TROPION-Breast04 (Triple Negative Breast Cancer)

Purpose of this Study

We are doing this study to find the safest and most effective dose of an experimental drug called Dato-DXd (the study drug) in patients with triple negative breast cancer (TNBC) and HER2-negative breast cancer.

Who Can Participate?

Eligibility

Adults ages 18+ who:
  • Are diagnosed with TNBC or HER2-negative breast cancer
  • Have not started treatment for breast cancer
For more information about who can join this study, please contact the study team at breastcl@dm.duke.edu.

Age Range

18-110

Sex/Genders

Female (cisgender)
Non-binary or gender fluid
Looking for Healthy Participants
No

What is Involved?

Description

If you choose to join the study, you will go through a screening period that lasts about 4 weeks. During this period, you will:
  • Agree to send a tumor tissue sample for genetic testing
  • Have a CT scan and MRI
  • Have blood and urine tests, EKGs, and physical exams
If you are found to be eligible during screening, you will proceed to the study regimen portion. During period, you will get a random assignnment to 1 of 2 different groups: Experimental arm - If you are in this group, you will get the study drug in combination with a drug callled durvalumab as an infusion (IV) into a vein every 3 weeks before your surgery. Control arm - If you are in this group, you will get durvalumab combined with one of the following choices of chemotherapy:
  • Doxorubicin/epirubicin + cyclophosphamide, followed by paclitaxel + carboplatin; OR
  • Doxorubicin/epirubicin + cyclophosphamide, followed by paclitaxel; OR
  • Carboplatin + paclitaxel; OR
  • Capecitabine

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

No

Spanish Materials Available

Yes

Study Details

Full 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 (TROPION-Breast04)

Principal Investigator

Carey
Anders

Protocol Number

PRO00115149

NCT ID

NCT06112379

Phase

III

Enrollment Status

Open to Enrollment
ClinicalTrials.gov