OncoMatch/Clinical Trials/NCT05795101
TRUDI: TDXD+Durva in HER2+/Low IBC
Is NCT05795101 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Trastuzumab deruxtecan and Durvalumab for invasive breast cancer.
Treatment: Trastuzumab deruxtecan · Durvalumab — 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
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression (HER2-positive as determined locally by the current ASCO/CAP guidelines)
HER2-positive status as determined locally by the current ASCO/CAP guidelines
Required: HER2 (ERBB2) low expression (IHC 2+/ISH-, IHC 1+/ISH-, or IHC 1+/ISH untested) (HER2-low tumor expression (IHC 2+/ISH-, IHC 1+/ISH-, or IHC 1+/ISH untested))
HER2-low tumor expression (IHC 2+/ISH-, IHC 1+/ISH-, or IHC 1+/ISH untested)
Disease stage
Required: Stage III
clinical diagnosis of stage III inflammatory breast cancer within the past 6 months
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic anti-cancer therapy
Has received prior systemic anti-cancer therapy for the current diagnosis of inflammatory breast cancer, including chemotherapy, immunotherapy, or targeted therapy
Cannot have received: radiotherapy
Has received any radiotherapy ... for the current diagnosis of inflammatory breast cancer
Cannot have received: surgery
Exception: Tumor biopsies are not considered surgery for the purpose of enrollment.
Has received any ... surgery for the current diagnosis of inflammatory breast cancer. Tumor biopsies are not considered surgery for the purpose of enrollment.
Lab requirements
Blood counts
Absolute neutrophil count ≥2,000/mcL; Platelets ≥100,000/mcL; Hemoglobin ≥ 9.0 g/dl; Serum albumin ≥2.5 g/dL; INR/PT/aPTT ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is in therapeutic range of anticoagulant
Kidney function
Serum creatinine ≤1.5 × institutional ULN OR creatinine clearance ≥ 30 mL/min/ 1.73m2 for participants with creatinine levels above institutional ULN
Liver function
Total bilirubin ≤1.5 × institutional ULN (or ≤2.0 x ULN in patients with documented Gilbert's Syndrome); AST(SGOT)/ALT(SGPT) ≤2.5 × institutional ULN
Cardiac function
LVEF ≥ 50% within 28 days prior to enrollment; Cardiac ejection fraction outside institutional range of normal or <50% (whichever is higher) as measured by echocardiogram (or MUGA if echo cannot be performed or is inconclusive) is excluded; Corrected QT interval (QTcF) prolongation to > 470 msec on screening EKG is excluded
Participants must have normal organ and marrow function prior to enrollment as defined below: ... LVEF ≥ 50% within 28 days prior to enrollment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Brigham and Women's Hospital · Boston, Massachusetts
- Dana Farber Cancer Institute · Boston, Massachusetts
- University of Texas MD Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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