Histamine and Bone Pain Association in Participants With Breast Cancer Metastatic in the Bone

PRIMARY OBJECTIVES:

I. To correlate levels of histamine in plasma with pain scores in patients with bone
metastases from breast cancer that have or have not been treated with palliative
radiotherapy.

SECONDARY OBJECTIVES:

I. To perform exploratory studies with additional markers not mentioned, including calcitonin
gene-related peptide (CGRP), stem cell factor (SCF), angiotensin II (Ang II) substance P,
angiotensin 1-7 (Ang1-7), may be performed at the investigator's discretion.

II. To perform next generation ribonucleic acid (RNA) sequences using the whole blood to
determine whether histamine system is involved in the development of cancer-induced bone pain
(CIBP).

III. To assess the impact of pain response after radiotherapy on bone structural properties
such as bone mineral density and cortical thickness, and patient quality of life, physical
and psychological function.

OUTLINE:

Participants undergo collection of blood samples for histamine level analysis via
enzyme-linked immunosorbent assay (ELISA).

After completion of study, participants are followed up at 1, 3, and 6 months.

Inclusion Criteria:

- Breast cancer patients with radiographic evidence of bone metastases (by plain film,
computed tomography [CT], magnetic resonance imaging [MRI], positron emission
tomography [PET] or bone scan) within 8 weeks of registration

- Weight bearing sites: pelvis (excluding pubis), femur, sacrum and/or sacroiliac
joints, tibia, up to 5 consecutive cervical, thoracic or lumbar vertebral bodies,
lumbosacral spine

- Non-weight bearing sites: up to 3 consecutive ribs, humerus, fibula, radius +/-
ulna, clavicle, sternum, scapula, pubis

- Patients with and without pain related to the radiographically documented metastases
are eligible for study

- Ability to understand and the willingness to sign an Institutional Review Board
(IRB)-approved informed consent document

Exclusion Criteria:

- Pregnant women will be excluded