ACTIVE_NOT_RECRUITING

A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-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, 2-arm, randomised, open-label, multicentre, global study assessing the efficacy and safety of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy compared with neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in participants with previously untreated TNBC or hormone receptor-low/HER2-negative breast cancer.

Official Title

A Phase III, Open-label, Randomised Study of Neoadjuvant Datopotamab Deruxtecan (Dato-DXd) Plus Durvalumab Followed by Adjuvant Durvalumab With or Without Chemotherapy Versus Neoadjuvant Pembrolizumab Plus Chemotherapy Followed by Adjuvant Pembrolizumab With or Without Chemotherapy for the Treatment of Adult Patients With Previously Untreated Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer (D926QC00001; TROPION-Breast04)

Quick Facts

Study Start:2023-11-14
Study Completion:2032-09-23
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06112379

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. * Participant must be ≥ 18 years, at the time of signing the ICF.
  2. * Histologically confirmed Stage II or III unilateral or bilateral primary invasive TNBC or hormone receptor-low/HER2-negative breast cancer
  3. * ECOG PS of 0 or 1
  4. * Provision of acceptable tumor sample
  5. * Adequate bone marrow reserve and organ function
  6. * Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies and aligned with protocol requirements.
  1. * History of any prior invasive breast malignancy
  2. * History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 5 years before randomization.
  3. * active or prior documented autoimmune or inflammatory disorders.
  4. * Evidence of distant disease.
  5. * Clinically significant corneal disease.
  6. * Has active or uncontrolled hepatitis B or C virus infection.
  7. * Known HIV infection that is not well controlled.
  8. * Uncontrolled infection requiring i.v. antibiotics, antivirals or antifungals; suspected infections; or inability to rule out infections.
  9. * Known to have active tuberculosis infection
  10. * Mean resting corrected QTcF interval \> 470 ms obtained from ECG
  11. * Uncontrolled or significant cardiac disease.
  12. * History of non-infectious ILD/pneumonitis
  13. * Has severe pulmonary function compromise
  14. * Any prior or concurrent surgery, radiotherapy or systemic anticancer therapy for TNBC or hormone receptor-low/HER2-negative breast cancer
  15. * For females only: is pregnant (confirmed with positive serum pregnancy test) or breastfeeding, or planning to become pregnant.
  16. * Female participants should refrain from breastfeeding from enrolment throughout the study and for at least 7 months after last dose of study intervention, or as dictated by local PI for SoC if longer.
  17. * Concurrent use of systemic hormone replacement therapy or oral hormonal contraception

Contacts and Locations

Study Locations (Sites)

Research Site
Daphne, Alabama, 36526
United States
Research Site
Prescott, Arizona, 86301
United States
Research Site
Jonesboro, Arkansas, 72401
United States
Research Site
Rogers, Arkansas, 72758
United States
Research Site
Los Angeles, California, 90033
United States
Research Site
Santa Barbara, California, 93105
United States
Research Site
Santa Rosa, California, 92805
United States
Research Site
Torrance, California, 90505
United States
Research Site
Aurora, Colorado, 80045
United States
Research Site
Longmont, Colorado, 80504
United States
Research Site
Bridgeport, Connecticut, 06606
United States
Research Site
New Haven, Connecticut, 06510
United States
Research Site
Fort Myers, Florida, 33901
United States
Research Site
Jacksonville, Florida, 32256
United States
Research Site
St. Petersburg, Florida, 33705
United States
Research Site
West Palm Beach, Florida, 33401
United States
Research Site
Atlanta, Georgia, 30342
United States
Research Site
Des Moines, Iowa, 50309
United States
Research Site
Edgewood, Kentucky, 41017
United States
Research Site
Louisville, Kentucky, 40202
United States
Research Site
Baton Rouge, Louisiana, 70817
United States
Research Site
Annapolis, Maryland, 21401
United States
Research Site
Boston, Massachusetts, 02215
United States
Research Site
Grand Rapids, Michigan, 49503
United States
Research Site
Traverse City, Michigan, 49684
United States
Research Site
Burnsville, Minnesota, 55337
United States
Research Site
Minneapolis, Minnesota, 55407
United States
Research Site
Columbia, Missouri, 65212
United States
Research Site
Omaha, Nebraska, 68130
United States
Research Site
East Brunswick, New Jersey, 08816
United States
Research Site
New Brunswick, New Jersey, 08901
United States
Research Site
Santa Fe, New Mexico, 87505
United States
Research Site
New York, New York, 10065
United States
Research Site
Charlotte, North Carolina, 28204
United States
Research Site
Durham, North Carolina, 27710
United States
Research Site
Winston-Salem, North Carolina, 27103
United States
Research Site
Blue Ash, Ohio, 45242
United States
Research Site
Eugene, Oregon, 97401
United States
Research Site
Portland, Oregon, 97223
United States
Research Site
Philadelphia, Pennsylvania, 19104
United States
Research Site
Pittsburgh, Pennsylvania, 15212
United States
Research Site
Chattanooga, Tennessee, 37404
United States
Research Site
Nashville, Tennessee, 37203
United States
Research Site
Austin, Texas, 78731
United States
Research Site
Dallas, Texas, 75231
United States
Research Site
Dallas, Texas, 75235
United States
Research Site
Dallas, Texas, 75390-8843
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, 77030
United States
Research Site
San Antonio, Texas, 78240
United States
Research Site
Webster, Texas, 77598
United States
Research Site
Fairfax, Virginia, 22031
United States
Research Site
Norfolk, Virginia, 23502
United States
Research Site
Roanoke, Virginia, 24014
United States
Research Site
Winchester, Virginia, 22601
United States
Research Site
Tacoma, Washington, 98405
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 Date2023-11-14
Study Completion Date2032-09-23

Study Record Updates

Study Start Date2023-11-14
Study Completion Date2032-09-23

Terms related to this study

Keywords Provided by Researchers

  • Breast Cancer;
  • Dato-DXd; DS1062a;
  • TROP2;
  • TNBC;
  • HR low:
  • Datopotamab deruxtecan;
  • Antibody Drug Conjugate;
  • ADC;
  • neoadjuvant therapy;
  • adjuvant therapy;
  • durvalumab;
  • PD-L1;
  • immune-checkpoint inhibitor (ICI);

Additional Relevant MeSH Terms

  • Breast Cancer