NCT02527317

Dose Dense Chemotherapy With Lipegfilgrastim Support in Early Breast Cancer

An Observational Study of Dose Dense Chemotherapy With Lipegfilgrastim Support

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 40 (actual)
• Sponsor: Beaumont Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, non-interventional, single arm study, which is examining doxorubicin and cyclophosphamide (AC) once every 2 weeks with lipegfilgrastim support in early breast cancer.

Detailed description

An important advance in the use of dose dense chemotherapy regimens for breast cancer was the development of pegylated form of G-CSF (pegfilgrastim and lipegfilgrastim), which offered the convenience of single subcutaneous injection, rather than multiple daily injections Lipegfilgrastim is a pegylated long-acting covalent conjugate of filgrastim (G-CSF). In a pivotal randomized phase III study in breast cancer lipegfilgrastim was shown to be non-inferior to pegfilgrastim. In this prospective observational study the incidence of treatment-related neutropenia following four cycles of dose dense (every 2 week) doxorubicin cyclophosphamide (AC) with lipegfilgrastim support is being investigated. Data will be collected on 40 consecutive patients treated with AC and lipegfilgrastim in Ireland. The primary objective of this study is to determine the incidence of treatment-related neutropenia following four cycles of dose dense doxorubicin cyclophosphamide (AC) with lipegfilgrastim support (8 weeks). Secondary Objectives 1. Determine the incidence of febrile neutropenia during 4 cycles (8 weeks)of dose dense AC with lipegfilgrastim 2. Examine the incidence of treatment-related neutropenia during subsequent intravenous cancer therapy up to 1 year.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Lipegfilgrastim	Investigate the incidence of treatment-related neutropenia following four cycles of dose dense (every 2 week) doxorubicin cyclophosphamide (AC) with lipegfilgrastim support (8 weeks).

Timeline

• Start date: 2015-01-01
• Primary completion: 2018-02-01
• Completion: 2018-02-01
• First posted: 2015-08-19
• Last updated: 2018-02-09

Locations

1 site across 1 country: Ireland