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

Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study ID
NCT06632405
Phase
PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Camrelizumab — DRUG
    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 paclitaxel — DRUG
    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 Hydrochloride — DRUG
    5mg daily, start 3 days before the 1st administration

Study Details

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.

Key Dates

Start date
Apr 1, 2025
Status verified
Oct 2024
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Camrelizumab+Nab-Paclitaxel+Levocetirizine
    Camrelizumab 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
  • Sham Comparator: Camrelizumab+Nab-Paclitaxel
    Camrelizumab 200mg(3mg/kg for patient whose weight is below 50kg) iv, d1, q3w, plus Nab-Paclitaxel 100mg/m2, iv, d1,8,15 q4w

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） ]

Central Contacts

Related Studies