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

March 30, 2017 updated by: Faina Nakhlis, MD, Dana-Farber Cancer Institute

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Anticipated)

78

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of upstaging from Lobular Neoplasia on core biopsy to invasive breast cancer or ductal carcinoma in situ on excisional biopsy
Time Frame: Concomittant
Concomittant

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

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

Investigators

  • Principal Investigator: Faina Nakhlis, MD, Dana-Farber Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

September 2, 2005

First Submitted That Met QC Criteria

September 2, 2005

First Posted (Estimate)

September 7, 2005

Study Record Updates

Last Update Posted (Actual)

March 31, 2017

Last Update Submitted That Met QC Criteria

March 30, 2017

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-164

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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