NCT06632405

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

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
DRUG	Camrelizumab	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.
DRUG	Nab paclitaxel	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.
DRUG	Levocetirizine Hydrochloride	5mg daily, start 3 days before the 1st administration

Timeline

• Start date: 2025-04-01
• Primary completion: 2027-03-31
• Completion: 2027-03-31
• First posted: 2024-10-09
• Last updated: 2025-03-26