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

Amgen

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Aranesp; Drug: Neulasta

Study type: Interventional

Funder types: Industry

Identifiers

NCT00261313

20040137

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Aranesp

Experimental group

Treatment:

Drug: Aranesp

Neulasta

Experimental group

Treatment:

Drug: Neulasta