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
  Purpose

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 Intervention
Breast Cancer
Other: Post Surgical Her2 testing

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Does Breast Tumor Heterogeneity Necessitate Additional HER2 Testing on the Surgical Specimens?

Resource links provided by NLM:


Further study details as provided by Anne Arundel Health System Research Institute:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 110
Study Start Date: April 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Breast Cancer pre-surgical patients

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02108561

Locations
United States, Maryland
Anne Arundel Medical Center Recruiting
Annapolis, Maryland, United States, 21401
Contact: Kristen Sawyer, MS, CCRA    443-481-5749    ksawyer@aahs.org   
Principal Investigator: Lorraine Tafra, MD         
Sponsors and Collaborators
Anne Arundel Health System Research Institute
Genentech
  More Information

No publications provided

Responsible Party: Anne Arundel Health System Research Institute
ClinicalTrials.gov Identifier: NCT02108561     History of Changes
Other Study ID Numbers: 505185
Study First Received: April 7, 2014
Last Updated: April 7, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 22, 2014