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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


N/A
20 Years
N/A
Not Enrolling
Female
Breast Neoplasms

Thank you

Trial Information

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


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.


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)

- A palpable abnormality diagnosed by core needle biopsy to be ALH or LCIS

- Received tamoxifen in the past

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Rate of upstaging from Lobular Neoplasia on core biopsy to invasive breast cancer or ductal carcinoma in situ on excisional biopsy

Outcome Time Frame:

Concomittant

Safety Issue:

No

Principal Investigator

Faina Nakhlis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

04-164

NCT ID:

NCT00146536

Start Date:

November 2004

Completion Date:

November 2012

Related Keywords:

  • Breast Neoplasms
  • ALH
  • LCIS
  • DCIS
  • adjacent ipsilateral infiltrating carcinoma
  • core needle biopsy
  • Lobular neoplasia of the breast
  • Breast Neoplasms
  • Neoplasms

Name

Location

Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Dana-Farber Cancer CenterBoston, Massachusetts  02115