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

NCT ID: NCT00261313

Last Updated: 2010-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2007-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Keywords

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Breast cancer Doses dense chemotherapy Growth factor support Adjuvant Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Aranesp

Group Type EXPERIMENTAL

Aranesp

Intervention Type DRUG

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

Neulasta

Group Type EXPERIMENTAL

Neulasta

Intervention Type DRUG

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

Interventions

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Neulasta

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

Intervention Type DRUG

Aranesp

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Amgen Inc.

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Countries

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Australia

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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20040137

Identifier Type: -

Identifier Source: org_study_id