Dato-DXd for Triple-negative Breast Cancer

This trial tests the effectiveness of Dato-DXd, an experimental treatment, compared to standard chemotherapy options for triple-negative breast cancer (TNBC), a hard-to-treat type. The trial includes two groups: one receiving Dato-DXd and the other receiving a chemotherapy option chosen by the investigator. Suitable candidates have TNBC that cannot be surgically removed or has metastasized and cannot be treated with certain immunotherapies. As a Phase 3 trial, this study represents the final step before FDA approval, providing patients access to a potentially groundbreaking treatment.

The trial requires a 'washout period' (time without taking certain medications) before starting the study. This includes stopping any anti-cancer therapy, including hormonal therapy, for at least 3 weeks, and other specific medications like chloroquine/hydroxychloroquine for more than 14 days. It's best to discuss your current medications with the trial team to see if they need to be stopped.

Research has shown that Dato-DXd yields promising results for treating advanced triple-negative breast cancer (TNBC). In earlier studies, patients experienced mostly mild or moderate side effects that could be managed, while serious side effects were less common. Reports indicate that patients generally tolerated the treatment well, even those with extensive prior treatments.

The Investigator's Choice of Chemotherapy (ICC) group includes well-known drugs like capecitabine, carboplatin, and eribulin mesylate. These drugs have been used for other types of cancer and are considered safe. Like many chemotherapy drugs, they can cause side effects, but these are usually known and manageable with medical care.

Dato-DXd is unique because it targets a specific protein called Trop-2 found on the surface of many triple-negative breast cancer cells. This precision approach allows the drug to directly attack cancer cells, potentially leading to better outcomes with fewer side effects compared to traditional chemotherapy. Researchers are excited about Dato-DXd because it combines a potent chemotherapy drug with an antibody that guides it straight to the cancer, offering a new hope for patients whose options are currently limited.

Research shows that Dato-DXd, which participants in this trial may receive, is a promising treatment for triple-negative breast cancer (TNBC). Studies indicate it can reduce the risk of cancer progression or death by 43% in patients who cannot use immunotherapy. Specifically, patients taking Dato-DXd lived an average of 23.7 months, five months longer than those receiving standard chemotherapy. The treatment is also considered safe, with fewer serious side effects. This evidence supports Dato-DXd as a strong option for treating TNBC. Another arm of this trial will involve the investigator's choice of chemotherapy, which may include capecitabine, carboplatin, or eribulin, depending on prior treatments.¹²⁵⁶⁷