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Completed No phase listed Observational

Characterization of Circulating Tumor Cells (CTC) From Patients With Metastatic Breast Cancer Using the CTC-Endocrine Therapy Index

ClinicalTrials.gov ID: NCT01701050

Public ClinicalTrials.gov record NCT01701050. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 27, 2026, 5:37 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

COMETI Phase 2: Characterization of Circulating Tumor Cells (CTC) From Patients With Metastatic Breast Cancer Using the CTC-Endocrine Therapy Index

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Utilizing CellSearch® technology, the ability to both enumerate and reliably and reproducibly characterize circulating tumor cells (CTC) for tumor markers that predict endocrine sensitivity (estrogen receptor \[ER\] and Bcl-2) and resistance (HER2 and Ki67) has been demonstrated. An algorithm for a CTC-Endocrine Therapy Index (CTC-ETI) has been constructed that can be calculated for each patient using the CTC enumeration and marker results. The primary goal of this study is to determine a CTC-ETI in ER positive, HER2 negative metastatic breast cancer patients before the initiation of a new endocrine therapy for the identification of patients that will progress rapidly.

Study identification

NCT ID
NCT01701050
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Lead sponsor
Janssen Diagnostics, LLC
Industry
Enrollment
121 participants

Conditions and interventions

Interventions

Other

Eligibility (public fields only)

Age range
18 Years and older
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 1, 2013 (Actual)
Primary completion
Nov 10, 2016 (Actual)
Completion
Nov 10, 2016 (Actual)
Last update posted
Mar 8, 2017

2013 – 2016

United States locations

U.S. sites
18
U.S. states
13
U.S. cities
17
Facility City State ZIP Site status
Arizona Oncology Associates Phoenix Arizona 85016 —
Florida Cancer Specialists Fort Myers Florida 33905 —
Florida Cancer Specialists St. Petersburg Florida 33705 —
Dana-Faber Cancer Institute Boston Massachusetts 02215 —
University of Michigan Comprehensive Cancer Center Ann Arbor Michigan 48109 —
Minnesota Oncology Hematology Minneapolis Minnesota 55404 —
Mayo Clinic Rochester Minnesota 55905 —
Nebraska Cancer Specialists Omaha Nebraska 68130 —
Comprehensive Cancer Centers of Nevada Henderson Nevada 89074 —
New York Oncology Hematology New York New York 12206 —
Waverly Hematology Oncology Cary North Carolina 27518 —
Duke University Durham North Carolina 27710 —
Northwest Cancer Specialists Portland Oregon 97213 —
Abramson Cancer Center, University of Pennsylvania Philadelphia Pennsylvania 19104 —
Thomas Jefferson University Philadelphia Pennsylvania 19107 —
Tennessee Oncology, PLLC Nashville Tennessee 37203 —
Texas Oncology - Baylor Dallas Texas 75246 —
Texas Oncology Houston Texas 77024 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01701050, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 8, 2017 · Synced Oct 27, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01701050 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →