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A Multicenter Retrospective Cohort Study Evaluating the Efficacy and Safety of Datopotamab Deruxtecan for Patients with Hormone Receptor-positive HER2 Negative Inoperable or Recurrent Breast Cancer in Japan (DAHLIA study) (JBCRG-C14(DAHLIA study))

JBCRG-C14(DAHLIA study) (JBCRG-C14(DAHLIA study))

Naito Yoichi

National Cancer Center Hospital East

6-5-1 Kashiwanoha, Kashiwa-shi, Chiba,

ynaito@east.ncc.go.jp

Naito Yoichi

National Cancer Center Hospital East

6-5-1 Kashiwanoha, Kashiwa-shi, Chiba

+81-4-7133-1111

ynaito@east.ncc.go.jp

Recruiting

Feb. 09, 2026

Observational

1) Patients with unresectable or recurrent breast cancer
2) Patients diagnosed with pathologically hormone receptor-positive and human epidermal growth factor receptor 2 (HER2)-negative breast cancer
3) Patients who initiated Dato-DXd treatment for the first time between March 19, 2025, and December 31, 2025
4) Patients aged 18 years or older at the time of Dato-DXd initiation
5) Patients who provided written informed consent to participate in this study*

*For patients for whom obtaining consent is difficult, opt-out enrollment is permitted after providing an adequate opportunity to decline.

1) Patients who received Dato-DXd outside of insurance-covered treatment
2) Patients deemed ineligible for study enrollment by the attending physician

Both

Hormone receptor-positive, HER2-negative, unresectable or recurrent breast cancer

Real world progression free survival (rwPFS)

1) Time to next treatment (TTNT)
2) Time to treatment failure (TTF)
3) TTF2
4) rwPFS2
5) Overall Survival(OS)
6) Adverse Event Rate
7) Interstitial lung disease(ILD) Stomatitis,Time to first occurrence of ocular surface events
8) Relative Dose Intensity of Dato-DXd
9) Percentage of patients receiving subsequent treatment regimens after Dato-DXd treatment

+81-3-3542-2511

Feb. 02, 2025

No

none