Dose Dense Chemotherapy With Lipegfilgrastim Support in Early Breast Cancer

Last updated: February 8, 2018
Sponsor: Beaumont Hospital
Overall Status: Completed

Phase

N/A

Condition

Breast Cancer

Cancer

Treatment

N/A

Clinical Study ID

NCT02527317
B1010
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥ 18 years

  2. Stage I-III Breast Cancer

  3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1(see below)

  4. Adequate Bone Marrow Function as defined by neutrophil count of ≥1.0 and plateletcount of ≥ 100

  5. Planned chemotherapy with Dose Dense Doxorubicin-Cyclophosphamide (AC) as deemedappropriate by a Consultant Medical Oncologist General Indications for Dose Dense AC include:

  6. T3 or T4 Tumours

  7. N1 - N3 (Node Positive) Disease

  8. Human Epidermal Growth Factor Receptor 2 (HER2) Positive Tumours.

  9. Triple Negative Breast Cancer as evidenced by lack of expression of the estrogenreceptor (ER), progesterone receptor (PR) and HER2

Exclusion

Exclusion Criteria:

  1. Stage IV Breast Cancer

  2. Pregnancy

  3. Previous Chemotherapy Exposure

  4. Prior Exposure to G-CSF

  5. Known positive HIV Status

  6. Cardiac or other concurrent illness, which at the investigator's discretioncontraindicates the use of AC

Study Design

Total Participants: 40
Study Start date:
January 01, 2015
Estimated Completion Date:
February 28, 2018

Study 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.

Connect with a study center

  • Beaumont Hospital

    Dublin, DUBLIN 9
    Ireland

    Site Not Available

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