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NCT06435429 · ClinicalTrials.gov registry record · 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

A Phase 3 study of Metastatic HER2-positive Breast Cancer, sponsored by Jazz Pharmaceuticals.

Recruiting
Registry status
Phase 3
Development phase
550
Enrollment target
20
Study locations

NCT06435429 is a Phase 3 study of Metastatic HER2-positive Breast Cancer that is actively recruiting participants, run by Jazz Pharmaceuticals. The registered enrollment target is 550 participants. The trial reports 20 study locations across 9 states.

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The verdict

NCT06435429, a Phase 3 study of Metastatic HER2-positive Breast Cancer, is actively recruiting participants, sponsored by Jazz Pharmaceuticals.

RECRUITING
Registry status
Phase 3
Development phase
550 participants
Enrollment target
20
Study locations

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

128 total trials

What the Registry Record Tells You About NCT06435429

The ClinicalTrials.gov registry entry for NCT06435429 describes a study currently listed as recruiting, categorized as Phase 3. 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 128 total studies on file at ClinicalTrials.gov.

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.

NCT06435429 reports 20 study locations spanning 9 distinct geographic areas - top geographies include California, Florida, Arizona.

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.

What interventions are being tested in trial NCT06435429?

The interventions under investigation include: Trastuzumab (DRUG), Gemcitabine (DRUG), Eribulin (DRUG), Zanidatamab (DRUG), Vinorelbine (DRUG).

Who is sponsoring clinical trial NCT06435429?

This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.