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

Breast Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00146536
• Other study ID #: 04-164
• Status: Completed
• Phase: N/A
• First received: September 2, 2005
• Last updated: March 30, 2017
• Start date: November 2004
• Est. completion date: November 2012

Study information

• Verified date: November 2012
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana-Farber Cancer Center	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Translational Breast Cancer Research Consortium

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of upstaging from Lobular Neoplasia on core biopsy to invasive breast cancer or ductal carcinoma in situ on excisional biopsy		Concomittant
Secondary	Factors which predict for upstaging from Lobular Neoplasia on core biopsy to invasive breast carcinoma or ductal carcinoma in situ