Characterization of Circulating Tumor Cells (CTC-s) in Patients With Locally Advanced or Metastatic Stage IV Breast Cancer
2 other identifiers
observational
280
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2008
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 4, 2008
CompletedFirst Submitted
Initial submission to the registry
January 12, 2010
CompletedFirst Posted
Study publicly available on registry
January 14, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 8, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 8, 2022
CompletedJuly 5, 2023
July 1, 2023
13.6 years
January 12, 2010
July 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Banking leftover blood. Used for future research purposes that have not yet been determined.
Future
Study Arms (1)
No Treatment
Eligibility Criteria
Brawerman Center-Outpatient clinics (City of Hope), Pasadena Satellite Office
You may qualify if:
- Patients must be \> 18 years old.
- Patients are being treated for breast cancer at City of Hope (COH).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- City of Hope Medical Centerlead
- National Cancer Institute (NCI)collaborator
- Palo Alto Research Centercollaborator
Study Sites (1)
City of Hope Medical Center
Duarte, California, 91010, United States
Related 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 Cellsearch Epithelial Kit (CEK) Demonstrates the CPK Produces Higher Circulating Tumor Cell (CTC) Yields and Is Better Suited for Use in Obtaining CTC's for Molecular Characterization. American Association for Cancer Research 2009; 69(Suppl.): (24). December 15, 2009
RESULT
Related Links
Biospecimen
Whole Blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yuan Yuan, MD, PhD
City of Hope Medical Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2010
First Posted
January 14, 2010
Study Start
September 4, 2008
Primary Completion
April 8, 2022
Study Completion
April 8, 2022
Last Updated
July 5, 2023
Record last verified: 2023-07