TROPION-Breast04 Trial for Triple-Negative Breast Cancer
Trial details
Overview: This goal of this study is to see if the experimental medicine Dato-DXd (datopotamab deruxtecan) plus the immunotherapy medicine Imfinzi (chemical name: durvalumab) is a better first treatment for early-stage triple-negative breast cancer than the current standard of care, which is the immunotherapy medicine Keytruda (chemical name: pembrolizumab) plus chemotherapy.
Imfinzi is approved by the U.S. Food and Drug Administration (FDA) to treat certain types of non-small cell lung cancer, biliary tract cancer, and liver cancer.
Phase: Phase III; Phase III trials compare the safety and effectiveness of a new treatment to the current standard of care. Phase III trials are usually large — some involve thousands of people — and are done at many places in the United States and around the world.
Number of people to enroll: 1,728
ClinicalTrials.gov ID number: NCT06112379
Sponsor of the trial: AstraZeneca
Who is the trial for?
The trial is for adults diagnosed with stage II or stage III triple-negative or hormone receptor-low, HER2-negative breast cancer who have not yet received treatment for breast cancer.
Hormone receptor-low means 1% to 10% of the breast cancer cells have estrogen receptors. This information will be in your pathology report.
Why is the trial being done?
The TROPION-Breast04 trial is one of a number of studies on using Dato-DXd to treat various types of breast cancer. Results from the TROPION-Breast01 trial published in 2023 showed that Dato-DXd offered better progression-free survival (how long a person lives without the cancer growing) than standard chemotherapy for inoperable or metastatic, hormone receptor-positive, HER2-negative breast cancer that had been previously treated.
In TROPION-Breast04, researchers want to see if treating early-stage triple-negative or hormone receptor-low, HER2-negative breast cancer with Dato-DXd and Imfinzi before surgery, and then Imfinzi with or without chemotherapy after surgery, is better than the standard of care. The current standard of care is Keytruda and chemotherapy before surgery, followed by Keytruda with or without chemotherapy after surgery.
Both Dato-DXd and Imfinzi are given intravenously, which means the medicine is delivered directly into your bloodstream through an IV or a port.
There will be two treatment groups in the study.
One group will receive Dato-DXd and Imfinzi before breast cancer surgery. After surgery, they will receive nine cycles of Imfinzi. People who have residual disease — meaning active cancer cells were found during breast cancer surgery — will receive chemotherapy along with Imfinzi after surgery. If the cancer has a BRCA mutation, people also may receive Lynparza (chemical name: olaparib).
The other group will receive Keytruda and chemotherapy before breast cancer surgery. After surgery they will receive nine cycles of Keytruda. People with residual disease also will receive eight cycles of Xeloda (chemical name: capecitabine). If the cancer has a BRCA mutation, people also may receive Lynparza.
Follow-up time is about seven years.
Specific eligibility requirements
People are eligible for the TROPION-Breast04 study if they:
have been diagnosed with stage II or stage III triple-negative or hormone receptor-low, HER2-negative breast cancer and haven’t received any breast cancer treatment
People are not eligible for the study if they:
have metastatic breast cancer
have corneal disease
have active or uncontrolled hepatitis B, hepatitis C, HIV, or tuberculosis infection
Read the detailed eligibility requirements.
Side effects
In the TROPION-Breast01 trial, the most common side effects of Dato-DXd included:
The most common side effects of Imfinzi include:
pneumonia
upper respiratory infections
The most common side effects of Keytruda are:
anemia (low red blood cell count)
Study locations
The study is being conducted at multiple locations across the United States and around the world, including sites in Australia, Europe, South America, Canada and Asia.
For more information or to enroll
Call the AstraZeneca Clinical Study Information Center at 1-877-240-9479 or email information.center@astrazeneca.com.
— Last updated on September 16, 2024 at 12:51 PM