NCT05730010

Brief Summary

This study will examine how ctDNA and additional prognostic genomic information in patients with early stage breast cancer might influences patient decision- making regarding systemic therapy options.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
289

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

January 31, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 15, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

April 16, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2023

Completed
Last Updated

August 3, 2023

Status Verified

August 1, 2023

Enrollment Period

2 months

First QC Date

January 31, 2023

Last Update Submit

August 1, 2023

Conditions

Triple Negative Breast Cancer

Keywords

breast cancer, ctDNA

Outcome Measures

Primary Outcomes (1)

  • Examine whether knowledge of ctDNA negativity influences patient decision-making

    Ratings- based analysis will be used to examine whether knowledge of ctDNA negativity increases patient acceptability (and if so, by how much) of no therapy in the adjuvant setting, compared to standard of care capecitabine.

    Once all surveys in the sample size are completed, 6 months anticipated

Secondary Outcomes (1)

  • Estimate at what degree of benefit a given treatment would be acceptable to patients

    Once all surveys in the sample size are completed, 6 months anticipated

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Approximately 200 subjects will be recruited by Research Advocacy Network (RAN) and their partner organizations through email and social media solicitation.

You may qualify if:

  • Self- reported history of non-metastatic breast cancer
  • Self- reported history of receiving chemotherapy for breast cancer
  • Self- reported history of chemotherapy completed at least 6 months ago but no more than 10 years ago
  • Able to complete an online survey
  • English speaking

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Triple Negative Breast NeoplasmsBreast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Clinical Medicine

Study Record Dates

First Submitted

January 31, 2023

First Posted

February 15, 2023

Study Start

April 16, 2023

Primary Completion

June 26, 2023

Study Completion

June 26, 2023

Last Updated

August 3, 2023

Record last verified: 2023-08

Locations

US(1)