Status:
ACTIVE_NOT_RECRUITING
Circulating Tumor DNA and Immunophenotyping as Potential Biomarkers With Regional Nodal Irradiation for Breast Cancer
Lead Sponsor:
Mayo Clinic
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-100 years
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 be...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 20 2028
Estimated Enrollment :
217 Patients enrolled
Trial Details
Trial ID
NCT04308720
Start Date
October 1 2019
End Date
October 20 2028
Last Update
January 8 2026
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905