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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00261313

Enrollment

Registered

2005-12-05

Start date

2005-12-31

Completion date

2007-12-31

Last updated

2010-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast cancer, Doses dense chemotherapy, Growth factor support, Adjuvant Breast Cancer

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.

Interventions

DRUGNeulasta

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

DRUGAranesp

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The proportion of subjects experiencing any delay in any cycle of chemotherapy over the course of the study	3 months

Secondary

Measure	Time frame
Febrile neutropenic events and adverse event profile will be assessed	4 months
To assess chemotherapy and subject dose delays and reductions which are specific and/or non specific to haematological toxicities	3 months
Frequency of red blood cell (RBC) transfusions	3 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026