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OpenTrials
Completed

NCT Number: NCT00146536

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

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Key information

Conditions

Breast Neoplasms Adenocarcinoma Breast Carcinoma In Situ Breast Diseases Carcinoma Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Glandular and Epithelial Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: Concomittant

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2012
Study completion
2012
First posted
Sep 7, 2005
Registry last updated
Mar 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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