Clinical trial details

A Phase 3, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) Versus Investigators Choice of Chemotherapy in Patients Who Are Not Candidates for PD-1/PD-L1 Inhibitor Therapy in First-line Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION Breast02)

Identifier

D926PC00001

Sponsor

ASTRAZENECA FARMACÉUTICA SPAIN, S.A.

Principal Investigator

MAFALDA OLIVEIRA

Service

Oncology

Study details

Tumor type: BREAST
Stage: Advanced, First Line/Previously Untreated
Main Investigational Agent : ADC
Phase: III
Randomization: Randomized

Molecular details

Biomarker: HER2 neg
Biomarker criteria: Mandatory
Prescreening: Local
Additional study population requirements: Histologically or cytologically documented locally recurrent inoperable or metastatic TNBC. TNBC is defined as: Negative for ER with < 1% of tumour cells positive for ER on IHC. Negative for progesterone receptor with < 1% of tumour cells positive for progesterone receptor on IHC. Negative for HER2 with 0 or 1+ intensity on IHC or 2+ intensity on IHC and negative by in situ hybridisation per the ASCO-CAP HER2 guideline

Drug details

Arm A: Datopotamab deruxtecan (Dato-DXd)
Arm B: Investigators Choice of Chemotherapy (ICC)

Links

Clinical Trials GOV (NCT identifier): NCT05374512
EU Clinical Trials Register (eudraCT Identifier): 2021-005223-21