NCT05097248

Camrelizumab in Combination With PLD and Losartan in Patients With TNBC Who Have Received ≦ 1 Line of Chemotherapy

Camrelizumab Combined With Liposomal Doxorubicin and Losartan in the Treatment With Advanced or Locally Advanced Triple-negative Breast Cancer Who Have Received no More Than 1 Prior Line of Chemotherapy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II, single-arm, multi-center, prospective clinical study of camrelizumab in combination with liposomal doxorubicin and losartan in patients with advanced or locally advanced triple-negative breast cancer who had received no more than 1 prior line of chemotherapy. Our aim was to explore the efficacy and safety of it.

Detailed description

This a phase II, open-labeled, multi-centered, single-arm, investigator-initiated clinical trial to assess the efficacy and safety of camrelizumab combination with liposomal doxorubicin and losartan in female patients age of 18 to 70 with advanced or locally advanced TNBC, and previously treated with no more than one line of chemotherapy in the advanced setting. The number of patients to be included is 52 patients (Simons two stage design). All enrolled patients will be treated with camrelizumab 200mg (iv. 3mg/kg for patient whose weight is below 50kg) on day 1 of each 21-day cycle, and liposomal doxorubicin (40 mg, Q3W for 6 weeks) plus oral losartan (50 mg loading dose followed by 100 mg QD, Q3W, until discontinuation of liposomal doxorubicin).The primary objective is to assess the overall response rate (ORR).

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	Liposomal Doxorubicin	Liposomal Doxorubicin 40 mg/m2 on D1 every 3 weeks; 6 cycles are planned to be completed or discontinued due to intolerable toxicity or progression.
DRUG	Losartan	Losartan will be orally administered at 50 mg for three days and increased to 100 mg if tolerated until the whole course of chemotherapy; if not tolerated, it will be maintained at 50 mg until the whole course of chemotherapy

Timeline

• Start date: 2021-10-01
• Primary completion: 2024-10-01
• Completion: 2024-10-01
• First posted: 2021-10-28
• Last updated: 2021-10-28

Locations

1 site across 1 country: China