NCT05795101

TRUDI: TDXD+Durva in HER2+/Low IBC

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (estimated)
• Sponsor: Filipa Lynce, MD · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Invasive Breast Cancer
• Inflammatory Breast Cancer Stage III
• HER2-positive Breast Cancer
• HER2 Low Breast Adenocarcinoma
• Breast Cancer

Interventions

Type	Name	Description
DRUG	Trastuzumab deruxtecan	via IV, protocol determined dosage once per cycle up to eight cycles. Each cycle will last for 21 days (three weeks).
DRUG	Durvalumab	via IV, protocol determined dosage once per cycle up to eight cycles. Each cycle will last for 21 days (three weeks).

Timeline

• Start date: 2023-05-04
• Primary completion: 2027-12-01
• Completion: 2032-12-01
• First posted: 2023-04-03
• Last updated: 2025-09-19

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study