Datopotamab Deruxtecan w/orw/out DurvalumabVSInvestigatorsTherapy w/StageI-III Following Neoadj Th

UCI Specialty Area: Cancer

Principal Investigator: Ritesh Parajuli

Official Title: A Phase III Open-label, Randomized Study of Datopotamab Deruxtecan (Dato DXd) 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 the Breast and/or Axillary Lymph Nodes Following Neoadjuvant Systemic Therapy and Surgical Resection (D926XC00001; TROPION-Breast03)

A Study On:

Breast

Study Description

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.

Eligibility

-Patients at least 18 years of age at the time of screening

-Patients with histologically confirmed invasive triple negative breast cancer

Patients with stage IV (metastatic) triple negative breast cancer

-Patients with any concurrent anticancer treatment

-Patients with prior invasive breast cancer, or evidence of recurrent disease following preoperative therapy and surgery

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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

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