Discerning the Impact of ctDNA Detection on Patient Decision Making in Early Stage Breast Cancer: a Conjoint Analysis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05730010

Enrollment

289

Registered

2023-02-15

Start date

2023-04-16

Completion date

2023-06-26

Last updated

2023-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Triple Negative Breast Cancer

Keywords

breast cancer, ctDNA

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.

Detailed description

This study is an electronically delivered, one time cross sectional survey study. The investigators want to understand how patients with triple negative breast cancer at high risk for disease recurrence will prioritize additional benefit over toxicity when considering treatment options, and if their knowledge of ctDNA positivity versus negativity will further shift this balance toward benefit.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

N/A

Design outcomes

Primary

Measure	Time frame	Description
Examine whether knowledge of ctDNA negativity influences patient decision-making	Once all surveys in the sample size are completed, 6 months anticipated	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.

Secondary

Measure	Time frame	Description
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	When assuming risk of recurrence of ctDNA positivity, we will use ratings- based conjoint analysis to determine part-worth utilities of each attribute - potential toxicity and potential benefit. Comparison of part-worth utilities will be used to estimate at what degree of benefit a given treatment would be acceptable, which will inform future trials.

Countries

United States

Outcome results