Breast Cancer Tumor Heterogeneity
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 1/11/2018 |
| Start Date: | April 2014 |
| End Date: | December 2018 |
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 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.
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 -
We found this trial at
1
site
Annapolis, Maryland 21401
Principal Investigator: Lorraine Tafra, MD
Phone: 443-481-5749
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