Actively Recruiting

Phase 2
Age: 18Years - 70Years
FEMALE
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

Led by Zhejiang Cancer Hospital · Updated on 2024-11-26

20

Participants Needed

1

Research Sites

140 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 70Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female aged 18 to under 70 years
  • Histologically confirmed metastatic triple-negative breast cancer (negative for HER2, ER, and PR)
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1
  • Expected survival time of 3 months or more
  • At least one bone metastasis confirmed by histology or imaging, with at least one measurable lesion by RECIST 1.1 criteria
  • No prior systemic therapy for advanced disease; prior neoadjuvant or adjuvant taxane therapy allowed if no progression occurred and appropriate time intervals have passed
  • Prior local radiotherapy for metastatic sites allowed if recovered from effects
  • Vital organ function meets protocol requirements within 1 week before first drug administration
  • Voluntary participation with signed informed consent form
Not Eligible

You will not qualify if you...

  • Currently participating in other clinical studies
  • Untreated central nervous system disease (asymptomatic CNS metastases allowed)
  • Carcinomatous meningitis
  • Uncontrolled pleural effusion, ascites, or pericardial effusion (patients with drainage tubes allowed)
  • Neuropathy grade 2 or higher per CTCAE v5.0
  • Uncontrolled tumor-related pain (patients on stable analgesia allowed)
  • Planned use of other systemic or local anti-tumor therapies during study treatment (some local radiotherapy exceptions with approval)
  • Diagnosis of other malignancies within 5 years, with some early-stage cancer exceptions
  • Currently pregnant or lactating
  • Significant comorbidities affecting study compliance or results
  • Severe cardiovascular disease
  • Known allergy to study drugs
  • Active autoimmune disease requiring systemic treatment within 2 years (with some exceptions)
  • Active hepatitis B or hepatitis C infection without viral control
  • Other significant liver diseases
  • Known HIV/AIDS
  • Prior allogeneic stem cell or solid organ transplantation
  • Active tuberculosis under treatment or treated within 1 year
  • Systemic immunosuppressive treatment within 4 weeks before first drug administration, with some exceptions
  • Any other severe medical condition or abnormal lab results that could impair safe study participation per investigator judgment

AI-Screening

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Trial Site Locations

Total: 1 location

1

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China, 310000

Actively Recruiting

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Research Team

X

Xaolin Li

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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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 | DecenTrialz