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

Purpose

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

Conditions

  • HER2-positive Breast Cancer
  • Breast Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Has newly diagnosed Stage II or III histologically confirmed invasive breast carcinoma. 2. Has histologically confirmed HER2-positive breast cancer 3. Has a known hormone receptor (HR) status of the primary tumor 4. Participants with multifocal or multicentric disease are eligible if the largest tumor (which must be larger than or equal to 2 cm in diameter) is HER2-positive, and the treating physician has determined the participant should be treated as HER2-positive. 5. Agrees to undergo a mastectomy or breast conserving surgery (BCS) after neoadjuvant therapy. 6. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 7. Adequate organ function 8. Has an LVEF ≥ 50% as determined by either ECHO or MUGA obtained within 6 weeks prior to randomization. 9. Adequate contraceptive precautions 10. Participants with known HIV are eligible unless: 1. CD4+ T Cell count is less than or equal to 350 microliters (uL) 2. Detectable viral load, or 3. Receiving protease inhibitors or cobicistat

Exclusion Criteria

  1. Has Stage IV (metastatic) breast cancer. 2. Has bilateral breast cancer. 3. Has a history of any severe and/or uncontrolled medical conditions or other conditions that, in the opinion of the investigator, could affect the participant's involvement in the study. 4. Has uncontrolled hypertension 5. Has significant symptoms from peripheral neuropathy 6. Has an active uncontrolled infection 7. Has a history of life-threatening hypersensitivity to monoclonal antibodies or to recombinant proteins or excipients in the drug formulation of zanidatamab or other study interventions. 8. Known active hepatitis B or C infection. 9. Has another malignancy diagnosed within the last 5 years. Exceptions include previously treated non melanomatous skin cancers, carcinoma in-situ, and melanoma in-situ. Participants with prior ipsilateral ductal carcinoma in situ (DCIS) or invasive breast cancer are not eligible. 10. Was treated with surgery, chemotherapy, anti-HER2 therapy, radiation therapy, endocrine therapy, or experimental therapy for invasive breast cancer 11. Is planning to receive concurrent therapy with any other investigational agent or anti-cancer therapy not specified in the protocol 12. Receipt of a live vaccine within 4 weeks prior to enrollment 13. Has a known hypersensitivity to any components of the study interventions, including chemotherapy

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Zanidatamab with paclitaxel 		Zanidatamab in combination with chemotherapy paclitaxel
  • Drug: Zanidatamab
    Administered intravenously (IV)
    Other names:
    • ZW25
    • JZP598
    • ZIIHERA®
  • Drug: Paclitaxel
    Administered intravenously (IV)
Active Comparator
Zanidatamab with docetaxel and carboplatin 		Zanidatamab in combination with chemotherapy docetaxel and carboplatin
  • Drug: Zanidatamab
    Administered intravenously (IV)
    Other names:
    • ZW25
    • JZP598
    • ZIIHERA®
  • Drug: Docetaxel
    Administered intravenously (IV)
  • Drug: Carboplatin
    Administered intravenously (IV)
Active Comparator
Trastuzumab and pertuzumab with docetaxel and carboplatin 		Trastuzumab and pertuzumab in combination with chemotherapy docetaxel and carboplatin
  • Drug: Docetaxel
    Administered intravenously (IV)
  • Drug: Carboplatin
    Administered intravenously (IV)
  • Drug: Trastuzumab
    Administered intravenously (IV)
  • Drug: Pertuzumab
    Administered intravenously (IV)

Recruiting Locations

Oncology Institute
Long Beach, California 90805

Cancer & Blood Research Center
Los Alamitos, California 90720

Rocky Mountain Cancer Centers
Denver, Colorado 80218

Holy Cross Hospital
Fort Lauderdale, Florida 33308

Accellacare of McFarland
Ames, Iowa 50010

New England Cancer Specialists
Scarborough, Maine 04074

Maryland Oncology Hematology
Laurel, Maryland 20707

Cancer Partners of Nebraska
Lincoln, Nebraska 68516

Medical Oncology Hematology Associates
Newark, New Jersey 19713

The University of New Mexico
Albuquerque, New Mexico 87131

Hematology Oncology Associates of Central New York
Camillus, New York 13031

Memorial Sloan Kettering Cancer Center
New York, New York 10065

Levine Cancer
Charlotte, North Carolina 28204

Sarah Cannon Research Institute (Nashville)
Nashville, Tennessee 37203

Texas Oncology DFW
Dallas, Texas 75246

Texas Oncology Gulf Coast
Houston, Texas 77024

Virginia Cancer Specialists
Fairfax, Virginia 22031

Virginia Oncology Associates
Norfolk, Virginia 23502

Shenandoah Oncology
Winchester, Virginia 22601

Northwest Medical Specialties
Puyallup, Washington 98373

Northwest Cancer Specialists
Vancouver, Washington 98648

University of Wisconsin
Madison, Wisconsin 53706

More Details

Status
Recruiting
Sponsor
Jazz Pharmaceuticals

Study Contact

Clinical Trial Disclosure & Transparency
215-832-3750
ClinicalTrialDisclosure@JazzPharma.com