Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer

Part of paid clinical trials in Springdale, Arkansas.

Sponsor
AstraZeneca
Study ID
NCT05113251
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Trastuzumab Deruxtecan — DRUG
    administered by intravenous infusion
  • Paclitaxel — DRUG
    administered by intravenous infusion
  • Trastuzumab — DRUG
    administered by intravenous infusion
  • Pertuzumab — DRUG
    administered by intravenous infusion
  • Doxorubicin — DRUG
    administered by intravenous infusion
  • cyclophosphamide — DRUG
    administered by intravenous infusion

Study Details

This study will look at the efficacy and safety of trastuzumab deruxtecan (T-DXd) in a neoadjuvant setting, in high-risk, HER2-positive early non-metastatic breast cancer.

Key Dates

Start date
Oct 25, 2021
Status verified
May 2026
Primary completion
Mar 12, 2025
Completion
Apr 30, 2027

Study Design

Enrollment
927 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    Trastuzumab deruxtecan
  • Experimental: Arm B
    T-DXd, followed by THP
  • Active Comparator: Arm C
    doxorubicin and cyclophosphamide, followed by THP

Primary Outcome Measure

Rate of Pathologic Complete Response (pCR). [ Time Frame: Through to definitive surgery or discontinuation/withdrawal from study, up to a maximum of approximately 40 months from randomization to primary pCR DCO (12MAR2025) ]

Locations (22)

FacilityCityStateZIPSite coordinators
Research SiteSpringdaleArkansas72762-
Research SiteBeverly HillsCalifornia90211-
Research SiteGlendaleCalifornia91204-
Research SiteLos AlamitosCalifornia90720-
Research SiteOrangeCalifornia92868-
Research SiteNew HavenConnecticut06510-
Research SiteFort WayneIndiana46804-
Research SiteLexingtonKentucky40503-
Research SiteLouisvilleKentucky40202-
Research SiteShreveportLouisiana71101-
Research SiteMinneapolisMinnesota55407-
Research SiteLas VegasNevada89102-
Research SiteEast BrunswickNew Jersey08816-
Research SiteSummitNew Jersey07901-
Research SiteCommackNew York11725-
Research SiteDurhamNorth Carolina27710-
Research SiteGreenvilleSouth Carolina29607-
Research SiteGermantownTennessee38138-
Research SiteNashvilleTennessee37203-
Research SiteFort WorthTexas76104-
Research SiteOgdenUtah84405-
Research SiteTacomaWashington98405-

Related coverage on Hipa.ai

Find similar trials in Springdale, AR

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Research Site· Springdale, ARResearch Site· Beverly Hills, CAResearch Site· Glendale, CAResearch Site· Los Alamitos, CAResearch Site· Orange, CAResearch Site· New Haven, CT

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