NCT00261313

Brief Summary

This is a study of dose dense doxorubicin/cyclophosphamide (AC) followed by paclitaxel (Taxol; T) with pegfilgrastim (Neulasta) and darbepoetin alfa support in the adjuvant breast cancer setting.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Timeline
Completed

Started Dec 2005

Shorter than P25 for phase_2 breast-cancer

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

December 1, 2005

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 2, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 5, 2005

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

February 26, 2010

Status Verified

February 1, 2010

Enrollment Period

1.5 years

First QC Date

December 2, 2005

Last Update Submit

February 25, 2010

Conditions

Breast Cancer

Keywords

Breast cancerDoses dense chemotherapyGrowth factor supportAdjuvant Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • The proportion of subjects experiencing any delay in any cycle of chemotherapy over the course of the study

    3 months

Secondary Outcomes (3)

  • Febrile neutropenic events and adverse event profile will be assessed

    4 months

  • To assess chemotherapy and subject dose delays and reductions which are specific and/or non specific to haematological toxicities

    3 months

  • Frequency of red blood cell (RBC) transfusions

    3 months

Study Arms (2)

Aranesp

EXPERIMENTAL
Drug: Aranesp

Neulasta

EXPERIMENTAL
Drug: Neulasta

Interventions

NeulastaDRUG

6mg Neulasta to be given approximately 24 hours afer each cycle of chemotherapy

Neulasta
AranespDRUG

If Hb drops below 110, 300mcg Aranesp will be administered.

Aranesp

Eligibility Criteria

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

You may qualify if:

  • Breast cancer diagnosis node-positive or high risk node negative
  • Estrogen receptor (ER) negative or ER positive (stage IIA, IIB or IIIA) disease.

You may not qualify if:

  • Metastatic breast cancer
  • Clinically significant cardiac disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

pegfilgrastimDarbepoetin alfa

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 2, 2005

First Posted

December 5, 2005

Study Start

December 1, 2005

Primary Completion

June 1, 2007

Study Completion

December 1, 2007

Last Updated

February 26, 2010

Record last verified: 2010-02