TROPION-Breast02 Trial for Metastatic Breast Cancer
Trial Details
Overview: The TROPION-Breast02 trial is studying whether datopotamab deruxtecan (Dato-DXd) offers more benefits than the investigators’ choice of chemotherapy as a first treatment for people diagnosed with inoperable locally recurrent or metastatic triple-negative breast cancer who who can’t receive Keytruda (chemical name: pembrolizumab). Inoperable locally recurrent breast cancer is cancer that has come back in an area near the breast and can’t be removed with surgery.
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: 600
ClinicalTrials.gov ID number: NCT05374512
Sponsor of the trial: AstraZeneca
Collaborator: Daiichi Sankyo, Inc.
Who is the trial for?
The TROPION-Breast02 study is enrolling adults diagnosed with metastatic or inoperable locally recurrent triple-negative breast cancer that has not been treated yet. People also must not be able to receive a PD-1 or PD-L1 inhibitor, such as Keytruda.
Locally recurrent breast cancer is breast cancer that has come back in tissue near the breast, but not to parts of the body away from the breast. Inoperable means the cancer can’t be removed with surgery. Metastatic breast cancer is breast cancer that has spread to parts of the body away from the breast, such as the bones or liver. Both locally recurrent and metastatic breast cancer are considered advanced-stage disease.
Triple-negative breast cancer is cancer that has no receptors for the hormones estrogen and progesterone, as well as no receptors for the HER2 protein. This limits the medicines that can be used to treat the cancer.
Why is the trial being done?
Because advanced-stage triple-negative breast cancer has no known receptors, chemotherapy is the standard treatment for it. Researchers are always looking for new, more effective treatments that may cause fewer or less severe side effects.
The trial is designed to see if a new medicine, datopotamab deruxtecan (dato-DXd), offers better outcomes for advanced-stage, triple-negative breast cancer than doctors’ choice of chemotherapy. The outcomes the researchers will be looking at are progression-free survival and overall survival.
Progression-free survival is how long a person lives without the cancer growing. Overall survival is how long a person lives, whether or not the cancer grows.
Dato-DXd is a targeted therapy medicine made up of three parts:
datopotamab: a type of molecule called a monoclonal antibody that targets the Trop-2 protein
deruxtecan (DXd): a topoisomerase I inhibitor chemotherapy medicine
a compound that links the datopotamab molecule to the DXd
Doctors call dato DXd an antibody-drug conjugate. The linking compound attaches (conjugates) the datopotamab monoclonal antibody to the DXd chemotherapy.
Research has shown that the Trop-2 protein is found on the surface of about 90% of breast cancers. Datopotamab, one of the compounds that makes up dato-DXd, targets the Trop-2 protein and attaches to it. DXd is the topoisomerase I inhibitor chemotherapy medicine part of dato-DXd. Like other chemotherapy medicines, it interferes with a cell’s ability to replicate. DXd isn’t a targeted medicine, which means it can affect healthy cells as well as cancer cells.
Dato-DXd was designed to deliver the DXd chemotherapy to cancer cells in a targeted way by attaching the DXd to the datopotamab. The datopotamab then carries the DXd to the triple-negative cancer cells. This way, the DXd is less toxic to healthy cells and more effective in treating cancer cells.
Dato-DXd is given intravenously, which means the medicine is delivered directly into your bloodstream through an IV or port.
Earlier research has shown that Dato-DXd had a 34% response rate in people diagnosed with metastatic, triple-negative breast cancer. This means that 34% of the cancers responded in some way to Dato-DXd.
In the study, people will receive either:
dato-DXd
doctors’ choice of chemotherapy; depending on previous treatments, people may receive Taxol (chemical name: paclitaxel), Abraxane (chemical name: nab-paclitaxel), Xeloda (chemical name: capecitabine), carboplatin, or Halaven (chemical name: eribulin)
Specific eligibility requirements
Adults are eligible for the TROPION-Breast02 study if they:
have been diagnosed with locally recurrent or metastatic triple-negative breast cancer that hasn’t been treated yet
are not able to receive a PD-1 or PD-L1 inhibitor
People are not eligible for the TROPION-Breast02 study if they:
test positive for hepatitis B or C
have been diagnosed with HIV that is not well controlled
have significant heart disease
have a history of interstitial lung disease, a group of conditions that cause scarring of the lungs
are being treated for another type of cancer
are taking hormone replacement therapy (HRT)
Possible side effects of dato-DXd
Because dato-DXd is a new medicine, there may be side effects we don’t know about yet. In earlier studies, the most common side effects of data-DXd were:
Possible side effects of the chemotherapy medicines in the study
The most common side effects of Taxol, Abraxane, Xeloda, carboplatin, and Halaven are:
Study locations
The TROPION-Breast02 study is being conducted at a number of sites across the United States, as well as in Argentina, Belgium, Brazil, Canada, China, France, Germany, Hungary, India, Italy, Japan, Korea, Mexico, the Philippines, Poland, Singapore, South Africa, Spain, Taiwan, Thailand, Turkey, and the United Kingdom. For a complete list of sites, visit: https://clinicaltrials.gov/ct2/show/NCT05374512.
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 May 1, 2025 at 4:42 PM