Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
A Study of ZW25 (Zanidatamab) With Palbociclib Plus Fulvestrant in Patients With HER2+/HR+ Advanced Breast Cancer
NCT04224272 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04224272
The ClinicalTrials.gov registry entry for NCT04224272 describes a study currently listed as completed. It is categorized as Phase 2, 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 51 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 HER2+/HR+ Breast Cancer appearing as the primary indexed condition, and to 3 interventions — of which Fulvestrant 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: NCT04224272 reports 13 study locations spanning 8 distinct geographic areas — top geographies include Other, Ontario, California. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04224272?
The interventions under investigation include: Fulvestrant (DRUG), Palbociclib (DRUG), ZW25 (Zanidatamab) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04224272?
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 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.
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