RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 3, Randomized, Open-label, Multicenter, Controlled Study to Evaluate the Efficacy and Safety of Zanidatamab in Combination With Physician's Choice Chemotherapy Compared to Trastuzumab in Combination With Physician's Choice Chemotherapy for the Treatment of Participants With Metastatic HER2-positive Breast Cancer Who Have Progressed on, or Are Intolerant to, Previous Trastuzumab Deruxtecan Treatment

Quick Facts

Study Start:2024-08-13
Study Completion:2031-11-26
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06435429

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Clinical Trial Disclosure & Transparency
CONTACT
215-832-3750
ClinicalTrialDisclosure@JazzPharma.com

Study Locations (Sites)

Arizona Oncology Tucson - Wilmot
Tucson, Arizona, 85711
United States
Rocky Mountain Cancer Centers
Denver, Colorado, 80218
United States
Minnesota Oncology Hematology
Coon Rapids, Minnesota, 55433
United States
Messino Cancer Center
Asheville, North Carolina, 28806
United States
Oncology Hematology Care (OHC)
Cincinnati, Ohio, 45226
United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
United States
Texas Oncology - Fort Worth
Fort Worth, Texas, 76104
United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031
United States
Virginia Oncology Associates, Sentara Health
Norfolk, Virginia, 23502
United States
Blue Ridge Cancer Care
Roanoke, Virginia, 24014
United States

Collaborators and Investigators

Sponsor: Jazz Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-13
Study Completion Date2031-11-26

Study Record Updates

Study Start Date2024-08-13
Study Completion Date2031-11-26

Terms related to this study

Keywords Provided by Researchers

  • Zanidatamab
  • Trastuzumab
  • Metastatic HER2-positive breast cancer

Additional Relevant MeSH Terms

  • Metastatic HER2-positive Breast Cancer