Clinical trial NCT04308720: Circulating Tumor DNA and Immunophenotyping As Potential Biomarkers with Regional Nodal Irradiation for Breast Cancer
Official title: Circulating Tumor DNA (ctDNA) and Immunophenotyping As Potential Biomarkers in Patients Undergoing Regional Nodal Irradiation for Breast Cancer
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Breast Cancer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-03-16
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women ages 18 and older with high-risk breast cancer with plan for adjuvant radiation therapy including the regional lymph nodes at Mayo Clinic.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in the ctDNA detection rate in mutational load in breast cancer patients with indications of regional nodal irradiation.
timeFrame: 3 Months
measure: The change in the proportion of patients with detectable ctDNA at the end of treatment and 3 months compared to baseline.
timeFrame: 3 Months
measure: The correlation of detectible ctDNA at each time point with invasive recurrence-free survival
timeFrame: 3 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic Radiation Oncology
name: Robert W. Mutter, M.D.
role: PRINCIPAL_INVESTIGATOR
References: