search
Back to results

Pegfilgrastim as Support to Advanced Breast Cancer Patients Receiving Chemotherapy

Primary Purpose

Neutropenia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
pegfilgrastim
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neutropenia focused on measuring Breast cancer, Neutropenia, Chemotherapy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)Does not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Placebo

    Pegfilgrastim

    Arm Description

    Breast cancer patients receiving docetaxel chemotherapy and placebo.

    Breast cancer patients receiving docetaxel chemotherapy and pegfilgrastim.

    Outcomes

    Primary Outcome Measures

    Proportion of subjects developing febrile neutropenia

    Secondary Outcome Measures

    Incidence of hospitalization and IV antiinfective use associated with FN; also chemotherapy planned dose on time

    Full Information

    First Posted
    May 3, 2002
    Last Updated
    May 7, 2013
    Sponsor
    Amgen
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00035594
    Brief Title
    Pegfilgrastim as Support to Advanced Breast Cancer Patients Receiving Chemotherapy
    Official Title
    A Double-Blind, Placebo-Controlled, Multicenter, Randomized Study Evaluating the Prophylactic Use of Pegfilgrastim on the Incidence of Febrile Neutropenia in Subjects With Advanced Breast Cancer Treated With Single Agent Docetaxel
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2002 (undefined)
    Primary Completion Date
    February 2004 (Actual)
    Study Completion Date
    June 2004 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Amgen

    4. Oversight

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neutropenia
    Keywords
    Breast cancer, Neutropenia, Chemotherapy

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    928 (false)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Breast cancer patients receiving docetaxel chemotherapy and placebo.
    Arm Title
    Pegfilgrastim
    Arm Type
    Experimental
    Arm Description
    Breast cancer patients receiving docetaxel chemotherapy and pegfilgrastim.
    Intervention Type
    Drug
    Intervention Name(s)
    pegfilgrastim
    Intervention Description
    Growth factor (GCSF) administered to promote neutrophil development post-chemotherapy.
    Primary Outcome Measure Information:
    Title
    Proportion of subjects developing febrile neutropenia
    Time Frame
    Through 4 cycles
    Secondary Outcome Measure Information:
    Title
    Incidence of hospitalization and IV antiinfective use associated with FN; also chemotherapy planned dose on time
    Time Frame
    Through 4 cycles

    10. Eligibility

    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Advanced breast cancer 18 years of age or older Patients who will be receiving Taxotere (docetaxel) chemotherapy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    MD
    Organizational Affiliation
    Amgen
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    15718314
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    25851633
    Citation
    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.
    Results Reference
    derived
    Links:
    URL
    http://www.amgentrials.com
    Description
    AmgenTrials clinical trials website
    URL
    http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf
    Description
    Notice regarding posted summaries of trial results
    URL
    http://download.veritasmedicine.com/REGFILES/amgen/08D_FDAMA_113_Posting_Summary_11_GCSFSD01_20010144.pdf
    Description
    To access clinical trial results information click on this link
    URL
    http://www.neulasta.com/
    Description
    FDA-approved Drug Labeling

    Learn more about this trial

    Pegfilgrastim as Support to Advanced Breast Cancer Patients Receiving Chemotherapy

    We'll reach out to this number within 24 hrs