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

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.

Trial Details

NCT ID
NCT06103864
Phase
PHASE3
Sponsor
AstraZeneca
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • Dato-DXd
  • Durvalumab
  • Paclitaxel
  • Nab-paclitaxel
  • Gemcitabine
  • Carboplatin
Locations (sample)
  • Daphne, Alabama, United States|30.60353,-87.9036
  • Springdale, Arkansas, United States|36.18674,-94.12881
  • Duarte, California, United States|34.13945,-117.97729
  • Glendale, California, United States|34.14251,-118.25508
  • Sacramento, California, United States|38.58157,-121.4944

Key Eligibility Criteria

  • Histologically or cytologically documented locally recurrent inoperable, which cannot be treated with curative intent, or metastatic TNBC, as defin…
  • 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 ar…
  • PD-L1 positive TNBC based on results from an appropriately validated investigational PD-L1 (22C3) assay (CPS ≥ 10) from a sponsor designated centra…

For full eligibility, visit ClinicalTrials.gov.

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