NCT00146562

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline
Completed

Started Jul 2003

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 7, 2005

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

August 2, 2023

Status Verified

May 1, 2023

Enrollment Period

3.8 years

First QC Date

September 2, 2005

Last Update Submit

August 1, 2023

Conditions

Breast CancerStage I Breast CancerStage II Breast Cancer

Keywords

adjuvant chemotherapyG-CSFpegfilgrastimdarbepoetin alfa

Outcome Measures

Primary Outcomes (1)

  • To determine the rate of febrile neutropenia in women treated with dose-dense adjuvant chemotherapy receiving pegfilgrastim every 2 weeks.

    2 years

Secondary Outcomes (1)

  • To determine the rate of RBC transfusion among patients treated with dose-dense adjuvant chemotherapy receiving darbepoetin every 2 weeks.

    2 years

Interventions

Darbepoetin AlfaDRUG

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

Also known as: Aranesp
PegfilgrastimDRUG

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

Also known as: Neulasta
PaclitaxelDRUG

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

DoxorubicinDRUG

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

CyclophosphamideDRUG

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Faulkner Hospital

Boston, Massachusetts, 02130, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Lowell General Hospital

Lowell, Massachusetts, 01854, United States

Location

North Shore Cancer Center

Peabody, Massachusetts, 01960, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Darbepoetin alfapegfilgrastimPaclitaxelDoxorubicinCyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesProteinsAmino Acids, Peptides, and ProteinsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticPolycyclic CompoundsAminoglycosidesGlycosidesPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus Compounds

Study Officials

  • Harold Burstein, MD, PhD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

September 2, 2005

First Posted

September 7, 2005

Study Start

July 1, 2003

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

August 2, 2023

Record last verified: 2023-05

Locations

US(6)