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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01765049
First received: January 8, 2013
Last updated: November 18, 2015
Last verified: June 2015
  Purpose
Breast density change after short term use of aromatase inhibitor in postmenopausal ER positive breast cancer would predict endocrine responsiveness

Condition
Invasive Breast Cancer
Estrogen Receptor Positive Breast Cancer

Study Type: Observational [Patient Registry]
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • disease free survival [ Time Frame: 5 year ] [ Designated as safety issue: No ]
    recurrence locoregional distant metastasis Confirmed by clinical imaging or pathology


Secondary Outcome Measures:
  • breast density change [ Time Frame: 6mos, 1yr, 2yr ] [ Designated as safety issue: No ]
    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:
  • overall survival [ Time Frame: 5 year ] [ Designated as safety issue: No ]
    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

Estimated Enrollment: 411
Study Start Date: January 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   up to 70 Years   (Child, Adult, Senior)
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01765049

Contacts
Contact: Wonshik Han, MD PhD 82-2-2072-1958 hanw@snu.ac.kr
Contact: Tae-Kyung Yoo, MD MS 82-2-2072-2096 robbie25@hanmail.net

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: Tae-Kyung Yoo, MD       robbie25@hanmail.net   
Sub-Investigator: Tae-Kyung Yoo, MD         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Wonshik Han, MD PhD SNUH
  More Information

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01765049     History of Changes
Other Study ID Numbers: SNUHBCC001 
Study First Received: January 8, 2013
Last Updated: November 18, 2015
Health Authority: Korea: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 23, 2016