Ireland
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Latest
Recruiting Phase 2

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

NCT07102381 · tracked via the Priya Life Science Italy tracker
Phase
Phase 2
Started
2025-09-24
Last updated
2026-10-01

Condition(s) studied

HER2-positive Breast CancerBreast Cancer

Investigational drug(s) / intervention(s)

Zanidatamab →Paclitaxel →Docetaxel →Carboplatin →Trastuzumab →Pertuzumab →

Zanidatamab: Administered intravenously (IV)

Paclitaxel: Administered intravenously (IV)

Docetaxel: Administered intravenously (IV)

Carboplatin: Administered intravenously (IV)

Trastuzumab: Administered intravenously (IV)

Pertuzumab: Administered intravenously (IV)

Study 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

Sex
ALL
Min age
18 Years
Max age
—
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

Primary outcome measure(s)

  • Number of participants with pCR — Up to 8 months
    Pathologic complete response (pCR) is defined as lacking all signs of cancer in the tissue samples removed in the breast or axilla (armpit) during surgery or biopsy after study treatment

Trial sites (44)

FacilityCityRegionStatus
Oncology Institute Long Beach California Recruiting
Cancer & Blood Research Center Los Alamitos California Recruiting
Rocky Mountain Cancer Centers Denver Colorado Recruiting
Holy Cross Hospital Fort Lauderdale Florida Recruiting
The Oncology Institute Lakeland Florida Recruiting
Accellacare of McFarland Ames Iowa Recruiting
LSU Health Sciences Center Shreveport Louisiana Recruiting
New England Cancer Specialists Scarborough Maine Recruiting
Maryland Oncology Hematology Laurel Maryland Recruiting
Henry Ford Hospital Detroit Michigan Recruiting
Cancer Partners of Nebraska Lincoln Nebraska Recruiting
Nebraska Cancer Specialists Omaha Nebraska Recruiting
Astera Cancer Care (Formerly Regional Cancer Care Associates) East Brunswick New Jersey Recruiting
Medical Oncology Hematology Associates Newark New Jersey Recruiting
The University of New Mexico Albuquerque New Mexico Recruiting
Hematology Oncology Associates of Central New York Camillus New York Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
Levine Cancer Charlotte North Carolina Recruiting
Sarah Cannon Research Institute (Nashville) Nashville Tennessee Recruiting
Texas Oncology DFW Dallas Texas Recruiting
The University of Texas Southwestern Medical Center Dallas Texas Recruiting
Texas Oncology Gulf Coast Houston Texas Recruiting
UT Health San Antonio, Mays Cancer Center San Antonio Texas Recruiting
Virginia Cancer Specialists Fairfax Virginia Recruiting
Virginia Oncology Associates Norfolk Virginia Recruiting
Shenandoah Oncology Winchester Virginia Recruiting
Northwest Medical Specialties Puyallup Washington Recruiting
Northwest Cancer Specialists Vancouver Washington Recruiting
University of Wisconsin Madison Wisconsin Recruiting
Hämatologie-Onkologie Zentrum Augsburg Germany Recruiting
Mammazentrum Hamburg MVZ GbR Hamburg Germany Recruiting
Marien Hospital Witten Witten Germany Recruiting
Ospedale San Raffaele Milan Lombardy Recruiting
AOU di Bologna Bologna Italy Recruiting
Policlinico San Martino Genoa Italy Recruiting
Istituto Europeo di Oncologia Milan Italy Recruiting
Humanitas Ist.Clinico Catanese Misterbianco Italy Recruiting
IRCCS San Gerardo dei Tintori Monza Italy Recruiting
Hospital Universitario San Cecilio Granada Andalusia Active Not Recruiting
Álvaro Cunqueiro Hospital Vigo Galicia Recruiting

+ 4 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07102381 on ClinicalTrials.gov ↗ ← All trials in Italy