Breast Cancer Tumor Heterogeneity

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Anne Arundel Health System Research Institute
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Anne Arundel Health System Research Institute
ClinicalTrials.gov Identifier:
NCT02108561
First received: April 7, 2014
Last updated: NA
Last verified: April 2014
History: No changes posted

April 7, 2014
April 7, 2014
April 2014
June 2016   (final data collection date for primary outcome measure)
Benefit of additional Her2 testing [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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.
Same as current
No Changes Posted
Not Provided
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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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

Breast Cancer pre-surgical patients

Breast Cancer
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
Breast Cancer
Post Surgical Her2 testing
Intervention: Other: Post Surgical Her2 testing
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
110
December 2016
June 2016   (final data collection date for primary outcome measure)

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 -
Female
18 Years and older
No
United States
 
NCT02108561
505185
No
Anne Arundel Health System Research Institute
Anne Arundel Health System Research Institute
Genentech
Not Provided
Anne Arundel Health System Research Institute
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP