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

Active:	Yes
Cancer Type:	Breast Cancer Unknown Primary	NCT ID:	NCT06112379
Trial Phases:	Phase III	Protocol IDs:	D926QC00001 (primary) NCI-2024-01327
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	AstraZeneca Pharmaceuticals LP
NCI Full Details:	http://clinicaltrials.gov/show/NCT06112379

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.

Objectives

The primary objectives of the study are to demonstrate superiority of neoadjuvant
Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy
relative to 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, by central assessment of pCR and/or
to demonstrate superiority of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant
durvalumab with or without chemotherapy relative to 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, by investigator assessment of EFS

Treatment Sites in Georgia

Northside Hospital Cancer Institute
1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-303-3355
www.northside.com

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