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Breast Cancer Tumor Heterogeneity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02108561
Recruitment Status : Active, not recruiting
First Posted : April 9, 2014
Last Update Posted : January 9, 2018
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Breast Cancer Other: Post Surgical Her2 testing

Study Design

Study Type : Observational
Estimated Enrollment : 110 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Does Breast Tumor Heterogeneity Necessitate Additional HER2 Testing on the Surgical Specimens?
Study Start Date : April 2014
Primary Completion Date : December 22, 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :
  1. Benefit of additional Her2 testing [ Time Frame: 2 years ]
    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.

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Breast Cancer pre-surgical patients

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 -
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02108561

United States, Maryland
Anne Arundel Medical Center
Annapolis, Maryland, United States, 21401
Sponsors and Collaborators
Anne Arundel Health System Research Institute
Genentech, Inc.
More Information

Responsible Party: Anne Arundel Health System Research Institute
ClinicalTrials.gov Identifier: NCT02108561     History of Changes
Other Study ID Numbers: 505185
First Posted: April 9, 2014    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018

Keywords provided by Anne Arundel Health System Research Institute:
Breast Cancer Heterogeneity Her2

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases