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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorZhejiang Cancer Hospital

About this trial

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 criteria

Qualifiers

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;

Disqualifiers

Currently participating in other clinical studies;

Untreated central nervous system disease (patients with asymptomatic central nervous system metastases are allowed);

Carcinomatous meningitis;

Uncontrolled pleural effusion, ascites, or pericardial effusion (patients with indwelling drainage tubes are allowed to enroll);

Trial design

Treatments tested in this trial

  • Tislelizumab + Nab-Paclitaxel
  • Rankl inhibitor

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators