Patients with TNBC or ER-low, HER2-negative BC who are Ineligible for Anti PD1/PD-L1 Treatment
Conditions
Interventions
Phase2
Arm A1:2.0 mg/kg iza-bren D1D8Q3W
Arm A2:2.5 mg/kg iza-bren D1D8Q3W
Arm B:TPC Specified dose on specified days
Phase3
Arm A:iza-bren RP3D
Arm B:TPC Specified dose on specified days
Sponsors
Itakura Eijun
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
Exclusion criteria: -Participants with history of severe heart disease -Participants with Grade >= 3 lung disease defined according to NCI-CTCAE v5.0, or a history of interstitial lung disease (ILD) or pneumonitis. -Prior history of clinically significant bleeding, intestinal obstruction, or perforation of the gastrointestinal tract within 3 months of randomization that has not recovered to Grade <=1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS by RECIST v1.1 per BICR | — |
Secondary
| Measure | Time frame |
|---|---|
| OS,Investigator-assessed PFS, Per BICR and investigator-assessed:(OR byRECIST v1.1,DCR,DOR,TTR),TTST,PFS2 | — |
Countries
Argentina, Australia, Austria, Brazil, Canada, Chile, China, Colombia, France, Germany, Greece, India, Israel, Italy, Japan, Korea, Mexico, Poland, Portugal, Romania, South Africa, Spain, Sweden, Switzerland, UAE, United Kingdom, United States
Contacts
Public ContactEijun Itakura
Bristol-Myers Squibb
Outcome results
None listed