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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: Recruiting Phase 3 study of Metastatic HER2-positive Breast Cancer, sponsored by Jazz Pharmaceuticals.
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (29% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
PFS is defined as the time in months from randomization to the date of first documented disease progression (as assessed by BICR according to RECIST v1.1) or death from any cause, whichever occurs first.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 550 participants |
| Start Date | 2024-08-13 |
| Est. Completion | 2030-10-18 |
| Phase | Phase 3 |
What NCT06435429 shows while recruiting
NCT06435429 is an interventional study that assigns participants to a tested intervention. The registered 550 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (29% lower).
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 names 20 study sites across 9 states, led by 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06435429's enrollment target sits among peer trials
550 680th of 2000 higher than 1,313 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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