Incidence of Carcinoma, Ductal Carcinoma In Situ (DCIS), or Atypical Ductal Hyperplasia (ADH) in Patients With Lobular Neoplasia of the Breast

This study is currently recruiting participants.

Verified by Dana-Farber Cancer Institute, January 2009

First Received: September 2, 2005 Last Updated: January 6, 2009 History of Changes

Sponsors and Collaborators:	Dana-Farber Cancer Institute Beth Israel Deaconess Medical Center Brigham and Women's Hospital
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00146536

Purpose

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.

Condition	Intervention
Breast Neoplasms	Procedure: Surgical Biopsy

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Surgery

U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Option of keeping tissue sample for further research

Estimated Enrollment:	78
Study Start Date:	November 2004
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Surgical biopsy of breast tissue

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Individuals who have ALH/LCIS detected on a needle biospy of the breast

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00146536

Contacts

Contact: Faina Nakhlis, MD

617-632-5178

faina_nakhlis@dfci.harvard.edu

Locations

United States, Massachusetts
Dana-Farber Cancer Center	Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Faina Nakhlis, MD
Beth Israel Deaconess Medical Center	Recruiting
Boston, Massachusetts, United States, 02215
Principal Investigator: Stuart J. Schnitt, MD

Sponsors and Collaborators

Dana-Farber Cancer Institute

Beth Israel Deaconess Medical Center

Brigham and Women's Hospital

Investigators

Principal Investigator:

Faina Nakhlis, MD

Dana-Farber Cancer Institute

More Information

No publications provided

Responsible Party:	Dana-Farber Cancer Institute ( Faina Nakhlis, MD )
Study ID Numbers:	04-164
Study First Received:	September 2, 2005
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00146536 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

ALH
LCIS
DCIS

adjacent ipsilateral infiltrating carcinoma
core needle biopsy
Lobular neoplasia of the breast

Study placed in the following topic categories:

Carcinoma, Ductal
Hyperplasia
Skin Diseases
Carcinoma in Situ
Breast Neoplasms
Carcinoma, Ductal, Breast

Carcinoma, Intraductal, Noninfiltrating
Adenocarcinoma
Breast Diseases
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Skin Diseases
Breast Neoplasms
Carcinoma
Hyperplasia
Neoplasms
Neoplasms by Site

Pathologic Processes
Carcinoma, Intraductal, Noninfiltrating
Neoplasms, Ductal, Lobular, and Medullary
Adenocarcinoma
Breast Diseases
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 04, 2009