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

Completed

Conditions studied: Metastatic Breast Cancer

In brief

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.

Key facts

Study ID

NCT01701050

Run by

Janssen Diagnostics, LLC

People needed

121

Starts

2013-04-01

Expected to finish

2016-11-10

Last updated by the study team

2017-03-08

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent.
• Women who are 18 years or older.
• Patients must have estrogen receptor (ER) positive, HER2 negative metastatic breast cancer (MBC) with at least one non-irradiated distant site of metastasis.
• ECOG performance status of 0-2.
• Patients must have currently progressive metastatic disease according to RECIST v1.1 criteria, AND
• They have progressed on at least one previous line of endocrine therapy (ET) for their metastatic disease (but are not currently progressing on fulvestrant), OR;
• They show evidence of disease progression during or within 12 months of the end of adjuvant ET.
• Patient is about to start a new line of ET for their metastatic disease
• Patient is willing and able to undergo standard of care imaging studies (same imaging/staging modality being used at each evaluation), which are anticipated to be performed prior to the initiation of therapy and subsequently every 3 months.
• Patient agrees to the collection and testing of their blood and is willing and able to provide approximately 40mL blood draw(s) at:
• Baseline (prior to the initiation of new ET), and;
• Subsequently at 1, 2, 3 and 12 months after the initiation of therapy, and/or;
• Time of disease progression.

You may not qualify if…

• Patients with local regional recurrence only or brain only metastasis.
• Patients who are progressing on current fulvestrant therapy (patients who have had fulvestrant therapy in the past and were subsequently treated with other therapies or those who are starting fulvestrant as their next line of ET are eligible for the study).
• Patients who are or will be taking other unapproved (i.e. not cleared/approved by the FDA) anti-neoplastic therapies concurrently are not eligible (exception: ET with everolimus is acceptable).
• Patients with concomitant malignancies or previous malignancies within the last 5 years, with exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
• Unable to provide informed consent or high risk that patient may not comply with protocol requirements (i.e. due to health and/or participation in other research studies).

Where it is running

• Arizona Oncology Associates — Phoenix, Arizona, United States
• Florida Cancer Specialists — Fort Myers, Florida, United States
• Florida Cancer Specialists — St. Petersburg, Florida, United States
• Dana-Faber Cancer Institute — Boston, Massachusetts, United States
• University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
• Minnesota Oncology Hematology — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Nebraska Cancer Specialists — Omaha, Nebraska, United States
• Comprehensive Cancer Centers of Nevada — Henderson, Nevada, United States
• New York Oncology Hematology — New York, New York, United States
• Waverly Hematology Oncology — Cary, North Carolina, United States
• Duke University — Durham, North Carolina, United States
• Northwest Cancer Specialists — Portland, Oregon, United States
• Abramson Cancer Center, University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Tennessee Oncology, PLLC — Nashville, Tennessee, United States
• Texas Oncology - Baylor — Dallas, Texas, United States
• Texas Oncology — Houston, Texas, United States
• Mt. Sinai Hosp., Marvette Koffler Breast Center — Toronto, Ontario, Canada
• Princess Margaret Hospital — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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