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

The purpose of this research study is to improve the treatment of breast cancer and reduce
the number of patients who require repeat surgical procedures to completely remove breast
malignancy.

In standard procedures, pathologists evaluate tissue samples on a microscope after the
surgery is over. The new investigative imaging instrument is an advanced type of microscope
that enables evaluation during surgery.

The microscope will not be used directly on the participant or in the operating room, but
instead will be used to image tissue immediately after excision but prior to the conclusion
of surgery. If pathologic examination using NLM concludes that there is invasive cancer or
ductal carcinoma in situ (DCIS) at or close to the margin of the specimen, the surgeon will
be notified and may decide to do additional surgical shavings before the patient leaves the
operating room, in order to improve the likelihood of achieving clean margins and reduce the
probability that the patient will be advised to have another operation to achieve clean
margins. For both patients on the experimental arm (NLM) and the control arm (without NLM),
standard pathologic evaluation of the specimen will be done some days after the lumpectomy is
completed. That pathologic evaluation will decide whether or not to recommend that the
patient has additional surgery in order to achieve clean margins. The primary outcome measure
is the percentage of patients in each group who are advised to have additional surgery for
this reason.

Inclusion 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 performed on core biopsy, if biopsy indicates invasive
cancer.Oncotype DX or other DNA testing performed on core biopsy or not requested.

- Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

- Contraindicated for radiation therapy.

- Pregnancy. (Pregnant women will be excluded from this study because radiation therapy
is contraindicated during pregnancy.)

- Previous surgery for DCIS or invasive cancer.

- 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.

- Recommendation for mastectomy based on radiology.

- Patients that have large areas 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.