RECRUITING

A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative 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

This is a Phase III, randomised, open-label, 3-arm, multicentre, international study assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with investigator's choice chemotherapy in combination with pembrolizumab in participants with PD-L1 positive locally recurrent inoperable or metastatic TNBC.

Official Title

A Phase III, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy (Paclitaxel, Nab-paclitaxel or Gemcitabine + Carboplatin) in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION-Breast05)

Quick Facts

Study Start:2023-11-23
Study Completion:2029-04-23
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06103864

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

AstraZeneca Clinical Study Information Center
CONTACT
1-877-240-9479
information.center@astrazeneca.com
AstraZeneca Breast Cancer Study Locator Service
CONTACT
+1-877-400-4656
az-bcsl@careboxhealth.com

Study Locations (Sites)

Research Site
Daphne, Alabama, 36526
United States
Research Site
Springdale, Arkansas, 72762
United States
Research Site
Duarte, California, 91010
United States
Research Site
Glendale, California, 91204
United States
Research Site
Sacramento, California, 95817
United States
Research Site
Santa Rosa, California, 95403
United States
Research Site
Aurora, Colorado, 80012
United States
Research Site
New Haven, Connecticut, 06510
United States
Research Site
Jacksonville, Florida, 32256
United States
Research Site
Miami, Florida, 33176
United States
Research Site
Palm Bay, Florida, 32909
United States
Research Site
Plantation, Florida, 33324
United States
Research Site
Atlanta, Georgia, 30318
United States
Research Site
Honolulu, Hawaii, 96819
United States
Research Site
Chicago, Illinois, 60637
United States
Research Site
Decatur, Illinois, 62526
United States
Research Site
Elmhurst, Illinois, 60126
United States
Research Site
Naperville, Illinois, 60540
United States
Research Site
New Albany, Indiana, 47150
United States
Research Site
Des Moines, Iowa, 50309
United States
Research Site
Lexington, Kentucky, 40503
United States
Research Site
Louisville, Kentucky, 40202
United States
Research Site
Louisville, Kentucky, 40202
United States
Research Site
Louisville, Kentucky, 40207
United States
Research Site
Baton Rouge, Louisiana, 70808
United States
Research Site
Baton Rouge, Louisiana, 70809
United States
Research Site
Baltimore, Maryland, 21215
United States
Research Site
Columbia, Maryland, 21044
United States
Research Site
Boston, Massachusetts, 02111
United States
Research Site
Worcester, Massachusetts, 01655
United States
Research Site
Detroit, Michigan, 48201
United States
Research Site
Grand Rapids, Michigan, 49503
United States
Research Site
Saint Paul, Minnesota, 55109
United States
Research Site
Hattiesburg, Mississippi, 39401
United States
Research Site
Saint Louis, Missouri, 63129
United States
Research Site
Albuquerque, New Mexico, 87109
United States
Research Site
Albany, New York, 12206
United States
Research Site
New York, New York, 10065
United States
Research Site
Stony Brook, New York, 11794-7263
United States
Research Site
Cincinnati, Ohio, 45219
United States
Research Site
Cincinnati, Ohio, 45245
United States
Research Site
Cleveland, Ohio, 44195
United States
Research Site
York, Pennsylvania, 17403
United States
Research Site
Providence, Rhode Island, 02903
United States
Research Site
Chattanooga, Tennessee, 37404
United States
Research Site
Nashville, Tennessee, 37203
United States
Research Site
Nashville, Tennessee, 37203
United States
Research Site
Dallas, Texas, 75230
United States
Research Site
Dallas, Texas, 75246
United States
Research Site
Dallas, Texas, 75246
United States
Research Site
El Paso, Texas, 79902
United States
Research Site
Flower Mound, Texas, 75028
United States
Research Site
Fort Worth, Texas, 76104
United States
Research Site
Houston, Texas, 77054
United States
Research Site
Houston, Texas, 77090
United States
Research Site
Houston, Texas, 77098
United States
Research Site
Kingwood, Texas, 77339
United States
Research Site
McKinney, Texas, 75071
United States
Research Site
Sugar Land, Texas, 77479
United States
Research Site
Charlottesville, Virginia, 22903
United States
Research Site
Fairfax, Virginia, 22031
United States
Research Site
Midlothian, Virginia, 23114
United States
Research Site
Norfolk, Virginia, 23502
United States
Research Site
Roanoke, Virginia, 24014
United States
Research Site
Tacoma, Washington, 98405
United States
Research Site
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: AstraZeneca

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 Date2023-11-23
Study Completion Date2029-04-23

Study Record Updates

Study Start Date2023-11-23
Study Completion Date2029-04-23

Terms related to this study

Keywords Provided by Researchers

  • Breast Cancer
  • Triple-negative
  • Metastatic
  • Inoperable
  • Datopotamab deruxtecan
  • Dato-DXd
  • DS1062a
  • DS1062
  • Durvalumab
  • Paclitaxel
  • Nab-paclitaxel
  • Gemcitabine
  • Carboplatin
  • Pembrolizumab
  • PD-1/PD-L1 Therapy
  • TROP2
  • Antibody Drug Conjugate (ADC)
  • Immune Checkpoint Inhibitor (ICI)

Additional Relevant MeSH Terms

  • Breast Cancer