First-line (1L) datopotamab deruxtecan (Dato-DXd) vs chemotherapy in patients (pts) with locally recurrent inoperable or metastatic triple-negative breast cancer (mTNBC) for whom immunotherapy was not an option: Exploratory analysis of pts with brain metastases in TROPION-Breast02

TROPION-Breast02

Patient / Population Intervention / Exposition Vergleich Endpunkt

In patients with metastatic triple-negative breast cancer and asymptomatic, stable brain metastases for whom immunotherapy was not an option, first-line datopotamab deruxtecan was reported to show extracranial efficacy benefit, with preliminary intracranial responses, compared with investigator's choice of chemotherapy.

N

61Patienten

Design

Exploratory subgroup analysis of a 1:1 randomised trial (644 patients enrolled) of first-line datopotamab deruxtecan vs investigator's choice of chemotherapy ((nab)-paclitaxel, capecitabine, eribulin mesylate or carboplatin) in patients with locally recurrent inoperable or metastatic triple-negative breast cancer for whom immunotherapy was not an option, restricted to the 61 patients with asymptomatic, stable brain metastases at baseline, with or without prior CNS-directed therapy (NCT05374512).

Endpunkt

Exploratory endpoints in patients with previously treated or untreated brain metastases: PFS by BICR, OS, confirmed ORR and intracranial response per mRECIST v1.1.

ErgebnisOf 644 patients enrolled, 61 had baseline brain metastases (31 previously treated vs 30 untreated). Extracranial efficacy figures for this subgroup appear only in a table that the abstract text does not reproduce. In a preliminary analysis of intracranial efficacy, Dato-DXd produced intracranial objective responses, including one complete response. Further intracranial data were to be presented. In the overall trial population, OS HR 0.79 (95.01% CI 0.64-0.98), PFS by BICR HR 0.57 (99% CI 0.44-0.73) and confirmed ORR 63% vs 29% with investigator's choice of chemotherapy.

Dent RA, Cescon DW, Jung KH, et al. Presented at ESMO Congress 2026, abstract LBA96, 24 October. Not yet published.

Diskussion & Kritik

This exploratory subgroup of 61 patients, split into 31 previously treated and 30 untreated, is too small to support firm conclusions, and the trial was not powered for it. The abstract text gives no subgroup hazard ratios, CIs or response rates because the extracranial results sit in a table that is not reproduced, and the intracranial data are preliminary: they report only that responses occurred, including one complete response, with no denominators and no comparison with chemotherapy. Only asymptomatic, stable brain metastases were eligible, so the findings do not apply to patients with active or symptomatic disease, and the abstract does not state whether treatment was blinded. The comparator was investigator's choice of chemotherapy in patients for whom immunotherapy was not an option.