RT Journal Article
SR Electronic
T1 Phase I Study of Combination Therapy With Weekly Nanoparticle Albumin-bound Paclitaxel and Cyclophosphamide in Metastatic Breast Cancer Patients
JF Anticancer Research
JO Anticancer Res
FD International Institute of Anticancer Research
SP 6903
OP 6907
DO 10.21873/anticanres.13910
VO 39
IS 12
A1 OTA, DAISUKE
A1 AKATSUKA, SOTARO
A1 NISHI, TSUNEHIRO
A1 KATO, TAKAO
A1 TAKEUCHI, MASASHI
A1 TSUJI, MUNECHIKA
A1 FUKUUCHI, ATSUSHI
YR 2019
UL http://ar.iiarjournals.org/content/39/12/6903.abstract
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.