Dose Dense Chemotherapy With Lipegfilgrastim Support in Early Breast Cancer

Study Overview
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Brief Summary
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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
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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 Determine the incidence of febrile neutropenia during 4 cycles (8 weeks)of dose dense AC with lipegfilgrastim Examine the incidence of treatment-related neutropenia during subsequent intravenous cancer therapy up to 1 year.

Official Title
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An Observational Study of Dose Dense Chemotherapy With Lipegfilgrastim Support

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Lipegfilgrastim


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Stage I-III Breast Cancer Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1(see below) Adequate Bone Marrow Function as defined by neutrophil count of ≥1.0 and platelet count of ≥ 100 Planned chemotherapy with Dose Dense Doxorubicin-Cyclophosphamide (AC) as deemed appropriate by a Consultant Medical Oncologist General Indications for Dose Dense AC include: T3 or T4 Tumours N1 - N3 (Node Positive) Disease Human Epidermal Growth Factor Receptor 2 (HER2) Positive Tumours. Triple Negative Breast Cancer as evidenced by lack of expression of the estrogen receptor (ER), progesterone receptor (PR) and HER2 Exclusion Criteria: Stage IV Breast Cancer Pregnancy Previous Chemotherapy Exposure Prior Exposure to G-CSF Known positive HIV Status Cardiac or other concurrent illness, which at the investigator's discretion contraindicates the use of AC

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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).|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of treatment-related neutropenia | 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). | four cycles of dose dense doxorubicin cyclophosphamide (AC) with lipegfilgrastim support (8 weeks). | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early