RecruitingPhase 2NCT06538896

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

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


Sponsor

Zhejiang Cancer Hospital

Enrollment

20 participants

Start Date

Aug 20, 2024

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of two treatments — tislelizumab (an immunotherapy drug that helps the immune system fight cancer) and nab-paclitaxel (a chemotherapy drug) — as a first-line treatment for a specific type of breast cancer called triple-negative breast cancer (TNBC) that has spread to the bones. It is a single-arm study, meaning all participants receive the same treatment. **You may be eligible if...** - You are a woman aged 18–70 with triple-negative breast cancer confirmed by tissue testing (negative for HER2, estrogen, and progesterone receptors) - Your cancer has spread to at least one bone and you have at least one measurable tumor on imaging - You have not had chemotherapy for metastatic disease before (this is your first-line treatment) - You are reasonably functional day-to-day (ECOG 0–1) and expected to survive at least 3 months **You may NOT be eligible if...** - You have had prior chemotherapy for metastatic/advanced disease - You have active autoimmune disease or a condition requiring systemic steroids - You are pregnant or breastfeeding - Your organ function (heart, liver, kidney) does not meet minimum safety levels Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTislelizumab + Nab-Paclitaxel

Tislelizumab, 200mg, intravenous, every 3 weeks

OTHERRankl inhibitor

RANKL inhibitor determined 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.


Locations(1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

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NCT06538896


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