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OncoMatch/Clinical Trials/NCT07102381

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

Is NCT07102381 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies multiple treatments for her2-positive breast cancer.

Phase 2RecruitingJazz PharmaceuticalsNCT07102381Data as of Sep 2026Location: United States · Italy · Spain

Treatment: Zanidatamab · Paclitaxel · Docetaxel · Carboplatin · Trastuzumab · PertuzumabThe 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

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Extracted eligibility criteria

Treatments studied

Targeted therapy

ZanidatamabTrastuzumabPertuzumab

Chemotherapy

PaclitaxelDocetaxelCarboplatin

Cancer type

Breast Carcinoma

Biomarker criteria

Required: HER2 (ERBB2) overexpression

Has histologically confirmed HER2-positive breast cancer

Disease stage

Required: Stage II, III

Excluded: Stage IV

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: surgery for invasive breast cancer

Was treated with surgery ... for invasive breast cancer

Cannot have received: chemotherapy for invasive breast cancer

Was treated with ... chemotherapy ... for invasive breast cancer

Cannot have received: anti-HER2 therapy

Was treated with ... anti-HER2 therapy ... for invasive breast cancer

Cannot have received: radiation therapy for invasive breast cancer

Was treated with ... radiation therapy ... for invasive breast cancer

Cannot have received: endocrine therapy for invasive breast cancer

Was treated with ... endocrine therapy ... for invasive breast cancer

Cannot have received: experimental therapy for invasive breast cancer

Was treated with ... experimental therapy ... for invasive breast cancer

Lab requirements

Blood counts

Kidney function

Liver function

Cardiac function

lvef ≥ 50% as determined by either echo or muga obtained within 6 weeks prior to randomization

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Oncology Institute · Long Beach, California
  • Accellacare of McFarland · Ames, Iowa
  • LSU Health Sciences Center · Shreveport, Louisiana
  • New England Cancer Specialists · Scarborough, Maine
  • Maryland Oncology Hematology · Laurel, Maryland

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT07102381 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Does this trial require ERBB2?

Yes, ERBB2 overexpression is a required biomarker for enrollment.

What disease stage is eligible?

Stage II or III is required.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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