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

Amgen80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

NeulastaDRUG

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

AranespDRUG

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 3 months

Secondary Outcomes

Febrile neutropenic events and adverse event profile will be assessed

Time frame: 4 months

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

Time frame: 3 months

Frequency of red blood cell (RBC) transfusions

Time frame: 3 months

Data from ClinicalTrials.gov

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