Breast Cancer Tumor Heterogeneity

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

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Post Surgical Her2 testing

• Study Type: Observational
• Enrollment (Anticipated): 110

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Anne Arundel Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Breast Cancer pre-surgical patients

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Men
2. Women with HER2 positive tumors detected on CNB specimens
3. Women receiving neoadjuvant chemotherapy
4. 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
5. Women whose IHC marker results were inconclusive on CNB or not performed -

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Breast Cancer; Post Surgical Her2 testing	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Anne Arundel Health System Research Institute
• Collaborators: Genentech, Inc.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): December 22, 2017
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: April 7, 2014
• First Submitted That Met QC Criteria: April 7, 2014
• First Posted (Estimate): April 9, 2014

Study Record Updates

• Last Update Posted (Actual): January 9, 2018
• Last Update Submitted That Met QC Criteria: January 8, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Breast Cancer Heterogeneity Her2
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 505185