NCT07471815

Camrelizumab Plus Risedronate and Chemotherapy for Triple-Negative Breast Cancer: An Exploratory Clinical Study on Mechanisms and Efficacy

Mechanisms and Efficacy of Camrelizumab Plus Risedronate and Chemotherapy in Triple-Negative Breast Cancer: An Exploratory Clinical Study

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Harbin Medical University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Treatment of triple-negative breast cancer (TNBC) remains a significant challenge. Although immune checkpoint inhibitors combined with chemotherapy have achieved breakthroughs, drug resistance persists, leaving clinical needs unmet. Bisphosphonates target the FDPS/mevalonate pathway, not only directly inhibiting tumors but also remodeling the immune microenvironment, positioning them as a potential strategy to reverse immune resistance. Therefore, this exploratory study of camrelizumab combined with risedronate sodium and chemotherapy aims to generate synergistic anti-tumor effects through the dual action of immune checkpoint blockade and metabolic-immune microenvironment remodeling. The goal is to overcome resistance, improve the objective response rate, and ultimately enhance the long-term survival prognosis for patients with TNBC.

Conditions

• Breast Cancer Triple Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Camrelizumab + Risedronate Sodium + Chemotherapy	Camrelizumab: 200 mg, intravenous drip, administered in line with the chemotherapy regimen cycles. Risedronate Sodium: Oral administration. Should be taken while in an upright position at least 30 minutes before the first food or drink of the day, swallowed with a full glass of plain water (approximately 200 ml). Patients should not lie down for at least 30 minutes after taking. Dosage is one 5 mg tablet once daily. Chemotherapy regimens are selected by the physician and include, but are not limited to: TAC, TP-AC, AC-T, etc. A total of 6 treatment cycles are planned; the subsequent regimen will be chosen by the investigator.

Timeline

• Start date: 2026-03-04
• Primary completion: 2028-03-31
• Completion: 2029-03-31
• First posted: 2026-03-13
• Last updated: 2026-03-13

Locations

1 site across 1 country: China