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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00146536

Enrollment

Registered

2005-09-07

Start date

2004-11-30

Completion date

2012-11-30

Last updated

2017-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms

Keywords

ALH, LCIS, DCIS, adjacent ipsilateral infiltrating carcinoma, core needle biopsy, Lobular neoplasia of the breast

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.

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results