Monitoring Neoadjuvant Chemotherapy Response in Breast Cancer Patients Using Diffuse Optical Spectroscopic Imaging

This study seeks to enroll women with breast cancer undergoing neoadjuvant chemotherapy to
evaluate the efficacy of an investigational imaging technology known as Diffuse Optical
Spectroscopy Imaging (DOSI) in predicting patient response to chemotherapy treatment. DOSI is
a noninvasive imaging method that uses harmless near-infrared light using a simple handheld
probe held against the skin to predict tumor metabolic activity. It uses nonionizing
radiation, requires no external contrast agent and uses low light exposure to human tissue.
DOSI scans can be performed frequently at the bedside in settings such as a doctor's office
or infusion center.

DOSI has already shown promise in monitoring breast cancer patients undergoing preoperative
chemotherapy. Several groups have demonstrated optical changes predictive of response in the
course of weeks to months of treatment. The investigators group has begun to show that DOSI
measurements during drug infusions and at early time-points (first 24 hours) correlate with
tumor final pathological response. While this data is provocative, significantly more work is
needed to confirm that early time-points are predictive in different treatment groups and
tumor molecular subtypes.

In this study, breast cancer patients will receive DOSI scans at a subset or all of the
following time-points: baseline, during drug infusion, early therapy, mid-therapy and
post-therapy. DOSI results will be compared to standard of care pathology results determined
after surgery. Additionally, the investigators will correlate DOSI parameters with any
additional biopsy specimens taken during treatment (typically for patients on adaptive
treatment trials). Each DOSI scan will take about 3045minutes/ session, although infusion
measurements will take longer. DOSI can potentially help doctors to gain information
necessary to make evidence-based changes in treatment strategies of individual patients. The
investigators long-term goal is to provide oncologists with a relatively simple, risk-free
bedside tool that can help predict response early, thereby maximizing therapeutic response
and minimizing unnecessary toxicity.

Inclusion Criteria:

1. Female;

2. Diagnosis of invasive breast cancer by clinical breast examination, by standard of
care diagnostic imaging, or by initial tissue biopsy;

3. Planned for primary systemic (neoadjuvant) chemotherapy and surgical resection of
residual primary tumor following completion of neoadjuvant chemotherapy;

4. Tumor size ≥ 2cm, measured on imaging or estimated by physical exam;

5. Planned definitive breast surgery (mastectomy or lumpectomy/breast conservation)
following completion of neoadjuvant therapy;

6. Age 18 years or older;

7. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2 (Karnofsky
performance status ≥ 60%;

8. Adequate organ and marrow function, as defined at Boston Medical Center;

9. Postmenopausal for a minimum of one year, OR surgically sterile, OR not pregnant,
confirmed by a pregnancy test as per institutional standard of care, and willing to
use adequate contraception (hormonal or barrier method of birth control; abstinence)
for the duration of study participation;

10. Able to understand and willing to sign a written informed consent document and a
Health Insurance Portability and Accountability Act (HIPAA) authorization in
accordance with institutional guidelines.

Exclusion Criteria:

1. Previous treatment (chemotherapy, radiation, or surgery) to involved breast;

2. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements;

3. Medically unstable;

4. Under age 18;

5. Pregnant or nursing;

6. Previous malignancy, other than basal cell or squamous cell carcinoma of the skin or
in situ carcinoma of the cervix, from which the patient has been disease free for less
than 5 years;

7. No contraindications for primary chemotherapy.