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Neoadjuvant zanidatamab plus chemotherapy for HER2-positive early breast cancer

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

Phase 2 Interventional Jazz Pharmaceuticals · NCT07102381

This study will test if adding zanidatamab to chemotherapy given before surgery helps people with HER2-positive early-stage breast cancer.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment125 (estimated)
Ages18 Years and up
SexAll
SponsorJazz Pharmaceuticals Industry-sponsored
Drugs / interventionszanidatamab, chemotherapy, radiation
Locations26 sites (Long Beach, California and 25 other locations)
Trial IDNCT07102381 on ClinicalTrials.gov

What this trial studies

This phase 2 neoadjuvant study gives zanidatamab together with standard chemotherapy to people with stage II–III HER2-positive invasive breast cancer. Participants receive combinations that may include paclitaxel, docetaxel, carboplatin, and trastuzumab alongside zanidatamab, with treatment delivered prior to planned mastectomy or breast-conserving surgery. Key eligibility includes confirmed HER2-positive status, known hormone receptor status, ECOG 0–1, adequate organ function and LVEF ≥50%, and outcomes will focus on safety and tumor response at the time of surgery. Patients will be monitored for cardiac function and other adverse events during therapy.

Who should consider this trial

Good fit: People with stage II or III HER2-positive invasive breast cancer who are candidates for neoadjuvant therapy, have ECOG 0–1, adequate organ function, and LVEF ≥50% are ideal candidates.

Not a fit: Patients with metastatic (stage IV) disease, bilateral breast cancer, poor cardiac function (LVEF <50%) or other uncontrolled severe illnesses are unlikely to benefit or are excluded.

Why it matters

Potential benefit: If successful, the combination could increase the chance of tumor shrinkage or a pathologic complete response before surgery, potentially allowing less extensive surgery and improving outcomes.

How similar studies have performed: Other HER2-targeted combinations (for example trastuzumab plus pertuzumab) have improved pre-surgery response rates, while zanidatamab is a newer bispecific antibody with promising early data but not yet proven in the neoadjuvant setting.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Long Beach, California and 25 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions HER2-positive Breast CancerBreast CancerHER2-positive early breast cancerinvasive breast carcinomazanidatamabbreast neoplasm
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.