Dose Dense Chemotherapy With Lipegfilgrastim Support in Early Breast Cancer

Completed

• Conditions: Breast Cancer

• Registration Number: NCT02527317
• Lead Sponsor: Beaumont Hospital

Brief 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.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-06-03
• Study First Submitted QC: 2015-08-17
• Study First Posted: 2015-08-19
• Status Verified: 2018-02
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Last Update Submitted: 2018-02-08
• Last Update Posted: 2018-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 platelet count of ≥ 100
5. Planned chemotherapy with Dose Dense Doxorubicin-Cyclophosphamide (AC) as deemed appropriate by a Consultant Medical Oncologist

General Indications for Dose Dense AC include:

1. T3 or T4 Tumours
2. N1 - N3 (Node Positive) Disease
3. Human Epidermal Growth Factor Receptor 2 (HER2) Positive Tumours.
4. Triple Negative Breast Cancer as evidenced by lack of expression of the estrogen receptor (ER), progesterone receptor (PR) and HER2

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 discretion contraindicates the use of AC

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
incidence of treatment-related neutropenia	four cycles of dose dense doxorubicin cyclophosphamide (AC) with lipegfilgrastim support (8 weeks).	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 Outcome Measures

Name	Time	Method
incidence of febrile neutropenia	four cycles of dose dense doxorubicin cyclophosphamide (AC) with lipegfilgrastim support (8 weeks).	Determine the incidence of febrile neutropenia during 4 cycles (8 weeks) of dose dense AC with lipegfilgrastim
incidence of treatment-related neutropenia	Up to 1 year of subsequent chemotherapy	Determine the incidence of treatment-related neutropenia during subsequent chemotherapy (up to 1 year)

Trial Locations

Locations (1)

Beaumont Hospital; 🇮🇪 Dublin, Ireland