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DEAR: Breast Density Change Predicting Response to Adjuvant Aromatase Inhibitor

Sponsor
Seoul National University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01765049
Collaborator
(none)
411
Enrollment
1
Location
71
Duration (Months)
5.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Breast density change after short term use of aromatase inhibitor in postmenopausal ER positive breast cancer would predict endocrine responsiveness

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Inclusion criteria ER positive breast cancer Postmenopause women Older than 60yr S/P bilateral salphingo-oophorectomy No menstruation history within 1yr and FSH>30mIU/mL Ipsilateral invasive breast cancer Undergone curative resection No evidence of distant metastasis Capable of breast MRI

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    411 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prospective Study Analyzing Value of Breast Density Change Predicting ENdocrine Therapy Response in Postmenopausal Women Taking Adjuvant ARomatase Inhibitor
    Study Start Date :
    Jan 1, 2013
    Anticipated Primary Completion Date :
    Dec 1, 2018
    Anticipated Study Completion Date :
    Dec 1, 2018

    Outcome Measures

    Primary Outcome Measures

    1. disease free survival [5 year]

      recurrence locoregional distant metastasis Confirmed by clinical imaging or pathology

    Secondary Outcome Measures

    1. breast density change [6mos, 1yr, 2yr]

      breast density change measured by cumulus(mammogram) and MRI(bilateral breast MRI) imagings taken after 6mos, 1yr, 2yr after endocrine therapy initiation

    Other Outcome Measures

    1. overall survival [5 year]

      disease specific survival overall survival during 5yr follow up

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 70 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • ER positive invasive breast cancer Postmenopause women age 60yrs or older s/p bilateral salphingo-oophorectomy No history of menstruation and FSH>30mIU Planned for aromatase inhibitor Unilateral breast cancer Curative resection No evidence of distant metastasis
    Exclusion Criteria:
    • Bilateral breast cancer Male breast cancer Acceptable for breast MRI Pregnancy or lactation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Hospital Seoul Korea, Republic of 110-744

    Sponsors and Collaborators

    • Seoul National University Hospital

    Investigators

    • Principal Investigator: Wonshik Han, MD PhD, SNUH

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT01765049
    Other Study ID Numbers:
    • SNUHBCC001
    First Posted:
    Jan 10, 2013
    Last Update Posted:
    Apr 19, 2018
    Last Verified:
    Oct 1, 2017
    Keywords provided by Seoul National University Hospital
    breast density change
    endocrine therapy response
    aromatase inhibitor
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Apr 19, 2018