A Study to Evaluate the Use of Cryoablation and Anti-PD-L1 Immunotherapy for Triple Negative Breast Cancer (TNBC)
Tab Title Description
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Jacksonville, Florida: 19-008704
NCT ID: NCT04249167
Sponsor Protocol Number: 19-008704
About this study
The purpose of this study is to evaluate whether or not cryoablation will enhance the effects of atezolizumab/nab-paclitaxel (standard of care immunotherapy and chemotherapy) and be safe/feasible for patients with metastatic or unresectable locally advanced triple negative breast cancer (TNBC).
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
- Female sex.
- Age ≥ 18 years old.
- Locally advanced or metastatic PD-L1 positive TNBC (TNBC is defined as ER < 10%, 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.
- History of autoimmune disease.
- History of 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).
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
|Mayo Clinic Location
Mayo Clinic principal investigator
Emmanuel Gabriel, M.D., Ph.D.
Contact us for the latest status
Cancer Center Clinical Trials Referral Office
Publications are currently not available
Study Results Summary
Not yet available
Supplemental Study Information
Not yet available