Reason(s) for refusal should be documented. i) TNBC i) Participants must be women with histologically or cytologically confirmed breast carcinoma. ii) Tumor must be “triple receptor negative” defined as ER/progesterone negative per lo cal lab and HER-2 negative defined as HER-2 0 or 1+ by IHC, or IHC 2+ and ISH not amplified, or ISH-non amplified. iii) Participants must have progression or refractory disease. iv) Participants must have had at least 1 and not more than 3 systemic chemotherapeutic, targeted or investigational regimens for the treatment of metastatic or locally advanced and unresectable disease. v) Participants may refuse chemotherapy for their disease. Participants actively refusing chemotherapy must have had best response of stable disease, or progression or refractory disease to other treatment options such as radiotherapy, targeted agents, or investigational therapy prior to starting study treatment. The participant’s refusal must be thoroughly documented. The investigator w ill discuss each individual participant refusing chemotherapy with the sponsor’s Medical Monitor/Study Director (or designee) to confirm eligibility. vi) Participants must have been offered a nd/or have received or refused at least 1 prior approved immune therapy regimen, that is considered standard of care for their disease stage and condition, in the country where they are receiving treatment, if such a regimen exists.