TRUDI: TDXD+Durva in HER2+/Low IBC

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Filipa Lynce, MD
Study ID
NCT05795101
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
May 4, 2023
Status verified
Sep 2025
Primary completion
Dec 1, 2027
Completion
Dec 1, 2032

Study Design

Enrollment
63 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HER2 Positive
    Participants will be enrolled into one of two cohorts: HER2 positive IBC (cohort 1) and HER2 low IBC (cohort 2). * HER2-positive determined locally by the current ASCO/CAP guidelines * Participants will receive trastuzumab deruxtecan plus durvalumab for eight cycles prior to surgery. (Cycle Length is 21 days) * After surgery, Participants will receive therapy per physician's choice and to reflect current standard of care.
  • Experimental: HER2-Low
    Participants will be enrolled into one of two cohorts: HER2 positive IBC (cohort 1) and HER2 low IBC (cohort 2) * HER2-low tumor expression (IHC 2+/ISH-, IHC 1+/ISH-, or IHC 1+/ISH untested) * Participants will receive trastuzumab deruxtecan plus durvalumab for eight cycles prior to surgery (Cycle Length is 21 days) * After surgery, Participants will receive therapy per physician's choice and to reflect current standard of care.

Primary Outcome Measure

Pathological complete response (pCR) Rate [ Time Frame: Assessed on surgical tissue: surgery occurs no later than 6 weeks post 8 cycles of neo-adjuvant therapy (one cycle=21 days) ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02215
Filipa Lynce, MD
(617) 632-3800
Filipa Lynce, MD (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer InstituteBostonMassachusetts02215
Filipa Lynce, MD
[email protected]
(617) 632-3800
Filipa Lynce, MD (PRINCIPAL_INVESTIGATOR)
University of Texas MD Anderson Cancer CenterHoustonTexas77030
Rachel Layman, MD
[email protected]
Rachel Layman, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Brigham and Women's Hospital· Boston, MADana Farber Cancer Institute· Boston, MAUniversity of Texas MD Anderson Cancer Center· Houston, TX

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