OncoMatch/Clinical Trials/NCT06538896
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
Is NCT06538896 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Tislelizumab + Nab-Paclitaxel for triple-negative breast cancer.
Treatment: Tislelizumab + Nab-Paclitaxel — 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
Check if I qualifyExtracted eligibility criteria
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) negative (negative)
Required: ESR1 negative (negative)
Required: PR (PGR) negative (negative)
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Lab requirements
Blood counts
Function of vital organs meets the protocol requirements within 1 week before the first administration of the study drug
Kidney function
Function of vital organs meets the protocol requirements within 1 week before the first administration of the study drug
Liver function
Function of vital organs meets the protocol requirements within 1 week before the first administration of the study drug
Function of vital organs meets the protocol requirements within 1 week before the first administration of the study drug
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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