Pegfilgrastim as Support to Advanced Breast Cancer Patients Receiving Chemotherapy

NCT ID: NCT00035594

Last Updated: 2013-05-09

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

PHASE3

Total Enrollment

928 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-02-28

Study Completion Date

2004-06-30

Brief Summary

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Physicians are conducting a clinical trial for patients with advanced breast cancer. Breast cancer can be treated with chemotherapy which can affect the bone marrow, where blood cells are produced. Neutrophils are a type of white blood cells that fight infection and are produced in the bone marrow. If the neutrophil count becomes low due to chemotherapy, a potentially serious condition called neutropenia occurs. Neutropenia is serious because it can affect the body's ability to protect against many types of infections. Pegfilgrastim is an investigational drug being evaluated for its potential ability to increase the number of neutrophils. The purpose of this study is to determine the safety and effectiveness of pegfilgrastim in preventing neutropenia following chemotherapy in patients with advanced breast cancer.

Detailed Description

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Conditions

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Neutropenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

Breast cancer patients receiving docetaxel chemotherapy and placebo.

Group Type PLACEBO_COMPARATOR

pegfilgrastim

Intervention Type DRUG

Growth factor (GCSF) administered to promote neutrophil development post-chemotherapy.

Pegfilgrastim

Breast cancer patients receiving docetaxel chemotherapy and pegfilgrastim.

Group Type EXPERIMENTAL

pegfilgrastim

Intervention Type DRUG

Growth factor (GCSF) administered to promote neutrophil development post-chemotherapy.

Interventions

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pegfilgrastim

Growth factor (GCSF) administered to promote neutrophil development post-chemotherapy.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Advanced breast cancer
* 18 years of age or older
* Patients who will be receiving Taxotere (docetaxel) chemotherapy
Eligible Sex

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

References

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Vogel CL, Wojtukiewicz MZ, Carroll RR, Tjulandin SA, Barajas-Figueroa LJ, Wiens BL, Neumann TA, Schwartzberg LS. First and subsequent cycle use of pegfilgrastim prevents febrile neutropenia in patients with breast cancer: a multicenter, double-blind, placebo-controlled phase III study. J Clin Oncol. 2005 Feb 20;23(6):1178-84. doi: 10.1200/JCO.2005.09.102.

Reference Type RESULT
PMID: 15718314 (View on PubMed)

Lyman GH, Reiner M, Morrow PK, Crawford J. The effect of filgrastim or pegfilgrastim on survival outcomes of patients with cancer receiving myelosuppressive chemotherapy. Ann Oncol. 2015 Jul;26(7):1452-8. doi: 10.1093/annonc/mdv174. Epub 2015 Apr 7.

Reference Type DERIVED
PMID: 25851633 (View on PubMed)

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

http://www.neulasta.com/

FDA-approved Drug Labeling

Other Identifiers

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20010144

Identifier Type: -

Identifier Source: org_study_id

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