NCT05670925

A Trial Exploring the Opportune Administration of Nab-paclitaxel in the First Line Treatment, Camrelizumab Combined With Nab-paclitaxel and Famitinib, of TNBC.

The Opportune Administration of Nab-paclitaxel in the First Line Treatment Strategy, Camrelizumab and Famitinib With/Without Nab-paclitaxel, of Patients With Unresectable Locally Advanced or Metastatic Immunomodulatory Triple Negative Breast Cancer：An Open, Single-arm, Multicenter Phase II Clinical Study.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The study is being conducted to evaluate the Opportune Administration of Nab-paclitaxel in the First Line Treatment Strategy, Camrelizumab and Famitinib with/without Nab-paclitaxel, of Patients with Unresectable Locally Advanced or Metastatic Immunomodulatory Triple Negative Breast Cancer.

Conditions

• Triple-Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Camrelizumab plus Famitinib with/without nab-Palitaxel	After enrollment confirmed, the regimen of Camrelizumab Combined with Famitinib will be conducted for 2 cycles (8 weeks). Patients of CR or PR after 2 cycles (8 weeks) will enter dual-therapy maintenance phase until disease progression and will be recorded as PFS-1α. Patients of PD after 2 cycles (8 weeks) will be recorded as PFS-1β. Patients of SD with 2 cycles of dual therapy wlii receive triple therapy regimen: Camrelizumab and Famitinib with nab-Paclitaxel.

Timeline

• Start date: 2023-03-01
• Primary completion: 2023-09-01
• Completion: 2023-09-01
• First posted: 2023-01-04
• Last updated: 2023-02-28

Locations

1 site across 1 country: China