ACCELERATE: Doxorubicin and Cyclophosphamide Followed by Paclitaxel With Pegfilgrastim and Darbepoetin Alfa Support for the Treatment of Women With Breast Cancer

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Aranesp; Drug: Neulasta

• Registration Number: NCT00261313
• Lead Sponsor: Amgen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2005-12-02
• Study First Submitted QC: 2005-12-02
• Study First Posted: 2005-12-05
• Primary Completion: 2007-06
• Study Completion: 2007-12
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-25
• Last Update Posted: 2010-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aranesp	Aranesp	-
Neulasta	Neulasta	-

Primary Outcome Measures

Name	Time	Method
The proportion of subjects experiencing any delay in any cycle of chemotherapy over the course of the study	3 months

Secondary Outcome Measures

Name	Time	Method
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