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
Breast Cancer
Unknown Primary
18 Years and older, Male and Female
D926QC00001 (primary)
NCI-2024-01327
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
Eligibility
- Participant must be = 18 years, at the time of signing the ICF.
- Histologically confirmed Stage II or III unilateral or bilateral primary invasive TNBC or hormone receptor-low/HER2-negative breast cancer
- ECOG PS of 0 or 1
- Provision of acceptable tumor sample
- Adequate bone marrow reserve and organ function
- Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Treatment Sites in Georgia
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