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

August 1, 2023 updated by: Harold J. Burstein, MD, PhD

A Phase II Study of Pegfilgrastim (Neulasta) and Darbepoetin Alfa (Aranesp) in Support of Dose-Dense Adjuvant Chemotherapy for Breast Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients will receive chemotherapy every 2 weeks for up to 8 cycles (spread out of approximately 16 weeks, total) of treatment. On the day of chemotherapy treatment patients may receive an injection of darbepoetin alfa in addition to chemotherapy if their red blood cell count is below normal levels.
On the day after chemotherapy treatment, patients will receive an injection of pegfilgrastim. There is one pegfilgrastim shot given per treatment cycle, for a total of 8 injections. Once the patient has finished chemotherapy and the last of the pegfilgrastim shots, their participation in this trial will be complete.
While on this study the following procedures will be performed: a physical exam will be done every 2 weeks, vital signs will be done every 2 weeks, and blood tests every 2 weeks.
This study also involves a Quality of Life Questionnaire done at the beginning of study treatment, at 2 months, 4 months, 6 months, and 1 year after starting the study treatment.
Patients will remain on this study unless they experience unacceptable side effects from any of the treatment drugs.

Study Type

Interventional

Enrollment (Actual)

135

Phase

Phase 2

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

United States
- Massachusetts
  - Boston, Massachusetts, United States, 02215
    - Beth Israel Deaconess Medical Center
  - Boston, Massachusetts, United States, 02115
    - Dana-Farber Cancer Institute
  - Boston, Massachusetts, United States, 02114
    - Massachusetts General Hospital
  - Boston, Massachusetts, United States, 02130
    - Faulkner Hospital
  - Lowell, Massachusetts, United States, 01854
    - Lowell General Hospital
  - Peabody, Massachusetts, United States, 01960
    - North Shore Cancer Center

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

Description

Inclusion Criteria:

Histologically or cytologically confirmed breast cancer clinical stage I, II or III disease. Patients must be deemed of sufficient risk for tumor or recurrence
Patients may receive the defined adjuvant chemotherapy treatment either following definitive breast surgery or prior to definitive breast surgery
18 years of age or older
ECOG performance status 0 or 1
ANC > 1,500/uL
Hemoglobin > 9 g/dL
Platelets > 100,000/ul
Total bilirubin less than or equal to ULN
AST/ALT < 1.5 x ULN
Creatinine within normal institutional limits
PT/PTT < institutional upper limit of normal
LVEF > 50%

Exclusion Criteria:

Previous cytotoxic chemotherapy or therapeutic radiation therapy
Pregnant or lactating women
Receiving any other investigational agents
Stage IV breast cancer
History of allergic reactions attributed to compounds of similar chemical or biologic composition to pegfilgrastim or darbepoetin
Previous exposure to G-CSF or pegfilgrastim or to recombinant erythropoetin-related growth factors.
On antibiotics within 72 hours of registration
Patients with immune deficiency who are at increased risk of lethal infections when treated with marrow-suppressive therapy, or HIV-positive patients receiving anti-retroviral therapy
Sickle cell disease
Known positive antibody response to any erythropoietic agent
Known hematologic diseases
Known history of hyperviscosity syndrome
Patients on lithium
RBC transfusion within past 4 weeks

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

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To determine the rate of febrile neutropenia in women treated with dose-dense adjuvant chemotherapy receiving pegfilgrastim every 2 weeks. Time Frame: 2 years	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
To determine the rate of RBC transfusion among patients treated with dose-dense adjuvant chemotherapy receiving darbepoetin every 2 weeks. Time Frame: 2 years	2 years

Collaborators and Investigators

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

Sponsor

Harold J. Burstein, MD, PhD

Collaborators

Massachusetts General Hospital

Dana-Farber Cancer Institute

Beth Israel Deaconess Medical Center

Brigham and Women's Hospital

Lowell General Hospital

North Shore Medical Center

Investigators

Principal Investigator: Harold Burstein, MD, PhD, Dana-Farber Cancer Institute

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

July 1, 2003

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)