NOvel Immunotherapy Strategies for Advanced Triple Negative Breast Cancer (TNBC) Patients:
This is a single center, non-blinded, multi-cohort, non-comparative phase II trial to study the safety and efficacy of tiragolumab with atezolizumab and/or ipilimumab in advanced triple-negative breast cancer.
| Condition(s) | Metastatic Breast Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | This is a single center, non-blinded, multi-cohort, non-comparative phase II trial to study the safety and efficacy of tiragolumab with atezolizumab and/or ipilimumab in advanced triple-negative breast cancer. |
| Who can participate | Inclusion Criteria: * Metastatic or incurable locally advanced triple negative breast cancer with confirmation of Estrogen receptor (ER) and Human Epidermal growth factor Receptor 2 (HER2) negativity (ER \<10%, HER2 IHC 0, 1+ or 2+ with no amplification) on a histological biopsy of a metastatic lesion * Patients with PD-L1 negative disease determined using the Combined Positivity Score (CPS\<10) (Dako 22C3 IHC) OR previously treated with anti-PD(L)1 in the (neo)adjuvant or metastatic setting (irrespective of PD-L1 status). * Metastatic lesion accessible for histological biopsy * 18 years or older * World Health Organisation (WHO) performance status of 0 or 1 * Maximum of three lines of chemotherapy, including antibody-drug conjugates and Poly-ADP Ribose Polymerase (PARP)-inhibitors, for me |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | The Netherlands Cancer Institute |
| Locations | Amsterdam, North Holland, Netherlands |
| Start date | 2024-06-12 |
| NCT ID | NCT06342037 |
| Official listing | https://clinicaltrials.gov/study/NCT06342037 |