Clinical Trials Logo
  1. Home
  2. Triple Negative Breast Cancer
  3. NCT05730010
  4. Details
NCT05730010 Clinical Trial

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

Triple Negative Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05730010
Other study ID # CTO-IUSCCC-0803
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 16, 2023
Est. completion date June 26, 2023

Study information
Verified date August 2023
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 289
Est. completion date June 26, 2023
Est. primary completion date June 26, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Indiana University Melvin and Bren Simon Comprehensive Cancer Center Indianapolis Indiana

Sponsors (1)
Lead Sponsor Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Estimate at what degree of benefit a given treatment would be acceptable to patients 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. Once all surveys in the sample size are completed, 6 months anticipated
See also
  Status Clinical Trial Phase
Recruiting NCT05174832 - Induction of Cisplatin/Nab-paclitaxel/Pembrolizumab Followed by Olaparib/Pembrolizumab Maintenance in mTNBC Patients Phase 2
Active, not recruiting NCT03667716 - COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors. Phase 1
Withdrawn NCT03634150 - Safety and Efficacy of IV Nerofe™ Followed by Doxorubicin, In Metastatic Ovarian Cancer and Triple Negative Breast Cancer Phase 1/Phase 2
Recruiting NCT03348098 - Clinical Study of Neoadjuvant Therapy With Apatinib and Paclitaxel in Local Advanced Triple-negative Breast Cancer Phase 2
Completed NCT04032080 - LY3023414 and Prexasertib in Metastatic Triple-negative Breast Cancer Phase 2
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Withdrawn NCT02427581 - Safety and Immunogenicity of a Personalized Synthetic Long Peptide Breast Cancer Vaccine Strategy in Patients With Persistent Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy Phase 1
Recruiting NCT03165487 - Comparison of the Breast Tumor Microenvironment
Completed NCT02225470 - Eribulin Versus Vinorelbine in Subjects With Locally Recurrent or Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes Phase 3
Recruiting NCT04452370 - Oral Etoposide Combined With Anlotinib in Advanced Triple Negative Breast Cancer Phase 2
Terminated NCT04123704 - Sitravatinib in Metastatic Breast Cancer Phase 2
Recruiting NCT04758780 - Imaging Performance Assessment of 89Zirconium-labelled Girentuximab (89Zr-TLX250) PET-CT in Metastatic Triple Negative Breast Cancer Patients Phase 2
Not yet recruiting NCT06351332 - A Phase I/II Single-arm Trial of Azenosertib (ZN-c3) Combined With Carboplatin and Pembrolizumab in Patients With Metastatic Triple-negative Breast Cancer (ZAP-IT) Phase 1/Phase 2
Withdrawn NCT04268693 - Bisphenol and Phthalate Exposures in Triple Negative Breast Cancer
Withdrawn NCT03982173 - Basket Trial for Combination Therapy With Durvalumab (Anti-PDL1) (MEDI4736) and Tremelimumab (Anti-CTLA4) in Patients With Metastatic Solid Tumors Phase 2
Not yet recruiting NCT02685657 - Neoadjuvant Chemotherapy Docetaxel With or Without SELUMETINIB in Patients With Triple Negative Breast Cancer Phase 2
Terminated NCT01918306 - GDC-0941 and Cisplatin in Treating Patients With Androgen Receptor-Negative Triple Negative Metastatic Breast Cancer Phase 1/Phase 2
Completed NCT01276899 - Study to Identify Molecular Mechanisms of Clinical Resistance to Chemotherapy in Triple Negative Breast Cancer Patients
Completed NCT00998036 - Study of Temsirolimus, Erlotinib and Cisplatin in Solid Tumors Phase 1
Recruiting NCT05309655 - Cardiac Outcomes With Near-Complete Estrogen Deprivation Early Phase 1