Dose Dense Chemotherapy With Lipegfilgrastim Support in Early Breast Cancer

Breast Cancer Clinical Trial

Official title:

An Observational Study of Dose Dense Chemotherapy With Lipegfilgrastim Support

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02527317
• Other study ID #: B1010
• Status: Completed
• Phase: N/A
• First received: June 3, 2015
• Last updated: February 8, 2018
• Start date: January 2015
• Est. completion date: February 2018

Study information

• Verified date: February 2018
• Source: Beaumont Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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).

Locations

Country	Name	City	State
Ireland	Beaumont Hospital	Dublin

Sponsors (1)

Lead Sponsor	Collaborator
Beaumont Hospital

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).
Secondary	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