TRUDI: TDXD+Durva in HER2+/Low IBC — TRUDI  

Breast Cancer Clinical Trial

Official title: TRUDI: A Phase II Study of Neoadjuvant Trastuzumab Deruxtecan and Durvalumab for Stage III, HER2-expressing Inflammatory Breast Cancer

Status Recruiting

Clinical Trial Summary

The purpose of this study is to test the safety and effectiveness of an investigational drug combination (trastuzumab deruxtecan and durvalumab) to learn whether the intervention works in treating Human Epidermal growth factor Receptor-2 (HER2)-expressing inflammatory breast cancer.

The names of the study drugs involved in this study are:

• Trastuzumab deruxtecan

• Durvalumab

Clinical Trial Description

This is a phase 2 open label study of neoadjuvant trastuzumab deruxtecan plus durvalumab for patients with stage III, HER2-positive or HER2-low inflammatory breast cancer (IBC), who have not received prior therapy for ipsilateral breast cancer.

Participants will be enrolled into one of two study treatment groups: HER2 positive IBC (Cohort 1) or HER2 low IBC (Cohort 2).

Research procedures including screening for eligibility, clinic visits for treatment, tumor biopsies, and blood tests.

The U.S. Food and Drug Administration (FDA) has not approved Durvalamab or Trastuzumab deruxtecan for inflammatory breast cancer, but both have been approved for other uses.

Participation in this study is expected to last about 22 months.

It is expected that about 63 people will take part in this research study.

The pharmaceutical company, AstraZeneca, is supporting this research study by providing the study drugs and funding. ;

Related Conditions & MeSH terms

• Adenocarcinoma
• Breast Cancer
• Breast Neoplasms
• HER2-positive Breast Cancer
• Invasive Breast Cancer

• NCT number: NCT05795101
• Study type: Interventional
• Source: Dana-Farber Cancer Institute
• Contact: Filipa Lynce, MD
• Phone: (617) 632-3800
• Email: filipa_lynce@dfci.harvard.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: May 4, 2023
• Completion date: December 1, 2032