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OpenTrials
Completed

NCT Number: NCT00261313

ACCELERATE: Doxorubicin and Cyclophosphamide Followed by Paclitaxel With Pegfilgrastim and Darbepoetin Alfa Support for the 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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neulasta

Drug

6mg Neulasta to be given approximately 24 hours afer each cycle of chemotherapy

Aranesp

Drug

If Hb drops below 110, 300mcg Aranesp will be administered.

Primary outcomes

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

    Time frame: 3 months

Secondary outcomes

  1. Febrile neutropenic events and adverse event profile will be assessed

    Time frame: 4 months

  2. To assess chemotherapy and subject dose delays and reductions which are specific and/or non specific to haematological toxicities

    Time frame: 3 months

  3. Frequency of red blood cell (RBC) transfusions

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Dec 5, 2005
Registry last updated
Feb 26, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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