Dose Dense Chemotherapy With Lipegfilgrastim Support in Early Breast Cancer

February 8, 2018 updated by: Patrick Morris, Beaumont Hospital

An Observational Study of Dose Dense Chemotherapy With Lipegfilgrastim Support

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Dublin, Ireland, Dublin 9
        • Beaumont Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Planned chemotherapy with Dose Dense Doxorubicin-Cyclophosphamide (AC) for early breast cancer

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beaumont Hospital

Investigators

  • Principal Investigator: Patrick G Patrick, MD, Beaumont Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

June 3, 2015

First Submitted That Met QC Criteria

August 17, 2015

First Posted (Estimate)

August 19, 2015

Study Record Updates

Last Update Posted (Actual)

February 9, 2018

Last Update Submitted That Met QC Criteria

February 8, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B1010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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