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

Dana-Farber Cancer Institute

Status: Completed

Conditions: Breast Neoplasms

Study type: Observational

Funder types: Other

Identifiers

NCT00146536

04-164

Details and patient eligibility

About

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.

Full 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.

Enrollment: 78 estimated patients

Sex: Female

Ages: 20+ years old

Volunteers: No 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