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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

December 2, 2005
February 25, 2010
December 2005
June 2007   (final data collection date for primary outcome measure)
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 ]
The proportion of subjects experiencing any delay in any cycle of chemotherapy over the course of the study
Complete list of historical versions of study NCT00261313 on ClinicalTrials.gov Archive Site
  • 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 ]
To assess chemotherapy and subject dose delays and reductions which are specific and/or non specific to haematological toxicities. Frequency of RBC transfusions. Febrile neutropenic events and adverse event protfile will be assessed.
Not Provided
Not Provided
 
ACCELERATE: Doxorubicin and Cyclophosphamide Followed by Paclitaxel With Pegfilgrastim and Darbepoetin Alfa Support for the Treatment of Women With Breast Cancer
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

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: Neulasta
    6mg Neulasta to be given approximately 24 hours afer each cycle of chemotherapy
  • Drug: Aranesp
    If Hb drops below 110, 300mcg Aranesp will be administered.
  • Experimental: Aranesp
    Intervention: Drug: Aranesp
  • Experimental: Neulasta
    Intervention: Drug: Neulasta
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
December 2007
June 2007   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00261313
20040137
Not Provided
Global Development Leader, Amgen Inc.
Amgen
Not Provided
Study Director: MD Amgen
Amgen
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP