Neoadjuvant zanidatamab plus chemotherapy for HER2-positive early breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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

Where it's running

• Oncology Institute
  Long Beach, California, United States Recruiting
• Cancer & Blood Research Center
  Los Alamitos, California, United States Recruiting
• Cedars Sinai Medical Center
  Los Angeles, California, United States Recruiting
• Rocky Mountain Cancer Centers
  Denver, Colorado, United States Recruiting
• Holy Cross Hospital
  Fort Lauderdale, Florida, United States Recruiting
• The Oncology Institute
  Lakeland, Florida, United States Recruiting

+3 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Clinical Trial Disclosure & Transparency
• Email: ClinicalTrialDisclosure@JazzPharma.com
• Phone: 215-832-3750

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.