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

NCT01701050 | Completed

• 1 other identifier: COMETI-P2-2012
• Study Type: observational
• Target: 121
• Locations: 2 countries
• Sites: 20

Brief Summary

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.

Conditions

Metastatic Breast Cancer

Keywords

circulating tumor cells; CTC; metastatic breast cancer; endocrine therapy; hormone therapy

Outcome Measures

Primary Outcomes (1)

• Rapid Disease Progression

  Within 30 days prior to the initiation of therapy, chest \& abdomen body imaging (computed tomography \[CT\], or magnetic resonance imaging \[MRI\] scanning) plus bone scintigraphic imaging (bone scans or PET scans) or PET-CT scans which encompass both will be performed to identify target and non-target lesions that will be followed with the same imaging techniques 3 months after the initiation of therapy. Objective tumor response will be determined using RECIST v1.1 criteria. Rapid disease progression will be defined as disease progression according to RECIST v1.1 criteria or death due to metastatic breast cancer within 3 months of starting a new ET.

  Within 3 months after initiation of a new line of enrocrine therapy

Secondary Outcomes (1)

• Progression Free Survival (PFS)

  Up to 12 months after initiation of therapy

Other Outcomes (2)

• Biomarker correlations

  End of study (up to 12 months after enrollment of final patient)

• Analytic Validity

  Baseline blood draw (within 30 days prior to the initiation of therapy)

Study Arms (1)

Blood collection

Female patients 18 years or older with estrogen receptor (ER) positive, HER2 negative, progressive metastatic breast cancer after one or more lines of endocrine therapy (ET) who are initiating a new ET will be enrolled into the study. Patients must have immunohistochemistry (IHC) proven ER positive disease, IHC and/or fluorescence in-situ hybridization (FISH) proven HER2 negative disease, and an ECOG performance status of 0-2. Patients with brain metastases only or those who are progressing on fulvestrant are not eligible for the study.

Other: Blood collection

Interventions

Blood collection OTHER

Patients will have blood drawn for circulating tumor cell (CTC) endocrine therapy index (CTC-ETI) calculation at baseline (within 30 days prior to the initiation of endocrine therapy) and then subsequently 1, 2, 3 and up 12 months after the initiation of therapy, or at the time of disease progression, whichever occurs first.

Blood collection

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Female patients 18 years or older with estrogen receptor (ER) positive, HER2 negative, progressive metastatic breast cancer (MBC) after one or more lines of endocrine therapy (ET) who are initiating a new ET will be enrolled into the study. Patients must have immunohistochemistry (IHC) proven ER positive disease, IHC and/or fluorescence in-situ hybridization (FISH) proven HER2 negative disease, and an ECOG performance status of 0-2. Patients with brain metastases only or those who are progressing on fulvestrant are not eligible for the study.

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).

Sponsors & Collaborators

• Janssen Diagnostics, LLC: lead

Study Sites (20)

Arizona Oncology Associates

Phoenix, Arizona, 85016, United States

Location

Florida Cancer Specialists

Fort Myers, Florida, 33905, United States

Location

Florida Cancer Specialists

St. Petersburg, Florida, 33705, United States

Location

Dana-Faber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Minnesota Oncology Hematology

Minneapolis, Minnesota, 55404, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Nebraska Cancer Specialists

Omaha, Nebraska, 68130, United States

Location

Comprehensive Cancer Centers of Nevada

Henderson, Nevada, 89074, United States

Location

New York Oncology Hematology

New York, New York, 12206, United States

Location

Waverly Hematology Oncology

Cary, North Carolina, 27518, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Northwest Cancer Specialists

Portland, Oregon, 97213, United States

Location

Abramson Cancer Center, University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Tennessee Oncology, PLLC

Nashville, Tennessee, 37203, United States

Location

Texas Oncology - Baylor

Dallas, Texas, 75246, United States

Location

Texas Oncology

Houston, Texas, 77024, United States

Location

Mt. Sinai Hosp., Marvette Koffler Breast Center

Toronto, Ontario, M5G 1X5, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (2)

• Paoletti C, Connelly MC, Chianese D, et al. Multi-parameter molecular characterization of circulating tumor cells (CTC): Development of a CTC-Endocrine Therapy Index (CTC-ETI). Proc Am Assoc Cancer Res, Abstract 4154, 2011.

  BACKGROUND

• Paoletti C, Connelly M, Chianese D, et al. Development of Circulating Tumor Cell-Endocrine Therapy Index in Metastaic Breast Cancer Patients. Cancer Research 71(24 Suppl):451 (Abs. P4-07-16), 2011.

  BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Cartridges containing Circulating Tumor Cells (isolated by CellSearch) as well as primary and/or metastatic tumor tissue (blocks or slides).

MeSH Terms

Conditions

Breast Neoplasms; Neoplastic Cells, Circulating

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Daniel F Hayes, M.D.

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

• Costanza Paoletti, M.D.

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2012
• First Posted: October 4, 2012
• Study Start: April 1, 2013
• Primary Completion: November 10, 2016
• Study Completion: November 10, 2016
• Last Updated: March 8, 2017

Record last verified: 2017-03

Locations

US (18); CA (2)