Circulating Tumor DNA and Immunophenotyping as Potential Biomarkers With Regional Nodal Irradiation for Breast Cancer

Breast Cancer Clinical Trial

Official title:

Circulating Tumor DNA (ctDNA) and Immunophenotyping as Potential Biomarkers in Patients Undergoing Regional Nodal Irradiation for Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04308720
• Other study ID #: 19-003532
• Secondary ID: NCI-2022-10695
• Status: Recruiting
• Start date: October 1, 2019
• Est. completion date: October 2025

Study information

• Verified date: November 2023
• Source: Mayo Clinic
• Contact: Clinical Trials Referral Office
• Phone: 855-776-0015
• Email: mayocliniccancerstudies[@]mayo.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will assess how radiation affects the patterns of circulating tumor deoxyribonucleic acid (ctDNA) and immune cells (T cells) during radiation treatment in patients with breast cancer. By better understanding how radiation therapy affects these markers (characteristic that is measured to see how well the body responds to a treatment for a disease) in the blood, researchers may better customize treatments for patients with breast cancer in the future.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• 18 years of age or older

• Histologically confirmed primary or recurrent non-metastatic invasive breast cancer with plans for adjuvant post-lumpectomy or post-mastectomy radiation therapy at the Mayo Clinic and indications for regional nodal irradiation.

• Or patients undergoing curative intent irradiation for oligometastatic breast cancer (=< 3 sites of metastases) is permitted

• Willingness to provide informed consent and expresses understanding of this protocol and its requirements, risks, and discomforts

• Patients with non-metastatic breast cancer must have completed their final breast surgery including re-excision of margins for invasive cancer and ductal carcinoma in situ (DCIS) or chemotherapy within 90 days prior to registration but no sooner than 21 days prior to the initiation of radiation therapy (RT).

• Bilateral breast cancer is permitted

• Positive or close margins is allowed

Exclusion Criteria:

• Other active malignancy =< 2 years prior to registration (exceptions: non-melanotic skin cancer or carcinoma-in-situ of the cervix)

• Pregnancy or lactation

• Inability on the part of the patient to understand the informed consent to be compliant with the protocol

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the ctDNA detection rate in mutational load in breast cancer patients with indications of regional nodal irradiation.		3 Months
Primary	The change in the proportion of patients with detectable ctDNA at the end of treatment and 3 months compared to baseline.		3 Months
Primary	The correlation of detectible ctDNA at each time point with invasive recurrence-free survival		3 Months

External Links

•   Mayo Clinic Clinical Trials