TRUDI: A Phase II Study of Neoadjuvant Trastuzumab Deruxtecan and Durvalumab for Stage III, HER2-expressing Inflammatory Breast Cancer
Filipa Lynce, MD
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
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 infl…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Participants must have a histological or cytological diagnosis of invasive breast cancer. * All histologic subtypes are eligible. * Participants must have a clinical diagnosis of stage III inflammatory breast cancer within the past 6 months * HER2-positive status as determined locally by the current ASCO/CAP guidelines or HER2-low tumor expression (IHC 2+/ISH-, IHC 1+/ISH-, or IHC 1+/ISH untested) (note: ISH may be determined by either fluorescence in situ hybridization \[FISH\] or dual in situ hybridization \[DISH\]) * Any ER and PR expressions are permitted but must be…
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 HospitalBoston, Massachusetts
- Dana Farber Cancer InstituteBoston, Massachusetts
- University of Texas MD Anderson Cancer CenterHouston, Texas