A recent clinical trial has found that datopotamab deruxtecan (Datroway), a targeted therapy, significantly improved survival for people with metastatic (advanced) triple-negative breast cancer (TNBC) who were not eligible for immunotherapy.

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This marks the first time any treatment has worked better than standard chemotherapy in this high-risk group, according to the study results announced by AstraZeneca and Daiichi Sankyo. The new findings may pave the way for future approval of datopotamab deruxtecan as a first-line treatment for TNBC, pending review by regulatory agencies like the U.S. Food and Drug Administration (FDA).

What Is Datroway, and How Does It Work?

Datopotamab deruxtecan is an antibody-drug conjugate (ADC). This type of treatment is designed to deliver chemotherapy directly to cancer cells while sparing more healthy tissue. The drug targets a protein called TROP2, which is found in high levels on the surface of many TNBC cells. By attaching to TROP2, it delivers the cancer-killing drug straight into the tumor. This approach aims to reduce side effects and boost effectiveness compared to traditional chemo.

TNBC is an aggressive form of breast cancer that does not respond to hormone therapy or drugs targeting HER2. Around 15 percent of breast cancers are triple-negative. Treatment options are limited, and the prognosis (outlook) for people with metastatic TNBC has been poor.

About the Study: How Was Datroway Tested?

The trial enrolled 644 people with locally advanced or metastatic TNBC across multiple continents. All participants were ineligible for immunotherapy, either because their tumors did not express PD-L1 or due to other medical reasons. These individuals would typically receive chemotherapy as the standard first treatment.

Participants were randomly assigned to receive either datopotamab deruxtecan or a chemotherapy regimen chosen by their doctor (options included paclitaxel, nab-paclitaxel, capecitabine, carboplatin, or eribulin).

According to the study results, datopotamab deruxtecan significantly improved both overall survival (how long people lived) and progression-free survival (how long before the cancer worsened) compared to chemotherapy.

Specifically, people treated with the drug lived a median of 23.7 months, compared to 18.7 months for those receiving standard chemotherapy.

Those who received the new drug saw a delay in cancer progression for a median of 10.8 months versus 5.6 months with chemotherapy.

Side Effects

Datroway’s safety profile was consistent with what had been seen in earlier studies, with no unexpected side effects.

The drug’s prescribing label lists several common side effects, including:

• Mouth sores or inflammation
• Nausea and vomiting
• Fatigue (extreme tiredness or weakness that doesn’t improve with rest)
• Alopecia (hair loss)
• Eye symptoms including dry eyes and eye inflammation
• Low blood cell counts
• Low calcium levels
• Changes in liver enzymes

Rare but serious side effects include:

• Lung problems, such as interstitial lung disease or pneumonitis
• Serious eye reactions (severe dryness, inflammation, or changes in vision)
• Severe mouth sores
• Potential harm to a fetus when taken during pregnancy

Why Does This Matter for People With High-Risk TNBC?

For people with metastatic TNBC who can’t get immunotherapy, the standard first-line option has long been chemotherapy. According to the American Cancer Society, the five-year relative survival rate for this type of breast cancer is 15 percent. This means that people with stage 4 disease are about 15 percent as likely as the general population to still be alive in five years.

This clinical trial shows that datopotamab deruxtecan may meaningfully extend life for some people living with advanced TNBC. The drug is already approved for some other types of breast cancer, and these findings could expand access and change the standard of care for metastatic TNBC.

Importantly, many factors play a role in a person’s prognosis, and a medication that may work well for one person may not work as well for another.

If you or a loved one is living with TNBC, the best way to explore your treatment options is by having an open, ongoing conversation with your healthcare team. They can help you understand the latest research, what treatments may fit your individual needs, and how to manage side effects or join a clinical trial if interested.

Learn about five treatment options for TNBC and how they work.

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