Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 3

A Study Comparing the Efficacy and Safety of Zanidatamab to Trastuzumab, Each in Combination With Physician's Choice Chemotherapy, for the Treatment of Participants With Metastatic HER2-positive Breast Cancer

NCT06435429 · View on ClinicalTrials.gov ↗

Study Summary

The efficacy and safety of zanidatamab in combination with physician's choice of chemotherapy compared with trastuzumab in combination with physician's choice of chemotherapy will be evaluated for the treatment of participants with metastatic HER2-positive breast cancer who have progressed on, or are intolerant to, previous T-DXd treatment.

Interventions

  • DRUG Trastuzumab
  • DRUG Gemcitabine
  • DRUG Eribulin
  • DRUG Zanidatamab
  • DRUG Vinorelbine

Study Locations (20)

California

  • The Oncology Institute Of Hope And Innovation — Cerritos
  • Los Angeles Hematology Oncology Medical Group Glendale — Glendale
  • USC-Norris Comprehensive Cancer Center - Investigational Drug Service IDS — Los Angeles
  • UCSF at Mission Bay MB — San Francisco

Florida

  • Florida Cancer Specialists Research South — Fort Myers
  • Mayo Clinic Jacksonville - PPDS — Jacksonville
  • Florida Cancer Specialists Research North — St. Petersburg
  • Florida Cancer Specialists Research East — West Palm Beach

Arizona

  • Mayo Clinic Scottsdale - PPDS — Phoenix
  • Arizona Oncology Tucson - Wilmot — Tucson
  • University of Arizona Cancer Center — Tucson

Colorado

  • University of Colorado-Cancer Center-PPDS — Aurora
  • Rocky Mountain Cancer Centers — Denver

District of Columbia

  • Medstar Georgetown University Hospital — Washington D.C.
  • Washington Cancer Center — Washington D.C.

Minnesota

  • Minnesota Oncology Hematology — Coon Rapids
  • Mayo Clinic - PPDS — Rochester

Massachusetts

  • Dana Farber Cancer Institute — Boston

Missouri

  • Saint Luke's Cancer Institute — Kansas City

Trial Details

FieldValue
Enrollment Target 550 participants
Start Date 2024-08-13
Est. Completion 2030-10-18
Phase Phase 3

Sponsor

Jazz Pharmaceuticals

37 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06435429

The ClinicalTrials.gov registry entry for NCT06435429 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 550 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jazz Pharmaceuticals, which has 37 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Metastatic HER2-positive Breast Cancer appearing as the primary indexed condition, and to 5 interventions — of which Trastuzumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06435429 reports 20 study locations spanning 9 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06435429 about?

NCT06435429 is a clinical study titled "A Study Comparing the Efficacy and Safety of Zanidatamab to Trastuzumab, Each in Combination With Physician's Choice Chemotherapy, for the Treatment of Participants With Metastatic HER2-positive Breast Cancer". The efficacy and safety of zanidatamab in combination with physician's choice of chemotherapy compared with trastuzumab in combination with physician's choice of chemotherapy will be evaluated for the treatment of participants with metastatic HER2-positive breast cancer who have progressed on, or ar...

What is the current status of trial NCT06435429?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 550 participants. The study started on 2024-08-13. Estimated completion is 2030-10-18.

What conditions does trial NCT06435429 study?

This clinical trial studies the following conditions: Metastatic HER2-positive Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06435429?

The interventions under investigation include: Trastuzumab (DRUG), Gemcitabine (DRUG), Eribulin (DRUG), Zanidatamab (DRUG), Vinorelbine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06435429?

This trial is sponsored by Jazz Pharmaceuticals, which has 37 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06435429 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial