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.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00261313
First received: December 2, 2005
Last updated: February 25, 2010
Last verified: February 2010
  Purpose

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00261313

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov 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
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Doxorubicin
Paclitaxel
Darbepoetin alfa
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic
Hematinics
Hematologic Agents

ClinicalTrials.gov processed this record on April 23, 2014