Randomized Non-Inferiority Trial Comparing Overall Survival of Patients Monitored With Serum Tumor Marker Directed Disease Monitoring (STMDDM) Versus Usual Care in Patients With Metastatic Hormone Receptor Positive Breast Cancer
Randomized Non-Inferiority Trial Comparing Overall Survival of Patients Monitored With Serum Tumor Marker Directed Disease Monitoring (STMDDM) Versus Usual Care in Patients With Metastatic Hormone Receptor Positive Breast Cancer
This randomized research trial studies how well serum tumor marker directed disease monitoring works in monitoring patients with hormone receptor positive Her2 negative breast cancer that has spread to other places in the body. Using markers to prompt when scans should be ordered may be as good as the usual approach to monitoring disease.
PRIMARY OBJECTIVES:
I. To assess whether patients with HER-2 negative, hormone receptor positive, metastatic breast cancer who are monitored with serum tumor marker directed disease monitoring (STMDDM) have non-inferior overall survival compared to patients monitored with usual care.
SECONDARY OBJECTIVES:
I. To compare cumulative direct healthcare costs through 48 weeks among patients monitored with STMDDM versus those monitored with usual care in this patient population.
II. To assess whether the patient-reported outcomes (PROs) of anxiety and quality of life (QOL) are different among patients who are monitored with STMDDM compared with patients who are monitored with usual care in this patient population.
TERTIARY OBJECTIVES:
I. To assess modality and frequency of disease monitoring testing in the usual care cohort.
II. To assess the association of PROs and patient preferences for disease monitoring testing.
III. To evaluate predictors of physician preferences for disease monitoring testing.
OUTLINE: Patients are randomized into 1 of 2 arms.
ARM I: Patients undergo imaging studies at a minimum frequency of every 12 weeks and continue with usual care disease monitoring for up to 312 weeks in the absence of disease progression.
ARM II: Patients undergo disease specific serum tumor marker (STM) evaluation every 4-8 weeks. Patients with elevated STM, undergo imaging evaluation. Patients continue with STMDDM for up to 312 weeks in the absence of disease progression.
Inclusion Criteria:
STEP 1 REGISTRATION
Patients must have a diagnosis of hormone receptor positive (estrogen receptor positive [ER+] and/or progesterone receptor positive [PR+]), HER-2 negative, metastatic (M1) breast cancer and must be receiving or plan to receive first-line systemic treatment for metastatic disease. (Systemic treatment is any treatment meant to treat the whole body such as endocrine therapy +/- targeted therapy +/- chemotherapy).
Patients must be registered to step 1 between 14 days prior to and 60 days after start of first-line systemic treatment for metastatic disease
Patients must have been tested for the following breast cancer specific STMs after diagnosis of metastatic disease and within +/-14 days of initiation of first-line systemic treatment for metastatic disease:
Testing all three STMs is encouraged but only two are required. Patients must plan to have the same two STMs tested for the duration that the patient is on protocol-specified disease monitoring.
Patients must have systemic radiographic imaging prior to initiation of systemic therapy or within 30 days of initiation of treatment for metastatic breast cancer and prior to step 1 registration. Modality of imaging is at the discretion of the treating physician.
Patients must be willing to obtain disease monitoring (imaging and/or serum tumor markers) from a consistent facility in which the registering site has access to the results for the duration of the study intervention (312 weeks after step 2 randomization). Imaging and STMs do not need to be completed at the same facility.
Patients with known cirrhosis, untreated B12 deficiency, thalassemia, or sickle cell anemia are not eligible as these could cause falsely elevated STM levels
Patients with known brain leptomeningeal metastases are not eligible as they may require regular radiographic monitoring to assess treatment response
Patients must not be currently enrolled or plan to participate in a first-line treatment trial for metastatic breast cancer with a defined monitoring schedule
Patients who are able to complete questionnaires in English or Spanish must participate in patient-reported outcome (PRO) assessments
Patients must not be pregnant due to the potential harm to the fetus from radiation exposure from radiographic imaging
Except for breast cancer (and previous history of breast cancer), no other prior malignancy is allowed with the following exceptions:
Patients must not have received prior systemic therapy for metastatic breast cancer, except for their current line of therapy.
Patients must have decision making capacity and be able to provide informed consent
Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines; use of legally-authorized representative is not permissible for this study. Remote consent is allowed with adequate documentation.
As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
STEP 2 RANDOMIZATION
Patients must be tested for the breast cancer specific STMs that were tested prior to STEP 1 Registration between 56 and 140 days after initiation of first-line systemic therapy for metastatic disease:
Testing all three STMs is encouraged but only two are required. Patients must plan to have the same two STMs tested for the duration that the patient is on protocol-specified disease monitoring.
Anchorage, Alaska 98508, United States
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Jonesboro, Arkansas 72401, United States
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Poulsbo, Washington 98370, United States
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Green Bay, Wisconsin 54303, United States
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research@sncrf.org702-384-0013
research@sncrf.org702-384-0013
research@sncrf.org
research@smcrf.org
research@sncrf.org702-384-0013
research@sncrf.org
research@sncrf.org702-384-0013
research@sncrf.org702-384-0013
research@sncrf.org702-384-0013
research@sncrf.org702-384-0013
research@sncrf.org702-384-0013
research@sncrf.org702-384-0013
research@sncrf.org702-384-0013
research@sncrf.org702-384-0013
research@sncrf.org702-384-0013
research@sncrf.org702-384-0013
research@sncrf.org702-384-0013
research@sncrf.org702-384-0013
research@sncrf.org702-384-0013
603-224-2556
800-339-6484
ONCTrialNow@jefferson.edu215-600-9151
HSC-ClinicalTrialInfo@salud.unm.edu505-925-0348
WBurman@phs.org505-559-6113
Kim.Hoffman@lpnt.net575-556-6545
WBurman@phs.org505-559-6113
CancerClinicalTrials@bassett.org877-547-1750
607-271-7000
CCTO@mssm.edu212-824-7309
CCTO@mssm.edu212-824-7309
CCTO@mssm.edu212-824-7309
nr2616@cumc.columbia.edu212-305-6361
585-275-5830
jfields@cancersmoc.com919-587-9084
tammy.cozad@caromonthealth.org704-834-2810
jfields@cancersmoc.com919-587-9084
jfields@cancersmoc.com910-587-9084
research@vidanthealth.com
OncologyClinicalTrialsFargo@sanfordhealth.org701-323-5760
701-234-6161
605-312-3320
800-437-4010
OncologyClinicalTrialsFargo@sanfordhealth.org701-323-5760
OncologyClinicalTrialsFargo@sanfordhealth.org701-234-6161
clinical.trials@daytonncorp.org937-528-2900
sheree@columbusccop.org800-523-3977
clinical.trials@daytonncorp.org937-528-2900
clinical.trials@daytonncorp.org937-528-2900
sheree@columbusccop.org877-779-7585
ResearchInstituteInquiries@CommonSpirit.org513-853-1300
clinical.trials@daytonncorp.org937-528-2900
ResearchInstituteInquiries@CommonSpirit.org513-853-1300
ResearchInstituteInquiries@CommonSpirit.org513-853-1300
ResearchInstituteInquiries@CommonSpirit.org513-853-1300
TaussigResearch@ccf.org866-223-8100
sheree@columbusccop.org614-488-2118
sheree@columbusccop.org614-488-2118
sheree@columbusccop.org614-566-4475
sheree@columbusccop.org614-566-4475
sheree@columbusccop.org614-488-2118
sheree@columbusccop.org614-234-5433
sheree@columbusccop.org614-566-3275
clinical.trials@daytonncorp.org937-528-2900
sheree@columbusccop.org740-615-0227
sheree@columbusccop.org740-615-2403
sheree@columbusccop.org614-566-3275
sheree@columbusccop.org800-752-9119
clinical.trials@daytonncorp.org937-528-2900
clinical.trials@daytonncorp.org937-528-2900
clinical.trials@daytonncorp.org937-528-2900
clinical.trials@daytonncorp.org937-528-2900
clinical.trials@daytonncorp.org937-528-2900
clinical.trials@daytonncorp.org937-528-2900
sheree@columbusccop.org877-779-7585
sheree@columbusccop.org614-488-2745
TaussigResearch@ccf.org866-223-8100
clinical.trials@daytonncorp.org937-528-2900
clinical.trials@daytonncorp.org937-528-2900
sheree@columbusccop.org740-687-8863
419-226-9617
sheree@columbusccop.org419-526-8018
TaussigResearch@ccf.org866-223-8100
sheree@columbusccop.org800-523-3977
sheree@columbusccop.org614-488-2118
pshoup@toledoclinic.com
TaussigResearch@ccf.org866-223-8100
sheree@columbusccop.org740-393-9000
sheree@columbusccop.org614-488-2745
sheree@columbusccop.org740-348-4000
sheree@columbusccop.org614-488-2118
sheree@columbusccop.org614-488-2118
sheree@columbusccop.org614-488-2118
TaussigResearch@ccf.org866-223-8100
clinical.trials@daytonncorp.org937-528-2900
clinical.trials@daytonncorp.org937-528-2900
TaussigResearch@ccf.org866-223-8100
sheree@columbusccop.org614-488-2118
sheree@columbusccop.org614-488-2118
800-444-3561
clinical.trials@daytonncorp.org937-528-2900
clinical.trials@daytonncorp.org937-528-2900
TaussigResearch@ccf.org866-223-8100
sheree@columbusccop.org614-234-5433
TaussigResearch@ccf.org866-223-8100
clinical.trials@daytonncorp.org937-528-2900
sheree@columbusccop.org740-454-5232
405-752-3402
mccinfo@mtcancer.org406-969-6060
nosall@stcharleshealthcare.org541-706-2909
CanRsrchStudies@providence.org503-215-2614
CanRsrchStudies@providence.org503-215-2614
cherie.cox@bayareahospital.org541-269-8392
CanRsrchStudies@providence.org503-215-2614
mccinfo@mtcancer.org406-969-6060
CanRsrchStudies@providence.org503-215-2614
CanRsrchStudies@providence.org503-215-2614
CanRsrchStudies@providence.org503-215-2614
541-706-2909
503-561-2618
Morgan_M.Horton@lvhn.org610-402-9543
Morgan_M.Horton@lvhn.org610-402-9543
HemonCCTrials@geisinger.edu570-271-5251
lheacock@dh.org215-345-2378
Morgan_M.Horton@lvhn.org610-402-9543
HemonCCTrials@geisinger.edu570-459-2901
Morgan_M.Horton@lvhn.org610-402-9543
HemonCCTrials@geisinger.edu570-374-8555
ONCTrialNow@jefferson.edu215-600-9151
610-983-1908
610-327-7544
HemonCCTrials@geisinger.edu800-275-6401
HemonCCTrials@geisinger.edu570-703-4768
HemonCCTrials@geisinger.edu570-374-8555
HemonCCTrials@geisinger.edu570-271-5251
HemonCCTrials@geisinger.edu570-271-5251
canceranswers@yale.edu203-785-5702
underberga@sjchs.org912-819-5704
864-241-6251
864-241-6251
Kim.Williams3@prismahealth.org864-522-2066
864-241-6251
864-241-6251
864-241-6251
864-241-6251
864-241-6251
underberga@sjchs.org912-819-5704
864-241-6251
OncologyClinicTrialsSF@sanfordhealth.org605-312-3320
OncologyClinicalTrialsSF@SanfordHealth.org605-312-3320
BCCclintrials@bmhcc.org901-226-1366
931-783-2714
BCCclintrials@bmhcc.org901-226-1366
CancerCare@ChesapeakeRegional.com
sharon.hubbard@lpnt.net276-666-7489
deidre.dillon@providence.org360-412-8958
protocols@swog.org
360-788-8223
clinicaltrials@sfmc-gi.org308-398-6518
ResearchInstituteInquiries@CommonSpirit.org253-426-6882
deidre.dillon@providence.org360-412-8958
PCRC-NCORP@Swedish.org206-215-3086
marilyn.birchman@providence.org425-261-3529
PCRC-NCORP@Swedish.org206-215-3086
research@kadlecmed.org509-783-4637
deidre.dillon@providence.org360-412-8958
kmakin-bond@peacehealth.org360-514-2016
360-344-3091
research@valleymed.org425-228-3440
PCRC-NCORP@Swedish.org206-215-3086
KPWAoncologytrials@kp.org206-287-2049
PCRC-NCORP@Swedish.org206-215-3086
PCRC-NCORP@Swedish.org206-215-3086
lkey@peacehealth.org360-788-8238
deidre.dillon@providence.org360-412-8958
kmakin-bond@peacehealth.org360-514-3940
Cheryl.Dodd@providence.org509-897-5993
Memorial-ClinicalTrials@yvmh.org509-574-3535
deidre.dillon@providence.org360-412-8958
Juli.Alford@aspirus.org715-623-9869
oncology.clinical.trials@marshfieldresearch.org800-782-8581
ewd_research_admin@hshs.org920-433-8889
oncology.clinical.trials@marshfieldresearch.org800-782-8581
ewd_research_admin@hshs.org920-433-8889
ewd_research_admin@hshs.org920-433-8889
oncologyclinicaltrials@mhemail.org608-756-6871
cancerctr@gundersenhealth.org608-775-2385
oncology.clinical.trials@marshfieldresearch.org800-782-8581
oncology.clinical.trials@marshfieldresearch.org800-782-8581
Beth.Knetter@aspirus.org715-847-2353
oncology.clinical.trials@marshfieldresearch.org800-782-8581
mmcorc@healthpartners.com952-993-1517
ewd_research_admin@hshs.org920-433-8889
oncology.clinical.trials@marshfieldresearch.org800-782-8581
ewd_research_admin@hshs.org920-433-8889
ewd_research_admin@hshs.org920-433-8889
ewd_research_admin@hshs.org920-433-8889
Beth.Knetter@aspirus.org715-847-2353
oncology.clinical.trials@marshfieldresearch.org800-782-8581
ewd_research_admin@hshs.org920-433-8889
877-405-6866
oncology.clinical.trials@marshfieldresearch.org800-782-8581
oncology.clinical.trials@marshfieldresearch.org800-782-8581
715-422-7718
oncology.clinical.trials@marshfieldresearch.org800-782-8581
ccrp@co-cancerresearch.org303-777-2663
research@billingsclinic.org800-996-2663
mccinfo@mtcancer.org406-969-6060
787-395-7085
787-621-4397
787-274-3387
ctsucontact@westat.com888-823-5923
info@PRoncology.com787-919-7919
787-763-1296