Trastuzumab deruxtecan for adults with advanced breast cancer
Trastuzumab Deruxtecan in Patients With Advanced Breast Cancer: a Real-world Study
This trial tests trastuzumab deruxtecan in adults with advanced breast cancer to see if it is safe and works well.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 118 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | RenJi Hospital Academic / other |
| Drugs / interventions | trastuzumab |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT07180264 on ClinicalTrials.gov |
What this trial studies
This observational study at Renji Hospital follows adults with advanced breast cancer who are planned to receive trastuzumab deruxtecan according to current guidelines. Eligible patients are 18 or older with ECOG performance status 0–1 and are followed during routine care for safety, adverse events, and clinical response. Data collected include dosing, treatment duration, laboratory and imaging results, and clinical outcomes without experimental treatment assignments. Pregnant and lactating people are excluded from participation.
Who should consider this trial
Good fit: Adults (≥18) with advanced breast cancer who meet guideline indications for trastuzumab deruxtecan, have ECOG 0–1, and are not pregnant or breastfeeding.
Not a fit: Patients who are pregnant or breastfeeding, have ECOG ≥2, or who are not planned to receive trastuzumab deruxtecan are unlikely to benefit from participating.
Why it matters
Potential benefit: If successful, the study could provide real-world safety and effectiveness data to help clinicians refine use of trastuzumab deruxtecan and inform patient care decisions.
How similar studies have performed: Large randomized programs (the DESTINY trials) have demonstrated substantial antitumor activity and clinical benefit for trastuzumab deruxtecan in metastatic HER2‑positive and HER2‑low breast cancer, and this observational work aims to add real‑world confirmation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged ≥18 and older * Breast cancer patients meeting current guideline recommendations and planning to receive trastuzumab deruxtecan * ECOG 0-1 Exclusion Criteria: * During pregnancy and lactation
Where this trial is running
Shanghai
- Renji Hospital, School of Medicine, Shanghai Jiaotong University — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Wenjin Yin, M.D. — Renji Hospital,School of Medicine, Shanghai Jiaotong University
- Study coordinator: Wenjin Yin, M.D.
- Email: yinwenjin@renji.com
- Phone: 86(21)68385569
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.