Breast Cancer Tumor Heterogeneity

NCT02108561 | Unknown

• 1 other identifier: 505185
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Breast Cancer Heterogeneity Her2

Outcome Measures

Primary Outcomes (1)

• Benefit of additional Her2 testing

  To identify a subset of women with invasive breast cancer who may benefit from additional Her2 testing (by immunochemistry and FISH) on their surgical specimen to ensure that areas of Her2 amplification are not missed due to sampling error of the core needle biopsy.

  2 years

Study Arms (1)

Breast Cancer

Post Surgical Her2 testing

Other: Post Surgical Her2 testing

Interventions

Post Surgical Her2 testing OTHER

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

Breast Cancer

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Breast Cancer pre-surgical patients

You may qualify if:

• Women \> age 18 with capacity to consent
• Invasive breast cancer identified on CNB at AAMC within 45 days of study consent
• IHC biomarkers performed on original CNB (including HER2)
• Tumors with greater than 2cm of invasive disease (measured radiographically prior to resection or microscopically after resection), or
• Multifocal or multicentric tumors

You may not qualify if:

• Men
• Women with HER2 positive tumors detected on CNB specimens
• Women receiving neoadjuvant chemotherapy
• Women whose CNB or surgical resection was performed at a hospital other than AAMC. If the CNB prior to resection was repeated at AAMC and new tumor biomarkers were performed, then the patient is eligible for enrollment
• Women whose IHC marker results were inconclusive on CNB or not performed -

Sponsors & Collaborators

• Anne Arundel Health System Research Institute: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Anne Arundel Medical Center

Annapolis, Maryland, 21401, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2014
• First Posted: April 9, 2014
• Study Start: April 1, 2014
• Primary Completion: December 22, 2017
• Study Completion: December 1, 2018
• Last Updated: January 9, 2018

Record last verified: 2018-01

Locations

US (1)