastatic Breast Cancer Patients
AID  - 10.21873/anticanres.13910
DP  - 2019 Dec 01
TA  - Anticancer Research
PG  - 6903--6907
VI  - 39
IP  - 12
4099  - http://ar.iiarjournals.org/content/39/12/6903.short
4100  - http://ar.iiarjournals.org/content/39/12/6903.full
SO  - Anticancer Res2019 Dec 01; 39
AB  - Background/Aim: The objective of this phase I study was to determine the maximum-tolerated dose (MTD) and recommended dose (RD) of combination therapy with weekly nanoparticle albumin-bound paclitaxel (nab-paclitaxel) and cyclophosphamide (CPA) in metastatic breast cancer (MBC) patients. Patients and Methods: Five patients who had human epidermal growth factor receptor 2 (HER2) negative MBC were recruited in this study. They received nab-paclitaxel at dose levels of 100-150 mg once a week for three weeks, repeated every 4 weeks, and CPA (600 mg/m2) administered on day 1. Results: No patient had grade 4 toxicity, however, two patients discontinued protocol treatment due to adverse events at level 2. Thus, the Data and Safety Monitoring Committee recommended the MTD of nab-paclitaxel and CPA to be determined at level 2. Conclusion: The combination therapy with weekly nab-paclitaxel and CPA was tolerable, and the RD for these drugs for MBC were 100 and 600 mg/m2, respectively.