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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

NCT06538896 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-11-26

No results posted yet for this study

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

Conditions

Interventions

DRUG

Tislelizumab + Nab-Paclitaxel

Tislelizumab, 200mg, intravenous, every 3 weeks

OTHER

Rankl 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.

Sponsors & Collaborators

  • Zhejiang Cancer Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-20
Primary Completion
2026-12-31
Completion
2027-05-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06538896 on ClinicalTrials.gov