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

Conditions

• Breast Cancer Triple Negative Breast Cancer

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• Camrelizumab + Risedronate Sodium + Chemotherapy — DRUG
  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.

Study Details

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.

Key Dates

Start date

Mar 4, 2026

Status verified

Mar 2026

Primary completion

Mar 31, 2028

Completion

Mar 31, 2029

Study Design

Enrollment

30 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment Group
  Camrelizumab + Risedronate Sodium + Chemotherapy

Primary Outcome Measure

ORR [ Time Frame: At the end of every 2 Cycles (each cycle is 21 days), From first treatment Cycle until achieving complete response (CR) or response (PR) per RECIST v1.1, assessed up to 1 year, defined as the proportion of patients achieving complete response ]