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

Anticancer Res. 2019 Dec;39(12):6903-6907. doi: 10.21873/anticanres.13910.

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.

Keywords: Nab-paclitaxel; cyclophosphamide; metastatic breast cancer.

Publication types

  • Clinical Trial, Phase I

MeSH terms

  • Adult
  • Aged
  • Albumin-Bound Paclitaxel / administration & dosage*
  • Albumin-Bound Paclitaxel / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage*
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Breast Neoplasms / drug therapy*
  • Cyclophosphamide / administration & dosage*
  • Cyclophosphamide / adverse effects
  • Drug Administration Schedule
  • Female
  • Humans
  • Middle Aged
  • Neoplasm Metastasis
  • Treatment Outcome
  • Young Adult

Substances

  • Albumin-Bound Paclitaxel
  • Cyclophosphamide