Inclusion Criteria:
- Histologically or cytologically confirmed and documented locally-advanced, recurrent
inoperable, or metastatic TNBC (ER < 1%, PgR < 1%, HER2 IHC 0, 1+, or 2+ with FISH
negative for HER2 gene amplification) or ER-low, HER2-negative BC (ER and / or PgR
1% to 10%, HER2 IHC 0, 1+, or 2+ with FISH negative for HER2 gene amplification) per
ASCO/CAP criteria, based on the most recently analyzed biopsy or other pathology
specimen.
- Patients with recurrent disease must have experienced disease relapse at least 6
months after finishing their last therapy with curative intent.
- Patients with TNBC must be considered ineligible for 1L chemotherapy combination
treatment with an anti-PD-1 or an anti-PD-L1 due to either one of the following
criteria:.
- Investigator-determined ineligibility based on PD-L1 negative disease determined and
documented prior to trial screening as part of SoC.
- Has experienced disease relapse between 6 to 12 months after the completion of
(neo)adjuvant therapy with an anti-PD(L)1.
- Has a severe auto-immune disease or other contraindication.
- Patients with ER-low, HER2-negative BC must be ineligible, in the opinion of the
Investigator, for endocrine therapy-based treatments.
- No previous systemic therapy in the locally advanced, recurrent inoperable or
metastatic setting (ie incurable setting).
- Measurable disease by CT or MRI as per RECIST v1.1.
- Other protocol-defined Inclusion/Exclusion criteria apply.
