A Trial of Trastuzumab Rezetecan in Unresectable Locally Recurrent/Metastatic Breast Cancer (NCT07497386) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Trial of Trastuzumab Rezetecan in Unresectable Locally Recurrent/Metastatic Breast Cancer
China150 participantsStarted 2026-04
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexFEMALE
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Inclusion criteria
✓. Female aged 18 to 75 years (inclusive).
✓. Unresectable locally recurrent or metastatic breast cancer.
✓. Prior therapy must meet the following: No prior chemotherapy for recurrent/metastatic disease. Must have received at least one prior line of endocrine therapy for recurrent/metastatic disease with disease progression, and the investigator judges that further benefit from endocrine therapy is not possible.
✓. Documented radiological disease progression (during or after the most recent therapy).
✓. ECOG performance status of 0 or 1.
✓. Life expectancy ≥ 12 weeks.
✓. At least one extracranial measurable lesion as a target lesion according to RECIST v1.1 criteria.
✓. Adequate function of major organs.
Exclusion criteria
✕. Presence of leptomeningeal metastasis/carcinomatous meningitis, spinal cord compression, or active central nervous system metastases.
✕. Patients with only skin or brain lesions as target lesions.
✕. History of other malignancies within the past 5 years, except for cured basal cell carcinoma of the skin or carcinoma in situ of the cervix.
✕. Presence of carcinomatous lymphangitis, or third-space fluid accumulation that cannot be controlled by methods such as drainage.
What they're measuring
1
Progression-free survival (PFS).
Timeframe: Every 6 weeks after administration, approximately 14 months.
✕. Prior surgery, chemotherapy, immunotherapy, or macromolecular targeted therapy within 4 weeks before the first dose; prior endocrine therapy, chemotherapy with 5-FU analogs, or radiotherapy within 2 weeks before the first dose; small molecule targeted agents require a washout period of 2 weeks or 5 half-lives; other investigational drugs require a washout period of 4 weeks or 5 half-lives before the first dose.
✕. Use of immunosuppressants or systemic corticosteroids for immunosuppressive purposes within 2 weeks before the first dose for therapeutic intent.
✕. History of immunodeficiency, including a positive HIV test, other acquired or congenital immunodeficiency diseases, or history of organ transplantation.
✕. Clinically significant cardiovascular disease, such as severe/unstable angina, symptomatic congestive heart failure, etc.; clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention; myocardial infarction or cerebrovascular accident within 6 months before the first dose.