Dose Dense Chemotherapy With Lipegfilgrastim Support in Early Breast Cancer

• Status: Completed
• Trial end date: 2018-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beaumont Hospital

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