Breast Cancer Tumor Heterogeneity

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedBiomarker/Laboratory analysis, Health services researchActive18 and overOther505185
NCT02108561

Trial Description

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.

Eligibility 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 -

Trial Contact Information

Trial Lead Organizations/Sponsors

DeCesaris Cancer Institute at Anne Arundel Medical Center

  • Genentech Incorporated

Trial Sites

U.S.A.

Maryland
Annapolis

DeCesaris Cancer Institute at Anne Arundel Medical Center

Kristen Sawyer, MS, CCRA
Ph: 443-481-5749
Email: ksawyer@aahs.org

Lorraine Tafra
Principal Investigator

See All Trial Sites

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT02108561
ClinicalTrials.gov processed this data on April 09, 2015

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.