Bone Scan Index for Breast Cancer Bone Metastasis

Bone Scan Index for Breast Cancer Bone Metastasis - BSI for Breast Cancer Bone Metastasis

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000016868

Enrollment

200

Registered

2015-03-23

Start date

2015-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with breast cacner and bone metastasis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Histologically or cytologically diagnosed breast cancer (2) Bone metastasis (confirmed by biopsy, Xp, CT, or MRI) (3) Zoledronate or denosumab is planning to be administrated (4) Less than 3 prior systemic treatments (chemotherapy, endocrine therapy, or both) for metastatic disease (5) 20 years or older (6) ECOG PS 0 to 2 (7) Written informed consent (8) Adequate organ function

Exclusion criteria

Exclusion criteria: (1) Creatinine clearance <30 mL/min (2) Infection of jawbone, tooth, or patients planning to have surgery in tooth or jaw (3) Severe allergy to bisphosphonate (including zoledronate) or denosumab (4) Symptomatic brain metastasis or leptomeningitis (5) Spinal cord compression (6) Severe comorbidity (7) Bone metastasis from cancer other than breast cancer (8) Judged to be inappropriate for inclusion by physician

Design outcomes

Primary

Measure	Time frame
Progression-free survival (PFS)	—

Secondary

Measure	Time frame
skeletal-related event (SRE), Overall survival (OS)	—

Countries

Japan

Contacts

Public ContactYoichi Naito

National Cancer Center Hospital East Division of Breast and Medical Oncology

ynaito@east.ncc.go.jp+81-4-7133-1111

Outcome results