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Breast Density Change Predicting Response to Adjuvant Aromatase Inhibitor

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01765049
Acronym
DEAR
Enrollment
260
Registered
2013-01-10
Start date
2013-01-31
Completion date
2025-12-15
Last updated
2022-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Estrogen Receptor Positive Breast Cancer, Invasive Breast Cancer

Keywords

breast density change, endocrine therapy response, aromatase inhibitor

Brief summary

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

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

Interventions

None listed

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
No minimum to 70 Years
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

Design outcomes

Primary

MeasureTime frameDescription
disease free survival5 yearrecurrence locoregional distant metastasis Confirmed by clinical imaging or pathology

Secondary

MeasureTime frameDescription
breast density change6mos, 1yr, 2yrbreast density change measured by cumulus(mammogram) and MRI(bilateral breast MRI) imagings taken after 6mos, 1yr, 2yr after endocrine therapy initiation

Other

MeasureTime frameDescription
overall survival5 yeardisease specific survival overall survival during 5yr follow up

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026