Pivotal Study of Intraoperative Detection of Residual Cancer in Breast Cancer Patients

For breast cancer lumpectomies, the presence of residual cancer cells left in the tumor bed
after initial resection is inferred by post-operative margin assessment of the resected
tissue by a pathologist.

The injection of the study drug will occur 2-6 hours prior to surgery at a dose of 1.0 mg/kg.
The surgeon will complete the lumpectomy and remove any standard of care shaves if
applicable. The surgeon will use the Lumicell device to look inside the lumpectomy cavity to
see if the dye indicates any areas that may contain residual tumor. If the imaging identifies
that there may be cancer cells remaining in the lumpectomy cavity, the surgeon will remove an
additional piece of tissue. This process will be continued until a negative reading from the
device is obtained or a maximum of 2 shaves of additional tissue has been removed in each
orientation.

Study treatment ends when the surgery is completed. All patients will continue their
enrollment in the study until their first follow-up visit and they will continue to be
followed until the medical team determines no further surgical intervention is required.
Patients with adverse events that are determined to be possibly related to the LUM Imaging
System will be followed until resolution or stabilization of the adverse event.

Inclusion Criteria:

- Subjects must have histologically or cytologically confirmed primary invasive breast
cancer, ductal carcinoma in situ (DCIS) or primary invasive breast cancer with a DCIS
component.

- Female, age of 21 years or older.

- Subjects must be scheduled for a lumpectomy for a breast malignancy.

- Subjects must be able and willing to follow study procedures and instructions.

- Subjects must have received and signed an informed consent form.

- Subjects must have no uncontrolled serious medical problems except for the diagnosis
of breast cancer, as per the exclusion criteria listed below.

- Subjects must have organ and marrow function within limits as defined below:

- Leukocytes > 3,000/mcL

- Platelets > 75,000/mcL

- total bilirubin within normal institutional limits

- AST (SGOT)/ALT (SGPT) < 2.5 X institutional upper limit of normal

- Creatinine ≤ 1.5 mg/dL or creatinine clearance > 60 mL/min/1.73 m2 for subjects
with creatinine levels above institutional normal.

- Subjects with ECOG performance status of 0 or 1.

Exclusion Criteria:

- Subjects who are treated for bilateral breast cancer resection procedure

- Subjects who are pregnant. Breastfeeding should be discontinues if the mothers is
treated with LUM015

- Subjects who are sexually active and not willing/able to use 2 medically acceptable
forms of contraception (hormonal or barrier method of birth control, abstinence) upon
entering the study and for 60 days after injection of LUM015.

- Subjects who have taken an investigational drug within 30 days of enrollment.

- Subjects who will have administration of methylene blue or any dye for sentinel lymph
node mapping on the day of the surgery prior to imaging the lumpectomy cavity with the
LUM Imaging Device.

- Subjects who have not recovered from adverse events due to other pharmaceutical or
diagnostic agents.

- Subjects with uncontrolled hypertension defined as persistent systolic blood pressure
> 180 mm Hg, or diastolic blood pressure > 110 mm Hg; those subjects with known HTN
should be stable with controlled HTN while under pharmaceutical therapy.

- History of allergic reaction attributed to any contrast agent or drugs containing
polyethylene glycol (PEG).

- History of allergic reaction to any oral or intravenous contrast agents.

- Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, COPD or asthma requiring hospitalization within the past 12 months, or
psychiatric illness/social situations that would limit compliance with study
requirements.

- HIV-positive individuals on combination antiretroviral therapy are ineligible.

- Any subject for whom the investigator feels participation is not in the best interest
of the subject.

- Subjects undergoing a second lumpectomy procedure because of positive margins in a
previous surgery prior to entering this study.

- Subjects with prior ipsilateral breast cancer surgeries, mastectomies, breast
reconstructions or implants.

- Subjects who have undergone a surgical biopsy for any reason in the ipsilateral breast
performed less than 2 years prior to enrollment of this study.

- Subjects with prior ipsilateral reduction mammoplasties (breast reductions) performed
less than 2 years prior to enrollment to this study.

- Subjects previously treated with systemic therapies to treat the cancer to be removed
during this clinical investigation, such as neo-adjuvant chemotherapy or hormonal
therapy.

- Subjects undergoing breast conserving surgery whose resected speciment will be
evaluated with frozen section.