TRUDI: TDXD+Durva in HER2+/Low IBC (NCT05795101) | Clinical Trial Compass
RecruitingPhase 2
TRUDI: TDXD+Durva in HER2+/Low IBC
United States63 participantsStarted 2023-05-04
Plain-language 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
Who can participate
Age range18 Years
SexFEMALE
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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 known
* Participants must be treatment-naïve
* Participants must agree to undergo two research biopsies of the tumor (if safely accessible, as determined by the treating investigator): at baseline (prior to the first treatment) and after the first week of treatment on C1D8. Previously collected archival tissue will also be obtained on all participants. For participants for whom the tumor is not safely accessible, this archival tissue needs to be located and availability confirmed at time of registration.
* Pre- and postmenopausal women or male patients ≥ 18 years of age
* ECOG performance status 0-1 (Karnofsky \> 60%, see Appendix A).
* LVEF ≥ 50% within 28 days prior to enrollment
* Participants must have normal organ and marrow function prior to enrollment as defined below:
* Absolute neutrophil count ≥2,000/mcL
* Platelets ≥100,000/mcL
* Hemoglobin ≥ 9.0 g/dl
* INR/PT/aPTT ≤…
What they're measuring
1
Pathological complete response (pCR) Rate
Timeframe: Assessed on surgical tissue: surgery occurs no later than 6 weeks post 8 cycles of neo-adjuvant therapy (one cycle=21 days)