RecruitingPhase 2NCT05795101

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

Sponsor

Filipa Lynce, MD

Enrollment

63 participants

Start Date

May 4, 2023

Study Type

INTERVENTIONAL

Conditions

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

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

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two cancer drugs — trastuzumab deruxtecan (T-DXd, an antibody-drug) and durvalumab (an immunotherapy) — for patients with inflammatory breast cancer (a rare, aggressive form of breast cancer) that is HER2-positive or HER2-low. **You may be eligible if...** - You have been diagnosed with invasive breast cancer - You have stage III inflammatory breast cancer (diagnosed within the last 6 months) - Your tumor is either HER2-positive or HER2-low (specific lab test criteria apply) - Other health and performance criteria apply **You may NOT be eligible if...** - You do not have inflammatory breast cancer - Your HER2 status does not meet the required profile - Other health conditions or prior treatments disqualify you (your doctor will review) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTrastuzumab deruxtecan

via IV, protocol determined dosage once per cycle up to eight cycles. Each cycle will last for 21 days (three weeks).

DRUGDurvalumab

via IV, protocol determined dosage once per cycle up to eight cycles. Each cycle will last for 21 days (three weeks).

Locations(3)

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT05795101

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