NCT01765049

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
260

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 10, 2013

Completed
12.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
Last Updated

October 18, 2022

Status Verified

October 1, 2022

Enrollment Period

13 years

First QC Date

January 8, 2013

Last Update Submit

October 16, 2022

Conditions

Invasive Breast CancerEstrogen Receptor Positive Breast Cancer

Keywords

breast density changeendocrine therapy responsearomatase inhibitor

Outcome Measures

Primary Outcomes (1)

  • disease free survival

    recurrence locoregional distant metastasis Confirmed by clinical imaging or pathology

    5 year

Secondary Outcomes (1)

  • breast density change

    6mos, 1yr, 2yr

Other Outcomes (1)

  • overall survival

    5 year

Eligibility Criteria

AgeUp to 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Postmenopausal women with ER positive invasive breast cancer taking adjuvant endocrine therapy with aromatase inhibitor

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Biospecimen

Retention: SAMPLES WITH DNA

Postoperatively collected specimen (normal and cancer tissue) Preoperatively collected blood sample

Study Officials

  • Wonshik Han, MD PhD

    SNUH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2013

First Posted

January 10, 2013

Study Start

January 1, 2013

Primary Completion

December 15, 2025

Study Completion

December 15, 2025

Last Updated

October 18, 2022

Record last verified: 2022-10

Locations

KR(1)