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

This study has been completed.
Sponsor:
Collaborators:
Translational Breast Cancer Research Consortium
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Information provided by (Responsible Party):
Faina Nakhlis, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00146536
First received: September 2, 2005
Last updated: November 29, 2012
Last verified: November 2012
History of Changes
  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
Breast Neoplasms

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Rate of upstaging from Lobular Neoplasia on core biopsy to invasive breast cancer or ductal carcinoma in situ on excisional biopsy [ Time Frame: Concomittant ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Factors which predict for upstaging from Lobular Neoplasia on core biopsy to invasive breast carcinoma or ductal carcinoma in situ [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Option of keeping tissue sample for further research


Estimated Enrollment: 78
Study Start Date: November 2004
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
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)
  • 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

Locations
United States, Massachusetts
Dana-Farber Cancer Center
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Dana-Farber Cancer Institute
Translational Breast Cancer Research Consortium
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: Faina Nakhlis, MD, Instructor in Surgery, Harvard Medical School, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00146536     History of Changes
Other Study ID Numbers: 04-164
Study First Received: September 2, 2005
Last Updated: November 29, 2012
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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 16, 2013