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Breast NeoplasmsPhase 1/2NCT06140576

The Efficacy and Safety of Lenvatinib Combined With Sindilimab and Nab-paclitaxel in the First-line Treatment for Recurrent and Metastatic Triple Negative Breast Cancer: a Phase Ib/IIa Clinical Trial.

A Phase 1/2 study testing Sindilimab, Nab-paclitaxel and Lenvatinib in people with Breast Neoplasms, run by Zhejiang Cancer Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The treatment regimen of lenvatinib combined with PD1 antibody has brought earth shaking changes to the immunotherapy of various "cold tumors". This is a phase Ib/IIa clinical trial to investigate the efficacy and safety of Lenvatinib combined with Sindilimab and Nab-paclitaxel in the first-line treatment for… Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Breast Neoplasms
What is being tested?
Sindilimab, Nab-paclitaxel and Lenvatinib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteChina
Study dates
30 Nov 2023to 31 Dec 2026
Phase
Phase 1/2
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

  • Breast cancer patients aged ≥ 18 years and ≤ 70 years.
  • According to the definition of the latest ASCO/CAP guidelines, recurrent metastatic triple negative invasive breast cancer confirmed by histopathology meets the following conditions according to recent and previous pathological results: HER2 negative: IHC 0/1+or IHC2+but ISH is negative; ER negative: IHC<1%, PR negative: IHC<1%.
  • Patients who have received (new) adjuvant chemotherapy need to make progress at least 6 months after the end of the last adjuvant chemotherapy.
  • ECOG score 0-1.
  • In the stage of recurrence and metastasis, without receiving systematic anti-tumor treatment;
  • According to RECIST 1.1 standard, at least one measurable lesion exists.
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  • The expected survival period is not less than 3 months.
  • The functional level of organs must meet the following requirements:
  • Blood routine Neutrophil count (ANC) ≥ 1.5 × 10^9/L (no hematopoietic stimulating factor drugs were used within 14 days before the first administration of the study); Platelet count (PLT) ≥ 100 × 10^9/L (no blood transfusion within 14 days before the first administration of the study); Hemoglobin (Hb) ≥ 90 g/L; Blood biochemistry Total bilirubin (TBIL) ≤ 1.5 × ULN; Glutathione aminotransferase and alanine aminotransferase (ALT and AST) ≤ 2.5 × ULN; Blood urea nitrogen (BUN) and creatinine clearance rate (Cr) ≤ 1.5 × ULN; Thyroid stimulating hormone (TSH) ≤ upper limit of normal value (ULN); If there are abnormalities, the levels of T3 and T4 should be examined. If the levels of T3 and T4 are normal, they can be selected; Cardiac function Left ventricular ejection fraction ≥ 50% and 12 lead electrocardiogram: QTcF<480ms.
  • Women of childbearing age must undergo a serum pregnancy test within 7 days before enrollment, with a negative result, and are willing to use a medically recognized and efficient contraceptive method during the study period and within 3 months after the last administration of the study medication.
  • The subjects voluntarily joined this study and signed an informed consent form.

Who cannot join

  • Tumor related symptoms and treatment
  • Active or symptomatic brain metastasis There are metastases in the midbrain, pons, medulla oblongata, or spinal cord. Meningeal metastasis; Symptoms related to the nervous system, such as increased intracranial pressure and abnormal neurological function; Received surgical treatment within 28 days of enrollment, received whole brain radiotherapy within 14 days, or received stereotactic radiotherapy within 7 days; If the patient only has supratentorial and/or cerebellar metastases and has undergone local treatment (surgery/radiotherapy for all known lesions), clinical stability is at least 2 weeks after completion of treatment, imaging shows no disease progression or bleeding, and does not need to receive hormone treatment or receive ≤ 10mg/day of prednisone or equivalent dose hormone treatment within 14 days of initial administration, patients can participate in the study.
  • Uncontrolled moderate to large amounts of pleural effusion, intraperitoneal effusion, or pericardial effusion that require repeated drainage;
  • Within 14 days prior to enrollment, receive systematic anti-tumor therapy (including chemotherapy, radiotherapy, immunotherapy, endocrine therapy, targeted therapy, biotherapy, or tumor embolization);
  • Imaging examination shows that the tumor invades large blood vessels, or researchers determine that the tumor is highly likely to invade important blood vessels and cause fatal massive bleeding during subsequent studies;
  • Subjects with uncontrollable or symptomatic hypercalcemia (>1.5mmol/L ionic calcium concentration or>12mg/dL serum calcium concentration or serum calcium (albumin corrected) concentration>ULN); Symptomatic hypercalcemia that may require further bisphosphate treatment;
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  • Previously received treatment with PD-1/PD-L1 antibodies, CTLA-4 antibodies, or other anti angiogenic drugs (including monoclonal antibodies, TKI) targeting PD-1/PD-L1;
  • Combined diseases/medical history
  • Having previously received any systematic anti-tumor treatment or local treatment (including surgery and radiation therapy) for other malignant tumors, excluding various cured malignant tumors such as in situ cancer, cervical cancer, basal cell carcinoma or squamous cell carcinoma, thyroid cancer, etc;
  • The patient has undergone major surgical procedures unrelated to breast cancer within 4 weeks before enrollment, or has not fully recovered from such surgical procedures (tissue biopsy and central venous catheter placement via peripheral vein puncture required for diagnosis are allowed);
  • Subjects with any known or suspected autoimmune diseases, except for those who only require hormone replacement therapy for hypothyroidism caused by autoimmune thyroiditis; Subjects with stable type I diabetes whose blood sugar is controlled;
  • Interstitial lung disease, non infectious pneumonia or uncontrollable systemic diseases (such as diabetes, pulmonary fibrosis and acute pneumonia);
  • A history of receiving live or attenuated vaccines within 28 days prior to the first study medication, or an estimated period of receiving live or attenuated vaccines during the study period;
  • Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); Active hepatitis (hepatitis B, defined as HBV-DNA ≥ 30 copies/ml; hepatitis C, defined as HCV-RNA higher than the detection limit of the analytical method) or co infection of hepatitis B and hepatitis C; Autoimmune hepatitis;
  • Severe infections, including but not limited to bacteremia, severe pneumonia, etc. that require hospitalization treatment, exist within 4 weeks before the first administration; Or there is an active infection of CTCAE ≥ 2 level that requires systemic antibiotic treatment within 2 weeks before the first administration, or an unexplained fever>38.5 ° C during the screening period/before the first administration (according to the researcher's judgment, fever caused by tumor can be included); There is evidence of active tuberculosis infection within one year before administration;
  • Subjects who have previously received or are preparing to receive allogeneic bone marrow transplantation or solid organ transplantation;
  • Peripheral neuropathy ≥ level 2;
  • Serious heart disease or discomfort, including but not limited to the following diseases:
  • Confirmed history of heart failure or systolic dysfunction (LVEF<50%) High risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart rate>100 bpm, significant ventricular arrhythmias (such as ventricular tachycardia), or higher-level atrioventricular block (such as Mobitz II second degree atrioventricular block or third degree atrioventricular block) Angina pectoris requiring treatment with anti angina drugs Clinically significant heart valve disease Electrocardiogram shows transmural myocardial infarction Poor control of hypertension (systolic blood pressure>180 mmHg and/or diastolic blood pressure>100 mmHg)
  • Research and treatment related
  • Subjects who have received systemic immunostimulatory therapy (including but not limited to interferon or interleukin-2, including immunostimulators in clinical research) within 4 weeks prior to the first administration;
  • Subjects who have received systemic immunosuppressive therapy (including but not limited to glucocorticoids, azathioprine, methotrexate, thalidomide, and anti-tumor factor drugs) within 2 weeks before the first administration. Excluding systemic corticosteroids with nasal spray and inhaled corticosteroids or physiological doses (i.e. other corticosteroids with physiological doses not exceeding 10mg/d prednisone or equivalent);
  • Known allergies to the study drug or any of its excipients; Or have experienced severe allergic reactions to other monoclonal antibodies;
  • Pregnant and lactating female patients, those with fertility and positive baseline pregnancy test results, or those of childbearing age who are unwilling to take effective contraceptive measures throughout the entire trial period.
  • Have a clear history of neurological or mental disorders, including epilepsy or dementia, and the subject is known to have a history of abuse of psychotropic substances, alcohol or drug use;
  • The researcher believes that the patient is not suitable to participate in any other situation of this study.

Trial locations and contacts

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

Xiying Shao contact

+86-0571-88122172

15824113524@163.com

Xiaojia Wang contact

+86-0571-88122172

wxiaojia0803@163.com

China1 site

  • ZhejiangCH

    Hangzhou, Zhejiang

    Ying Xi Shao

    Jia Xiao Wang

Other trials in China

About this study

The treatment regimen of lenvatinib combined with PD1 antibody has brought earth shaking changes to the immunotherapy of various "cold tumors". This is a phase Ib/IIa clinical trial to investigate the efficacy and safety of Lenvatinib combined with Sindilimab and Nab-paclitaxel in the first-line treatment for recurrent and metastatic triple negative breast cancer.

Read the detailed description

In recent years, the research on immunotherapy in triple negative breast cancer has been carried out in full swing, but the results are inconsistent. Lenvatinib is an oral multi kinase inhibitor with main targets including VEGFR1-3, FGFR1-4, and PDGFR-α, KIT and RET. It inhibits the FGFR4 signaling pathway, and downregulate the expression of PD-L1 in tumor cells, thereby regulating the tumor immune microenvironment. The treatment regimen of lenvatinib combined with PD1 antibody has brought earth shaking changes to the immunotherapy of various "cold tumors". This is a phase Ib/IIa clinical trial to investigate the efficacy and safety of Lenvatinib combined with Sindilimab and Nab-paclitaxel in the first-line treatment for recurrent and metastatic triple negative breast cancer.

Being tested
Sindilimab, Nab-paclitaxel, Lenvatinib
Medical subject headings
Breast Neoplasms

What participants receive

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

  • SindilimabDrug

    Sindilimab, 200mg, Intravenous，every three weeks

  • Nab-paclitaxelDrug

    Nab-paclitaxel，125mg/m^2, d1,8, every three weeks

  • LenvatinibDrug

    Lenvatinib 8mg, 12mg, 16mg everyday

Study groups in NCT06140576
Study groupRoleWhat they receive
Lenvatinib combined with Sindilimab and Nab-paclitaxelExperimentalThe Efficacy and Safety of Lenvatinib Combined With Sindilimab and Nab-paclitaxel in the First-line Treatment for Recurrent and Metastatic Triple Negative Breast Cancer: a Phase Ib/IIa Clinical Trial.
Receives: Drug: Sindilimab; Drug: Nab-paclitaxel; Drug: Lenvatinib

What is being measured

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

  1. safety and tolerability

    safety and tolerability of Lenvatinib combined with Sindilimab and Nab-paclitaxel.Number of participants with treatment-related adverse events as assessed by NCI-CTCAE 5.0

    Measured: up to 24 months

  2. Objective Response Rate (ORR)

    ORR is defined as the percentage of patients who achieved a best overall response of Complete Response (CR) or Partial Response (PR), per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions as assessed by the Investigator: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: up to 24 months

Secondary outcomes (3)

  1. Progression-Free Survival (PFS)

    From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.

    Measured: up to 24 months

  2. Overall survival (OS)

    Time to death from any cause from the date of first dose of study treatment

    Measured: up to 24 months

  3. Clinical Benefit Rate (CBR)

    Percentage of participants with complete response (CR) or partial response (PR) or stable disease (SD) lasting 24 weeks or longer as defined in RECIST v1.1.

    Measured: up to 24 months

Timeline

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

  1. First posted20 Nov 2023
  2. Study start30 Nov 2023 (estimated)
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2026 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Lenvatinib combined with Sindilimab and Nab-paclitaxel in the first-line treatment for recurrent and metastatic triple negative breast cancer.
Masking
None (open label)
Enrolment
58 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06140576
Sponsor's protocol ID
HIM-B001
Status last verified
Nov 2023
First submitted
1 Nov 2023
Last updated
20 Nov 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Sindilimab, Nab-paclitaxel and Lenvatinib in people with Breast Neoplasms, 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 11 inclusion and 26 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: opening soon, as of the sponsor's last update on 20 Nov 2023. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 Xiying Shao (+86-0571-88122172, 15824113524@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

safety and tolerability (time frame: up to 24 months). The study lists 2 primary outcomes in all. 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 NCT06140576.

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 20 Nov 2023; AzTrials last refreshed its copy on 8 Nov 2026.

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