At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed locally recurrent inoperable or metastatic TNBC per ASCO-CAP guidelines
- ✓ECOG performance status 0 or 1
- ✓FFPE tumor sample from recurrent/metastatic lesion or archival sample ≤3 years old at screening
- ✓PD-L1 positive (CPS ≥10) by validated 22C3 assay from central laboratory
- ✕Severe or uncontrolled medical conditions: uncontrolled hypertension, GI conditions with diarrhea, chronic/complicated diverticulitis, allogeneic organ transplant history, active bleeding, ongoing infection, significant cardiac conditions, substance abuse, psychiatric illness, or non-compliance risk
- ✕History of another primary malignancy except those treated with curative intent with no active disease within 2 years
- ✕Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals
- ✕Active or uncontrolled hepatitis B or C infection
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy (Paclitaxel, Nab-paclitaxel or Gemcitabine + Carboplatin) in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION-Breast05)
In Brief
A Phase 3 clinical trial evaluating Dato-DXd, Durvalumab, and 5 other interventions for Breast Cancer. Currently recruiting, targeting 625 participants across 317 sites in 24 countries.
Signals
Detailed 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.
Study Details
Timeline
Arms & Interventions
Arm 1: Dato-DXd + durvalumab
Arm 2: Investigator's Choice of Chemotherapy (ICC) in combination with pembrolizumab (paclitaxel, nab-paclitaxel, or gemcitabine + carboplatin)
Arm 3: Dato-DXd
Interventions
Provided in 100mg vials. IV infusion. Experimental drug.
Provided in 500mg vials. IV infusion. Experimental drug.
IV infusion. Active comparator.
IV infusion. Active comparator.
IV infusion. Active comparator.
IV infusion. Active comparator.
IV infusion. Active comparator.