A Trial of Camrelizumab Plus Nab-paclitaxel and Levocetirizine in Metastatic or Recurrent TNBC (NCT06632405) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Trial of Camrelizumab Plus Nab-paclitaxel and Levocetirizine in Metastatic or Recurrent TNBC
60 participantsStarted 2025-04-01
Plain-language 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 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.
Who can participate
Age range18 Years β 70 Years
SexFEMALE
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Inclusion criteria
β. Sign the written informed consent;
β. Aged β₯ 18 and β€ 70 years old;
β. 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;
β. Untreated local recurrence of unresectable TNBC or untreated distant metastasis of TNBC
β. Must be able to swallow tablets;
β. Clarify the positive status of PD-L1 expression and CPS score β₯ 1
β. ECOG score: 0 to 1;
β. Expected survival period β₯ 12 weeks;
Exclusion criteria
β. Received other interventional clinical trials within 28 days before the first dose;
β. Failure to recover from adverse reactions of previous treatment
β. Neurological disorders of grade β₯ 2
β. Untreated active brain metastases or meningeal metastases
β. Previously received nab-paclitaxel neoadjuvant therapy or adjuvant therapy and experienced local recurrence or distant metastasis within 12 months;
What they're measuring
1
Overall response rate (ORR)
Timeframe: from the first drug administration up to the first occurrence of progression or death οΌup to 36 weeksοΌ
Trial details
NCT IDNCT06632405
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University
β. Has experienced severe allergic reactions to other monoclonal antibodies;
β. Received other anti-tumor treatments within 28 days before the first administration;
β. Suffering from hypertension and unable to achieve good control with antihypertensive medication (systolic blood pressure β₯ 140 mmHg or diastolic blood pressure β₯ 90 mmHg);