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NCT04224272 · ClinicalTrials.gov registry record · Phase 2
A Study of ZW25 (Zanidatamab) With Palbociclib Plus Fulvestrant in Patients With HER2+/HR+ Advanced Breast Cancer
A Phase 2 study of HER2+/HR+ Breast Cancer, sponsored by Jazz Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 51
- Enrollment target
- 13
- Study locations
NCT04224272: Completed Phase 2 study of HER2+/HR+ Breast Cancer, sponsored by Jazz Pharmaceuticals.
NCT04224272 is a Phase 2 study of HER2+/HR+ Breast Cancer that has completed, run by Jazz Pharmaceuticals. The registered enrollment target is 51 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). The trial reports 13 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04224272, a Phase 2 study of HER2+/HR+ Breast Cancer, has completed, sponsored by Jazz Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 51 participants
- Enrollment target
- 13
- Study locations
Study Summary
This is a multicenter, Phase 2a, open-label, 2-part study to investigate the safety, tolerability, and anti-tumor activity of ZW25 (zanidatamab) in combination with palbociclib plus fulvestrant. Eligible patients include those with locally advanced (unresectable) and/or metastatic human epidermal growth factor receptor 2 (HER2)-positive, hormone receptor (HR)-positive breast cancer.
Primary Outcome
Dose-limiting toxicities, defined using NCI CTCAE version 5.0, are events that 1) occur following administration of ZW25, palbociclib, and fulvestrant, or any combination of ZW25 and 1 or more of these drugs; and 2) meet the criteria as specified in the protocol.
Conditions Studied
Interventions
- DRUG Fulvestrant
- DRUG Palbociclib
- DRUG ZW25 (Zanidatamab)
Study Locations (13)
Other
- Hospital Universitario Vall d'Hebrón - Barcelona
- Hospital Ruber Internacional - Madrid
- Hospital Universitario Virgen de la Victoria - Málaga
- Hospital Universitario Virgen del Rocío - Seville
- Hospital Clínico Universitario de Valencia - Valencia
Ontario
- The Ottawa Hospital Cancer Centre - Ottawa
- Sunnybrook Research Institute - Toronto
California
- UCLA Hematology/Oncology Parkside - Santa Monica
Tennessee
- Sarah Cannon Research Institute - Nashville
Washington
- Seattle Cancer Care Alliance - Seattle
Alberta
- Tom Baker Cancer Centre - Calgary
Quebec
- Jewish General Hospital - Montreal
Alicante
- Hospital General Universitario de Elche - Elche
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2020-06-10 |
| Est. Completion | 2025-06-30 |
| Phase | Phase 2 |
What the finished NCT04224272 record still lists
NCT04224272 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 1 condition, with HER2+/HR+ Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Fulvestrant is the first listed.
NCT04224272 lists 13 locations in 8 states (Other, Ontario, California).
Frequently Asked Questions
What is clinical trial NCT04224272 about?
NCT04224272 is a clinical study titled "A Study of ZW25 (Zanidatamab) With Palbociclib Plus Fulvestrant in Patients With HER2+/HR+ Advanced Breast Cancer". This is a multicenter, Phase 2a, open-label, 2-part study to investigate the safety, tolerability, and anti-tumor activity of ZW25 (zanidatamab) in combination with palbociclib plus fulvestrant. Eligible patients include those with locally advanced (unresectable) and/or metastatic human epidermal gr...
What is the current status of trial NCT04224272?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2020-06-10. Estimated completion is 2025-06-30.
What conditions does trial NCT04224272 study?
This clinical trial studies the following conditions: HER2+/HR+ Breast Cancer.
What interventions are being tested in trial NCT04224272?
The interventions under investigation include: Fulvestrant (DRUG), Palbociclib (DRUG), ZW25 (Zanidatamab) (DRUG).
Who is sponsoring clinical trial NCT04224272?
This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04224272 being conducted?
This trial has 13 study locations across California, Tennessee, Washington, Alberta, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04224272's enrollment target sits among peer trials
51 1190th of 2000 higher than 806 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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