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Clinical Trials/NCT00261313
NCT00261313CompletedPhase 2

An Open Label Phase 2 Study of Doxorubicin and Cyclophosphamide Followed by Paclitaxel Delivered Every 14 Days With Pegfilgrastim and Darbepoetin Alfa Support for the Adjuvant Treatment of Women With Breast Cancer

Amgen0 sites80 target enrollmentStarted: December 2005Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Amgen
Enrollment
80
Primary Endpoint
The proportion of subjects experiencing any delay in any cycle of chemotherapy over the course of the study
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • •Metastatic breast cancer
  • •Clinically significant cardiac disease

Arms & Interventions

Aranesp

Experimental

Intervention: Aranesp (Drug)

Neulasta

Experimental

Intervention: Neulasta (Drug)

Outcomes

Primary Outcomes

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

Time Frame: 3 months

Secondary Outcomes

  • 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)

Investigators

Sponsor
Amgen
Sponsor Class
Industry

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