Breast cancer with bone metastasis
Conditions
Interventions
Treatment group:Narlumosbartmab
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Fully informed and voluntarily signed the informed consent form; 2.Either gender, aged >= 18 years and = 30 mL/min, calculated using the Cockcroft-Gault formula. Serum calcium or albumin-corrected serum calcium >= 2.0 mmol/L (8.0 mg/dL) and 3.1 mmol/L may be enrolled if levels are reduced to 2.0–3.1 mmol/L after hydration, diuresis, and fluid replacement (medications listed in Exclusion Criteria 5 and 11 are prohibited).]; 7.Subjects of reproductive potential must use effective medical contraception (for both male and female subjects, from signing informed consent until 6 months after the last study drug administration); 8.Expected survival time >= 3 months.
Exclusion criteria
Exclusion criteria: 1.Past or current diagnosis of osteomyelitis or osteonecrosis of the jaw; unhealed dental or oral surgery; acute dental or jaw disease requiring oral surgery; or planned invasive dental procedures during the study period; 2.Planned radiotherapy to bone or orthopedic surgery on bone during the study period; 3.Previous treatment with anti-receptor activator of nuclear factor-?B ligand (RANKL) antibody or bisphosphonates; 4.Presence of active metabolic bone diseases (Paget’s disease of bone, Cushing’s syndrome, hyperprolactinemia), rheumatoid arthritis, uncontrolled hyperthyroidism/hypothyroidism, or hyperparathyroidism/hypoparathyroidism; 5.Uncontrolled comorbidities including, but not limited to: symptomatic congestive heart failure, hypertension (blood pressure > 150/90 mmHg despite standard treatment), unstable angina pectoris, cardiac arrhythmia requiring medication or device therapy, myocardial infarction within the past 6 months, or left ventricular ejection fraction < 50% on echocardiography; 6.Active bacterial or fungal infection requiring systemic therapy within 7 days prior to randomization; 7.Known positive HIV serology; active hepatitis B (positive HBsAg and positive HBV-DNA); or hepatitis C (positive anti-HCV antibody and positive HCV-RNA). Hepatitis B patients with HBV-DNA below the lower limit of detection after effective antiviral therapy before enrollment are not excluded; 8.Pregnancy (positive serum ß-HCG test) or lactation; 9.Use of any of the following anti-resorptive/anti-metabolic bone agents within 6 months prior to enrollment: Parathyroid hormone (PTH) or its derivatives,Calcitonin Osteoprotegerin (OPG),Mithramycin (plicamycin), Strontium salts; 10.Known hypersensitivity to narlumosbartmab, denosumab, calcium or vitamin D preparations; 11.Any other factors that, in the investigator’s judgment, render the subject unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change from baseline in urinary N-telopeptide of type I collagen corrected for urinary creatinine (uNTx/uCr), a bone biochemical marker, at Week 13.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to bone pain relief after treatment;Safety of Narlumosbartmab;Proportion of subjects with >65% change from baseline in uNTx/uCr at Week 13 during treatment;Change from baseline in pain score (Brief Pain Inventory-Short Form, BPI-SF) and quality of life score (EORTC QLQ-C30) during the first cycle of treatment.;Changes in other bone biochemical markers during treatment [including serum bone-specific alkaline phosphatase (BALP) and serum C-terminal telopeptide of type I collagen (sCTX-I)].;Incidence of skeletal-related events (SREs) during treatment; | — |
Countries
China
Contacts
Public ContactLi Zhu
Shanghai General Hospital
Outcome results
None listed