Real-Time Assessment Of Breast Cancer Lumpectomy Specimen Margins With Nonlinear Microscopy

Eligibility Criteria

• * Patient scheduled to undergo lumpectomy for breast cancer at BIDMC.
• * Core needle biopsy revealing invasive breast cancer or DCIS.
• * Female.
• * Minimum age of 21 years.
• * Eligible for breast conserving surgery, lumpectomy and radiation.
• * Estrogen receptor positive (ER+) on core needle biopsy, or if estrogen receptor negative (ER-), have evaluable estrogen receptor status with positive internal control on core biopsy.
• * Progesterone receptor positive (PR+) on core needle biopsy if biopsy indicates invasive cancer, or if progesterone receptor negative (PR-) on biopsy indicating invasive cancer, have evaluable progesterone receptor status with positive internal control on core biopsy.
• * HER2 IHC and/or FISH ordered on core biopsy, if biopsy indicates invasive cancer.
• * Oncotype DX or other genetic assay performed on core biopsy or not requested.
• * Ability to understand and the willingness to sign a written informed consent document.
• * Contraindicated for radiation therapy.
• * Pregnancy. (Pregnant women will be excluded from this study because radiation therapy is contraindicated during pregnancy.)
• * Current invasive cancer or DCIS at the site of a previous surgery.
• * Any systemic neoadjuvant (or preoperative) therapy between the core biopsy and lumpectomy.
• * Involvement in another therapeutic trial for breast cancer at Dana Farber or elsewhere.
• * Risk of poor cosmetic outcome after initial lumpectomy and possible additional excision, as assessed by a study surgeon.
• * Recommendation for mastectomy based on radiology.
• * Patients that have complex DCIS as indicated on radiology, which would require excising a large tissue volume.
• * No or equivocal ER, PR or HER2 testing performed prior to surgery if biopsy indicates invasive cancer.
• * No or equivocal ER testing performed prior to surgery if biopsy indicates ductal carcinoma in situ.