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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.

Phase 2RecruitingZhejiang Cancer HospitalNCT06538896Data as of May 2026

Treatment: Tislelizumab + Nab-PaclitaxelThe 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

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Extracted 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

No prior treatment (treatment-naive required)
Max 0 prior lines

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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