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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

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ClinicalTrials.gov Identifier: NCT00261313
Recruitment Status : Completed
First Posted : December 5, 2005
Last Update Posted : February 26, 2010
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Neulasta Drug: Aranesp Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2005
Actual Primary Completion Date : June 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. The proportion of subjects experiencing any delay in any cycle of chemotherapy over the course of the study [ Time Frame: 3 months ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00261313


Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen

Additional Information:
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00261313     History of Changes
Other Study ID Numbers: 20040137
First Posted: December 5, 2005    Key Record Dates
Last Update Posted: February 26, 2010
Last Verified: February 2010

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
Paclitaxel
Cyclophosphamide
Doxorubicin
Darbepoetin alfa
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Hematinics