ACCELERATE: doxorubicin and cyclophosphamide followed by paclitaxel with pegfilgrastim and darbepoetin alfa support for the treatment of women with breast cancer

Sponsor ID

20040137

Clinicaltrials.gov ID

NCT00261313

EUCTIS ID

N/A

EudraCT ID

N/A

Study Details

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.

Additional Study Details

Phase

Phase 2

Product

pegfilgrastim

Type

Interventional

Masking

None (Open Label)

Enrollment

Additional Study Details

Protocol Summary

Primary Outcome Measures

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

Timeframe: 3 months

Secondary Outcome Measures

Febrile neutropenic events and adverse event profile will be assessed

Timeframe: 4 months

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

Timeframe: 3 months

Frequency of red blood cell (RBC) transfusions

Timeframe: 3 months

Study Documents

Study Synopsis

Available Language(s): English

Download Document(s)

Locations

No locations found.