Health TrialsbyHealthPanel

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

ConditionsTriple-negative Breast CancerBone Metastases
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Tislelizumab + Nab-Paclitaxel

    Drug

    Tislelizumab, 200mg, intravenous, every 3 weeks

  • Rankl inhibitor

    Other intervention

    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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Tislelizumab + Nab-PaclitaxelExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Objective Response Rate(ORR)

Objective Response Rate (ORR) - percentage of patients with at least one investigator-assessed visit response of complete or partial response (as assessed by the investigator, using RECIST 1.1)

Time frame
Up to approximately 33 months

Secondary outcomes

1

Progression-Free Survival (PFS)

Progression-Free Survival by investigator assessment (in accordance with RECIST 1.1)

Time frame
The time from date of randomization to the date of progression or death due to any cause, whichever occurs earlier, up to approximately 33 months
2

Overall Survival (OS)

Overall Survival (OS)

Time frame
The time from date of enrollment to the date of death due to any cause up to approximately 33 months
3

Skeletal Related Events(SRE)

Time frame
Time from the date of first medication to the first occurrence of pathological fractures, bone surgery, bone radiotherapy, or spinal cord compression caused by tumor bone metastasis, up to 33 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhejiang Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov
Apply now