Breast Density Change Predicting Response to Adjuvant Aro... | NCT01765049

Studies
Breast Density Change Predicting Response to Adjuvant Aromatase Inhibitor

NCT01765049

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Oct 18, 2022Actual

Enrollment

260Actual

Phase

Not provided

Conditions

Invasive Breast Cancer
Estrogen Receptor Positive Breast Cancer

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Dec 15, 2025Estimated

Completion Date

Dec 15, 2025Estimated

First Submitted Date

Jan 8, 2013

First Submission Date that Met QC Criteria

Jan 8, 2013

First Posted Date

Jan 10, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 16, 2022

Last Update Posted Date

Oct 18, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

260Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
disease free survival	recurrence locoregional distant metastasis Confirmed by clinical imaging or pathology	5 year

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Measure	Description	Time Frame
overall survival	disease specific survival overall survival during 5yr follow up	5 year

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wonshik Han, MD PhD	SNUH	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul		110-744	South Korea