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Metastatic Breast CancerCOMETI P2NCT01701050

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

An observational study of Metastatic Breast Cancer, run by Janssen Diagnostics, LLC at 20 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Metastatic Breast Cancer
What is being tested?
Blood collection
How many people
121 participants
Where
20 sitesin 2 countries
Study dates
1 Apr 2013to 10 Nov 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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;
Show all 13Show fewer
  • 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.

Who cannot join

  • 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).

Trial locations and contacts

20 sites in 2 countries.

20 sites in 2 countries

United States18 sites

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Dana-Faber Cancer Institute

    Boston, Massachusetts, 02215

  • Waverly Hematology Oncology

    Cary, North Carolina, 27518

  • Texas Oncology - Baylor

    Dallas, Texas, 75246

  • Duke University

    Durham, North Carolina, 27710

  • Florida Cancer Specialists

    Fort Myers, Florida, 33905

  • Comprehensive Cancer Centers of Nevada

    Henderson, Nevada, 89074

  • Texas Oncology

    Houston, Texas, 77024

  • Minnesota Oncology Hematology

    Minneapolis, Minnesota, 55404

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203

  • New York Oncology Hematology

    New York, New York, 12206

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130

  • Abramson Cancer Center, University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Arizona Oncology Associates

    Phoenix, Arizona, 85016

  • Northwest Cancer Specialists

    Portland, Oregon, 97213

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Florida Cancer Specialists

    St. Petersburg, Florida, 33705

Other trials in United States

Canada2 sites

  • Mt. Sinai Hosp., Marvette Koffler Breast Center

    Toronto, Ontario, M5G 1X5

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

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

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.

Read the detailed description

Patients with estrogen receptor (ER) positive metastatic breast cancer (MBC) starting their first line of endocrine therapy (ET) only have a 30-50% chance of receiving clinical benefit. For the other 50-70% of patients, ET is ineffective and these patients should probably be treated with chemotherapy, as is done for ER negative patients. More importantly, in nearly every clinical trial of ET in ER positive, MBC patients, between 15-30% of enrolled patients progress in the first 2-3 months, regardless of whether they are receiving first or later lines of ET. Currently there is no validated method to identify which ER positive MBC patients will be refractory to ET. Therefore, almost all ER positive patients are treated with serial endocrine therapies before switching to chemotherapy. The investigators propose that a subset of these patients would be better served with chemotherapy, in spite of its increased toxicity profile, rather than delaying chemotherapy during a several month trial of ineffective, albeit less toxic, ET.

To try and predict benefit from or resistance to ET, an index (the CTC-ETI) has been created that takes into account the number of CTC (which is prognostic) as well as the phenotype of the CTC, based on the hypothesis that relative levels of ER and Bcl-2 (high=benefit) and HER2 and Ki67 (high=resistance) are predictive of ET responsiveness or resistance. Although the preliminary data demonstrate the ability to detect, enumerate, and characterize CTC utilizing the CellSearch® System, the purpose of the current study is to establish proof of principle that these 4 markers can be used to generate a CTC-ETI which can be performed at baseline from patients enrolled at different centers, and that baseline CTC-ETI predicts relative outcome for patients with ER positive MBC starting a new ET, and can be monitored in such patients during ET. Successful completion of this study will set the stage for a larger, definitive study designed to demonstrate the clinical utility of a "refined" CTC-ETI in patients with ER positive, HER2 negative MBC.

Being tested
Blood collection
Keywords
circulating tumor cells, CTC, metastatic breast cancer, endocrine therapy, hormone therapy
Medical subject headings
Breast Neoplasms, Neoplastic Cells, Circulating

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood collectionOther

    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.

Study groups in NCT01701050
Study groupRoleWhat they receive
Blood collectionFemale 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.
Receives: Other: Blood collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (1)

  1. Progression Free Survival (PFS)

    Within 30 days prior to the initiation of of a new line of endocrine therapy (ET), chest \& abdomen body imaging (computed tomography [CT], or magnetic resonance imagine [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, 6 months, 9 months, and up to 12 months after the initiation of therapy. Objective tumor response will be determined using RECIST v1.1 criteria. Progression Free Survival (PFS) will be measured as the time from the date of starting ET until the date of first documentation of progressive disease according to RECIST v1.1 criteria or death due to any cause. In the absence of these events, PFS will be censored at the date of the last objective disease assessment (up to a maximum of 12 months after the initiation of ET).

    Measured: Up to 12 months after initiation of therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2012 (estimated)
  2. Study start1 Apr 2013
  3. Primary completion10 Nov 2016
  4. Study completion10 Nov 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01701050
Sponsor's protocol ID
COMETI-P2-2012
Acronym
COMETI P2
Status last verified
Mar 2017
First submitted
1 Oct 2012
Last updated
8 Mar 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

  • 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.

Questions about this trial

What is this clinical trial studying?

An observational study of Metastatic Breast Cancer, run by Janssen Diagnostics, LLC at 20 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rapid Disease Progression (time frame: Within 3 months after initiation of a new line of enrocrine therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01701050, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2017.

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