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Randomized trialESMO open · 2026

Datopotamab deruxtecan versus chemotherapy in previously treated inoperable/metastatic hormone receptor-positive HER2-negative breast cancer: safety and patient-reported outcomes from the phase III TROPION-Breast01 study.

H S Rugo, K Jhaveri, S Pernas … TROPION-Breast01 investigators

OphthalmologyRandomized trial

Nausea was the most common treatment-related side effect with datopotamab deruxtecan.

Datopotamab deruxtecan versus chemotherapy in previously treated inoperable/metastatic hormone receptor-positive HER2-negative breast cancer: safety and patient-reported outcomes from the phase III TROPION-Breast01 study.

H S Rugo … TROPION-Breast01 investigators

ESMO open · 2026

Background

In TROPION-Breast01 (NCT05104866), datopotamab deruxtecan (datopotamab deruxtecan) improved progression-free survival by blinded independent central review versus investigator's choice of chemotherapy (ICC) in patients with inoperable/metastatic hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer, who had disease progression on endocrine therapy and for whom endocrine therapy was unsuitable, and who had received 1-2 prior lines of chemotherapy in the inoperable/metastatic setting.

Methods

Received datopotamab deruxtecan (6 mg/kg every 3 weeks) or ICC (eribulin/capecitabine/vinorelbine/gemcitabine).

n = 360

51.9%

Results

51.9%

over half of patients getting the drug felt nauseated during treatment

n = 360

More results

The AEs of special interest (grouped terms), treatment-related oral mucositis/stomatitis and ocular surface events, occurred in 57.2% (grade ≥3: 7.2%) and 43.9% (grade ≥3: 1.9%) of patients, respectively.

More results

Per protocol recommendations, most patients receiving datopotamab deruxtecan received anti-emetics (76.7%), prophylactic mouthwash (77.2%), or artificial tears (71.7%).

Adjudicated drug-related interstitial lung disease/pneumonitis with datopotamab deruxtecan was mostly low-grade (3.9%; grade ≥3: 0.8%; one grade 5 event).

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Conclusion

Safety and patient-reported outcomes data from TROPION-Breast01 complement the improvements in efficacy demonstrated with datopotamab deruxtecan versus ICC, supporting datopotamab deruxtecan as a treatment option for patients with previously treated, inoperable/metastatic HR+/HER2- breast cancer.

Post

Datopotamab deruxtecan versus chemotherapy in previously treated inoperable/metastatic hormone receptor-positive HER2-negative breast cancer: safety and patient-reported outcomes from the phase III TROPION-Breast01 study.

Nausea was the most common treatment-related side effect with datopotamab deruxtecan.

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