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New treatment option for Triple-negative Breast Cancer
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
ClinicalTrials.gov ID: NCT06538896
What this study is testing
What is Tislelizumab + Nab-Paclitaxel?
Tislelizumab + Nab-Paclitaxel is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for triple-negative breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70, women only
You may be able to join if
- 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...
- Eastern Cooperative Oncology Group (ECOG) performance status score: 0-1;
- Expected survival time ≥3 months;
- ≥1 bone metastasis confirmed by histology or imaging. There must be at least one measurable lesion defined according to RECIST 1.1 criteria. For...
You likely can't join if
- 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);
- Existing neuropathy ≥ Grade 2 according to the Common Terminology Criteria for Adverse Events (CTCAE v5.0);
- Uncontrolled tumor-related pain; patients requiring analgesia are allowed to enroll if they have a stable and effective analgesia regimen at the time...
See the full eligibility criteria
- 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;
- ≥1 bone metastasis confirmed by histology or imaging. There must be at least one measurable lesion defined according to RECIST 1.1 criteria. For lesions that have undergone previous radiotherapy, they can only be...
- Patients with initially diagnosed stage IV (staging based on AJCC 8th edition) or recurrent/metastatic TNBC who are not suitable for surgical treatment, and have not received prior systemic therapy for advanced disease...
- Prior local radiotherapy for metastatic sites is allowed, with no limit on the time of completion of radiotherapy, but the patient must have recovered from the effects of radiotherapy before enrolled;
- Function of vital organs meets the protocol requirements within 1 week before the first administration of the study drug;
- Patients voluntarily participate in this study and sign the informed consent form.
- 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);
- Existing neuropathy ≥ Grade 2 according to the Common Terminology Criteria for Adverse Events (CTCAE v5.0);
- Uncontrolled tumor-related pain; patients requiring analgesia are allowed to enroll if they have a stable and effective analgesia regimen at the time of enrollment;
- Patients expected to use any other systemic or local anti-tumor therapy during the study treatment; local radiotherapy for symptomatic isolated lesions or isolated brain metastases is allowed after evaluation and...
- Diagnosis of other malignancies within 5 years. Exceptions include: radically treated early-stage malignancies (carcinoma in situ or stage I tumors), such as adequately treated cervical carcinoma in situ, basal cell or...
- Currently pregnant/lactating women;
- Evidence of significant comorbidities that may affect the patients' compliance with the study protocol or interpretation of the study results;
- Severe cardiovascular disease;
- Known allergy to any drug used in the study;
- Patients with any active autoimmune disease requiring systemic treatment (i.e., use of disease-modulating drugs, corticosteroids, or immunosuppressive drugs) within the past 2 years (including but not limited to...
- Active hepatitis B patients (including chronic or acute, defined as HBsAg positive at baseline). Previously active HBV infection or cured hepatitis B patients are allowed to enroll if they meet the following conditions...
- Active hepatitis C patients. HCV antibody-positive patients are allowed to enroll only if HCV RNA test results are negative;
- Other liver diseases with known clinically significance, including alcoholic hepatitis or other hepatitis, cirrhosis, hereditary liver diseases;
- Known history of HIV positivity or acquired immune deficiency syndrome (AIDS);
- Prior receipt of allogeneic stem cell or solid organ transplantation;
- Patients with active tuberculosis (TB) who are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year before screening;
- Received systemic immunosuppressive drug treatment within 4 weeks before the first administration of the study drug (including but not limited to corticosteroids, cyclophosphamide, azathioprine, methotrexate...
- Any other severe medical condition or abnormal clinical laboratory results that may hinder the patient's safe participation and completion of the study，based on the investigator's judgment
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.