NCT02108561

Breast Cancer Tumor Heterogeneity

Does Breast Tumor Heterogeneity Necessitate Additional HER2 Testing on the Surgical Specimens?

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 110 (estimated)
• Sponsor: Anne Arundel Health System Research Institute · Academic / Other
• Sex: Female
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

Breast cancer biomarkers are usually performed on core needle biopsy (CNB) specimens and are not routinely repeated on surgical specimens (SS). However, preliminary data suggests that testing these biomarkers, on SS when compared to CNB samples can lead to different results. Our hypothesis is that The aim of this study is to identify a group of women with invasive breast cancer who may benefit from additional HER2 testing on their SS to ensure that areas of HER2 amplification are not missed. Another aim is to determine whether further HER2 testing on the SS in select patients would lead to changes in breast cancer treatment options.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
OTHER	Post Surgical Her2 testing	Eligible patients will have post surgical Her2 testing on the primary tumor, a satellite lesion and a tumor positive node. The results will be provided to medical oncologist, who will comment as to whether the additional testing will prompt treatment recommendation changes

Timeline

• Start date: 2014-04-01
• Primary completion: 2017-12-22
• Completion: 2018-12-01
• First posted: 2014-04-09
• Last updated: 2018-01-09

Locations

1 site across 1 country: United States