Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07478705
Eligibility Criteria:
Inclusion Criteria:
* Men or women aged 18 and over
* Biopsy proven invasive triple negative breast cancer (defined here as estrogen receptor \<10%, progesterone receptor \<10%, human epidermal growth factor receptor 2 (HER2) negative status, with HER2 status being defined as per ASCO/CAP guidelines)
* T2-4/N0 (\>2 cm primary breast cancer as assessed clinically or on imaging in the absence of nodal involvement) OR T1c-4/N1-3 disease (\>10mm with fine needle aspirate or core biopsy confirming nodal involvement is required)
* Residual disease (RCB 2 or 3) on surgical specimen after completion of neoadjuvant chemo(-immuno)therapy
Exclusion Criteria:
* Inability to provide informed consent. Participants who require translators are allowed to enroll
* Prior history of invasive breast cancer -Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the detection of BC recurrence on a liquid biopsy (patients with a history of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and carcinoma-in-situ of cervix are permitted to participate)-
* Pregnant patients are not permitted
* Creatinine clearance \<45 mL/min using the Cockcroft-Gault equation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07478705
Study Brief:
Protocol Section:
NCT07478705