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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

Eligibility

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

Inclusion Criteria

  1. Has 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 4 weeks prior to first dose of study intervention. 9. Adequate contraceptive precautions

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. 10. Was treated with 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

More Details

Status
Recruiting
Sponsor
Jazz Pharmaceuticals

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.