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Characterization of Circulating Tumor Cells (CTCs) to Direct Pre-Operative and Systemic Therapy in Patients With Locally Advanced or Metastatic Stage IV Breast Cancer


N/A
18 Years
N/A
Open (Enrolling)
Female
Locally Advanced Breast Cancer, Metastatic (Stage IV) Breast Cancer, Stage III-IV Breast Cancer or Inflammatory

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Trial Information

Characterization of Circulating Tumor Cells (CTCs) to Direct Pre-Operative and Systemic Therapy in Patients With Locally Advanced or Metastatic Stage IV Breast Cancer


Up to 60 mL of blood will be collected from each patient at up to 6 time points. Samples
will be delivered to the Bruce Laboratory (Palo Alto Research Center) for immunolabeling and
FAST scanning. The FAST scanning will utilize CK+, CD45-and DAPI+ labeling as well as cell
morphology confirmed by collaborating pathologists to select for CTC with the technology
allowing for assessment of up to four additional protein expressions on the surface of
CTC's. Additional samples at the proposed time points will be placed on ice and sent over
to the Wang Laboratory for the purpose of extracting RNA/microRNA and proteins from CTC's
for profiling and further analysis. Benefits are only to society, not the individual.
Knowledge obtained from applying the two technologies may help with better selection of
therapy, early detection of progression, possibly better diagnosis and development of
targeted therapeutic agents in the future.


Inclusion Criteria:



- Patients must be > 18 years old.

- Patients are being treated for breast cancer at City of Hope (COH).

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Targets ER, Her2, and possible M30, VEGFR2, EGFR. Tumor cells found in blood stream.

Outcome Time Frame:

Blood will be collected at up to 6 time points: Prior to initiating therapy, 8-12 weeks, 20-24 weeks, and at 9,12 and 24 months after initiation of therapy.

Safety Issue:

No

Principal Investigator

Georg Somlo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

City of Hope Medical Center

Authority:

United States: Institutional Review Board

Study ID:

08128

NCT ID:

NCT01048918

Start Date:

September 2008

Completion Date:

August 2014

Related Keywords:

  • Locally Advanced Breast Cancer
  • Metastatic (Stage IV) Breast Cancer
  • Stage III-IV Breast Cancer or Inflammatory
  • Circulating tumor cells in breast cancer
  • Breast Neoplasms
  • Neoplastic Cells, Circulating

Name

Location

City of Hope Medical Center Duarte, California  91010