breast cancer •HER2-positive patients who have received prior first-line anti-HER2 therapy. • HR-positive, HER2-low or ultralow patients who progressed on 1-2 lines o
Conditions
Interventions
experimental group:Expert Intelligent Avatar – Provided by the Zhiliao Doctor Mini Program (for intelligent, proactive whole-process patient management)
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Provision of informed consent prior to any study specific procedures. 2. Age >= 18 years at the time of informed consent. 3. Histologically or cytologically confirmed unresectable or metastatic breast cancer. 4. Cohort A (HER2-positive): Documented HER2-positive status (IHC 3+ or ISH positive) and have received prior first-line anti-HER2 therapy in the metastatic setting. Cohort B (HER2-low/ultralow): Documented HR-positive (ER and/or PgR >= 1%) and HER2-low (IHC 1+ or IHC 2+/ISH-negative) or HER2-ultralow (IHC 0 with membrane staining) status. Must have progressed on 1-2 prior lines of endocrine therapy (+/- targeted therapy) in the metastatic setting and have received no more than one prior line of chemotherapy in the metastatic setting. 5. Scheduled to initiate standard treatment with Trastuzumab Deruxtecan (T-DXd) as per the locally approved label. 6. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Appendix C). 7. Be able to operate the "AI doctor" digital companion application for this study. 8. Assessed by the researcher or sub-researcher, capable of completing weekly ePROs.
Exclusion criteria
Exclusion criteria: 1. Uncontrolled intercurrent illness that would limit compliance with study requirements. 2. Have interstitial lung disease as a coexisting illness or a history thereof. 3. Have a history of hypersensitivity to any component of T-DXd. 4. Are ineligible as judged by an investigator or subinvestigator in accordance with the approved label of T-DXd. 5. Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site). 6. Are currently receiving treatment with T-DXd in other interventional trials. 7. Have experienced multiple primary malignancies within the past 3 years (excluding appropriately resected non-melanoma skin cancer, cured carcinoma in situ, and contralateral breast cancer). 8. Are ineligible as judged by an investigator or subinvestigator because of the presence of mental illness that can affect QoL assessment. 9. Are currently pregnant, breastfeeding, or planning to become pregnant during the study. 10. The researcher or co-researcher thinks there are other reasons why someone doesn't meet the study's selection criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Deterioration of Quality of Life (TTDQoL); | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Treatment (DoT); | — |
Countries
China
Contacts
Public ContactJiuwei Cui
The First Hospital of Jilin University
Outcome results
None listed