A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer

Part of paid clinical trials in Long Beach, California.

Sponsor
Jazz Pharmaceuticals
Study ID
NCT07102381
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Zanidatamab — DRUG
    Administered intravenously (IV)
  • Paclitaxel — DRUG
    Administered intravenously (IV)
  • Docetaxel — DRUG
    Administered intravenously (IV)
  • Carboplatin — DRUG
    Administered intravenously (IV)
  • Trastuzumab — DRUG
    Administered intravenously (IV)
  • Pertuzumab — DRUG
    Administered intravenously (IV)

Study Details

The purpose of this study is to see if zanidatamab is safe and effective, when combined with chemotherapy, in treating people who has Human Epidermal Growth Factor Receptor 2 (HER2)-positive, early-stage breast cancer

Key Dates

Start date
Sep 24, 2025
Status verified
Apr 2026
Primary completion
Jan 1, 2028
Completion
Aug 1, 2030

Study Design

Enrollment
125 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Zanidatamab with paclitaxel
    Zanidatamab in combination with chemotherapy paclitaxel
  • Active Comparator: Zanidatamab with docetaxel and carboplatin
    Zanidatamab in combination with chemotherapy docetaxel and carboplatin
  • Active Comparator: Trastuzumab and pertuzumab with docetaxel and carboplatin
    Trastuzumab and pertuzumab in combination with chemotherapy docetaxel and carboplatin

Primary Outcome Measure

Number of participants with pCR [ Time Frame: Up to 8 months ]

Central Contacts

Locations (22)

FacilityCityStateZIPSite coordinators
Oncology InstituteLong BeachCalifornia90805-
Rocky Mountain Cancer CentersDenverColorado80218-
The Oncology InstituteLakelandFlorida33812-
Accellacare of McFarlandAmesIowa50010-
LSU Health Sciences CenterShreveportLouisiana71103-
New England Cancer SpecialistsScarboroughMaine04074-
Maryland Oncology HematologyLaurelMaryland20707-
Cancer Partners of NebraskaLincolnNebraska68516-
Nebraska Cancer SpecialistsOmahaNebraska68124-
Astera Cancer Care (Formerly Regional Cancer Care Associates)East BrunswickNew Jersey08816-
Medical Oncology Hematology AssociatesNewarkNew Jersey19713-
Hematology Oncology Associates of Central New YorkCamillusNew York13031-
Sarah Cannon Research Institute (Nashville)NashvilleTennessee37203-
Texas Oncology DFWDallasTexas75246-
The University of Texas Southwestern Medical CenterDallasTexas75390-
Texas Oncology Gulf CoastHoustonTexas77024-
Virginia Cancer SpecialistsFairfaxVirginia22031-
Virginia Oncology AssociatesNorfolkVirginia23502-
Shenandoah OncologyWinchesterVirginia22601-
Northwest Medical SpecialtiesPuyallupWashington98373-
Northwest Cancer SpecialistsVancouverWashington98648-
University of WisconsinMadisonWisconsin53706-

Find similar trials in Long Beach, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Oncology Institute· Long Beach, CARocky Mountain Cancer Centers· Denver, COThe Oncology Institute· Lakeland, FLAccellacare of McFarland· Ames, IALSU Health Sciences Center· Shreveport, LANew England Cancer Specialists· Scarborough, ME

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