Datopotamab deruxtecan (Datroway) may help control cancer in the brain for some people with metastatic triple-negative breast cancer who cannot receive immunotherapy. New findings from the TROPION-Breast02 clinical trial showed longer control of cancer in the central nervous system and higher rates of brain tumor shrinkage with Datroway than with chemotherapy. The results were presented at the 2026 European Society for Medical Oncology Congress.
The findings are encouraging, but they come from an exploratory analysis of just 61 patients with brain metastases—breast cancer that had spread to the brain. The analysis offers evidence of potential benefit, rather than a definitive answer about how well the treatment works in this population.
Longer control of cancer in the brain
Among patients with brain metastases, the median time before cancer worsened in the central nervous system or the patient died was 9.5 months with Datroway, compared with 2.6 months with chemotherapy. This outcome is called central nervous system progression-free survival. The median represents the midpoint of the study results, not how long treatment will work for every patient.
Researchers also examined whether tumors in the brain shrank. Among patients with brain tumors that could be measured, 62.5% receiving Datroway had a confirmed response, compared with 37.5% receiving chemotherapy. These results were based on small groups: 16 patients taking Datroway and eight receiving chemotherapy. At 12 weeks, brain tumors had shrunk or remained stable in 75% and 50% of these patients, respectively.
Benefits were also seen beyond the brain
When researchers looked at cancer progression anywhere in the body, the median time before cancer worsened or the patient died was 7.7 months with Datroway versus 3.5 months with chemotherapy. The overall tumor response rate was 62.9% with Datroway, compared with 19.2% with chemotherapy.
Median overall survival was 13.5 months with Datroway and 10.7 months with chemotherapy. However, the survival difference was not statistically conclusive in this small subgroup, so the analysis does not establish that Datroway helps patients with brain metastases live longer.
Who was included?
The larger TROPION-Breast02 trial enrolled 644 people with previously untreated, inoperable locally recurrent or metastatic triple-negative breast cancer for whom immunotherapy was not an option. Participants received either Datroway or one of several standard chemotherapies selected by their doctor.
Of the 61 participants with brain metastases, 35 received Datroway and 26 received chemotherapy. About half had not previously received treatment directed at their brain metastases. Researchers observed activity with Datroway both in patients who had received prior brain-directed treatment and in those who had not. Importantly, the patients in this analysis did not have symptoms from their brain metastases.
What do the findings mean for patients?
The results add evidence that Datroway can have activity against breast cancer in the brain, including brain metastases that have not previously been treated. That is an important finding because people with untreated brain metastases are often excluded from clinical trials.
Still, the small number of participants limits how broadly the findings can be applied. This analysis does not answer how well Datroway works for brain metastases that are causing symptoms, nor did it test whether the drug can replace radiation or surgery. The findings are best understood as additional information to help guide individualized treatment discussions—not as evidence that brain-directed treatment is no longer needed.
Reference
Dent R, Cescon DW, Jung KH, et al. First-line datopotamab deruxtecan (Dato-DXd) vs chemotherapy in patients with locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC) for whom immunotherapy was not an option: exploratory analysis of patients with brain metastasis in TROPION-Breast02. Presented at: 2026 ESMO Congress; October 23-27, 2026; Madrid, Spain. Abstract LBA96.
