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Post Operative Adjuvant Chemotherapy Followed by Adjuvant Tamoxifen vs Nil for Patients With Operable Breast Cancer

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tamoxifen
Sponsored by
King Faisal Specialist Hospital & Research Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional health services research trial for Breast Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with operable breast cancer

Sites / Locations

    Outcomes

    Primary Outcome Measures

    safety

    Secondary Outcome Measures

    Full Information

    First Posted
    October 1, 2007
    Last Updated
    December 11, 2011
    Sponsor
    King Faisal Specialist Hospital & Research Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00538330
    Brief Title
    Post Operative Adjuvant Chemotherapy Followed by Adjuvant Tamoxifen vs Nil for Patients With Operable Breast Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2011
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2007 (undefined)
    Primary Completion Date
    September 2020 (Anticipated)
    Study Completion Date
    September 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    King Faisal Specialist Hospital & Research Center

    4. Oversight

    5. Study Description

    Brief Summary
    Post operative adjuvant chemotherapy followed by adjuvant Tamoxifen vs nil for patients with operable breast cancer

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    2000 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Tamoxifen
    Intervention Description
    Tamoxifen
    Primary Outcome Measure Information:
    Title
    safety
    Time Frame
    10 years

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with operable breast cancer
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Adnan Ezzat, MD
    Organizational Affiliation
    KFSH&RC, Riyadh
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Post Operative Adjuvant Chemotherapy Followed by Adjuvant Tamoxifen vs Nil for Patients With Operable Breast Cancer

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