Breast Cancer Tumor Heterogeneity

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02108561
• Other study ID #: 505185
• Status: Active, not recruiting
• Phase: N/A
• First received: April 7, 2014
• Last updated: January 8, 2018
• Start date: April 2014
• Est. completion date: December 2018

Study information

• Verified date: January 2018
• Source: Anne Arundel Health System Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 110
• Est. completion date: December 2018
• Est. primary completion date: December 22, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Anne Arundel Medical Center	Annapolis	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Anne Arundel Health System Research Institute	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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