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Breast Density Change Predicting Response to Adjuvant Aromatase Inhibitor (DEAR)

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ClinicalTrials.gov Identifier: NCT01765049
Recruitment Status : Recruiting
First Posted : January 10, 2013
Last Update Posted : April 19, 2018
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital

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
Invasive Breast Cancer Estrogen Receptor Positive Breast Cancer

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 Type : Observational [Patient Registry]
Estimated Enrollment : 411 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Prospective Study Analyzing Value of Breast Density Change Predicting ENdocrine Therapy Response in Postmenopausal Women Taking Adjuvant ARomatase Inhibitor
Study Start Date : January 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. disease free survival [ Time Frame: 5 year ]
    recurrence locoregional distant metastasis Confirmed by clinical imaging or pathology


Secondary Outcome Measures :
  1. breast density change [ Time Frame: 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 [ Time Frame: 5 year ]
    disease specific survival overall survival during 5yr follow up


Biospecimen Retention:   Samples With DNA
Postoperatively collected specimen (normal and cancer tissue) Preoperatively collected blood sample


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Ages Eligible for Study:   up to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Postmenopausal women with ER positive invasive breast cancer taking adjuvant endocrine therapy with aromatase inhibitor
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01765049


Contacts
Contact: Wonshik Han, MD PhD 82-2-2072-1958 hanw@snu.ac.kr
Contact: Yumi Kim, MD MS 1028040324 yumssky@gmail.com

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Wonshik Han, MD PhD    82-2-2072-1958    hanw@snu.ac.kr   
Contact: Yumi Kim, MD       yumssky@gmail.com   
Sub-Investigator: Yumi Kim, MD         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Wonshik Han, MD PhD SNUH

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01765049     History of Changes
Other Study ID Numbers: SNUHBCC001
First Posted: January 10, 2013    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: October 2017

Keywords provided by Seoul National University Hospital:
breast density change
endocrine therapy response
aromatase inhibitor

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs