Breast Cancer Screening Adherence for Women at Moderate R... | NCT07076147

Studies
Breast Cancer Screening Adherence for Women at Moderate Risk for Breast Cancer

NCT07076147

Sponsor

University of Southern California

Status

Recruiting

Last Update Posted

Jun 1, 2026Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Breast Carcinoma

Interventions

Non-Interventional Study

Countries

United States

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

ID	Type	Description	Link
NCI-2025-04494	Registry Identifier	CTRP (Clinical Trial Reporting Program)
1B-25-1	Other Identifier	USC / Norris Comprehensive Cancer Center
P30CA014089	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2, 2025Actual

Primary Completion Date

Jun 2, 2027Estimated

Completion Date

Jun 2, 2028Estimated

First Submitted Date

Jul 7, 2025

First Submission Date that Met QC Criteria

Jul 17, 2025

First Posted Date

Jul 21, 2025Actual

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

May 29, 2026

Last Update Posted Date

Jun 1, 2026Actual

Name	Class
National Cancer Institute (NCI)	NIH

Description Module

Brief Summary

This study assesses breast cancer screening adherence for women at moderately increased risk for developing breast cancer based on gene mutation status or empiric risk model estimates. It also seeks to determine facilitators and barriers to screening.

Detailed Description

PRIMARY OBJECTIVE:

I. Among women without a history of breast cancer: to compare women with moderate risk breast cancer gene mutations (Mutation Carrier Group) to women with a 20-40% empiric lifetime risk of breast cancer (Empiric Risk Group) in terms of how likely they are to undergo recommended breast MRI screening.

OUTLINE: This is an observational study.

Patients complete a questionnaire and have their medical records reviewed on study.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Label	Type	Description	Intervention Names
Observational		Patients complete a questionnaire and have their medical records reviewed on study.	Other: Non-Interventional Study

Name	Type	Description	Arm Group Labels	Other Names
Non-Interventional Study	Other	Non-interventional study	Observational

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of women who undergo a screening breast MRI within 12 months of genetic test counseling	Will be calculated for each of the 4 Hospital-by-Age subgroups for the 2 risk groups; then a one-sided, α=0.05 Mantel Haenszel test, stratifying by hospital and age, will be used to compare the Mutation Carrier Risk and the Empiric Risk groups in terms of adherence to screening MRI. Homogeneity of odds ratios will be tested to ensure that difference (odds ratio) between the two risk groups is fairly consistent across the 4 strata.	Up to 2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

* >= 30 years
- =< 75 years
- Women with either:
  - Genetic test results showing moderately increased breast cancer risk due to a pathogenic/likely pathogenic variant in ATM, CHEK2, BARD1, RAD51C, or RAD51D (Mutation carrier group) OR
  - Calculated lifetime breast cancer risk estimates between 20% and 40% according to the Tyrer-Cuzick V8.0B empiric risk model (Empiric risk group)
- Patients provided breast cancer risk assessments by genetic counselors at USC Norris or LA General Hospital beginning in 2021 and at least 12 months ago
- Women recommended to undergo annual breast MRI and/or annual mammogram beginning at the time of their genetic counseling risk assessment
- English or Spanish speaking patients

Exclusion Criteria:

* History of breast cancer before genetic counseling at University of Southern California (USC)
- Any metastatic cancer diagnosis at time of genetic counseling risk assessment
- Deceased
- Patient underwent a risk reducing mastectomy before their genetic counseling risk assessment

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Women provided with a breast cancer risk assessment by genetic counselors at USC Norris or LA General Hospital with either genetic test results showing moderately increased breast cancer risk due to a pathogenic/likely pathogenic variant in ATM, CHEK2, BARD1, RAD51C, or RAD51D or a calculated lifetime breast cancer risk estimates between 20% and 40% according to the Tyrer-Cuzick V8.0B empiric risk model who are recommended to undergo annual breast MRI and/or annual mammogram.

Sampling Method

Non-Probability Sample

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases