Characterization of Circulating Tumor Cells (CTC-s) in Patients With Locally Advanced or Metastatic Stage IV Breast Cancer

Locally Advanced Breast Cancer Clinical Trial

Official title:

Characterization of Circulating Tumor Cells (CTC-s) in Patients With Locally Advanced or Metastatic Stage IV Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01048918
• Other study ID #: 08128
• Secondary ID: CA 111359
• Status: Completed
• Start date: September 4, 2008
• Est. completion date: April 8, 2022

Study information

• Verified date: July 2023
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to identify tumor cells in the bloodstream (Circulating Tumor Cells, CTC's) from patient's with locally advanced or metastatic (stage IV) breast cancer. Analyzing the tumor is helpful in guiding therapy; however, research has suggested that the number of tumor cells found in the bloodstream (CTC's) signifies more aggressive behavior and increased difficulty in eliminating the cancer. This research will help to develop better ways to treat breast cancer which could be tailored to a patient and may be adjusted to a patient's individual needs.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: April 8, 2022
• Est. primary completion date: April 8, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients must be > 18 years old.
• Patients are being treated for breast cancer at City of Hope (COH).

Related Conditions & MeSH terms

• Breast Neoplasms
• Locally Advanced Breast Cancer
• Metastatic (Stage IV) Breast Cancer
• Neoplastic Cells, Circulating
• Stage III-IV Breast Cancer or Inflammatory

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (3)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI), Palo Alto Research Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

Flores LM, Kindelberger DW, Ligon AH, Cappeletti M, Fiorentino M, Loda M, Cibas ES, Janne PA, Krop IE. Dana-Farber Cancer Institute, Boston, MA; Brigham and Women's Hospital, Boston, MA. Comparison of the Cellsearch Profile Kit (CPK) with the Standard Cel

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Targets ER, Her2, and possible M30, VEGFR2, EGFR. Tumor cells found in blood stream.		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.
Secondary	Banking leftover blood. Used for future research purposes that have not yet been determined.		Future

External Links

•   San Antonio Breast Cancer Symposium