Triple-Negative Breast Cancer
Conditions
Interventions
Experimental Group (Camrelizumab combined with risedronate sodium and chemotherapy):Camrelizumab: 200 mg, intravenous infusion, administered primarily according to the chemotherapy regimen cycle.
Ris
Sponsors
Harbin Medical University Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Female patients aged >=18 years and = 1.5 × 10^9/L. Platelet Count (PLT) >= 90 × 10^9/L. Hemoglobin (Hb) >= 90 g/L. (2) Biochemistry: Total Bilirubin (TBIL) = 50 mL/min (calculated by Cockcroft-Gault formula). (3) Thyroid function: Thyroid Stimulating Hormone (TSH) = 50%, as assessed by echocardiography. (5) Electrocardiogram: Fridericia-corrected QT interval (QTcF) < 480 ms on 18-lead ECG for females. 7.Female patients of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to enrollment and voluntarily agree to use adequate contraception during the study period and for 4 months after the last dose of the study drug. 8.Voluntary participation with written informed consent obtained and good compliance.
Exclusion criteria
Exclusion criteria: 1.Concurrent receipt of anti-tumor therapy in another clinical trial. 2.Receipt of other anti-tumor therapy within 14 days prior to the first dose of study drug. 3.Major surgical procedure unrelated to breast cancer within 4 weeks prior to enrollment, or failure to fully recover from such a procedure. 4.Patients with an active autoimmune disease or a history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism). Patients with vitiligo or childhood asthma that has completely resolved and requires no intervention in adulthood are eligible. Patients with asthma requiring bronchodilators for medical intervention are not eligible. 5.Significant cardiac disease or discomfort, including but not limited to the following:Documented history of heart failure or systolic dysfunction (LVEF 100 bpm, significant ventricular arrhythmias (e.g., ventricular tachycardia), or higher-grade atrioventricular block (i.e., Mobitz II second-degree atrioventricular block or third-degree atrioventricular block);Angina pectoris requiring anti-anginal medication.;Clinically significant valvular heart disease;ECG evidence of transmural myocardial infarction;Poorly controlled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg). 6.Patients with congenital or acquired immunodeficiency disorders (e.g., HIV infection). 7.Administration of a live vaccine within 4 weeks prior to study treatment or anticipation that such a live vaccine will be required during the study period. 8.Inability to swallow tablets, malabsorption syndrome, or any condition affecting gastrointestinal absorption. 9.Known history of allergy to any component of the study drug regimen. 10.Patients with hypocalcemia. 11.Inability to maintain a standing or sitting position for 30 minutes. 12.Presence of severe concomitant diseases or other comorbid conditions that would interfere with planned treatment, or any other condition for which the investigator deems the patient unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bone Mineral Density;Incidence of new bone metastases;Disease Control Rate;Progression-free survival at 6 months;Overall Survival;Safety; | — |
Countries
China
Contacts
Public ContactLiu Tong
Harbin Medical University Cancer Hospital
Outcome results
None listed