1380GCC: Prospective Study of GP-88 Blood Test in Healthy Women With Baseline Gail Model Risk Assessment Undergoing Screening for Breast Cancer

Eligible healthy women >= 40 years old at average risk for developing breast cancer will be
offered participation in the study at the time they present for routine screening mammogram
(MM) at the University of Maryland Breast Screening Center and Baltimore Washington Medical
Center; includes women who present to the center as a referral for further diagnostic workup
of recent screening diagnosis of breast cancer <= to 3 months with mammographic findings on
screening MM with BIRADS 0-6<= 3 months.

Informed consent will be reviewed with the study participant and She will be asked if She
wishes to participate in this study. Once the volunteer agrees and signs the consent, her
eligibility criteria will be reviewed by the study coordinator and if eligible the patient
will be enrolled. Her MM, US or MRI results will be obtained and the study subject will be
assigned to one of the 3 cohorts of patients.

COHORT I-BIRADS 1 or 2, COHORT II -BIRADS 3 COHORT III-BIRADS 4-6.

The first blood sample (20ml) for GP-88 will be drawn within 31 days of the initial signing
of the informed consent. It is expected that majority of women attending the screening and
diagnostic program at the UM Breast Center will be approached about this study. The
investigator expects to screen 1400 and consent approximately 800 women in 12 months.

Once deemed eligible the study participant will have their first GP-88 blood sample drawn
(20ml) within 31 days of signing the consent. The investigator will make every effort to
draw the blood sample for GP-88 on the day of the visit to our breast center and will try
not to ask study participants to come back to have the blood samples drawn unless the
patient is willing to do it. However the study participant does have the option to have the
GP-88 blood sample drawn within 31 days of her screening or diagnostic MM, US or breast MRI
or biopsy if she wishes to participate but cannot do it on the day of her visit here. If the
initial-first blood sample is never drawn the patient will be considered a screen failure,
if subsequent blood samples will not be drawn or if the patient does not return for follow
up screening or diagnostic MM or other testing as recommended by the radiologists, she will
be replaced by another subject.

Inclusion Criteria:

- Female greater than or equal to 40 years.

- Presenting to UM Breast Center and BWMC for breast imaging: screening or diagnostic
mammogram, breast ultrasound (US), breast MRI, stereotactic core needle biopsy,
ultrasound core needle biopsy, MRI guided breast biopsy.

- Patients with a recent screening diagnosis of breast cancer < = 3months.

- Patients presenting with mammogram findings with BIRADS of 0-6 < =3 months.

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

Exclusion Criteria:

- Patients with a personal history of stage 0-4 breast cancer >3months.

- Patients who have known severe and/or uncontrolled medical or psychiatric conditions
or other conditions that could affect their participation in the study, or personal
history of other malignancies.

- Patients who are unfit or unable to comply with having breast imaging studies such as
mammogram, ultrasound, and MRI or breast biopsy or with study procedures-blood draw.

- Patients with personal history of ovarian cancer or other cancers.

- Patients with a personal history of breast biopsy positive for atypical ductal
hyperplasia (ADH), atypical lobular hyperplasia (ALH), lobular carcinoma in situ
(LCIS).