Characterization of Circulating Tumor Cells (CTC) From Patients With Metastatic Breast Cancer Using the CTC-Endocrine Therapy Index (COMETI P2)
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ClinicalTrials.gov Identifier: NCT01701050 |
Recruitment Status
:
Completed
First Posted
: October 4, 2012
Last Update Posted
: March 8, 2017
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Tracking Information | |||||||
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First Submitted Date | October 1, 2012 | ||||||
First Posted Date | October 4, 2012 | ||||||
Last Update Posted Date | March 8, 2017 | ||||||
Actual Study Start Date | April 1, 2013 | ||||||
Actual Primary Completion Date | November 10, 2016 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures |
Rapid Disease Progression [ Time Frame: Within 3 months after initiation of a new line of enrocrine therapy ] 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.
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Original Primary Outcome Measures |
Rapid Disease Progression [ Time Frame: Within 3 months after initiation of a new line of enrocrine therapy ] Within 21 days prior to the initiation of therapy, whole body anatomic imaging (CT, or MRI scanning) 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 MBC within 3 months of starting a new ET.
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Change History | Complete list of historical versions of study NCT01701050 on ClinicalTrials.gov Archive Site | ||||||
Current Secondary Outcome Measures |
Progression Free Survival (PFS) [ Time Frame: Up to 12 months after initiation of therapy ] 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).
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Original Secondary Outcome Measures |
Progression Free Survival (PFS) [ Time Frame: Up to 12 months after initiation of therapy ] Within 21 days prior to the initiation of therapy, whole body anatomic imaging (CT, or MRI scanning) 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. 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).
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Current Other Outcome Measures |
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Original Other Outcome Measures |
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Descriptive Information | |||||||
Brief Title | Characterization of Circulating Tumor Cells (CTC) From Patients With Metastatic Breast Cancer Using the CTC-Endocrine Therapy Index | ||||||
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 | 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. | ||||||
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. |
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Study Type | Observational | ||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||||
Biospecimen | Retention: Samples With DNA Description: Cartridges containing Circulating Tumor Cells (isolated by CellSearch) as well as primary and/or metastatic tumor tissue (blocks or slides). |
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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. | ||||||
Condition | Metastatic Breast Cancer | ||||||
Intervention | Other: Blood collection
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. |
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Study Groups/Cohorts | 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.
Intervention: Other: Blood collection |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status | Completed | ||||||
Actual Enrollment |
121 | ||||||
Original Estimated Enrollment |
200 | ||||||
Actual Study Completion Date | November 10, 2016 | ||||||
Actual Primary Completion Date | November 10, 2016 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries | Canada, United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number | NCT01701050 | ||||||
Other Study ID Numbers | COMETI-P2-2012 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement | Not Provided | ||||||
Responsible Party | Janssen Diagnostics, LLC | ||||||
Study Sponsor | Janssen Diagnostics, LLC | ||||||
Collaborators | Not Provided | ||||||
Investigators |
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PRS Account | Janssen Diagnostics, LLC | ||||||
Verification Date | March 2017 |