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

This study is not yet open for participant recruitment.
Verified January 2013 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: NA
Last verified: January 2013
History: No changes posted
  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

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:

U.S. FDA Resources

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
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
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: Jisun Kim, MD MS 82-2-2072-4755 leticeclear@naver.com

Locations
Korea, Republic of
Seoul National University Hospital Not yet recruiting
Seoul, Korea, Republic of, 110-744
Contact: Jung-Hee Cha, MS     82-2-2072-0694     snuirb@gmail.com    
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Wonshik Han, MD PhD SNUH
  More Information

No publications provided

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: January 8, 2013
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
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013