Dose Dense Chemotherapy With Lipegfilgrastim Support in Early Breast Cancer

NCT ID: NCT02527317

Last Updated: 2018-02-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2018-02-28

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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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).

Intervention Type: DRUG

Other Intervention Names

Lonquex

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beaumont Hospital

OTHER

Sponsor Role: lead

Responsible Party

Patrick Morris

Consultant Medical Oncologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patrick G Patrick, MD

Role: PRINCIPAL_INVESTIGATOR

Beaumont Hospital

Locations

Beaumont Hospital

Dublin, , Ireland

Countries

Ireland

Other Identifiers

B1010

Identifier Type: -

Identifier Source: org_study_id