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A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

A Phase 2, Randomized, Multicenter, Open-label Neoadjuvant Study Evaluating Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer

NCT07102381•Jazz Pharmaceuticals

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
•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
+3 more criteria

Locations (21)

Oncology Institute

Long Beach, California, United States

Rocky Mountain Cancer Centers

Denver, Colorado, United States

The Oncology Institute

Lakeland, Florida, United States

Accellacare of McFarland

Ames, Iowa, United States

LSU Health Sciences Center

Shreveport, Louisiana, United States

New England Cancer Specialists

Scarborough, Maine, United States

Maryland Oncology Hematology

Laurel, Maryland, United States

Cancer Partners of Nebraska

Lincoln, Nebraska, United States

Nebraska Cancer Specialists

Omaha, Nebraska, United States

Astera Cancer Care (Formerly Regional Cancer Care Associates)

East Brunswick, New Jersey, United States

Key Dates

Start Date

September 24, 2025

Primary Completion Date

January 1, 2028

Completion Date

August 1, 2030

Last Updated

March 12, 2026

Enrollment

125

ESTIMATED participants

Conditions

HER2-positive Breast CancerBreast Cancer

Interventions

Zanidatamab

DRUG

Paclitaxel

DRUG

Docetaxel

DRUG

Carboplatin

DRUG

Trastuzumab

DRUG

Pertuzumab

DRUG

Contacts

Clinical Trial Disclosure & Transparency

CONTACT

215-832-3750 ClinicalTrialDisclosure@JazzPharma.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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