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

NCT05097248 | Unknown Phase 2 DMC

• 1 other identifier: WHUH-BC-001
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

  Estimated 12 months

Secondary Outcomes (5)

• Progression-Free Survival (PFS)

  Estimated 12 months

• Overall Survival (OS)

  Estimated 24 months

• Duration of Response (DoR)

  Estimated 12 months

• Clinical Benefit rate (CBR)

  Estimated 12 months

• Adverse events (AEs)

  Estimated 12 months

Study Arms (1)

Camrelizumab, Liposomal doxorubicin and Losartan

EXPERIMENTAL

Participants receive intravenous camrelizumab (200 mg, Q3W) 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).

Drug: Camrelizumab; Drug: Liposomal Doxorubicin; Drug: Losartan

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.

Camrelizumab, Liposomal doxorubicin and Losartan

Liposomal Doxorubicin DRUG

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.

Camrelizumab, Liposomal doxorubicin and Losartan

Losartan DRUG

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

Camrelizumab, Liposomal doxorubicin and Losartan

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 18-70.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• The pathologic diagnosis of unresectable recurrent or metastatic triple-negative breast cancer ［ER-negative(IHC\<1%), PR-negative(IHC\<1%), HER2-negative（IHC-/+ or IHC++ and FISH/CISH-）］. Patients with at least one measuring lesion that was conformed to RECIST v1.1 standard.
• With a life expectancy of at least 12 weeks.
• The cumulative dose of prior doxorubicin and epirubicin should not exceed 300 mg/m2 and 600 mg/m2, respectively, with randomization \> = 12 months since last treatment.
• Previously treated with no more than one line of chemotherapy in the advanced setting.
• PD-L1 positive, CPS score ≥ 1.
• At least one measurable lesion according to RECIST 1.1;
• The functional level of major organs must meet the following requirements:
• blood routine: neutrophil (ANC)≥1.5×10\^9/L; platelet count (PLT)≥90×10\^9/L; hemoglobin (Hb) ≥90 g/L;
• blood biochemistry: total bilirubin (TBIL)≤upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5×ULN; alkaline phosphatase ≤ 2.5×ULN; blood urea nitrogen (BUN) and creatinine (Cr)≤1.5×ULN;
• coagulation: international normalized ratio (INR) or prothrombin time (PT)≤1.5×ULN; activated partial thromboplastin time (APTT) ≤1.5×ULN.
• Heart: left ventricular ejection fraction (LVEF)≥50% as assessed by echocardiography (ECHO) or multigated acquisition (MUGA).
• Thyroid function: thyroid stimulating hormone (TSH) ≤ ULN; if abnormal, T3 and T4 levels should be investigated, and normal T3 and T4 levels can be included.
• Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose and must be willing to use very efficient barrier methods of contraception for the course of the study through 6 months after the last dose of study treatment.

You may not qualify if:

• The subjects had a central nervous system metastases with clinical symptoms.
• Other clinical trials of drugs were used in the first four weeks before the first dose.
• Subjects with severe allergic reactions to other monoclonal antibodies.
• Received other anti-tumor treatments within 28 days before the first dose.
• A heart condition or disease that is not well controlled.
• Subjects with treatment history of anti-angiogenesis drugs, or immunotherapy (previous use of anti-PD-1/PD-L1 antibodies was allowed) or eribulin.
• The subjects had any history of autoimmune disease or any use of systemic glucocorticoid or immunosuppressive medications.
• Subjects had history of hypertension and poor control with antihypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥100 mmHg)；
• Subjects must not have baseline hypotension, defined as systolic blood pressure less than 100 mmHg in both readings taken 2 days prior to the study.
• Urine routine indicated that urine protein ≥ ++, or the 24-hour urine protein quantity ≥ 1.0g.
• Hereditary or acquired bleeding and thrombotic tendencies (such as hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism, etc.).
• Human immunodeficiency virus (HIV) infection, active hepatitis B (hepatitis B indicates antigen positive and HBV DNA ≥ 500 IU/ml), hepatitis C (hepatitis C antibody positive and HCV-RNA above the lower limit of detection of the analytical method).
• Receive live vaccine within 4 weeks before or during the study period;
• Patients who are allergic to or contraindicated to the experimental drugs.
• Concurrent medical conditions that, in the judgment of the investigator, would jeopardize the subject's safety, could confound the study results, or affect the subject's completion of this study.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator
• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: collaborator

Study Sites (1)

Union Hospital, Tongji Medical College of HUST

Wuhan, Hubei, 430000, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

camrelizumab; liposomal doxorubicin; Losartan

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Study Officials

• Yanxia Zhao, M.D.

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  STUDY CHAIR

Central Study Contacts

Yanxia Zhao, M.D.

CONTACT

13407192551; sophia7781@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Breast Oncology

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: October 28, 2021
• Study Start: October 1, 2021
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: October 28, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)