Chemotherapy-induced Cognitive and Brain Changes in Older Adults With Breast Cancer

- This study is being done to study effects of chemotherapy (cancer treatment) on the
brain and cognition (thinking). "Chemo-brain" is a term sometimes used to refer to
effects of chemotherapy on the brain and cognition (thinking).

- This study is being done to test for "chemo-brain" in older adults with breast cancer
treated with chemotherapy, and to identify people who are most likely to be affected.
The investigators will look at thinking abilities and brain images before and after
chemotherapy to see if it can help identify people at risk for cognitive side effects of
the treatment, and to better understand effects of treatment on brain structure and
function.

- The investigators are looking for participants who have either been recently recently
diagnosed breast cancer participant or a healthy volunteer.

- What is involved in the study:

- Memory and Thinking Tests

- Imaging: Either MRI/or MRI and PET Scans

Inclusion Criteria:

- Breast cancer patients treated with chemotherapy- Group 1 (experimental group)

- Participants must meet the following criteria on screening examination to be
eligible to participate in the behavioral +/- imaging components of study

- New diagnosis histologically confirmed invasive breast cancer

- Treatment plan to include chemotherapy

- Female subjects age ≥ 60 years.

- Life expectancy ≥ 1 year

- Karnofsky Performance Score (KPS) ≥ 80

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

- Non-treated breast cancer patient controls- Group 2 (control group)

- Participants must meet the following criteria on screening examination to be
eligible to participate in the behavioral +/- imaging components of study:

- New diagnosis histologically confirmed invasive breast cancer

- Treatment plan does not include chemotherapy

- Age ≥ 60 years.

- Life expectancy ≥ 1 year

- Karnofsky Performance Score (KPS) ≥ 80

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

- Healthy control subjects- Group 3 (control group)

- Participants must meet the following criteria on screening examination to be
eligible to participate in the behavioral +/- imaging components of study:

- Age ≥ 60 years.

- Life expectancy ≥ 1 year

- Karnofsky Performance Score (KPS) ≥ 80

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

- Participants with well-controlled vascular risk factors, such as treated
hypertension, treated hyperlipidemia or well-controlled Type II diabetes (glucose
levels <250) may be included.

- Serum Pregnancy Testing: STAT quantitative serum hCG pregnancy testing for all
women of childbearing potential. Imaging will not start until and unless the test
result returns negative.

Exclusion Criteria:

- Participants who exhibit any of the following conditions at screening will not be
eligible for admission into the study:

- Participants with clinical or radiographic evidence of metastatic CNS disease

- Subjects with MMSE scores below 24

- Active or history of major psychiatric disorders such as schizophrenia,
schizoaffective disorder, major affective disorder in mid-life, or treatment with
ECT (Mild depression that is well treated with stable dose of SSRI
antidepressants may be allowed).

- Substance abuse within the past 2 years

- Huntington's disease, hydrocephalus or seizure disorder

- In addition to exclusion criteria above, participants who exhibit any of the following
conditions at screening will not be eligible for admission into imaging portion of the
study:

- Participants with contraindications to MRI (i.e., implanted metal including
pacemakers, cerebral spinal fluid shunts, aneurysm clips, artificial heart
valves, ear implants or metal/foreign objects in the eyes and those with a
history of claustrophobia), injuries to the eyes with metal without X-ray
documentation that metal was removed