Breast Density Change Predicting Response to Adjuvant Aromatase Inhibitor

Active, not recruiting

• Conditions: Estrogen Receptor Positive Breast Cancer; Invasive Breast Cancer

• Registration Number: NCT01765049
• Lead Sponsor: 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

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 Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-08
• Study First Submitted QC: 2013-01-08
• Study First Posted: 2013-01-10
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-16
• Last Update Posted: 2022-10-18
• Primary Completion: 2025-12-15
• Study Completion: 2025-12-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 260

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

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Exclusion Criteria

• Bilateral breast cancer Male breast cancer Acceptable for breast MRI Pregnancy or lactation

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
disease free survival	5 year	recurrence locoregional distant metastasis Confirmed by clinical imaging or pathology

Secondary Outcome Measures

Name	Time	Method
breast density change	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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of