Actively Recruiting
Efficacy and Safety of Trastuzumab-rezetecan in HER2-Expressing Breast Cancer
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2026-01-22
300
Participants Needed
1
Research Sites
317 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a multicenter, observational, real-world investigation. The research plans to enroll 300 HER2-positive and HER2-low breast cancer patients who meet the inclusion criteria. All patients included in the analysis are currently receiving or are scheduled to receive a treatment regimen containing Trastuzumab-rezetecan. There are no restrictions on the treatment regimen, which is entirely based on the clinician's choice. The study aims to evaluate the efficacy and safety of the treatment regimen containing Trastuzumab-rezetecan. After completing screening examinations and assessments, eligible patients will enter the study treatment phase. They will receive the treatment regimen containing Trastuzumab-rezetecan and undergo follow-up visits according to the protocol. During the study treatment period, patients will undergo imaging and safety assessments as per clinical routine, with the investigator's assessment serving as the final result. Upon treatment completion or study withdrawal, corresponding safety examinations and imaging assessment data will be collected. For neoadjuvant patients, pathological complete response (pCR) will be assessed post-surgery by pathologists at the participating centers.
CONDITIONS
Official Title
Efficacy and Safety of Trastuzumab-rezetecan in HER2-Expressing Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older with confirmed HER2-positive or HER2-low breast cancer
- Planned treatment with Trastuzumab-rezetecan in neoadjuvant, adjuvant, or advanced/metastatic setting
- Advanced/metastatic patients must have progressed after at least one prior systemic therapy
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
- Women of childbearing potential must have a negative pregnancy test within 28 days before enrollment
- Both male and female patients must agree to use effective contraception during the study and for 1 year after last dose
- Female patients must not be pregnant or breastfeeding
- Not participating in any other ongoing clinical studies
- Provided informed consent and able to comply with study visits and procedures
You will not qualify if you...
- Severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding disorders, infections (hepatitis B, hepatitis C, HIV), or severe bone marrow or organ impairment
- Not recovered from prior treatment-related toxicity of grade higher than 3 at start of Trastuzumab-rezetecan treatment
- Known allergy to Trastuzumab-rezetecan or similar drugs
- Considered unsuitable for enrollment by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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