Breast Density Change Predicting Response to Adjuvant Aromatase Inhibitor

Invasive Breast Cancer Clinical Trial

— DEAR  

Official title:

Prospective Study Analyzing Value of Breast Density Change Predicting ENdocrine Therapy Response in Postmenopausal Women Taking Adjuvant ARomatase Inhibitor

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01765049
• Other study ID #: SNUHBCC001
• Status: Active, not recruiting
• Start date: January 2013
• Est. completion date: December 15, 2025

Study information

• Verified date: October 2022
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 260
• Est. completion date: December 15, 2025
• Est. primary completion date: December 15, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Estrogen Receptor Positive Breast Cancer
• Invasive Breast Cancer

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	overall survival	disease specific survival overall survival during 5yr follow up	5 year
Primary	disease free survival	recurrence locoregional distant metastasis Confirmed by clinical imaging or pathology	5 year
Secondary	breast density change	breast density change measured by cumulus(mammogram) and MRI(bilateral breast MRI) imagings taken after 6mos, 1yr, 2yr after endocrine therapy initiation	6mos, 1yr, 2yr