Protocol: SWOG – S2212
Please Note: Below is a partial list of eligibility, please contact the Genesys Hurley Cancer Institute, Research Department at (810)762-8181, (810)762-8079 or (810)762-8038 to discuss complete eligibility requirements. Thank you!
Eligibility:
- Participants must have histologically confirmed ER-negative, PR-negative, and HER2-negative breast cancer (TNBC) defined as ER<5%, PR<5%, and HER2 negative. NOTE: Participants with weakly ER or PR positive disease, defined as ER and/or PR between 1-4% by immunohistochemistry, are eligible if adjuvant endocrine therapy is not recommended/planned by the treating physician.
- Participants must have AJCC 8 anatomic tumor clinical stage either: T2-T4, N0, M0 orT1-T3, N1-2, M0. Note: All participants with clinically suspicious nodes must undergo core needle
biopsy or fine needle biopsy per standard clinical practice to pathologically confirm nodal status. - Participants must have breast and axillary imaging with mammogram and/or ultrasound and/or MRI within 49 days prior to randomization. Note: Participants with bilateral invasive breast cancer are eligible if both breast cancers are ER-negative, PR-negative, and HER2-negative provided they meet the other eligibility criteria.
- Participants must not have T4/N+, any N3, or inflammatory breast cancer.
- Participants must not have metastatic disease (M1).
- Participants must not have received prior systemic therapy or radiation therapy with curative intent for the current breast cancer.
- Participants must not have had previous definitive ipsilateral breast surgery for the current breast cancer.
- Participants must not have current or anticipated use of other investigational agents while participating in this study.
- Participants must not have received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory
T-cell receptor (e.g. CTLA-4, OX-40, CD137). - Participants must be ≥ 18 years old.
- Participants must have Zubrod Performance Status of 0-2.
- Participants must have adequate cardiac function.
- Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at randomization and have undetectable viral load
test on the most recent test results obtained within 6 months prior to randomization. - Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test
results obtained within 6 months prior to randomization, if indicated. - Participants with history of diabetes must not have uncontrolled diabetes in the opinion of the treating investigator.
- Participants must not have uncontrolled hypertension in the opinion of the treating investigator.
- Participants must not have had a major surgery within 14 days prior to randomization.
- Participants must not have severe or active infections within 14 days prior to Randomization, including but not limited to hospitalization for infection, bacteremia, or severe pneumonia.
- Participants must not have active autoimmune disease that has required systemic treatment in 2 years prior to randomization (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
- Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the treatment regimen.