CAREFOR: Precision Medicine Driving Precision Nutrition for the Treatment of NeoAdjuvant Breast Cancer

Primary objective:

I To determine if dietary alternations designed to downregulate the dominate molecular
drivers of an individuals' breast cancer will enhance the effect of neoadjuvant chemotherapy
and allow for an increase in the pathologic complete response rate.

Secondary objectives

I) Investigator measurable changes to molecular and patient characteristics from precision
nutrition to determine a metric for evaluation this treatment in future studies.

Inclusion Criteria:

- Pathologically proven invasive breast cancer

- Planned neoadjuvant chemotherapy determined by the judgment of the medical oncologist

- The patient must be female

- Age ≥ 18

- Non-metastatic and non-inflammatory breast cancer

- History/physical examination, including breast exam and documentation of weight and
Karnofsky Performance Status of 80-100% for at least 60 days prior to study entry.

- Women of childbearing potential must be non-pregnant and non-lactating and willing to
use medically acceptable form of contraception during chemotherapy

- Patient must capable of and provide study specific informed consent prior to study
entry

- BMI ≥21

- Weight ≥120lbs

- No prior history of non-breast malignancies in the past 1 year unless it was a non-
melanomatous skin lesion or carcinoma in situ of the cervix.

- Patient must not have Acquired Immune Deficiency Syndrome (AIDS) or HIV positive based
upon current CDC definition; note, however, that HIV testing is not required for entry
into this protocol. The need to exclude patients with AIDS or HIV from this protocol
is necessary because anti-retrovirals may alter patient metabolism.

- Patient may not have any active Gastrointestinal/Malabsorption disorder at the
discretion of the Principal Investigator which may include:

- Chronic Pancreatitis

- Chronic Diarrhea or Vomiting

- Active Eating Disorder

- No history of or current active drug/alcohol dependence.

- No patients with decisional impairment.

Exclusion Criteria:

- Patient is male.

- Age <18 years

- Clinical stage IV cancer

- Inflammatory breast cancer (T4d)

- Women of childbearing potential with a positive serum beta hCG.

- Decision impaired patients.

- BMI < 21

- Weight < 120lbs

- Weight loss ≥10% in the last 3 mos

- Prior invasive non-breast malignancy (except non-melanomatous skin cancer, carcinoma
in situ of the cervix) unless disease free for a minimum of 1 year prior to
registration

- Non-epithelial breast malignancies such as sarcoma or lymphoma

- Active Gastrointestinal/Malabsorption disorder at the discretion of the Principal
-Investigator which may include:

- Chronic Diarrhea or Vomiting

- Active Eating Disorder

- Active drug/alcohol dependence or abuse history.