Brief Summary
The purpose of this study is to assess the efficacy and safety of iza-bren, a bi-specific antibody-drug conjugate against EGFR and HER3 with a topoisomerase inhibitor payload versus treatment of physician’s choice (TPC) (paclitaxel, nab-paclitaxel, carboplatin plus gemcitabine, and capecitabine) for the treatment of first-line metastatic triple-negative breast cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs (TNBC) or estrogen receptor (ER)-low, human epidermal growth factor receptor 2 (HER2)-negative BC patients who are not candidates for anti-PD(L)1 therapy and endocrine therapies.
Intervention / Treatment
- Drug: Iza-bren
- Drug: Nab-paclitaxel
- Drug: Paclitaxel
- Drug: Capecitabine
- Drug: Carboplatin
- Drug: Gemcitabine
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 biopsyremoval of a section of tissue to analyse for cancer cells or other pathologythe study of disease specimena sample for investigating (e.g. blood, stools, urine, sputum etc.).
- Patients with recurrent disease must have experienced disease relapsethe return of disease at least 6 months after finishing their last therapy with curative intent.
- Patients with TNBC must be considered ineligible for 1L chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells 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 screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer 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 advancedat a late stage, far along, 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.