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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 is a Phase 2 study of HER2+/HR+ Breast Cancer that has completed, run by Jazz Pharmaceuticals. The registered enrollment target is 51 participants. The trial reports 13 study locations across 8 states.

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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.

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

FieldValue
Enrollment Target 51 participants
Start Date 2020-06-10
Est. Completion 2025-06-30
Phase Phase 2

Sponsor

Jazz Pharmaceuticals

128 total trials

What the Registry Record Tells You About NCT04224272

The ClinicalTrials.gov registry entry for NCT04224272 describes a study currently listed as completed, categorized as Phase 2. 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 128 total studies on file at ClinicalTrials.gov.

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 reports 13 study locations spanning 8 distinct geographic areas - top geographies include 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.

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.