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

This study has been completed.
Information provided by:
Amgen Identifier:
First received: December 2, 2005
Last updated: February 25, 2010
Last verified: February 2010
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.

Condition Intervention Phase
Breast Cancer
Drug: Neulasta
Drug: Aranesp
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Amgen:

Primary Outcome Measures:
  • The proportion of subjects experiencing any delay in any cycle of chemotherapy over the course of the study [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Febrile neutropenic events and adverse event profile will be assessed [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
  • To assess chemotherapy and subject dose delays and reductions which are specific and/or non specific to haematological toxicities [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Frequency of red blood cell (RBC) transfusions [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: December 2005
Study Completion Date: December 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aranesp Drug: Aranesp
If Hb drops below 110, 300mcg Aranesp will be administered.
Experimental: Neulasta Drug: Neulasta
6mg Neulasta to be given approximately 24 hours afer each cycle of chemotherapy


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00261313

Sponsors and Collaborators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Global Development Leader, Amgen Inc. Identifier: NCT00261313     History of Changes
Other Study ID Numbers: 20040137 
Study First Received: December 2, 2005
Last Updated: February 25, 2010
Health Authority: Australia: Therapeutic Goods Administration

Keywords provided by Amgen:
Breast cancer
Doses dense chemotherapy
Growth factor support
Adjuvant Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases
Darbepoetin alfa
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Physiological Effects of Drugs processed this record on May 24, 2016