Pegfilgrastim and Darbepoetin Alfa in Support of Adjuvant Chemotherapy for Breast Cancer

Summary

The main purpose of this study is to see if pegfilgrastim (Neulasta) is safe and useful in supporting people through dose-dense chemotherapy, and to see if a long-acting red blood cell growth factor, darbepoetin alfa(Aranesp) can reduce the need for blood transfusion in chemotherapy recipients.

Conditions

• Breast Cancer
• Stage I Breast Cancer
• Stage II Breast Cancer

Interventions

DRUG

Darbepoetin Alfa

Given day before chemotherapy of red blood cell count is below normal

DRUG

Pegfilgrastim

Given as an injection the day before chemotherapy for a total of 8 injections

DRUG

Paclitaxel

As part of standard adjuvant chemotherapy: Given every two weeks for 8 cycles

DRUG

Doxorubicin

As part of standard adjuvant chemotherapy: Given every two weeks for 8 cycles

DRUG

Cyclophosphamide

As part of standard adjuvant chemotherapy: Given every two weeks for 8 cycles

Sponsors & Collaborators

• Dana-Farber Cancer Institute

  collaborator OTHER

• Massachusetts General Hospital

  collaborator OTHER

• Beth Israel Deaconess Medical Center

  collaborator OTHER

• Lowell General Hospital

  collaborator OTHER

• Brigham and Women's Hospital

  collaborator OTHER

• North Shore Medical Center

  collaborator OTHER

• Harold J. Burstein, MD, PhD

  lead OTHER

Principal Investigators

• Harold Burstein, MD, PhD · Dana-Farber Cancer Institute

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2003-07-31

Primary Completion

2007-05-31

Completion

2007-05-31

Countries

• United States

Study Locations