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Steroid Aromatase Inhibitors Versus Progestogens for nSAID-resistanced Late Stage Breast Cancer

Sponsor
Tianjin Medical University Cancer Institute and Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02161315
Collaborator
(none)
80
Enrollment
1
Location
32
Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Steroid Aromatase Inhibitors and Non-Steroid Aromatase Inhibitors in Late Stage Breast Cancer is the recommended scheme in National Comprehensive Cancer Network (NCCN) guideline. In the past controlled clinical trials with small sample.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    A Randomized Study of Steroid Aromatase Inhibitors Versus Progestogens for Non-Steroid Aromatase Inhibitor-resistanced Late Stage Breast Cancer.The primary endpoints of the study is progression free survival (PFS). The secondary endpoints are overall response rate (ORR), overall survival (OS) and safety.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    80 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    A Randomized Study of Steroid Aromatase Inhibitors Versus Progestogens for Non-Steroid Aromatase Inhibitor-resistanced Late Stage Breast Cancer
    Study Start Date :
    Apr 1, 2014
    Anticipated Primary Completion Date :
    Nov 1, 2016
    Anticipated Study Completion Date :
    Dec 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    Observation group

    Steroid Aromatase Inhibitors
    Control group

    Non-Steroid Aromatase Inhibitor

    Outcome Measures

    Primary Outcome Measures

    1. RECIST 1.1 [-7 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Patients must be the postmenopausal women

    2. Patients must be diagnosed with advanced breast cancer by imageology，cytology or histopathology

    3. Immunohistochemistry shows ER and/or PR positive

    4. Patients ECOG score must be 0-2

    5. Drug resistant about Non-Steroid Aromatase Inhibitors

    Exclusion Criteria:

    1. Not suitable for endocrine therapy

    2. Have receive the standard Steroid Aromatase Inhibitors treatment

    3. Severe hepatic dysfunction

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tianjin Medical University Cancer Institute and Hospital Tianjin Tianjin China 300060

    Sponsors and Collaborators

    • Tianjin Medical University Cancer Institute and Hospital

    Investigators

    • Principal Investigator: Yehui Shi, M.D., Tianjin Medical University Cancer Institute and Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tianjin Medical University Cancer Institute and Hospital
    ClinicalTrials.gov Identifier:
    NCT02161315
    Other Study ID Numbers:
    • CIH-SYH-201205001
    First Posted:
    Jun 11, 2014
    Last Update Posted:
    Dec 22, 2015
    Last Verified:
    Feb 1, 2012
    Keywords provided by Tianjin Medical University Cancer Institute and Hospital
    SAID, Progestogens, nSAID-resistanced, LSBC
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Dec 22, 2015