Phase I Study of Combination Therapy With Weekly Nanoparticle Albumin-bound Paclitaxel and Cyclophosphamide in Metastatic Breast Cancer Patients.

Abstract:

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.

journal_name

Anticancer Res

journal_title

Anticancer research

authors

Ota D,Akatsuka S,Nishi T,Kato T,Takeuchi M,Tsuji M,Fukuuchi A

doi

10.21873/anticanres.13910

subject

Has Abstract

pub_date

2019-12-01 00:00:00

pages

6903-6907

issue

12

eissn

0250-7005

issn

1791-7530

pii

39/12/6903

journal_volume

39

pub_type

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