The Incidence of Adjacent Synchronous Ipsilateral Infiltrating Carcinoma, DCIS, or Atypical Ductal Hyperplasia (ADH) in Patients Diagnosed With Lobular Neoplasia of the Breast by Core Needle Biopsy
| City: |
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Boston |
| State: |
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Massachusetts |
| Zip Code: |
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02215 |
| Conditions: |
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Breast Neoplasms |
| Purpose: |
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The goal of this study is to determine how often patients who have atypical lobular
hyperplasia (ALH) or lobular carcinoma in situ (LCIS) on core needle biopsy of an imaging
(found by mammogram or breast ultrasound) abnormality will have associated breast cancer at
surgical removal of the area.
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| Study Summary: |
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Patients will undergo a breast biopsy at which the area found to be ALH or LCIS on core
biopsy will be removed surgically through a small incision in the breast.
- The surgical biopsy specimen will be carefully examined by a pathologist, and may be
useful in guiding further therapy if needed.
- In the future, tissue from the surgical biopsy may be used to study genetic changes
that may be responsible for cancer formation and prevention. The tissue will be kept
for future research for up to 10 years.
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| Criteria: |
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Inclusion Criteria:
- Women 20 years of age or older
- Imaging abnormality necessitating a core needle biopsy
- Core needle biopsy revealing ALH or LCIS
- Patients may have a history of fibroadenoma and/or proliferative breast lesions with
atypia
Exclusion Criteria:
- History and/or concomitant diagnosis of invasive breast cancer or ductal carcinoma in
situ (DCIS)
- Past history of ALH or LCIS
- A palpable abnormality diagnosed by core needle biopsy to be ALH or LCIS
- Received tamoxifen in the past
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| NCT ID: |
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NCT00146536 |
| Primary Contact: |
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Principal Investigator
Faina Nakhlis, MD
Dana-Farber Cancer Institute
Faina Nakhlis, MD
Phone: 617-632-5178
Email: faina_nakhlis@dfci.harvard.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Boston, Massachusetts 02215
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 19, 2013 |
| Modifications to this listing: |
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