Trastuzumab-rezetecan for HER2-positive and HER2-low breast cancer
Efficacy and Safety of Trastuzumab-rezetecan in HER2-Positive and HER2-Low Breast Cancer: A Multicenter, Observational, Real-World Study Protocol
This project will test Trastuzumab-rezetecan in adults with HER2-positive or HER2-low breast cancer who are receiving it as part of routine care to see if it works and is safe.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Drugs / interventions | Trastuzumab |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT07358182 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, observational real-world study planned to enroll 300 patients with HER2-positive or HER2-low breast cancer who are receiving Trastuzumab-rezetecan as part of routine clinical care. There are no restrictions on the specific treatment regimen, which will be chosen by treating clinicians and may include neoadjuvant, adjuvant, or advanced/metastatic settings. Patients will undergo routine imaging and safety assessments, and investigators will record outcomes and adverse events according to the protocol. Data will be analyzed to describe treatment effectiveness and safety in routine practice.
Who should consider this trial
Good fit: Adults (≥18) with pathologically confirmed HER2-positive (IHC 3+ or IHC 2+/ISH+) or HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who are planned to receive Trastuzumab-rezetecan and have ECOG performance status 0–2 are ideal candidates.
Not a fit: Patients who are pregnant, have ECOG >2, will not receive Trastuzumab-rezetecan, or whose tumor does not meet the HER2-positive or HER2-low definitions are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, the findings could clarify how well Trastuzumab-rezetecan works and its safety in everyday clinical practice, helping inform treatment choices for HER2-positive and HER2-low patients.
How similar studies have performed: Other HER2-directed antibody–drug conjugates have demonstrated clinical benefit in trials, but real-world evidence specifically for Trastuzumab-rezetecan is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 18 years, with pathologically confirmed HER2-positive or HER2-low-expressing breast cancer: HER2-positive is defined as IHC 3+ or IHC 2+ with a positive ISH result; HER2-low-expressing is defined as IHC 1+ or IHC 2+ with a negative ISH result for HER2 amplification; hormone receptor status must be clearly documented. 2. Planned to receive treatment with Trastuzumab-rezetecan for Injection in the neoadjuvant, adjuvant, or advanced/metastatic setting; patients with advanced/metastatic disease must have progressed after at least one prior line of systemic therapy. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2. 4. Women of childbearing potential must have a negative serum pregnancy test within 28 days prior to enrollment, and both male and female patients must be willing to use a highly effective, medically approved method of contraception during the study and for 1 year after the last dose of the study drug. 5. Non-pregnant and non-lactating female patients. 6. Not concurrently participating in any other ongoing clinical studies. The patient or their legal representative has provided informed consent by signing the informed consent form and is willing and able to comply with scheduled visits, the study treatment plan, laboratory tests, and other trial procedures. Exclusion Criteria: 1. Any evidence of severe or uncontrolled systemic disease, including uncontrolled hypertension, active bleeding disorders, active infections (such as hepatitis B, hepatitis C, and human immunodeficiency virus), or severely impaired bone marrow reserve or organ function (including hepatic and renal impairment), which, in the investigator's opinion, would significantly alter the risk-benefit balance. 2. At the initiation of treatment with Trastuzumab-rezetecan for Injection, the patient has not recovered from any prior treatment-related toxicity of CTCAE grade \>3. 3. Known history of hypersensitivity to Trastuzumab-rezetecan for Injection, its excipients, or drugs with similar chemical structures or classes as Trastuzumab-rezetecan. 4. Patients deemed unsuitable for enrollment by the investigator.
Where this trial is running
Guangzhou, Guangdong
- Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
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.