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Breast CancerPhase 2NCT06632405

A Trial of Camrelizumab Plus Nab-paclitaxel and Levocetirizine in Metastatic or Recurrent TNBC

A Phase 2 study testing Camrelizumab, Nab paclitaxel and Levocetirizine Hydrochloride in people with Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.

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

This is a phase II, explorative, open-labeled, multi-centered, double-arm, investigator-initiated clinical trial of Camrelizumab (an anti-PD-1 antibody) in combination with Nab-paclitaxel (a chemotherapeutic agent against breast cancer) and Levocetirizine (an antihistamine) in patients with advanced triple-negative… Read more about this study

Who is it for?
Ages 18 to 70 years, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Cancer
What is being tested?
Camrelizumab, Nab paclitaxel and Levocetirizine Hydrochloride
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
No sites listed yet
Study dates
1 Apr 2025to 31 Mar 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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Sign the written informed consent;
  • Aged ≥ 18 and ≤ 70 years old;
  • Confirmed recurrent and metastatic triple negative breast cancer by imaging and pathology (ER negative (IHC ER positive percentage < 1%), PR negative (IHC PR positive percentage < 1%), HER2 negative (IHC -/+or IHC++but FISH/CISH -)), at least one measurable focus meeting the RECIST v1.1 standard;
  • Untreated local recurrence of unresectable TNBC or untreated distant metastasis of TNBC
  • Must be able to swallow tablets;
  • Clarify the positive status of PD-L1 expression and CPS score ≥ 1
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  • ECOG score: 0 to 1;
  • Expected survival period ≥ 12 weeks;
  • The results of patient's blood tests are as follows (excluding the use of any blood components and cell growth factors during screening):
  • Absolute neutrophil count ≥ 1.5 × 109/L;
  • Platelets ≥ 100 × 109/L;
  • Hemoglobin ≥ 9g/dL;
  • Serum albumin ≥ 3g/dL;
  • Thyroid stimulating hormone (TSH) ≤ ULN (if abnormal, T3 and T4 levels should be examined simultaneously. If T3 and T4 levels are normal, they can be included in the group);
  • Bilirubin ≤ 1.0 times ULN (Gilbert's syndrome or liver metastasis subject total bilirubin ≤ 1.5 times ULN);
  • ALT and AST ≤ 1.5 times ULN (liver metastasis subjects ≤ 3 times ULN);
  • AKP ≤ 2.5 times ULN;
  • Renal function within 7 days before the first administration: serum creatinine ≤ 1.5 times ULN or creatinine clearance rate ≥ 60mL/min (using the standard Cockcroft Gault formula, see Appendix 3);
  • Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose and must be willing to use very efficient barrier methods of contraception for the course of the study through 6 months after the last dose of study treatment.
  • Left ventricular ejection fraction ≥ 50%

Who cannot join

  • Received other interventional clinical trials within 28 days before the first dose;
  • Failure to recover from adverse reactions of previous treatment
  • Neurological disorders of grade ≥ 2
  • Untreated active brain metastases or meningeal metastases
  • Previously received nab-paclitaxel neoadjuvant therapy or adjuvant therapy and experienced local recurrence or distant metastasis within 12 months;
  • Has experienced severe allergic reactions to other monoclonal antibodies;
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  • Received other anti-tumor treatments within 28 days before the first administration;
  • Suffering from hypertension and unable to achieve good control with antihypertensive medication (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg);
  • Received antibody or T cell co stimulatory therapy such as PD-1, PD-L1, PD-L2, CTLA-4, Tim3, LAG3, etc;
  • Special genetic diseases (including rare galactose intolerance, primary lactase deficiency, or glucose galactose malabsorption);
  • Active autoimmune disease or history of autoimmune disease (such as but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or complete remission of childhood asthma without any intervention in adulthood may be included; subjects with asthma requiring medical intervention with bronchodilators may not be included);
  • Heart diseases, such as:
  • NYHA grade 2 or above heart failure
  • Unstable angina pectoris
  • Have experienced a myocardial infarction within the past year
  • Clinically significant supraventricular or ventricular arrhythmias require treatment or intervention；
  • Urine protein level is ≥++, or the 24-hour urine protein level is ≥ 1.0 g;
  • Known genetic or acquired bleeding and thrombophilia tendencies (such as hemophilia patients, coagulation dysfunction, thrombocytopenia, splenomegaly, etc.);
  • Have a history of tuberculosis;
  • Active period of HBV or HCV, and other active infectious diseases;
  • Had or is currently experiencing qualitative pneumonia or requires steroid treatment for pneumonia;
  • Congenital or acquired immune dysfunction (such as HIV infected individuals);
  • Received or about to receive a live vaccine within 4 weeks prior to the study or possibly during the study period;
  • Allergic or contraindicated to the experimental drug.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Jieqiong Liu contact

86-13922272706

liujieqiong01@163.com

About this study

Official title: Camrelizumab Plus Nab-paclitaxel and Anti-histamine Drug Levocetirizine in Metastatic or Recurrent Triple-negative Breast Cancer: a Randomized, Double-arm, Phase 2 Randomized Controlled Trial

This is a phase II, explorative, open-labeled, multi-centered, double-arm, investigator-initiated clinical trial of Camrelizumab (an anti-PD-1 antibody) in combination with Nab-paclitaxel (a chemotherapeutic agent against breast cancer) and Levocetirizine (an antihistamine) in patients with advanced triple-negative breast cancer. 60 subjects will be enrolled in multiple centers. This study aims to evaluate the effects of Camrelizumab combined with Nab-paclitaxel and Levocetirizine in the treatment of advanced TNBC.

Read the detailed description

This is a phase II, explorative, open-labeled, multi-centered, double-arm, investigator-initiated clinical trial to evaluate the effects of Camrelizumab combined with Nab-paclitaxel and Levocetirizine in the treatment of advanced TNBC. The study aims to enroll 60 subjects in multiple centers. The primary objective is to assess the overall response rate (ORR). All enrolled patients will be treated with Camrelizumab 200mg (iv. 3mg/kg for patient whose weight is below 50kg) on day 1 of each 3 week, and Nab-paclitaxel 100mg/m2, iv, on d1,8,15 of each 4 week, in combination with Levocetirizine of 5mg, po., 3 days before 1st administration.

Conditions
Breast Cancer
Being tested
Camrelizumab, Nab paclitaxel, Levocetirizine Hydrochloride
Medical subject headings
Breast Neoplasms

What participants receive

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

  • CamrelizumabDrug

    Camrelizumab 200mg (3mg/kg for patient whose weight is below 50kg) will be administered as an intravenous infusion over 30 minutes every three weeks until unacceptable toxic effects or disease progression or other termination criteria appeared.

  • Nab paclitaxelDrug

    Nab paclitaxel 100mg/m2 will be administered as an intravenous infusion every 4 weeks in d1,8,15until unacceptable toxic effects or disease progression or other termination criteria appeared.

  • Levocetirizine HydrochlorideDrug

    5mg daily, start 3 days before the 1st administration

Study groups in NCT06632405
Study groupRoleWhat they receive
Camrelizumab+Nab-Paclitaxel+LevocetirizineExperimentalCamrelizumab 200mg(3mg/kg for patient whose weight is below 50kg) iv, d1, q3w, plus Nab-Paclitaxel 100mg/m2, iv, d1,8,15 q4w, and Levocetirizine 5mg, po, 3 days before 1st administration
Receives: Drug: Camrelizumab; Drug: Nab paclitaxel; Drug: Levocetirizine Hydrochloride
Camrelizumab+Nab-PaclitaxelSham comparatorCamrelizumab 200mg(3mg/kg for patient whose weight is below 50kg) iv, d1, q3w, plus Nab-Paclitaxel 100mg/m2, iv, d1,8,15 q4w
Receives: Drug: Camrelizumab; Drug: Nab paclitaxel

What is being measured

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

  1. Overall response rate (ORR)

    The propotion of subjects with CR or PR.

    Measured: from the first drug administration up to the first occurrence of progression or death （up to 36 weeks）

Secondary outcomes (10)

  1. Adverse events/Serious adverse events

    Adverse events/Serious adverse events

    Measured: from the first drug administration to within 90 days for the last dose

  2. Disease Control Rate (DCR)

    The propotion of subjects with CR, PR, or SD.

    Measured: from the first drug administration up to the first occurrence of progression or death （up to 36 weeks）

  3. Clinical benefit rate (CBR)

    The propotion of subjects with CR, PR, or SD for >=6 months during the study

    Measured: propotion of subjects with CR, PR, or SD for >=6 months （up to 36 weeks）

  4. Duration of response (DoR)

    The time from randomization to disease progression or death for patients who achieve complete or partial alleviation

    Measured: from the first drug administration up to the first occurrence of progression or death （up to 36 weeks）

  5. Time to response (TTR)

    Time from date of first dose to date of first occurrence of response

    Measured: from the first drug administration up to the first occurrence of progression （up to 36 weeks）

  6. Progression-Free-Survival (PFS)

    from the first drug administration up to the first occurrence of progression or death (up to 24 months)

    Measured: from the first drug administration up to the first occurrence of progression or death （up to 36 weeks）

  7. Overall survival (OS)

    12 months after the first drug administration

    Measured: 12 months after the first drug administration

  8. Biomarkers

    Compare the change of biomarkers from urine, blood or tissues, such as the carcinoembryonic antigen (ug/L), before or after the treatments.

    Measured: pre-treatment, up to 24 months

  9. Biomarkers

    Compare the change of biomarkers from urine, blood or tissues, such as the CA125/199/153(u/ml), before or after the treatments.

    Measured: pre-treatment, up to 24 months

  10. patient reported outcomes (PRO)

    direct reports from patients about their health, the scale Quality of Life questionnaire (QLQ)-BR23/C30 will be used for assecessment. Higher score indicate better life quality

    Measured: during the study and up to 36 weeks after the end

Timeline

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

  1. First posted9 Oct 2024
  2. Study start1 Apr 2025 (estimated)
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion31 Mar 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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06632405
Sponsor's protocol ID
CAnTiH
Status last verified
Oct 2024
First submitted
27 Aug 2024
Last updated
26 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Camrelizumab, Nab paclitaxel and Levocetirizine Hydrochloride in people with Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.

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 20 inclusion and 24 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 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Jieqiong Liu (86-13922272706, liujieqiong01@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (ORR) (time frame: from the first drug administration up to the first occurrence of progression or death （up to 36 weeks）). 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 NCT06632405.

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 Mar 2025.

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