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TRUDI: TDXD+Durva in HER2+/Low IBC

NCT05795101 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2025-09-19

No results posted yet for this study

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

Conditions

Interventions

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).

Sponsors & Collaborators

Principal Investigators

  • Filipa Lynce, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-04
Primary Completion
2027-12-01
Completion
2032-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05795101 on ClinicalTrials.gov