Clinical Trial Details
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NCT01836640 : Developing Plasma DNA as a Surrogate for Tumor Biopsy to Identify Tumor Genetic Alterations in Patients With Advanced Breast Cancer
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- 3.2 Radiographic evidence of new or progressive metastatic breast cancer by CT
chest/abdomen/pelvis and bone scan, or by PET scan.

- 3.3 Patient must have 3 or more distant sites of disease involving 2 or more organ
sites appropriate for biopsy.

If patient has primary intact, primary tumor must also be biopsied, and this will count as
1 site of disease. If available, biopsies obtained from 2-3 distantly separated regions
of the primary tumor will be counted as independent sites.

If a patient has locally recurrent disease in the breast, tumor in breast must also be
biopsied, and this will count as 1 site of disease. If available, biopsies obtained from
2-3 distantly separated regions of the recurrent breast tumor are preferred.

If a patient has bilateral breast tumors, both tumors must be biopsied;however, a biopsy
of a metastatic tumor will also be required in these patients;skin is not eligible as a
site of metastatic disease in patients with bilateral disease.

If a patient has multicentric disease within one or both breasts (defined as more than one
tumor >1 cm in diameter, tumors must be separated by at least 4 cm), at least one tumor
from each diseased breast must be biopsied;however, a biopsy of a metastatic tumor will
also be required in these patients.

- 3.4 Histologic documentation of metastatic invasive breast cancer with metastasis to
a distant organ site (lung, liver, pleural/peritoneal, skin (if skin, must be >20 cm
away from breast), and/or bone) by core needle or excisional biopsy. It is
preferable to have patients consent to study prior to diagnostic procedure. Ascites
and effusions are eligible as a site of biopsy of metastatic disease, but cytological
analysis by a Pathologist will be required to confirm tumor cell content >50%, and a
sample containing > 1x 106 tumor cells. Fine needle aspirates are not eligible. If
routine evaluation has identified brain metastases and patient is a candidate for
resection of brain tumor, brain is eligible as a metastatic site if tissue is
available for analysis.

- 3.5 Archived tumor tumor biopsy specimens may be used for this study if

1. Biopsy was obtained within 2 months prior to research blood draw.

2. Patient did not receive systemic, endocrine, biological, or radiation therapy in
the interim.

3. Biopsied tumor remains intact at time of research blood draw.

- 3.6 Archived primary tumor may be obtained if available, but it is not required.

- 3.7 The subject must agree to undergo and be able to tolerate the research
biopsy(ies) and blood draw.

- 3.8 Prior chemotherapy, endocrine therapy, or radiotherapy with therapeutic intent
is allowed in the metastatic setting. However, for patients currently receiving such
treatment(s), archived tumor specimens will not count toward the required biopsy of 3

- 3.8. Women or men > age 18.

- 3.9. Ability to give informed consent.

- 3.10 Normal Prothrombin (PT)/International Normalized Ratio (INR) within 30 days of
any diagnostic biopsies.

- 3.11 Negative pregnancy test or beyond reproductive potential.

- 3.12 Medical evaluation by medical oncology within 4 weeks.

- 3.13 Non-smokers only are eligible, see exclusion criteria #4.

Exclusion Criteria:

- 1. Poor venous access (unable to tolerate 19-gauge needle).

- 2. Unable to tolerate blood draw or research biopsy procedures.

- 4. Current smokers, smoked at all within the last 10 years, or have a lifetime
smoking history greater than equal to 5 pk years. (One pack year is equal to smoking
1 pack per day for 1 year; 5 pack years = one pack/day for 5 years, or 1/2 pack/day
for 10 yrs, etc). There is evidence that smoking increased the likelihood of
detecting mutations in cancer-related genes in plasma DNA in healthy individuals
(i.e., who do not have detectable cancer). We wish to avail detecting such genetic
lesions in this pilot study.
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