Clinical trial details

A Phase 3 Open-label, Randomised Study of Datopotamab Deruxtecan (DatoDXd) With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Who Have Residual Invasive Disease in the Breast and/or Axillary Lymph Nodes at Surgical Resection Following Neoadjuvant Systemic Therapy (TROPION-Breast03)

Identifier

D926XC00001

Sponsor

AstraZeneca AB

Principal Investigator

MAFALDA OLIVEIRA

Service

Oncology

Study details

Tumor type: BREAST
Stage: Early/Locally advanced
Main Investigational Agent : ADC
Phase: III
Randomization: Randomized

Molecular details

Biomarker: HER2 neg
Biomarker criteria: Mandatory
Prescreening: Local
Additional study population requirements: Inclusion Criteria: Histologically confirmed invasive TNBC, as defined by the ASCO/CAP guidelines. Residual invasive disease in the breast and/or axillary lymph node(s) at surgical resection following neoadjuvant therapy. Completed at least 6 cycles of neoadjuvant therapy containing an anthracycline and/or a taxane with or without carboplatin, with or without pembrolizumab.

Drug details

Arm A: Datopotamab deruxtecan (Dato-DXd)
Arm B: Datopotamab deruxtecan (Dato-DXd) + Durvalumab
Arm C: Investigators Choice Therapy

Links

Clinical Trials GOV (NCT identifier): NCT05629585
EU Clinical Trials Register (eudraCT Identifier): 2022-002680-30