Tislelizumab Combined with Nab-Paclitaxel for First-Line Treatment of Advanced Triple-Negative Breast Cancer with Bone Metastasis，an Exploratory, Single-Arm, Multicenter Phase II Clinical Study
Trial Parameters
Brief Summary
The goal of this clinical trial is to learn if Tislelizumab Combined with Nab-Paclitaxel works to treat patients of TNBC with bone metastasis as first line treatment. It will also learn about the safety of the combination. The main questions it aims to answer are: How effective is the combination therapy of tislelizumab and nab-paclitaxel in treating advanced first-line triple-negative breast cancer with bone metastasis? And is it safe? Participants will: * Receive the treatment as follows: Tislelizumab, 200mg, intravenous, every 3 weeks; nab-paclitaxel, 125mg/m2 on day 1 and day 8, followed by once every three weeks; RANKL inhibitor chosen by investigator is administered at a dose of 120 mg every 4 weeks, with dosing on Days 1, 8, and 15 during the first cycle. * Visit the clinic once every 3 weeks for checkups and tests * Keep a diary of their symptoms and the number of times they use a rescue inhaler
Eligibility Criteria
Inclusion Criteria: 1. Female, aged ≥18 years and \<70 years; 2. Metastatic triple-negative breast cancer (TNBC) confirmed by histological examination, i.e., negative for human epidermal growth factor receptor 2 (HER2), estrogen receptor (ER), and progesterone receptor (PR); 3. Eastern Cooperative Oncology Group (ECOG) performance status score: 0-1; 4. Expected survival time ≥3 months; 5. ≥1 bone metastasis confirmed by histology or imaging. There must be at least one measurable lesion defined according to RECIST 1.1 criteria. For lesions that have undergone previous radiotherapy, they can only be considered measurable if there is definite disease progression after radiotherapy; 6. Patients with initially diagnosed stage IV (staging based on AJCC 8th edition) or recurrent/metastatic TNBC who are not suitable for surgical treatment, and have not received prior systemic therapy for advanced disease. Prior neoadjuvant and/or adjuvant therapy with taxanes and other antitumor treatments is