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NCT Number: NCT07750340

Breast Cancer Molecular Subtypes and Skeletal Metastases Patterns on Bone Scintigraphy

The goal of this observational study is to evaluate the association between different molecular subtypes of breast cancer and their specific patterns of skeletal metastases on Technetium-99m MDP bone scintigraphy.

The study will include adult male and female patients aged 18 to 80 years with histopathologically confirmed breast cancer who are referred for whole-body bone scintigraphy.

The main questions it aims to answer are:

* What is the frequency and pattern of skeletal metastases across different breast cancer molecular subtypes (Luminal A, Luminal B, HER2-enriched, and Triple-Negative) on bone scintigraphy? * How do nuclear medicine scintigraphic findings correlate with tumor biomarker profiles? Researchers will compare imaging patterns among the different molecular subtype groups to determine if specific biomarker profiles correlate with distinct bone metastatic behaviors.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine Sohag University

Sohag, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients of both sexes (females and males) with a confirmed histopathological diagnosis of breast cancer, including all major histological types: Invasive Ductal Carcinoma (IDC), Invasive Lobular Carcinoma (ILC), other mixed or less common epithelial variants.
  • Patient's age ranging from 18 to 80 years.
  • Available immunohistochemical (IHC) profiles from the primary breast tumor biopsy or surgery, covering all molecular subtypes including; Luminal A: (ER-positive, PR-positive, HER2-negative, and low Ki-67 index). Luminal B: (ER-positive, PR-variable, HER2-variable "either positive or negative", and high Ki-67 index). HER2-enriched: (ER-negative, PR-negative, and HER2-positive). Triple-Negative breast cancer (TNBC): (no ER, PR or HER2 expression).
  • Patients referred for bone scintigraphy as part of initial staging, follow-up, or due to clinical suspicion of bone metastasis.

Exclusion criteria

  • Patients with other primary malignancies (to avoid confusion regarding the origin of bone metastases).
  • Patients with incomplete medical records or unavailable immunohistochemical data.
  • Pregnant female patients.
  • Patients aged under 18 years old.

Treatment and study plan

Primary outcomes

  1. Presence of skeletal metastases on Tc-99m MDP whole-body bone scintigraphy.

    Time frame: Baseline

    Number of participants with skeletal metastases detected by Tc-99m MDP whole-body bone scintigraphy according to breast cancer molecular subtype.

  2. Anatomical distribution of skeletal metastases.

    Time frame: Baseline

    Anatomical distribution of skeletal metastases (axial skeleton, appendicular skeleton or mixed) according to breast cancer molecular subtype.

Study contacts

Contact information is provided by the study sponsor or research team.

Reham S Mohamed

CONTACT

[email protected]

+20 1064214014

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

Association of Breast Cancer Molecular Subtypes With Patterns of Skeletal Metastases on Bone Scintigraphy

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 6, 2026
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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