Clinical Utility of CTC Test in Medicare-Eligible Metastatic Breast Cancer Patients

Janssen (J&J Innovative Medicine)

Status: Withdrawn

Conditions: Breast Cancer; Metastatic Breast Cancer

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02111031

JDX-2014-001

Details and patient eligibility

About

The objective of the registry study is to demonstrate the clinical utility of the CELLSEARCH® CTC Test among the Medicare-Eligible metastatic Breast Cancer (mBC) patients in the United States. The objective of the present registry is to demonstrate the impact on patient management of the CELLSEARCH® CTC Test among the Medicare-eligible mBC patients. Hereto the hypothesis that the availability of CTC information provides clinicians important, timely information and impacts treatment decisions, will be tested.

This study is IDE-exempt since CELLSEARCH® CTC Test is a legally marketed device in the US, and is being used in accordance with its labeling.

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patient has documented (histologically/pathologically confirmed) mBC diagnosis

• Patient is at least 65 years of age at time of mBC diagnosis
• Patient is male or female
• Patient is being actively treated at the cancer center by a physician who uses or plans to use CTC testing on his mBC patients at lease every quarter.

Exclusion criteria

• Patients breast cancer is secondary not primary

Trial design

0 participants in 1 patient group

Case

Description:

Patients with documented (histologically/pathologically confirmed) mBC diagnosis, at lease 65 years of age at documented mBC diagnosis, and actively treated by a physician at a participating cancer center who routinely (i.e., test at lease every quarter) use CTC testing (excluding patients who sought consults or second opinions).