A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choi
This is a Phase III, randomised, open-label, 3-arm, multicentre, international study assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with investigator's choice chemotherapy in combination with pembrolizumab in participants with PD-L1 positive locally recurrent inoperable or metastatic
| Condition(s) | Breast Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | This is a Phase III, randomised, open-label, 3-arm, multicentre, international study assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with investigator's choice chemotherapy in combination with pembrolizumab in participants with PD-L1 positive locally recurrent inoperable or metastatic TNBC. |
| Who can participate | Key Inclusion Criteria * Histologically or cytologically documented locally recurrent inoperable, which cannot be treated with curative intent, or metastatic TNBC, as defined by the ASCO-CAP guidelines. * ECOG PS 0 or 1. * Participants are expected to provide an FFPE tumour sample collected from a locally recurrent inoperable or metastatic tumour. Alternatively, an archival FFPE tumour sample can be submitted; it must have been collected ≤ 3 years prior to the participant signing informed consent (screening start). * PD-L1 positive TNBC based on results from an appropriately validated investigational PD-L1 (22C3) assay (CPS ≥ 10) from a sponsor designated central laboratory. * No prior chemotherapy or other systemic anti-cancer therapy for metastatic or locally recurrent inoperable breast |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | AstraZeneca |
| Locations | Daphne, Alabama, United States; Springdale, Arkansas, United States; Duarte, California, United States; Glendale, California, United States; Sacramento, California, United States; Santa Rosa, California, United States (+310 more sites) |
| Start date | 2023-11-23 |
| NCT ID | NCT06103864 |
| Official listing | https://clinicaltrials.gov/study/NCT06103864 |