S1703 Serum Tumor Marker Directed Disease Monitoring in Patients With Hormone Receptor Positive Her2 Negative Metastatic Breast Cancer
Anatomic Stage IV Breast Cancer AJCC v8, Estrogen Receptor Positive, HER2/Neu Negative
About this trial
This is an interventional health services research trial for Anatomic Stage IV Breast Cancer AJCC v8
Eligibility Criteria
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).
- NOTE: Participants are eligible if they have either de-novo metastatic breast cancer and/or recurrent breast cancer from an earlier stage that is now metastatic
- 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:
- CEA (must be tested)
- CA 15-3 or CA 27.29 (at least one of these must be tested)
- At least one of the tested STMs must have been >= 2 x the institutional upper limit of normal at this time.
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.
- Note: the treating physician can order additional imaging tests at any point prior to randomization at their discretion
- 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 except for adequately treated basal (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease free for five years
- 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
- 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:
- CEA (must be tested)
- CA 15-3 or CA 27.29 (whichever was tested prior to Step 1)
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.
- At least one of the STMs that was previously elevated must have decreased from the assessment at step 1 by >= 10% at this time.
- Patients must not have known progression since registration to step 1
- Patients must be registered to step 2 randomization between 56 days and 140 days after the initiation of first-line systemic therapy for metastatic disease; This window is inclusive; patients may be registered to Step 2 on day 56 or Day 140. Patients must have been eligible for Step 1 in order to be eligible for Step 2 Randomization
- Baseline questionnaires must be completed within 28 days prior to step 2 randomization; (Note: Those patients who cannot complete the PRO questionnaires in English or Spanish can be registered to step 2 without contributing to PRO research)
Sites / Locations
- Anchorage Associates in Radiation MedicineRecruiting
- Anchorage Radiation Therapy CenterRecruiting
- Alaska Breast Care and Surgery LLCRecruiting
- Alaska Oncology and Hematology LLCRecruiting
- Alaska Women's Cancer CareRecruiting
- Anchorage Oncology CentreRecruiting
- Katmai Oncology GroupRecruiting
- Providence Alaska Medical CenterRecruiting
- Fairbanks Memorial HospitalRecruiting
- Kingman Regional Medical CenterRecruiting
- Cancer Center at Saint Joseph'sRecruiting
- University of Arizona Cancer Center-Orange Grove CampusRecruiting
- Banner University Medical Center - TucsonRecruiting
- University of Arizona Cancer Center-North CampusRecruiting
- Mercy Hospital Fort SmithRecruiting
- CHI Saint Vincent Cancer Center Hot Springs
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - JonesboroRecruiting
- University of Arkansas for Medical SciencesRecruiting
- Kaiser Permanente-AnaheimRecruiting
- Mission Hope Medical Oncology - Arroyo GrandeRecruiting
- PCR OncologyRecruiting
- Kaiser Permanente-Baldwin ParkRecruiting
- Kaiser Permanente-BellflowerRecruiting
- Providence Saint Joseph Medical Center/Disney Family Cancer CenterRecruiting
- Marshall Cancer CenterRecruiting
- Mercy Cancer Center �� CarmichaelRecruiting
- Mercy San Juan Medical CenterRecruiting
- Epic Care-DublinRecruiting
- Mercy Cancer Center - Elk GroveRecruiting
- Bay Area Breast Surgeons IncRecruiting
- Epic Care Partners in Cancer CareRecruiting
- Kaiser Permanente-FontanaRecruiting
- Kaiser Permanente-IrvineRecruiting
- Kaiser Permanente Los Angeles Medical CenterRecruiting
- Los Angeles County-USC Medical Center
- USC / Norris Comprehensive Cancer Center
- Kaiser Permanente West Los AngelesRecruiting
- Contra Costa Regional Medical CenterRecruiting
- Providence Queen of The ValleyRecruiting
- USC Norris Oncology/Hematology-Newport Beach
- Bay Area Tumor InstituteRecruiting
- Kaiser Permanente-OntarioRecruiting
- Desert Regional Medical Center
- Kaiser Permanente - Panorama CityRecruiting
- Keck Medical Center of USC Pasadena
- Kaiser Permanente-RiversideRecruiting
- Mercy Cancer Center - RocklinRecruiting
- Mercy Cancer Center - SacramentoRecruiting
- Kaiser Permanente-San Diego MissionRecruiting
- Kaiser Permanente-San Diego ZionRecruiting
- Pacific Central Coast Health Center-San Luis ObispoRecruiting
- Kaiser Permanente-San MarcosRecruiting
- Mission Hope Medical Oncology - Santa MariaRecruiting
- Providence Medical Foundation - Santa RosaRecruiting
- Providence Santa Rosa Memorial HospitalRecruiting
- Saint Joseph's Medical Center
- Epic Care Cyberknife CenterRecruiting
- Kaiser Permanente-Woodland HillsRecruiting
- Woodland Memorial HospitalRecruiting
- Rocky Mountain Cancer Centers-AuroraRecruiting
- The Medical Center of Aurora
- Boulder Community HospitalRecruiting
- Boulder Community Foothills HospitalRecruiting
- Rocky Mountain Cancer Centers-BoulderRecruiting
- Rocky Mountain Cancer Centers - CentennialRecruiting
- Penrose-Saint Francis HealthcareRecruiting
- Rocky Mountain Cancer Centers-PenroseRecruiting
- Saint Francis Cancer CenterRecruiting
- Cancer Center of Colorado at Sloan's Lake
- Denver Health Medical Center
- National Jewish Health-Main CampusRecruiting
- The Women's Imaging CenterRecruiting
- Porter Adventist HospitalRecruiting
- Colorado Blood Cancer InstituteRecruiting
- Presbyterian - Saint Lukes Medical Center - Health OneRecruiting
- Rocky Mountain Cancer Centers-MidtownRecruiting
- SCL Health Saint Joseph Hospital
- Rocky Mountain Cancer Centers-RoseRecruiting
- Rose Medical Center
- Western Surgical Care
- Mercy Medical CenterRecruiting
- Southwest Oncology PCRecruiting
- Mountain Blue Cancer Care Center - SwedishRecruiting
- Rocky Mountain Cancer Centers - SwedishRecruiting
- Swedish Medical CenterRecruiting
- The Melanoma and Skin Cancer InstituteRecruiting
- Mountain Blue Cancer Care Center
- National Jewish Health-Western Hematology OncologyRecruiting
- Saint Mary's Hospital and Regional Medical Center
- North Colorado Medical Center
- Good Samaritan Medical Center
- Rocky Mountain Cancer Centers-LakewoodRecruiting
- Saint Anthony HospitalRecruiting
- Rocky Mountain Cancer Centers-LittletonRecruiting
- Littleton Adventist HospitalRecruiting
- Rocky Mountain Cancer Centers-Sky RidgeRecruiting
- Sky Ridge Medical Center
- Longmont United HospitalRecruiting
- Rocky Mountain Cancer Centers-Longmont
- McKee Medical Center
- Parker Adventist HospitalRecruiting
- Rocky Mountain Cancer Centers-Parker
- Saint Mary Corwin Medical CenterRecruiting
- Rocky Mountain Cancer Centers - Pueblo
- National Jewish Health-Northern Hematology OncologyRecruiting
- Rocky Mountain Cancer Centers-ThorntonRecruiting
- SCL Health Lutheran Medical Center
- Smilow Cancer Hospital-Derby Care CenterRecruiting
- Smilow Cancer Hospital Care Center-FairfieldRecruiting
- Smilow Cancer Hospital Care Center at GlastonburyRecruiting
- Smilow Cancer Hospital Care Center at GreenwichRecruiting
- Smilow Cancer Hospital Care Center - GuilfordRecruiting
- Smilow Cancer Hospital Care Center at Saint FrancisRecruiting
- Smilow Cancer Center/Yale-New Haven HospitalRecruiting
- Yale UniversityRecruiting
- Yale-New Haven Hospital North Haven Medical CenterRecruiting
- Smilow Cancer Hospital-Orange Care CenterRecruiting
- Smilow Cancer Hospital Care Center at Long RidgeRecruiting
- Smilow Cancer Hospital-Torrington Care CenterRecruiting
- Smilow Cancer Hospital Care Center-TrumbullRecruiting
- Smilow Cancer Hospital-Waterbury Care CenterRecruiting
- Smilow Cancer Hospital Care Center - WaterfordRecruiting
- Mount Sinai Comprehensive Cancer Center at AventuraRecruiting
- Broward Health North
- Holy Cross HospitalRecruiting
- Broward Health Medical Center
- The Watson ClinicRecruiting
- Mount Sinai Medical CenterRecruiting
- Sacred Heart HospitalRecruiting
- Cleveland Clinic-WestonRecruiting
- Grady Health SystemRecruiting
- Emory University Hospital MidtownRecruiting
- Emory University Hospital/Winship Cancer InstituteRecruiting
- Emory Saint Joseph's HospitalRecruiting
- Lewis Cancer and Research Pavilion at Saint Joseph's/CandlerRecruiting
- Summit Cancer Care-Candler
- Hawaii Cancer Care - WestridgeRecruiting
- Pali Momi Medical CenterRecruiting
- Queen's Cancer Center - PearlridgeRecruiting
- Straub Pearlridge ClinicRecruiting
- The Cancer Center of Hawaii-Pali MomiRecruiting
- The Queen's Medical Center - West OahuRecruiting
- Hawaii Cancer Care Inc - Waterfront PlazaRecruiting
- Island Urology
- Queen's Cancer Cenrer - POB IRecruiting
- Queen's Medical CenterRecruiting
- Straub Clinic and HospitalRecruiting
- University of Hawaii Cancer CenterRecruiting
- Hawaii Cancer Care Inc-Liliha
- Hawaii Diagnostic Radiology Services LLCRecruiting
- Kuakini Medical CenterRecruiting
- Queen's Cancer Center - KuakiniRecruiting
- The Cancer Center of Hawaii-LilihaRecruiting
- Kapiolani Medical Center for Women and ChildrenRecruiting
- Straub Medical Center - Kahului ClinicRecruiting
- Castle Medical CenterRecruiting
- Wilcox Memorial Hospital and Kauai Medical ClinicRecruiting
- Saint Alphonsus Cancer Care Center-BoiseRecruiting
- Saint Luke's Cancer Institute - BoiseRecruiting
- Saint Alphonsus Cancer Care Center-CaldwellRecruiting
- Kootenai Health - Coeur d'AleneRecruiting
- Walter Knox Memorial HospitalRecruiting
- Saint Luke's Cancer Institute - FruitlandRecruiting
- Idaho Urologic Institute-MeridianRecruiting
- Saint Luke's Cancer Institute - MeridianRecruiting
- Saint Luke's Cancer Institute - NampaRecruiting
- Saint Alphonsus Cancer Care Center-NampaRecruiting
- Kootenai Clinic Cancer Services - Post FallsRecruiting
- Kootenai Cancer ClinicRecruiting
- Saint Luke's Cancer Institute - Twin FallsRecruiting
- Saint Anthony's HealthRecruiting
- Rush - Copley Medical CenterRecruiting
- Illinois CancerCare-BloomingtonRecruiting
- Loyola Center for Health at Burr RidgeRecruiting
- Illinois CancerCare-CantonRecruiting
- Memorial Hospital of CarbondaleRecruiting
- SIH Cancer InstituteRecruiting
- Illinois CancerCare-CarthageRecruiting
- Centralia Oncology ClinicRecruiting
- Saint Mary's HospitalRecruiting
- Carle at The RiverfrontRecruiting
- Cancer Care Specialists of Illinois - DecaturRecruiting
- Decatur Memorial HospitalRecruiting
- Illinois CancerCare-DixonRecruiting
- Carle Physician Group-EffinghamRecruiting
- Crossroads Cancer CenterRecruiting
- Illinois CancerCare-EurekaRecruiting
- Illinois CancerCare-GalesburgRecruiting
- Western Illinois Cancer Treatment CenterRecruiting
- Loyola Medicine Homer GlenRecruiting
- Illinois CancerCare-Kewanee ClinicRecruiting
- Illinois CancerCare-MacombRecruiting
- Carle Physician Group-Mattoon/CharlestonRecruiting
- Loyola University Medical CenterRecruiting
- Marjorie Weinberg Cancer Center at Loyola-GottliebRecruiting
- Trinity Medical CenterRecruiting
- Good Samaritan Regional Health CenterRecruiting
- Cancer Care Center of O'FallonRecruiting
- Illinois CancerCare-Ottawa ClinicRecruiting
- Illinois CancerCare-PekinRecruiting
- Illinois CancerCare-PeoriaRecruiting
- Methodist Medical Center of IllinoisRecruiting
- Illinois CancerCare-PeruRecruiting
- Valley Radiation OncologyRecruiting
- Illinois CancerCare-PrincetonRecruiting
- West Suburban Medical CenterRecruiting
- Southern Illinois University School of MedicineRecruiting
- Springfield ClinicRecruiting
- Memorial Medical CenterRecruiting
- Southwest Illinois Health Services LLP
- Carle Cancer CenterRecruiting
- The Carle Foundation HospitalRecruiting
- Illinois CancerCare - WashingtonRecruiting
- Rush-Copley Healthcare CenterRecruiting
- Franciscan Health IndianapolisRecruiting
- Franciscan Saint Elizabeth Health - Lafayette EastRecruiting
- Franciscan Health MooresvilleRecruiting
- IU Health Ball Memorial HospitalRecruiting
- Reid HealthRecruiting
- Mary Greeley Medical CenterRecruiting
- McFarland Clinic - AmesRecruiting
- McFarland Clinic - BooneRecruiting
- Medical Oncology and Hematology Associates-West Des MoinesRecruiting
- Mercy Cancer Center-West LakesRecruiting
- Alegent Health Mercy HospitalRecruiting
- Greater Regional Medical CenterRecruiting
- Mercy Medical Center - Des MoinesRecruiting
- Mission Cancer and Blood - LaurelRecruiting
- McFarland Clinic - Trinity Cancer CenterRecruiting
- McFarland Clinic - JeffersonRecruiting
- McFarland Clinic - MarshalltownRecruiting
- MercyOne Waterloo Cancer Center
- Mercy Medical Center-West LakesRecruiting
- Central Care Cancer Center - Garden City
- Central Care Cancer Center - Great BendRecruiting
- HaysMed University of Kansas Health SystemRecruiting
- Lawrence Memorial HospitalRecruiting
- Kansas Institute of Medicine Cancer and Blood Center
- Minimally Invasive Surgery Hospital
- Olathe Health Cancer CenterRecruiting
- Menorah Medical Center
- Ascension Via Christi - PittsburgRecruiting
- Freeman Physician Group of PittsburgRecruiting
- Salina Regional Health CenterRecruiting
- Cotton O'Neil Cancer Center / Stormont Vail HealthRecruiting
- University of Kansas Health System Saint Francis CampusRecruiting
- Cancer Center of Kansas-Wichita Medical Arts Tower
- Cancer Center of Kansas - Wichita
- Flaget Memorial HospitalRecruiting
- Commonwealth Cancer Center-CorbinRecruiting
- Saint Joseph HospitalRecruiting
- Saint Joseph Radiation Oncology Resource CenterRecruiting
- Saint Joseph Hospital EastRecruiting
- Saint Joseph LondonRecruiting
- Jewish Hospital
- Saints Mary and Elizabeth Hospital
- UofL Health Medical Center Northeast
- Saint Joseph Mount SterlingRecruiting
- Mercy Health - Paducah Medical Oncology and HematologyRecruiting
- Jewish Hospital Medical Center South
- West Jefferson Medical CenterRecruiting
- Ochsner LSU Health Monroe Medical Center
- Louisiana State University Health Science CenterRecruiting
- University Medical Center New OrleansRecruiting
- Ochsner LSU Health Saint Mary's Medical Center
- LSU Health Sciences Center at Shreveport
- University of Maryland Shore Medical Center at EastonRecruiting
- Holy Cross Hospital
- Lahey Hospital and Medical CenterRecruiting
- Lahey Medical Center-PeabodyRecruiting
- Mercy Medical Center
- Winchester HospitalRecruiting
- Hickman Cancer CenterRecruiting
- Saint Joseph Mercy HospitalRecruiting
- Bronson Battle CreekRecruiting
- Saint Joseph Mercy BrightonRecruiting
- Trinity Health IHA Medical Group Hematology Oncology - BrightonRecruiting
- Saint Joseph Mercy CantonRecruiting
- Trinity Health IHA Medical Group Hematology Oncology - CantonRecruiting
- Caro Cancer CenterRecruiting
- Saint Joseph Mercy ChelseaRecruiting
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea HospitalRecruiting
- Hematology Oncology Consultants-ClarkstonRecruiting
- Newland Medical Associates-ClarkstonRecruiting
- Ascension Saint John HospitalRecruiting
- Great Lakes Cancer Management Specialists-Doctors ParkRecruiting
- Green Bay Oncology - EscanabaRecruiting
- Genesee Cancer and Blood Disease Treatment CenterRecruiting
- Genesee Hematology Oncology PCRecruiting
- Genesys Hurley Cancer InstituteRecruiting
- Hurley Medical CenterRecruiting
- Helen DeVos Children's Hospital at Spectrum HealthRecruiting
- Spectrum Health at Butterworth CampusRecruiting
- Trinity Health Grand Rapids HospitalRecruiting
- Academic Hematology Oncology SpecialistsRecruiting
- Great Lakes Cancer Management Specialists-Van Elslander Cancer CenterRecruiting
- Michigan Breast Specialists-Grosse Pointe Woods
- Bronson Methodist HospitalRecruiting
- West Michigan Cancer CenterRecruiting
- Ascension Borgess Cancer CenterRecruiting
- Borgess Medical CenterRecruiting
- Sparrow HospitalRecruiting
- Hope Cancer Clinic
- Trinity Health Saint Mary Mercy Livonia HospitalRecruiting
- Great Lakes Cancer Management Specialists-Macomb Medical CampusRecruiting
- Michigan Breast Specialists-Macomb Township
- Saint Mary's Oncology/Hematology Associates of MarletteRecruiting
- Toledo Clinic Cancer Centers-MonroeRecruiting
- Trinity Health Muskegon HospitalRecruiting
- Lakeland Hospital NilesRecruiting
- Cancer and Hematology Centers of Western Michigan - Norton ShoresRecruiting
- 21st Century Oncology-PontiacRecruiting
- Hope Cancer CenterRecruiting
- Newland Medical Associates-PontiacRecruiting
- Saint Joseph Mercy OaklandRecruiting
- Spectrum Health Reed City HospitalRecruiting
- Great Lakes Cancer Management Specialists-Rochester Hills
- Ascension Saint Mary's HospitalRecruiting
- Oncology Hematology Associates of Saginaw Valley PCRecruiting
- Lakeland Medical Center Saint JosephRecruiting
- Marie Yeager Cancer CenterRecruiting
- Bhadresh Nayak MD PC-Sterling HeightsRecruiting
- Ascension Saint Joseph HospitalRecruiting
- Munson Medical CenterRecruiting
- Advanced Breast Care Center PLLCRecruiting
- Great Lakes Cancer Management Specialists-Macomb Professional BuildingRecruiting
- Macomb Hematology Oncology PCRecruiting
- Michigan Breast Specialists-WarrenRecruiting
- Saint John Macomb-Oakland HospitalRecruiting
- Saint Mary's Oncology/Hematology Associates of West BranchRecruiting
- University of Michigan Health - WestRecruiting
- Huron Gastroenterology PCRecruiting
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor CampusRecruiting
- Sanford Joe Lueken Cancer CenterRecruiting
- Fairview Ridges Hospital
- Minnesota Oncology - BurnsvilleRecruiting
- Cambridge Medical CenterRecruiting
- Mercy HospitalRecruiting
- Fairview Southdale HospitalRecruiting
- Unity HospitalRecruiting
- Fairview Clinics and Surgery Center Maple GroveRecruiting
- Minnesota Oncology Hematology PA-MaplewoodRecruiting
- Saint John's Hospital - HealtheastRecruiting
- Abbott-Northwestern HospitalRecruiting
- Hennepin County Medical CenterRecruiting
- Health Partners IncRecruiting
- Monticello Cancer CenterRecruiting
- New Ulm Medical CenterRecruiting
- Fairview Northland Medical CenterRecruiting
- North Memorial Medical Health CenterRecruiting
- Park Nicollet Clinic - Saint Louis ParkRecruiting
- Regions HospitalRecruiting
- United HospitalRecruiting
- Saint Francis Regional Medical CenterRecruiting
- Lakeview HospitalRecruiting
- Sanford Thief River Falls Medical CenterRecruiting
- Ridgeview Medical CenterRecruiting
- Rice Memorial HospitalRecruiting
- Minnesota Oncology Hematology PA-WoodburyRecruiting
- Sanford Cancer Center WorthingtonRecruiting
- Fairview Lakes Medical CenterRecruiting
- Baptist Memorial Hospital and Cancer Center-Golden TriangleRecruiting
- Baptist Cancer Center-GrenadaRecruiting
- Gulfport Memorial HospitalRecruiting
- Baptist Memorial Hospital and Cancer Center-Union CountyRecruiting
- Baptist Memorial Hospital and Cancer Center-OxfordRecruiting
- Singing River Hospital
- Baptist Memorial Hospital and Cancer Center-DesotoRecruiting
- Saint Louis Cancer and Breast Institute-BallwinRecruiting
- Central Care Cancer Center - Bolivar
- Parkland Health Center-Bonne Terre
- Cox Cancer Center BransonRecruiting
- Saint Francis Medical CenterRecruiting
- Southeast Cancer CenterRecruiting
- Saint Luke's HospitalRecruiting
- University of Missouri - Ellis FischelRecruiting
- Parkland Health Center - FarmingtonRecruiting
- Centerpoint Medical Center LLC
- Capital Region Southwest CampusRecruiting
- Freeman Health SystemRecruiting
- Mercy Hospital JoplinRecruiting
- Truman Medical CentersRecruiting
- Research Medical Center
- Delbert Day Cancer Institute at PCRMCRecruiting
- Mercy Clinic-Rolla-Cancer and HematologyRecruiting
- Heartland Regional Medical CenterRecruiting
- Saint Louis Cancer and Breast Institute-South CityRecruiting
- Mercy Hospital SouthRecruiting
- Missouri Baptist Medical CenterRecruiting
- Mercy Hospital Saint LouisRecruiting
- Sainte Genevieve County Memorial HospitalRecruiting
- Mercy Hospital SpringfieldRecruiting
- CoxHealth South HospitalRecruiting
- Missouri Baptist Sullivan HospitalRecruiting
- Missouri Baptist Outpatient Center-Sunset HillsRecruiting
- Mercy Hospital WashingtonRecruiting
- Community Hospital of AnacondaRecruiting
- Billings Clinic Cancer CenterRecruiting
- Saint Vincent Healthcare
- Saint Vincent Frontier Cancer Center
- Bozeman Deaconess HospitalRecruiting
- Saint James Community Hospital and Cancer Treatment Center
- Benefis Healthcare- Sletten Cancer InstituteRecruiting
- Great Falls ClinicRecruiting
- Saint Peter's Community Hospital
- Kalispell Regional Medical CenterRecruiting
- Saint Patrick Hospital - Community HospitalRecruiting
- Community Medical HospitalRecruiting
- CHI Health Saint Francis
- Nebraska Cancer Specialists/Oncology Hematology West PC - Hastings
- Heartland Hematology and Oncology
- CHI Health Good SamaritanRecruiting
- Saint Elizabeth Regional Medical CenterRecruiting
- Alegent Health Immanuel Medical CenterRecruiting
- Hematology and Oncology Consultants PC
- Alegent Health Bergan Mercy Medical CenterRecruiting
- Alegent Health Lakeside HospitalRecruiting
- Creighton University Medical CenterRecruiting
- Midlands Community HospitalRecruiting
- Carson Tahoe Regional Medical CenterRecruiting
- Cancer and Blood Specialists-HendersonRecruiting
- Comprehensive Cancer Centers of Nevada - HendersonRecruiting
- Comprehensive Cancer Centers of Nevada-Horizon RidgeRecruiting
- Las Vegas Cancer Center-Henderson
- OptumCare Cancer Care at Seven HillsRecruiting
- Comprehensive Cancer Centers of Nevada-Southeast HendersonRecruiting
- GenesisCare USA - HendersonRecruiting
- Las Vegas Urology - Green ValleyRecruiting
- Las Vegas Urology - PebbleRecruiting
- Urology Specialists of Nevada - Green ValleyRecruiting
- Las Vegas Urology - PecosRecruiting
- Desert West Surgery
- OptumCare Cancer Care at CharlestonRecruiting
- University Medical Center of Southern NevadaRecruiting
- Hope Cancer Care of NevadaRecruiting
- Radiation Oncology Centers of Nevada CentralRecruiting
- Urology Specialists of Nevada - CentralRecruiting
- GenesisCare USA - Las VegasRecruiting
- Sunrise Hospital and Medical CenterRecruiting
- Las Vegas Prostate Cancer CenterRecruiting
- Las Vegas Urology - SunsetRecruiting
- Urology Specialists of Nevada - SouthwestRecruiting
- Radiation Oncology Centers of Nevada SoutheastRecruiting
- Ann M Wierman MD LTDRecruiting
- Comprehensive Cancer Centers of Nevada - NorthwestRecruiting
- GenesisCare USA - Vegas TenayaRecruiting
- Las Vegas Urology - Cathedral RockRecruiting
- Las Vegas Urology - Smoke RanchRecruiting
- OptumCare Cancer Care at MountainViewRecruiting
- Urology Specialists of Nevada - NorthwestRecruiting
- Alliance for Childhood Diseases/Cure 4 the Kids FoundationRecruiting
- Comprehensive Cancer Centers of Nevada - Town CenterRecruiting
- Comprehensive Cancer Centers of Nevada-SummerlinRecruiting
- Summerlin Hospital Medical CenterRecruiting
- Las Vegas Cancer Center-Medical Center
- Comprehensive Cancer Centers of NevadaRecruiting
- GenesisCare USA - Fort ApacheRecruiting
- OptumCare Cancer Care at Fort ApacheRecruiting
- Comprehensive Cancer Centers of Nevada - Central ValleyRecruiting
- University Cancer CenterRecruiting
- Hope Cancer Care of Nevada-PahrumpRecruiting
- Renown Regional Medical CenterRecruiting
- Saint Mary's Regional Medical CenterRecruiting
- Radiation Oncology AssociatesRecruiting
- New Hampshire Oncology Hematology PA-ConcordRecruiting
- Elliot Hospital
- Solinsky Center for Cancer CareRecruiting
- AtlantiCare Health Park-Cape May Court House
- AtlantiCare Surgery Center
- Morristown Medical Center
- Sidney Kimmel Cancer Center Washington TownshipRecruiting
- Medical Diagnostic Associates
- Overlook Hospital
- University of New Mexico Cancer CenterRecruiting
- Presbyterian Kaseman HospitalRecruiting
- Memorial Medical Center - Las CrucesRecruiting
- Presbyterian Rust Medical Center/Jorgensen Cancer CenterRecruiting
- Montefiore Medical Center-Einstein Campus
- Montefiore Medical Center-Weiler Hospital
- Montefiore Medical Center - Moses Campus
- Mary Imogene Bassett HospitalRecruiting
- Arnot Ogden Medical Center/Falck Cancer CenterRecruiting
- Mount Sinai ChelseaRecruiting
- Mount Sinai WestRecruiting
- Mount Sinai HospitalRecruiting
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer CenterRecruiting
- University of RochesterRecruiting
- Southeastern Medical Oncology Center-ClintonRecruiting
- CaroMont Regional Medical CenterRecruiting
- Southeastern Medical Oncology Center-GoldsboroRecruiting
- Wayne Memorial Hospital
- Onslow Memorial Hospital
- Southeastern Medical Oncology Center-JacksonvilleRecruiting
- Outer Banks HospitalRecruiting
- Sanford Bismarck Medical CenterRecruiting
- Sanford South University Medical CenterRecruiting
- Southpointe-Sanford Medical Center FargoRecruiting
- Sanford Medical Center FargoRecruiting
- Sanford Broadway Medical CenterRecruiting
- Sanford Roger Maris Cancer CenterRecruiting
- Altru Cancer Center
- Indu and Raj Soin Medical CenterRecruiting
- Strecker Cancer Center-BelpreRecruiting
- Saint Elizabeth Boardman HospitalRecruiting
- Dayton Physicians LLC-Miami Valley SouthRecruiting
- Miami Valley Hospital South
- Adena Regional Medical CenterRecruiting
- Good Samaritan Hospital - CincinnatiRecruiting
- Oncology Hematology Care Inc-KenwoodRecruiting
- Bethesda North HospitalRecruiting
- TriHealth Cancer Institute-WestsideRecruiting
- TriHealth Cancer Institute-AndersonRecruiting
- Cleveland Clinic Cancer Center/Fairview HospitalRecruiting
- Mount Carmel East HospitalRecruiting
- Columbus Oncology and Hematology Associates IncRecruiting
- Riverside Methodist HospitalRecruiting
- Grant Medical CenterRecruiting
- The Mark H Zangmeister CenterRecruiting
- Mount Carmel Health Center WestRecruiting
- Doctors HospitalRecruiting
- Good Samaritan Hospital - Dayton
- Miami Valley Hospital
- Dayton Physician LLC-Miami Valley Hospital NorthRecruiting
- Miami Valley Hospital North
- Delaware Health Center-Grady Cancer CenterRecruiting
- Delaware Radiation Oncology
- Grady Memorial HospitalRecruiting
- Columbus Oncology and Hematology AssociatesRecruiting
- Dublin Methodist HospitalRecruiting
- Armes Family Cancer CenterRecruiting
- Blanchard Valley HospitalRecruiting
- Orion Cancer CareRecruiting
- Atrium Medical Center-Middletown Regional Hospital
- Dayton Physicians LLC-AtriumRecruiting
- Dayton Physicians LLC-WayneRecruiting
- Wayne HospitalRecruiting
- Mount Carmel Grove City HospitalRecruiting
- Zangmeister Center Grove CityRecruiting
- Cleveland Clinic Cancer Center IndependenceRecruiting
- Greater Dayton Cancer CenterRecruiting
- First Dayton Cancer Care
- Kettering Medical CenterRecruiting
- Fairfield Medical CenterRecruiting
- Saint Rita's Medical CenterRecruiting
- OhioHealth Mansfield HospitalRecruiting
- Cleveland Clinic Cancer Center MansfieldRecruiting
- Marietta Memorial HospitalRecruiting
- OhioHealth Marion General HospitalRecruiting
- Toledo Clinic Cancer Centers-MaumeeRecruiting
- Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
- Hillcrest Hospital Cancer CenterRecruiting
- Knox Community HospitalRecruiting
- Mount Carmel New Albany Surgical HospitalRecruiting
- Licking Memorial HospitalRecruiting
- Newark Radiation OncologyRecruiting
- Mercy Health Perrysburg Cancer CenterRecruiting
- Southern Ohio Medical CenterRecruiting
- North Coast Cancer CareRecruiting
- Springfield Regional Cancer CenterRecruiting
- Springfield Regional Medical CenterRecruiting
- Cleveland Clinic Cancer Center StrongsvilleRecruiting
- Saint Vincent Mercy Medical CenterRecruiting
- Mercy Health - Saint Anne HospitalRecruiting
- Toledo Clinic Cancer Centers-ToledoRecruiting
- Dayton Physicians LLC - TroyRecruiting
- Upper Valley Medical Center
- South Pointe HospitalRecruiting
- Saint Joseph Warren HospitalRecruiting
- Saint Ann's HospitalRecruiting
- Cleveland Clinic Wooster Family Health and Surgery CenterRecruiting
- Saint Elizabeth Youngstown HospitalRecruiting
- Genesis Healthcare System Cancer Care CenterRecruiting
- Mercy Hospital Oklahoma CityRecruiting
- Saint Alphonsus Medical Center-Baker CityRecruiting
- Saint Charles Health SystemRecruiting
- Clackamas Radiation Oncology CenterRecruiting
- Providence Cancer Institute Clackamas ClinicRecruiting
- Bay Area HospitalRecruiting
- Providence Newberg Medical CenterRecruiting
- Saint Alphonsus Medical Center-OntarioRecruiting
- Providence Willamette Falls Medical CenterRecruiting
- Providence Portland Medical CenterRecruiting
- Providence Saint Vincent Medical CenterRecruiting
- Saint Charles Health System-RedmondRecruiting
- Salem HospitalRecruiting
- Lehigh Valley Hospital-Cedar CrestRecruiting
- Lehigh Valley Hospital - MuhlenbergRecruiting
- Geisinger Medical CenterRecruiting
- Doylestown HospitalRecruiting
- Pocono Medical CenterRecruiting
- UPMC Pinnacle Harrisburg
- UPMC Pinnacle Cancer Center/Community Osteopathic Campus
- Geisinger Medical Center-Cancer Center HazletonRecruiting
- Lehigh Valley Hospital-HazletonRecruiting
- Geisinger Medical Oncology-LewisburgRecruiting
- Thomas Jefferson University HospitalRecruiting
- Phoenixville HospitalRecruiting
- University of Pittsburgh Cancer Institute (UPCI)
- Pottstown HospitalRecruiting
- Geisinger Cancer Services-PottsvilleRecruiting
- Community Medical CenterRecruiting
- Geisinger Medical Oncology-SelinsgroveRecruiting
- Geisinger Medical GroupRecruiting
- Geisinger Wyoming Valley/Henry Cancer CenterRecruiting
- UPMC Susquehanna
- Smilow Cancer Hospital Care Center - WesterlyRecruiting
- Saint Joseph's/Candler - Bluffton CampusRecruiting
- Prisma Health Cancer Institute - SpartanburgRecruiting
- Prisma Health Cancer Institute - LaurensRecruiting
- Prisma Health Cancer Institute - EasleyRecruiting
- Prisma Health Cancer Institute - ButternutRecruiting
- Prisma Health Cancer Institute - FarisRecruiting
- Prisma Health Greenville Memorial HospitalRecruiting
- Prisma Health Cancer Institute - EastsideRecruiting
- Prisma Health Cancer Institute - GreerRecruiting
- South Carolina Cancer Specialists PCRecruiting
- Prisma Health Cancer Institute - SenecaRecruiting
- Rapid City Regional Hospital
- Sanford Cancer Center Oncology ClinicRecruiting
- Sanford USD Medical Center - Sioux FallsRecruiting
- Memorial Hospital
- Baptist Memorial Hospital and Cancer Center-ColliervilleRecruiting
- Cookeville Regional Medical CenterRecruiting
- Pulmonary Medicine Center of Chattanooga-Hixson
- Baptist Memorial Hospital and Cancer Center-MemphisRecruiting
- Memorial GYN Plus
- Saint Joseph Regional Cancer Center
- American Fork Hospital / Huntsman Intermountain Cancer Center
- Sandra L Maxwell Cancer Center
- Logan Regional Hospital
- Intermountain Medical Center
- McKay-Dee Hospital Center
- Utah Valley Regional Medical Center
- Riverton Hospital
- Saint George Regional Medical Center
- Utah Cancer Specialists-Salt Lake City
- LDS Hospital
- Chesapeake Regional Medical CenterRecruiting
- Sovah Health MartinsvilleRecruiting
- Providence Regional Cancer System-AberdeenRecruiting
- MultiCare Auburn Medical Center
- Kaiser Permanente Bellevue Medical CenterRecruiting
- Overlake Medical Center
- PeaceHealth Saint Joseph Medical CenterRecruiting
- Harrison HealthPartners Hematology and Oncology-BremertonRecruiting
- Harrison Medical CenterRecruiting
- Highline Medical Center-Main Campus
- Providence Regional Cancer System-CentraliaRecruiting
- Swedish Cancer Institute-EdmondsRecruiting
- Saint Elizabeth Hospital
- Providence Regional Cancer PartnershipRecruiting
- Saint Francis Hospital
- MultiCare Gig Harbor Medical Park
- Swedish Cancer Institute-IssaquahRecruiting
- Kadlec Clinic Hematology and OncologyRecruiting
- Providence Regional Cancer System-LaceyRecruiting
- Saint Clare Hospital
- PeaceHealth Saint John Medical CenterRecruiting
- Jefferson HealthcareRecruiting
- Harrison HealthPartners Hematology and Oncology-Poulsbo
- MultiCare Good Samaritan Hospital
- Valley Medical CenterRecruiting
- Pacific Gynecology Specialists
- Swedish Medical Center-Ballard CampusRecruiting
- Kaiser Permanente WashingtonRecruiting
- Swedish Medical Center-Cherry HillRecruiting
- Swedish Medical Center-First HillRecruiting
- PeaceHealth United General Medical CenterRecruiting
- Providence Regional Cancer System-SheltonRecruiting
- MultiCare Deaconess Cancer and Blood Specialty Center - Valley
- MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
- MultiCare Deaconess Cancer and Blood Specialty Center - North
- Franciscan Research Center-Northwest Medical Plaza
- Mary Bridge Children's Hospital and Health Center
- MultiCare Tacoma General Hospital
- Northwest Medical Specialties PLLC
- PeaceHealth Southwest Medical CenterRecruiting
- Providence Saint Mary Regional Cancer CenterRecruiting
- North Star Lodge Cancer Center at Yakima Valley Memorial HospitalRecruiting
- Providence Regional Cancer System-YelmRecruiting
- Langlade Hospital and Cancer CenterRecruiting
- Marshfield Clinic-Chippewa CenterRecruiting
- HSHS Sacred Heart HospitalRecruiting
- Marshfield Medical Center-EC Cancer CenterRecruiting
- Saint Vincent Hospital Cancer Center Green BayRecruiting
- Saint Vincent Hospital Cancer Center at Saint Mary'sRecruiting
- Mercyhealth Hospital and Cancer Center - JanesvilleRecruiting
- Gundersen Lutheran Medical CenterRecruiting
- Marshfield Clinic - Ladysmith CenterRecruiting
- Marshfield Medical Center-MarshfieldRecruiting
- Aspirus Medford HospitalRecruiting
- Marshfield Clinic-Minocqua CenterRecruiting
- Cancer Center of Western WisconsinRecruiting
- Saint Vincent Hospital Cancer Center at Oconto FallsRecruiting
- Marshfield Medical Center-Rice LakeRecruiting
- HSHS Saint Nicholas HospitalRecruiting
- Saint Vincent Hospital Cancer Center at SheboyganRecruiting
- Sheboygan Phyisicans GroupRecruiting
- Ascension Saint Michael's HospitalRecruiting
- Marshfield Medical Center-River Region at Stevens PointRecruiting
- Saint Vincent Hospital Cancer Center at Sturgeon BayRecruiting
- Aspirus Regional Cancer CenterRecruiting
- Marshfield Clinic-Wausau CenterRecruiting
- Marshfield Medical Center - WestonRecruiting
- Aspirus Cancer Care - Wisconsin RapidsRecruiting
- Marshfield Clinic - Wisconsin Rapids CenterRecruiting
- Cheyenne Regional Medical Center-WestRecruiting
- Billings Clinic-CodyRecruiting
- Welch Cancer CenterRecruiting
- FHP Health Center-Guam
- Advance Oncology Center
- Doctor's Cancer Center-Arecibo
- Cancer Center-Metro Medical Center BayamonRecruiting
- Hematologia Oncologia San Pablo
- HIMA San Pablo Oncologic Hospital
- Doctors Cancer CenterRecruiting
- Instituto Oncologia Moderna Ponce
- San Juan Community Oncology GroupRecruiting
- Primary Care Physician Group
- Centro Comprensivo de Cancer de UPRRecruiting
- PROncologyRecruiting
- San Juan City HospitalRecruiting
- Centro de Hematologia y Oncologia del Sur
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Arm I (usual care)
Arm II (serum tumor directed disease monitoring)
Patients will have imaging studies (modality and frequency per treating physician, however at a minimum frequency of every 12 weeks) alone or in conjunction with STMs (frequency determined by treating physician). Patients will continue with usual care disease monitoring for up to 312 weeks in the absence of disease progression.
Patients undergo disease specific serum tumor marker evaluation (CEA and either CA 15-3 or CA 27.29, whichever were tested at Step 1 Registration and Step 2 Registration) every 4-8 weeks (starting from randomization) without imaging until an elevation of at least one disease specific STM. In the event of an elevated STM, the patient will have imaging within 4 weeks to evaluate for disease progression. Patients continue with STMDDM for up to 312 weeks in the absence of disease progression.