Hormone receptor-positive, HER2-negative, unresectable or recurrent breast cancer
Conditions
Interventions
None listed
Sponsors
Naito Yoichi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 1) Patients who received Dato-DXd outside of insurance-covered treatment 2) Patients deemed ineligible for study enrollment by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Real world progression free survival (rwPFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactYoichi Naito
National Cancer Center Hospital East
Outcome results
None listed