A Study of BEBT-209 in Combination With Chemotherapy for the Treatment of Advanced Triple-Negative Breast Cancer
Trial Parameters
Brief Summary
This is a multicenter, open-label, two-stage Phase II clinical study to evaluate the safety and efficacy of BEBT-209 capsule in combination with carboplatin and gemcitabine for the treatment of advanced triple-negative breast cancer (TNBC).
Eligibility Criteria
Inclusion Criteria: 1. Age: ≥18 years old, female; 2. The subject has fully understood and is willing to sign the Informed Consent Form (ICF); 3. Confirmed diagnosis of HR-negative, HER2-negative locally recurrent or metastatic breast cancer by pathological biopsy; 4. Estrogen and progesterone receptor immunohistochemical assessment of tumor tissue is negative (defined as \<1% nuclear staining), and HER2 is negative (i.e., no overexpression, including local immunohistochemical assessment \[0 or 1+\], or immunohistochemical assessment \[2+\] with negative in situ hybridization testing); 5. The subject has previously received 1-2 lines of systemic treatment (if progression within 12 months after the last treatment of adjuvant/new adjuvant, it can be considered as one line of treatment); 6. At least one measurable lesion in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria; 7. Eastern Cooperative Oncology Group (ECOG) score of 0-1 , and no decline in physi