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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00261313
• Other study ID #: 20040137
• Status: Completed
• Phase: Phase 2
• First received: December 2, 2005
• Last updated: February 25, 2010
• Start date: December 2005
• Est. completion date: December 2007

Study information

• Verified date: February 2010
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Neulasta
6mg Neulasta to be given approximately 24 hours afer each cycle of chemotherapy
• Aranesp
If Hb drops below 110, 300mcg Aranesp will be administered.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of subjects experiencing any delay in any cycle of chemotherapy over the course of the study		3 months	No
Secondary	Febrile neutropenic events and adverse event profile will be assessed		4 months	Yes
Secondary	To assess chemotherapy and subject dose delays and reductions which are specific and/or non specific to haematological toxicities		3 months	No
Secondary	Frequency of red blood cell (RBC) transfusions		3 months	No

External Links

•   AmgenTrials clinical trials website