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Triple-negative Breast CancerPhase 2NCT06538896

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

A Phase 2 study testing Tislelizumab + Nab-Paclitaxel and Rankl inhibitor in people with Triple-negative Breast Cancer and Bone Metastases, run by Zhejiang Cancer Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
What is being tested?
Tislelizumab + Nab-Paclitaxel and Rankl inhibitor
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
20 Aug 2024to May 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 considered measurable if there is definite disease progression after radiotherapy;
  • 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 neoadjuvant and/or adjuvant therapy with taxanes and other antitumor treatments is allowed, but it must meet the criteria of no progression after neoadjuvant therapy, and the time interval between the end of taxane (neo)adjuvant therapy and recurrence/metastasis must be ≥12 months, and the time interval between the end of capecitabine (neo)adjuvant therapy and recurrence/metastasis must be ≥6 months. If immunotherapy was conducted during neoadjuvant phase, the time interval between the last immunotherapy and the screening enrollment for this study must be ≥24 months;
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  • 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.

Who cannot join

  • 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;
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  • 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 approval by the investigator; local radiotherapy is not allowed for all target lesions during the study treatment;
  • 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 squamous cell skin cancer;
  • 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: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism; patients with autoimmune-related hypothyroidism receiving stable doses of thyroxine replacement therapy and patients with controllable type 1 diabetes receiving stable doses of insulin are allowed; patients with vitiligo or childhood asthma that has completely resolved and requires no intervention in adulthood are allowed; patients with asthma requiring medical intervention with bronchodilators are not allowed). Replacement therapy (such as thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered systemic treatment;
  • 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: viral hepatitis patients with HBcAb positive and HBsAg negative, with HBV DNA copy number less than the upper limit of normal value of the testing laboratory at the research center before enrollment;
  • 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, thalidomide, and anti-tumor necrosis factor [TNF]-α drugs). Patients receiving short-term, low-dose systemic immunosuppressive drug treatment or a single bolus of systemic immunosuppressive drugs (e.g., glucocorticoids for 48 hours to treat contrast allergy) may be enrolled in the study after approval by the medical monitor. Patients receiving mineralocorticoids (such as fludrocortisone), corticosteroids for chronic obstructive pulmonary disease or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study;
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xaolin Li contact

8615024437258 ext. 86057188122222

847678911@qq.com

China1 site, 1 recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310000

    Xiaolin Li, +86-571-88122222, 847678911@qq.com

    Recruiting

Other trials in China

About this study

Official title: Exploratory Single-Arm, Multicenter Phase II Study of Tislelizumab Combined with Nab-Paclitaxel As First Line Treatment for Patients of Triple-negative Breast Cancer(TNBC) with Bone Metastasis

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?

Read more

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
Being tested
Tislelizumab + Nab-Paclitaxel, Rankl inhibitor
Medical subject headings
Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tislelizumab + Nab-PaclitaxelDrug

    Tislelizumab, 200mg, intravenous, every 3 weeks

  • Rankl inhibitorOther

    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.

Study groups in NCT06538896
Study groupRoleWhat they receive
Tislelizumab + Nab-PaclitaxelExperimentalTislelizumab, 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.
Receives: Drug: Tislelizumab + Nab-Paclitaxel; Other: Rankl inhibitor

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Up to approximately 33 months

Secondary outcomes (3)

  1. Progression-Free Survival (PFS)

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

    Measured: 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)

    Measured: 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)

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2024
  2. Study start20 Aug 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Intervention
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06538896
Sponsor's protocol ID
IIT-2024-136
Status last verified
Nov 2024
First submitted
11 Jul 2024
Last updated
26 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tislelizumab + Nab-Paclitaxel and Rankl inhibitor in people with Triple-negative Breast Cancer and Bone Metastases, run by Zhejiang Cancer Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xaolin Li (8615024437258 ext. 86057188122222, 847678911@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate(ORR) (time frame: Up to approximately 33 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06538896.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.

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