NCT01048918

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

Completed Last updated 5 July 2023

What this trial tests

trial in Locally Advanced Breast Cancer in 280 participants. Completed in 8 April 2022.

Timeline

4 September 2008

Primary endpoint
8 April 2022

8 April 2022

Quick facts

Lead sponsor	City of Hope Medical Center
Status	Completed
Study type	OBSERVATIONAL
Enrollment	280
Start date	4 September 2008
Primary completion	8 April 2022
Estimated completion	8 April 2022
Sites	1 location across United States

Conditions studied

• Locally Advanced Breast Cancer — all drugs for Locally Advanced Breast Cancer →
• Metastatic (Stage IV) Breast Cancer — all drugs for Metastatic (Stage IV) Breast Cancer →
• Stage III-IV Breast Cancer or Inflammatory — all drugs for Stage III-IV Breast Cancer or Inflammatory →

Sponsor

City of Hope Medical Center

Who can join

18 and older, female only, with Locally Advanced Breast Cancer or Metastatic (Stage IV) Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. A conduit to metastasis: circulating tumor cell biology.
   Micalizzi DS, Maheswaran S, Haber DA. · · 2017 · cited 320× · PMID 29051388 · DOI 10.1101/gad.305805.117
2. Circulating tumor cells: a review of present methods and the need to identify heterogeneous phenotypes.
   Millner LM, Linder MW, Valdes R. · · 2013 · cited 127× · PMID 23884225
3. Multiple biomarker expression on circulating tumor cells in comparison to tumor tissues from primary and metastatic sites in patients with locally advanced/inflammatory, and stage IV breast cancer, using a novel detection technology.
   Somlo G, Lau SK, Frankel P, Hsieh HB, et al · · 2011 · cited 98× · PMID 21499685 · DOI 10.1007/s10549-011-1508-0
4. Exploring Glycan Markers for Immunotyping and Precision-targeting of Breast Circulating Tumor Cells.
   Wang D, Liu X, Hsieh B, Bruce R, et al · · 2015 · cited 16× · PMID 26657044 · DOI 10.1016/j.arcmed.2015.11.007
5. Prognostic significance of prospectively detected bone marrow micrometastases in esophagogastric cancer: 10-year follow-up confirms prognostic significance.
   Ryan P, Furlong H, Murphy CG, O'Sullivan F, et al · · 2015 · cited 6× · PMID 25914238 · DOI 10.1002/cam4.470
6. Redefining cancer care: harnessing circulating tumor cells' potential for improved diagnosis and prognosis.
   Janjua D, Chaudhary A, Joshi U, Tripathi T, et al · · 2025 · cited 4× · PMID 40676582 · DOI 10.1186/s12935-025-03883-y
7. Detection, significance and potential utility of circulating tumor cells in clinical practice in breast cancer (Review).
   Rusnáková DŠ, Aziri R, Dubovan P, Jurík M, et al · · 2025 · cited 3× · PMID 39492933 · DOI 10.3892/ol.2024.14756