Actively Recruiting
A Trial of Trastuzumab Rezetecan in Unresectable Locally Recurrent/Metastatic Breast Cancer
Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2026-05-11
150
Participants Needed
1
Research Sites
135 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is designed to compare the efficacy and safety of different dose groups of Trastuzumab Rezetecan or Trastuzumab Deruxtecan in patients with HR-positive, HER2-low unresectable locally recurrent/metastatic breast cancer. It will also exploratively evaluate the pharmacokinetic profile and immunogenicity of Trastuzumab Rezetecan.
CONDITIONS
Official Title
A Trial of Trastuzumab Rezetecan in Unresectable Locally Recurrent/Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 to 75 years (inclusive)
- Diagnosis of unresectable locally recurrent or metastatic breast cancer
- No prior chemotherapy for recurrent/metastatic disease
- Received at least one prior line of endocrine therapy for recurrent/metastatic disease with disease progression
- Documented radiological disease progression during or after most recent therapy
- ECOG performance status of 0 or 1
- Life expectancy of at least 12 weeks
- At least one extracranial measurable lesion according to RECIST v1.1
- Adequate function of major organs
- Women of childbearing potential must use highly effective contraception from screening until 7 months after last dose and agree not to breastfeed
- Negative serum pregnancy test within 7 days before first dose
- Voluntary participation with signed informed consent, good compliance, and willingness to cooperate with visits and procedures
You will not qualify if you...
- Presence of leptomeningeal metastasis, carcinomatous meningitis, spinal cord compression, or active central nervous system metastases
- Only skin or brain lesions as target lesions
- History of other malignancies within past 5 years except cured basal cell carcinoma of the skin or carcinoma in situ of the cervix
- Presence of carcinomatous lymphangitis or uncontrolled third-space fluid accumulation
- Recent prior surgery, chemotherapy, immunotherapy, or macromolecular targeted therapy within 4 weeks before first dose
- Recent prior endocrine therapy, chemotherapy with 5-FU analogs, or radiotherapy within 2 weeks before first dose
- Use of small molecule targeted agents requiring washout of 2 weeks or 5 half-lives before first dose
- Use of other investigational drugs requiring washout of 4 weeks or 5 half-lives before first dose
- Use of immunosuppressants or systemic corticosteroids for immunosuppressive purposes within 2 weeks before first dose
- History of immunodeficiency including positive HIV, other immunodeficiency diseases, or organ transplantation
- Clinically significant cardiovascular disease or arrhythmias requiring treatment
- Myocardial infarction or cerebrovascular accident within 6 months before first dose
- Known or suspected interstitial lung disease or moderate-to-severe pulmonary disease affecting drug toxicity detection or respiratory function within 3 months before first dose
- Autoimmune, connective tissue, or inflammatory disorders with lung involvement
- Known hereditary or acquired bleeding tendency
- Active hepatitis B, hepatitis C, cirrhosis, or severe infection requiring treatment
- Unresolved toxicities from prior anti-tumor therapy above grade 1
- Any severe physical or mental illness or lab abnormality increasing risk or interfering with study participation or results
AI-Screening
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Trial Site Locations
Total: 1 location
1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
Research Team
X
Xia Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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