A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer

Brief summary

This is a Phase III, 2-arm, randomised, open-label, multicentre, global study assessing the efficacy and safety of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy compared with neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in participants with previously untreated TNBC or hormone receptor-low/HER2-negative breast cancer.

Source: ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters. Not a U.S. Government endorsement.

Trial details

status

ACTIVE_NOT_RECRUITING

phase

PHASE3

study type

INTERVENTIONAL

enrollment

1902

sponsor

AstraZeneca

conditions

Breast Cancer

interventions

DRUG: Dato-DXd; DRUG: Durvalumab; DRUG: Pembrolizumab; DRUG: Doxorubicin; DRUG: Epirubicin; DRUG: Cyclophosphamide; DRUG: Paclitaxel; DRUG: Carboplatin; DRUG: Capecitabine; DRUG: Olaparib

start date

2023-11-14

start date type

ACTUAL

primary completion date

2028-11-20

has results

false

data source

ClinicalTrials.gov

data processed

2026-10-29T09:00:05

modifications

selected fields only; whitespace normalized; brief summary truncated to 2,000 characters