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:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT04249167
Eligibility Criteria:
Inclusion Criteria:
* Locally advanced or metastatic PD-L1 positive TNBC (TNBC is defined as estrogen receptor \[ER\] \< 10%, progesterone receptor \[PR\] \< 10%, and HER2 non-amplified; and PD-L1 positive is defined as \>= 1%.)
* Presents with primary breast tumor lesion amenable to cryoablation
* Have at least one additional distant lesion feasible for biopsies
* Agreeable to start on atezolizumab and nab-paclitaxel as per standard of care
* Patients with locally advanced disease must be ineligible for curative surgery for any reason, including but not limited to comorbid status precluding surgery due to safety, unresectability, or patient refusal
* Patient may have received prior systemic chemotherapy regimens
Exclusion Criteria:
* History of autoimmune disease
* History of human immunodeficiency virus (HIV)
* Previous immune checkpoint targeting therapies
* No primary breast lesion amenable for cryoablation due to size (greater than 5 cm) or location (proximity of \< 0.5 cm to the skin or nipple-areola complex)
* Pregnancy
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04249167
Study Brief:
Protocol Section:
NCT04249167