Exploratory Single-Arm, Multicenter Phase II Study of Tislelizumab Combined with Nab-Paclitaxel As First Line Treatment for Patients of Triple-negative Breast Cancer(TNBC) with Bone Metastasis
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
• Female, aged ≥18 years and \<70 years;
• 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);
• Eastern Cooperative Oncology Group (ECOG) performance status score: 0-1;
• Expected survival time ≥3 months;
• ≥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;
• 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 allowed, but it must meet the criteria of no progression after neoadjuvant therapy, and the time interval between the end of taxane (neo)adjuvant therapy and recurrence/metastasis must be ≥12 months, and the time interval between the end of capecitabine (neo)adjuvant therapy and recurrence/metastasis must be ≥6 months. If immunotherapy was conducted during neoadjuvant phase, the time interval between the last immunotherapy and the screening enrollment for this study must be ≥24 months;
• Prior local radiotherapy for metastatic sites is allowed, with no limit on the time of completion of radiotherapy, but the patient must have recovered from the effects of radiotherapy before enrolled;
• Function of vital organs meets the protocol requirements within 1 week before the first administration of the study drug;
• Patients voluntarily participate in this study and sign the informed consent form.