Phase 3, Open-Label, Randomized Study of Datopotamab Deruxtecan 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 Breast and/or Axillary Lymph Nodes Following Neoadjuvant Systemic Therapy and Surgical Resection (TROPION-Breast03)

Primary Objective

This is a Phase III, randomized, open-label, 3-arm, multicenter, international study assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with ICT in participants with stage I to III TNBC with residual invasive disease in the breast and/or axillary lymph nodes at surgical resection following neoadjuvant systemic therapy

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Description

The study will investigate the efficacy and safety of Dato-DXd with or without durvalumab when compared with ICT (capecitabine and/or pembrolizumab) in participants with stage I to III TNBC who have residual invasive disease in the breast and/or axillary lymph nodes at surgical resection following neoadjuvant systemic therapy. The primary objective of the study is to demonstrate superiority of Dato-DXd in combination with durvalumab relative to ICT by assessment of iDFS in participants with stage I to III TNBC with residual invasive disease at surgical resection following neoadjuvant therapy.

Details
Age
Adult
Eligibility
Detailed eligibility criteria is available on clinicaltrials.gov. These requirements will be discussed with your doctor and/or study representative. Click the NCT number link below to learn more about this study on ClinicalTrials.gov
Locations

CTRC Inpatient
Outpatient CTRC
University of Colorado Hospital

Principal Investigator
Photograph of Jennifer Diamond

Jennifer Diamond

Study ID

Protocol Number: 23-0452

More information available at ClinicalTrials.gov: NCT05629585

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