A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer
- Trial number:
- NCT06103864
- Trial phase:
- 3
- Study type:
- Immunotherapy, Targeted therapy
- Overall status:
- Recruiting
Study start date
Scientific title
Summary
Key
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. All participants must provide a FFPE metastatic or locally recurrent inoperable tumour sample. 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 targeted systemic anti-cancer therapy for metastatic or locally recurrent inoperable breast cancer.
- Patients with recurrent disease will be eligible if they have completed treatment for Stage I-III breast cancer, if indicated, and ≥6 months have elapsed between completion of treatment with curative intent and the first documented recurrence.
Eligible for one of the chemotherapy options listed as ICC (paclitaxel, nab-paclitaxel, or gemcitabine + carboplatin).Measurable disease as per RECIST 1.1. Adequate bone marrow reserve and organ function. Male and female participants of childbearing potential must agree to use protocol-specified method(s) of contraception.
Key