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

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.

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Key information

Conditions

Locally Advanced Breast Cancer Breast Diseases Breast Neoplasms Metastatic (Stage IV) Breast Cancer Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Stage III-IV Breast Cancer or Inflammatory

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

City of Hope Medical Center

Duarte, California, 91010, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Primary outcomes

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

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.

Secondary outcomes

Banking leftover blood. Used for future research purposes that have not yet been determined.

Time frame: Future

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

National Cancer Institute (NCI)
Palo Alto Research Center

Registry information

Important dates

Study start: 2008
Primary completion: 2022
Study completion: 2022
First posted: Jan 14, 2010
Registry last updated: Jul 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed