A Study of SI-B003 or BL-B01D1+SI-B003 in Patients With Unresectable Locally Advanced or Recurrent Metastatic HER2 Negative Breast Cancer
Trial Parameters
Brief Summary
This phase II study is a clinical study to explore the efficacy and safety of SI-B003 monotherapy and BL-B01D1+SI-B003 combination therapy in patients with unresectable locally advanced or recurrent metastatic HER-2 negative breast cancer.
Eligibility Criteria
Inclusion Criteria: 1. Voluntarily sign the informed consent and follow the requirements of the protocol. 2. Age: ≥18 years old and ≤75 years old. 3. Expected survival time ≥3 months. 4. ECOG 0 or 1. 5. Pathologically and/or cytologically confirmed patients who have failed standard treatment, or have no access to standard treatment Patients with unresectable, locally advanced or recurrent, metastatic HER2-negative breast cancer after posterior line. 6. Agree to provide archived tumor tissue specimens (unstained sections (anti-slip)) from primary or metastatic sites within 2 years. 10 to 12 surgical specimens (4-5 μm thick) or fresh tissue samples if the subject is unable to provide them for 2 years tumor tissue samples from within, can be communicated with the sponsor if other inclusion criteria are met, enrollment was permitted after investigator assessment. 7. Must have at least one measurable lesion according to RECIST v1.1 definition; So let's say that we've done this before radiot