NCT02111031 - Clinical Utility of CTC Test in Medicare-Eligible Metastatic Breast Cancer Patients | Crick

Overview

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.

Study Type

OBSERVATIONAL

Conditions

Metastatic Breast Cancer Breast Cancer

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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

Locations (2)

Abramson Cancer Center, University of Pennsylvania

Philadelphia, Pennsylvania, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Percentage of treatment decisions that are indicated to be changed by the availability CTC results, stratified by relevant criteria (e.g. patient and tumor characteristics, concordance and discordance with other test results)

Percentage of treatment decisions that are indicated to be changed by the availability CTC results, stratified by relevant criteria (e.g. patient and tumor characteristics, concordance and discordance with other test results).

Time frame: 15 months

The percentage of treatment decisions for which CTC results are indicated to add value to treatment decision making, stratified by relevant criteria (e.g. patient and tumor characteristics, concordance and discordance with other test results)

Time frame: 15 Months

Secondary Outcomes

The relative value of CTC testing in treatment decisions as compared to other parameters, stratified by relevant criteria (e.g. patient and tumor characteristics, concordance and discordance with other test results)

Time frame: 15 months

Overall survival, calculated as the median (+/- standard deviation [SD]) length of time from initial diagnosis to death.

Overall survival, calculated as the median (+/- standard deviation \[SD\]) length of time from initial diagnosis to death.

Time frame: 60 months