Upstaging of ALH/LCIS Found on Core Biopsy Based on Subsequent Excisional Biopsy

Sponsor

Dana-Farber Cancer Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00146536

Collaborator

Translational Breast Cancer Research Consortium (Other), Beth Israel Deaconess Medical Center (Other), Brigham and Women's Hospital (Other)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Breast Neoplasms

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

78 participants

Observational Model:

Case-Only

Time Perspective:

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

Study Start Date :

Nov 1, 2004

Actual Primary Completion Date :

Nov 1, 2012

Actual Study Completion Date :

Nov 1, 2012

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Factors which predict for upstaging from Lobular Neoplasia on core biopsy to invasive breast carcinoma or ductal carcinoma in situ []

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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