De-Escalation of Breast Radiation Trial for Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer (DEBRA) (DEBRA)
Stage I Breast Cancer
About this trial
This is an interventional treatment trial for Stage I Breast Cancer
Eligibility Criteria
Inclusion Criteria:
• The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the U.S., authorization permitting release of personal health information.
- The patient must have an ECOG performance status of 0 or 1.
- The patient must have undergone a lumpectomy and the margins of the resected specimen or re-excision must be histologically free of invasive tumor and DCIS with no ink on tumor as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional excisions may be performed to obtain clear margins. (Patients with margins positive for LCIS are eligible without additional resection.)
- The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination.
- Patient must have undergone axillary staging (sentinel node biopsy and/or axillary node dissection).
- The following staging criteria must be met postoperatively according to AJCC 8th edition criteria: By pathologic evaluation, primary tumor must be pT1 (less than or equal to 2 cm).
By pathologic evaluation, ipsilateral nodes must be pN0. (Patients with pathologic staging of pN0(i+) or pN0(mol+) are NOT eligible.)
Oncotype DX Recurrence Score of less than or equal to 18 on diagnostic core biopsy or resected specimen.
** For patients with a T1a tumor (less than or equal to 0.5 cm in size) who do not already have an Oncotype DX Recurrence Score at study entry, a specimen (unstained blocks or slides) must be sent to the Genomic Health centralized laboratory.
- The tumor must have been determined to be ER and/or PgR positive assessed by current ASCO/CAP Guideline Recommendations for hormone receptor testing. Patients with greater than or equal to 1% ER or PgR staining by IHC are considered positive.
- The tumor must have been determined to be HER2-negative by current ASCO/CAP guidelines.
- Patients may be premenopausal or postmenopausal at the time of study entry. For study purposes, postmenopausal is defined as: Age 56 or older with no spontaneous menses for at least 12 months prior to study entry; or a documented hysterectomy; or Age 55 or younger with no spontaneous menses for at least 12 months prior to study entry (e.g., spontaneous or secondary to hysterectomy) and with a documented estradiol level in the postmenopausal range according to local institutional/laboratory standard; or Documented bilateral oophorectomy.
- The interval between the last surgery for breast cancer (including re-excision of margins) and study entry must be no more than 70 days.
- The patient must have recovered from surgery with the incision completely healed and no signs of infection.
- Bilateral mammogram or MRI within 6 months prior to study entry. HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Patients must be intending to take endocrine therapy for a minimum 5 years duration (tamoxifen or aromatase inhibitor). The specific regimen of endocrine therapy is at the treating physician's discretion.
Exclusion Criteria:
• Definitive clinical or radiologic evidence of metastatic disease.
- pT2 - pT4 tumors including inflammatory breast cancer.
- Pathologic staging of pN0(i+) or pN0(mol+), pN1, pN2, or pN3 disease.
- Patient had a mastectomy.
- Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor.
- Suspicious microcalcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign.
- Non-epithelial breast malignancies such as sarcoma or lymphoma.
- Proven multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant or separated by 4 or more centimeters. (Patients with multifocal carcinoma are eligible.)
- Paget's disease of the nipple.
- Any history, not including the index cancer, of ipsilateral invasive breast cancer or ipsilateral DCIS treated or not treated. (Patients with synchronous or previous ipsilateral LCIS are eligible.)
- Synchronous or previous contralateral invasive breast cancer or DCIS. (Patients with synchronous and/or previous contralateral LCIS are eligible.)
- Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation. (If surgical margins are rendered free of disease by re- excision, the patient is eligible.)
- Treatment plan that includes regional nodal irradiation.
- Any treatment with radiation therapy, chemotherapy, biotherapy, and/or endocrine therapy administered for the currently diagnosed breast cancer prior to study entry.
(Short course endocrine therapy of less than 6 weeks duration is acceptable post core biopsy pre surgery if the Oncotype DX Recurrence Score is assessed on the biopsy core and is less than or equal to 18.)
- History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to study entry.
- Current therapy with any endocrine therapy such as raloxifene (Evista®), tamoxifen, or other selective estrogen receptor modulators (SERMs), either for osteoporosis or breast cancer prevention. (Short course endocrine therapy of < 6 weeks duration is acceptable post core biopsy pre surgery if the Oncotype DX Recurrence Score is assessed on the biopsy core and is less than or equal to 18.)
- Patients intending to continue on oral, transdermal, or subdermal estrogen replacement (including all estrogen only and estrogen-progesterone formulas) are not eligible. Patients that discontinue oral, transdermal, or subdermal estrogen replacement prior to registration are eligible.
- Prior breast or thoracic RT for any condition.
- Active collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma.
- Pregnancy or lactation at the time of study entry or intention to become pregnant during treatment. (Note: Pregnancy testing according to institutional standards for women of childbearing potential must be performed within 2 weeks prior to study entry.)
- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of study therapy or that may affect the interpretation of the results or render the patient at high risk from treatment complications.
- Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements or interfere with interpretation of study results.
- Use of any investigational product within 30 days prior to study entry.
Sites / Locations
- University of Alabama at Birmingham Cancer Center
- Kingman Regional Medical CenterRecruiting
- Cancer Center at Saint Joseph'sRecruiting
- Mayo Clinic Hospital in ArizonaRecruiting
- University of Arkansas for Medical SciencesRecruiting
- Kaiser Permanente-AnaheimRecruiting
- Kaiser Permanente-Deer Valley Medical CenterRecruiting
- Mission Hope Medical Oncology - Arroyo GrandeRecruiting
- PCR OncologyRecruiting
- Alta Bates Summit Medical Center-Herrick Campus
- Tower Cancer Research FoundationRecruiting
- Mercy Cancer Center �� CarmichaelRecruiting
- Mercy San Juan Medical CenterRecruiting
- Epic Care-DublinRecruiting
- Kaiser Permanente DublinRecruiting
- Mercy Cancer Center - Elk GroveRecruiting
- Bay Area Breast Surgeons IncRecruiting
- Epic Care Partners in Cancer CareRecruiting
- Kaiser Permanente-FremontRecruiting
- Washington HospitalRecruiting
- Fresno Cancer CenterRecruiting
- Kaiser Permanente-FresnoRecruiting
- Kaiser Permanente Los Angeles Medical CenterRecruiting
- Los Angeles County-USC Medical CenterRecruiting
- USC / Norris Comprehensive Cancer CenterRecruiting
- Cedars Sinai Medical CenterRecruiting
- Contra Costa Regional Medical CenterRecruiting
- Kaiser Permanente-ModestoRecruiting
- Bay Area Tumor InstituteRecruiting
- Kaiser Permanente Oakland-BroadwayRecruiting
- Kaiser Permanente-OaklandRecruiting
- Kaiser Permanente-OntarioRecruiting
- Saint Joseph Hospital - OrangeRecruiting
- UC Irvine Health/Chao Family Comprehensive Cancer CenterRecruiting
- Stanford Cancer Institute Palo AltoRecruiting
- Kaiser Permanente-Rancho Cordova Cancer CenterRecruiting
- Kaiser Permanente- Marshall Medical OfficesRecruiting
- Kaiser Permanente-RichmondRecruiting
- Mercy Cancer Center - RocklinRecruiting
- Rohnert Park Cancer CenterRecruiting
- Kaiser Permanente-RosevilleRecruiting
- The Permanente Medical Group-Roseville Radiation OncologyRecruiting
- Kaiser Permanente Downtown CommonsRecruiting
- Mercy Cancer Center - SacramentoRecruiting
- University of California Davis Comprehensive Cancer CenterRecruiting
- Kaiser Permanente-South SacramentoRecruiting
- South Sacramento Cancer CenterRecruiting
- Saint Helena HospitalRecruiting
- California Pacific Medical Center-Pacific Campus
- Kaiser Permanente-San FranciscoRecruiting
- Kaiser Permanente-Santa Teresa-San JoseRecruiting
- Stanford Cancer Center South BayRecruiting
- Kaiser Permanente San LeandroRecruiting
- Pacific Central Coast Health Center-San Luis ObispoRecruiting
- Kaiser San Rafael-GallinasRecruiting
- Ridley-Tree Cancer CenterRecruiting
- Kaiser Permanente Medical Center - Santa ClaraRecruiting
- Dominican Santa Cruz HospitalRecruiting
- Mission Hope Medical Oncology - Santa MariaRecruiting
- Kaiser Permanente-Santa RosaRecruiting
- Kaiser Permanente Cancer Treatment CenterRecruiting
- Kaiser Permanente-South San FranciscoRecruiting
- Kaiser Permanente-StocktonRecruiting
- Cedars-Sinai Cancer - TarzanaRecruiting
- Torrance Memorial Physician Network - Cancer CareRecruiting
- Torrance Memorial Medical CenterRecruiting
- Gene Upshaw Memorial Tahoe Forest Cancer CenterRecruiting
- Kaiser Permanente Medical Center-VacavilleRecruiting
- Kaiser Permanente-VallejoRecruiting
- Sutter Solano Medical Center/Cancer Center
- Kaiser Permanente-Walnut CreekRecruiting
- Woodland Memorial HospitalRecruiting
- UCHealth University of Colorado HospitalRecruiting
- Rocky Mountain Cancer Centers-BoulderRecruiting
- Saint Francis Cancer CenterRecruiting
- UCHealth - Cherry CreekRecruiting
- Porter Adventist HospitalRecruiting
- Shaw Cancer CenterRecruiting
- Mountain Blue Cancer Care Center - SwedishRecruiting
- Swedish Medical CenterRecruiting
- The Melanoma and Skin Cancer InstituteRecruiting
- Poudre Valley HospitalRecruiting
- Cancer Care and Hematology-Fort CollinsRecruiting
- UCHealth Greeley HospitalRecruiting
- UCHealth Highlands Ranch HospitalRecruiting
- Littleton Adventist HospitalRecruiting
- Medical Center of the RockiesRecruiting
- Parker Adventist HospitalRecruiting
- 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-Hamden Care CenterRecruiting
- Smilow Cancer Hospital Care Center at Saint FrancisRecruiting
- Yale-New Haven Hospital Saint Raphael CampusRecruiting
- 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
- Beebe South Coastal Health CampusRecruiting
- Beebe Medical CenterRecruiting
- Delaware Clinical and Laboratory Physicians PARecruiting
- Helen F Graham Cancer CenterRecruiting
- Medical Oncology Hematology Consultants PARecruiting
- Christiana Care Health System-Christiana HospitalRecruiting
- Beebe Health CampusRecruiting
- MedStar Georgetown University HospitalRecruiting
- MedStar Washington Hospital CenterRecruiting
- AdventHealth AltamonteRecruiting
- GenesisCare USA - Aventura FPRecruiting
- GenesisCare USA - AventuraRecruiting
- Mount Sinai Comprehensive Cancer Center at AventuraRecruiting
- UM Sylvester Comprehensive Cancer Center at Coral GablesRecruiting
- UM Sylvester Comprehensive Cancer Center at Deerfield BeachRecruiting
- Regional Cancer Center-Lee Memorial Health SystemRecruiting
- Mayo Clinic in FloridaRecruiting
- The Watson ClinicRecruiting
- Mount Sinai Medical CenterRecruiting
- University of Miami Miller School of Medicine-Sylvester Cancer CenterRecruiting
- AdventHealth OrlandoRecruiting
- Orlando Health Cancer InstituteRecruiting
- GenesisCare USA - PlantationRecruiting
- Tampa General HospitalRecruiting
- Saint Joseph's Hospital/Children's Hospital-TampaRecruiting
- Cleveland Clinic-WestonRecruiting
- Northside Hospital-AlpharettaRecruiting
- Grady Health SystemRecruiting
- Emory University Hospital MidtownRecruiting
- Piedmont HospitalRecruiting
- Emory University Hospital/Winship Cancer InstituteRecruiting
- Emory Saint Joseph's HospitalRecruiting
- Northside HospitalRecruiting
- Northside Hospital-CherokeeRecruiting
- Northside Hospital-ForsythRecruiting
- Piedmont Fayette HospitalRecruiting
- Piedmont Newnan HospitalRecruiting
- Piedmont Henry HospitalRecruiting
- Hawaii Cancer Care - WestridgeRecruiting
- Pali Momi Medical CenterRecruiting
- Queen's Cancer Center - PearlridgeRecruiting
- The Cancer Center of Hawaii-Pali MomiRecruiting
- Hawaii Cancer Care Inc - Waterfront PlazaRecruiting
- Queen's Cancer Cenrer - POB IRecruiting
- Queen's Medical CenterRecruiting
- Straub Clinic and HospitalRecruiting
- University of Hawaii Cancer CenterRecruiting
- Hawaii Cancer Care Inc-Liliha
- Kuakini Medical CenterRecruiting
- Queen's Cancer Center - KuakiniRecruiting
- The Cancer Center of Hawaii-LilihaRecruiting
- Kaiser Permanente Moanalua Medical CenterRecruiting
- Kapiolani Medical Center for Women and ChildrenRecruiting
- Wilcox Memorial Hospital and Kauai Medical ClinicRecruiting
- Saint Alphonsus Cancer Care Center-BoiseRecruiting
- Saint Alphonsus Cancer Care Center-CaldwellRecruiting
- Kootenai Health - Coeur d'AleneRecruiting
- Saint Alphonsus Cancer Care Center-NampaRecruiting
- Advocate Good Shepherd HospitalRecruiting
- Saint Joseph Medical CenterRecruiting
- Illinois CancerCare-BloomingtonRecruiting
- Illinois CancerCare-CantonRecruiting
- Illinois CancerCare-CarthageRecruiting
- Centralia Oncology ClinicRecruiting
- Saint Mary's HospitalRecruiting
- Northwestern UniversityRecruiting
- John H Stroger Jr Hospital of Cook CountyRecruiting
- Rush University Medical CenterRecruiting
- Advocate Illinois Masonic Medical CenterRecruiting
- AMG Crystal Lake - OncologyRecruiting
- Carle at The RiverfrontRecruiting
- Cancer Care Specialists of Illinois - DecaturRecruiting
- Decatur Memorial HospitalRecruiting
- Northwestern Medicine Cancer Center KishwaukeeRecruiting
- Advocate Good Samaritan HospitalRecruiting
- Carle Physician Group-EffinghamRecruiting
- Crossroads Cancer CenterRecruiting
- Advocate Sherman HospitalRecruiting
- Elmhurst Memorial HospitalRecruiting
- Illinois CancerCare-EurekaRecruiting
- Illinois CancerCare-GalesburgRecruiting
- Western Illinois Cancer Treatment CenterRecruiting
- Northwestern Medicine Cancer Center DelnorRecruiting
- Advocate South Suburban HospitalRecruiting
- Illinois CancerCare-Kewanee ClinicRecruiting
- Northwestern Medicine Lake Forest HospitalRecruiting
- AMG Libertyville - OncologyRecruiting
- Condell Memorial HospitalRecruiting
- Illinois CancerCare-MacombRecruiting
- Carle Physician Group-Mattoon/CharlestonRecruiting
- Edward Hospital/Cancer CenterRecruiting
- Cancer Care Center of O'FallonRecruiting
- Advocate Christ Medical CenterRecruiting
- Illinois CancerCare-Ottawa ClinicRecruiting
- Advocate Lutheran General HospitalRecruiting
- Illinois CancerCare-PekinRecruiting
- Illinois CancerCare-PeoriaRecruiting
- OSF Saint Francis Radiation Oncology at Peoria Cancer CenterRecruiting
- Methodist Medical Center of IllinoisRecruiting
- OSF Saint Francis Medical CenterRecruiting
- Illinois CancerCare-PeruRecruiting
- Illinois CancerCare-PrincetonRecruiting
- SwedishAmerican Regional Cancer Center/ACTRecruiting
- Carle Cancer CenterRecruiting
- The Carle Foundation HospitalRecruiting
- Northwestern Medicine Cancer Center WarrenvilleRecruiting
- Illinois CancerCare - WashingtonRecruiting
- IU Health West HospitalRecruiting
- IU Health North HospitalRecruiting
- Northwest Cancer Center - Main CampusRecruiting
- Northwest Oncology LLCRecruiting
- Northwest Cancer Center - HobartRecruiting
- Saint Mary Medical CenterRecruiting
- Indiana University/Melvin and Bren Simon Cancer CenterRecruiting
- IU Health Methodist HospitalRecruiting
- Franciscan Health IndianapolisRecruiting
- Franciscan Health MooresvilleRecruiting
- The Community HospitalRecruiting
- Women's Diagnostic Center - MunsterRecruiting
- Northwest Cancer Center - ValparaisoRecruiting
- Mary Greeley Medical CenterRecruiting
- McFarland Clinic - AmesRecruiting
- Saint Luke's HospitalRecruiting
- Medical Oncology and Hematology Associates-West Des MoinesRecruiting
- Mercy Cancer Center-West LakesRecruiting
- Greater Regional Medical CenterRecruiting
- Mercy Medical Center - Des MoinesRecruiting
- Mission Cancer and Blood - LaurelRecruiting
- Mercy Medical Center-West LakesRecruiting
- University of Kansas Cancer CenterRecruiting
- University of Kansas Cancer Center-Overland ParkRecruiting
- University of Kansas Hospital-Indian Creek CampusRecruiting
- Cancer Center of Kansas - SalinaRecruiting
- Salina Regional Health CenterRecruiting
- University of Kansas Health System Saint Francis CampusRecruiting
- University of Kansas Hospital-Westwood Cancer CenterRecruiting
- Cancer Center of Kansas-Wichita Medical Arts TowerRecruiting
- Ascension Via Christi Hospitals WichitaRecruiting
- Cancer Center of Kansas - WichitaRecruiting
- Saint Joseph HospitalRecruiting
- Saint Joseph Radiation Oncology Resource CenterRecruiting
- Saint Joseph Hospital EastRecruiting
- University of Kentucky/Markey Cancer CenterRecruiting
- Ochsner Hematology Oncology North Shore - Covington (West Region)Recruiting
- Tulane University Health Sciences CenterRecruiting
- Ochsner Medical Center JeffersonRecruiting
- LSU Health Sciences Center at ShreveportRecruiting
- Lafayette Family Cancer Center-EMMCRecruiting
- University of Maryland/Greenebaum Cancer CenterRecruiting
- Greater Baltimore Medical CenterRecruiting
- Sinai Hospital of Baltimore
- MedStar Franklin Square Medical Center/Weinberg Cancer InstituteRecruiting
- MedStar Good Samaritan HospitalRecruiting
- UM Upper Chesapeake Medical CenterRecruiting
- Central Maryland Radiation Oncology in Howard CountyRecruiting
- University of Maryland Shore Medical Center at EastonRecruiting
- UM Baltimore Washington Medical Center/Tate Cancer CenterRecruiting
- Kaiser Permanente - Largo Medical CenterRecruiting
- Kaiser Permanente Lutherville - Timonium Medical CenterRecruiting
- Lowell General Hospital
- Saint Joseph Mercy HospitalRecruiting
- University of Michigan Comprehensive Cancer CenterRecruiting
- Bronson Battle CreekRecruiting
- McLaren Cancer Institute-Bay CityRecruiting
- Saint Joseph Mercy BrightonRecruiting
- Trinity Health IHA Medical Group Hematology Oncology - BrightonRecruiting
- University of Michigan - Brighton Center for Specialty CareRecruiting
- Henry Ford Cancer Institute-DownriverRecruiting
- 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
- GenesisCare USA - ClarkstonRecruiting
- McLaren Cancer Institute-ClarkstonRecruiting
- Henry Ford Macomb Hospital-Clinton TownshipRecruiting
- Henry Ford Medical Center-FairlaneRecruiting
- Wayne State University/Karmanos Cancer InstituteRecruiting
- Henry Ford HospitalRecruiting
- Ascension Saint John HospitalRecruiting
- GenesisCare USA - Farmington HillsRecruiting
- Weisberg Cancer Treatment CenterRecruiting
- Beaumont Hospital - Farmington HillsRecruiting
- McLaren Cancer Institute-FlintRecruiting
- Helen DeVos Children's Hospital at Spectrum HealthRecruiting
- Spectrum Health at Butterworth CampusRecruiting
- Trinity Health Grand Rapids HospitalRecruiting
- Allegiance HealthRecruiting
- Bronson Methodist HospitalRecruiting
- West Michigan Cancer CenterRecruiting
- Borgess Medical CenterRecruiting
- McLaren Cancer Institute-Lapeer RegionRecruiting
- Trinity Health Saint Mary Mercy Livonia HospitalRecruiting
- GenesisCare USA - MacombRecruiting
- GenesisCare USA - Madison HeightsRecruiting
- Saint Mary's Oncology/Hematology Associates of MarletteRecruiting
- McLaren Cancer Institute-MacombRecruiting
- Trinity Health Muskegon HospitalRecruiting
- Lakeland Hospital NilesRecruiting
- Cancer and Hematology Centers of Western Michigan - Norton ShoresRecruiting
- Henry Ford Medical Center-ColumbusRecruiting
- McLaren Cancer Institute-Northern MichiganRecruiting
- 21st Century Oncology-PontiacRecruiting
- Saint Joseph Mercy OaklandRecruiting
- McLaren-Port HuronRecruiting
- William Beaumont Hospital-Royal OakRecruiting
- Ascension Saint Mary's HospitalRecruiting
- Oncology Hematology Associates of Saginaw Valley PCRecruiting
- Lakeland Medical Center Saint JosephRecruiting
- Marie Yeager Cancer CenterRecruiting
- Ascension Saint Joseph HospitalRecruiting
- Munson Medical CenterRecruiting
- William Beaumont Hospital - TroyRecruiting
- GenesisCare USA - TroyRecruiting
- Saint John Macomb-Oakland HospitalRecruiting
- Henry Ford West Bloomfield HospitalRecruiting
- Saint Mary's Oncology/Hematology Associates of West BranchRecruiting
- University of Michigan Health - WestRecruiting
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor CampusRecruiting
- Mayo Clinic Health System in Albert LeaRecruiting
- Fairview Ridges Hospital
- Minnesota Oncology - BurnsvilleRecruiting
- Mercy HospitalRecruiting
- Fairview Southdale HospitalRecruiting
- Unity HospitalRecruiting
- Mayo Clinic Health Systems-MankatoRecruiting
- Fairview Clinics and Surgery Center Maple GroveRecruiting
- Minnesota Oncology Hematology PA-MaplewoodRecruiting
- Abbott-Northwestern HospitalRecruiting
- Health Partners IncRecruiting
- Monticello Cancer CenterRecruiting
- Mayo Clinic in RochesterRecruiting
- Coborn Cancer Center at Saint Cloud HospitalRecruiting
- Regions HospitalRecruiting
- United HospitalRecruiting
- Saint Francis Regional Medical CenterRecruiting
- Lakeview HospitalRecruiting
- Ridgeview Medical CenterRecruiting
- Minnesota Oncology Hematology PA-WoodburyRecruiting
- Saint Francis Medical CenterRecruiting
- MU Health - University Hospital/Ellis Fischel Cancer CenterRecruiting
- Parkland Health Center - FarmingtonRecruiting
- Capital Region Southwest CampusRecruiting
- Freeman Health SystemRecruiting
- University of Kansas Cancer Center - NorthRecruiting
- University of Kansas Cancer Center - Lee's SummitRecruiting
- University of Kansas Cancer Center at North Kansas City HospitalRecruiting
- Delbert Day Cancer Institute at PCRMCRecruiting
- Mercy Clinic-Rolla-Cancer and HematologyRecruiting
- Heartland Regional Medical CenterRecruiting
- 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
- Billings Clinic Cancer CenterRecruiting
- Bozeman Deaconess HospitalRecruiting
- Benefis Healthcare- Sletten Cancer InstituteRecruiting
- Community Medical HospitalRecruiting
- Nebraska Medicine-BellevueRecruiting
- Cancer Partners of Nebraska - Pine LakeRecruiting
- Southeast Nebraska Cancer Center - 68th Street PlaceRecruiting
- Nebraska Medicine-Village PointeRecruiting
- University of Nebraska Medical CenterRecruiting
- OptumCare Cancer Care at Seven HillsRecruiting
- OptumCare Cancer Care at CharlestonRecruiting
- Radiation Oncology Centers of Nevada CentralRecruiting
- Radiation Oncology Centers of Nevada SoutheastRecruiting
- OptumCare Cancer Care at MountainViewRecruiting
- Alliance for Childhood Diseases/Cure 4 the Kids FoundationRecruiting
- Comprehensive Cancer Centers of NevadaRecruiting
- OptumCare Cancer Care at Fort ApacheRecruiting
- Renown Regional Medical CenterRecruiting
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterRecruiting
- Memorial Sloan Kettering Basking RidgeRecruiting
- Memorial Sloan Kettering MonmouthRecruiting
- Memorial Sloan Kettering BergenRecruiting
- Virtua Samson Cancer CenterRecruiting
- Capital Health Medical Center-HopewellRecruiting
- Holy Name HospitalRecruiting
- Virtua VoorheesRecruiting
- University of New Mexico Cancer CenterRecruiting
- Northwell Health Imbert Cancer CenterRecruiting
- Montefiore Medical Center-Einstein Campus
- Montefiore Medical Center-Weiler Hospital
- Montefiore Medical Center - Moses Campus
- Roswell Park Cancer InstituteRecruiting
- Memorial Sloan Kettering CommackRecruiting
- Mary Imogene Bassett HospitalRecruiting
- Cancer Institute at Saint Francis HospitalRecruiting
- Hematology Oncology Associates of Central New York-East SyracuseRecruiting
- Arnot Ogden Medical Center/Falck Cancer CenterRecruiting
- Glens Falls HospitalRecruiting
- Memorial Sloan Kettering WestchesterRecruiting
- Northwell Health/Center for Advanced MedicineRecruiting
- NYU Winthrop HospitalRecruiting
- Northern Westchester HospitalRecruiting
- Mount Sinai Union SquareRecruiting
- Mount Sinai ChelseaRecruiting
- Laura and Isaac Perlmutter Cancer Center at NYU LangoneRecruiting
- Mount Sinai WestRecruiting
- Lenox Hill HospitalRecruiting
- Mount Sinai HospitalRecruiting
- Manhattan Eye Ear and Throat HospitalRecruiting
- Memorial Sloan Kettering Cancer CenterRecruiting
- Upstate Cancer Center at OneidaRecruiting
- Upstate Cancer Center at OswegoRecruiting
- Wilmot Cancer Institute Radiation Oncology at GreeceRecruiting
- Highland HospitalRecruiting
- Pluta Cancer CenterRecruiting
- University of RochesterRecruiting
- Mercy Hospital-Rockville CenterRecruiting
- Phelps Memorial Hospital CenterRecruiting
- Staten Island University HospitalRecruiting
- Stony Brook University Medical CenterRecruiting
- State University of New York Upstate Medical UniversityRecruiting
- Hematology Oncology Associates of Central New York-Onondaga HillRecruiting
- SUNY Upstate Medical Center-Community CampusRecruiting
- Memorial Sloan Kettering NassauRecruiting
- Wilmot Cancer Institute at WebsterRecruiting
- Atrium Health Stanly/LCI-AlbemarleRecruiting
- Mission HospitalRecruiting
- Hope Women's Cancer Centers-AshevilleRecruiting
- Carolinas Medical Center/Levine Cancer InstituteRecruiting
- Novant Health Presbyterian Medical CenterRecruiting
- Atrium Health Pineville/LCI-PinevilleRecruiting
- Atrium Health University City/LCI-UniversityRecruiting
- Atrium Health Cabarrus/LCI-ConcordRecruiting
- Levine Cancer Institute - RutherfordRecruiting
- Novant Health Cancer Institute - HuntersvilleRecruiting
- Novant Health Cancer Institute - KernersvilleRecruiting
- Levine Cancer Institute - Union WestRecruiting
- Matthews Radiation Oncology CenterRecruiting
- Novant Health Cancer Institute - MatthewsRecruiting
- Atrium Health Union/LCI-UnionRecruiting
- Novant Health Cancer Institute - MooresvilleRecruiting
- CarolinaEast Medical CenterRecruiting
- Rowan Regional Medical CenterRecruiting
- Atrium Health Cleveland/LCI-ClevelandRecruiting
- Novant Health Cancer Institute - ThomasvilleRecruiting
- Novant Health Forsyth Medical CenterRecruiting
- Wake Forest University Health SciencesRecruiting
- Sanford Broadway Medical CenterRecruiting
- Sanford Roger Maris Cancer CenterRecruiting
- Summa Health System - Akron CampusRecruiting
- Cleveland Clinic Akron GeneralRecruiting
- UH Seidman Cancer Center at UH Avon Health CenterRecruiting
- Summa Health System - Barberton CampusRecruiting
- UHHS-Chagrin Highlands Medical CenterRecruiting
- Indu and Raj Soin Medical CenterRecruiting
- Cleveland Clinic Mercy HospitalRecruiting
- Aultman Health FoundationRecruiting
- Dayton Physicians LLC-Miami Valley SouthRecruiting
- Miami Valley Hospital SouthRecruiting
- University of Cincinnati Cancer Center-UC Medical CenterRecruiting
- Case Western Reserve UniversityRecruiting
- Cleveland Clinic Cancer Center/Fairview HospitalRecruiting
- Cleveland Clinic FoundationRecruiting
- Ohio State University Comprehensive Cancer CenterRecruiting
- Mount Carmel Health Center WestRecruiting
- Dayton Physician LLC-Miami Valley Hospital NorthRecruiting
- Miami Valley Hospital NorthRecruiting
- Armes Family Cancer CenterRecruiting
- Blanchard Valley HospitalRecruiting
- Orion Cancer CareRecruiting
- Atrium Medical Center-Middletown Regional HospitalRecruiting
- Dayton Physicians LLC-AtriumRecruiting
- Mount Carmel Grove City HospitalRecruiting
- Kettering Medical CenterRecruiting
- Cleveland Clinic Cancer Center MansfieldRecruiting
- Hillcrest Hospital Cancer CenterRecruiting
- Summa Health Medina Medical CenterRecruiting
- UH Seidman Cancer Center at Lake Health Mentor CampusRecruiting
- UH Seidman Cancer Center at Southwest General HospitalRecruiting
- Mount Carmel New Albany Surgical HospitalRecruiting
- University Hospitals Parma Medical CenterRecruiting
- University Hospitals Portage Medical CenterRecruiting
- North Coast Cancer CareRecruiting
- UH Seidman Cancer Center at Firelands Regional Medical CenterRecruiting
- Cleveland Clinic Cancer Center StrongsvilleRecruiting
- ProMedica Flower HospitalRecruiting
- ProMedica Toledo Hospital/Russell J Ebeid Children's HospitalRecruiting
- Dayton Physicians LLC - TroyRecruiting
- Upper Valley Medical CenterRecruiting
- South Pointe HospitalRecruiting
- University of Cincinnati Cancer Center-West ChesterRecruiting
- Cleveland Clinic Wooster Family Health and Surgery CenterRecruiting
- Genesis Healthcare System Cancer Care CenterRecruiting
- University of Oklahoma Health Sciences CenterRecruiting
- Mercy Hospital Oklahoma CityRecruiting
- Clackamas Radiation Oncology CenterRecruiting
- Providence Cancer Institute Clackamas ClinicRecruiting
- Legacy Mount Hood Medical CenterRecruiting
- Providence Newberg Medical CenterRecruiting
- Providence Willamette Falls Medical CenterRecruiting
- Legacy Good Samaritan Hospital and Medical CenterRecruiting
- Providence Portland Medical CenterRecruiting
- Providence Saint Vincent Medical CenterRecruiting
- Kaiser Permanente Northwest
- Oregon Health and Science UniversityRecruiting
- Legacy Meridian Park HospitalRecruiting
- Saint Luke's Cancer Center - AllentownRecruiting
- Saint Luke's University Hospital-Bethlehem CampusRecruiting
- Crozer-Keystone Regional Cancer Center at BroomallRecruiting
- Christiana Care Health System-Concord Health CenterRecruiting
- Chambersburg HospitalRecruiting
- Geisinger Medical CenterRecruiting
- Mercy Fitzgerald HospitalRecruiting
- Fox Chase Cancer Center - East Norriton Hospital Outpatient CenterRecruiting
- Saint Luke's Hospital-Anderson CampusRecruiting
- Ephrata Cancer CenterRecruiting
- Saint Vincent HospitalRecruiting
- Fox Chase Cancer Center BuckinghamRecruiting
- Adams Cancer CenterRecruiting
- Crozer Regional Cancer Center at Brinton LakeRecruiting
- Penn State Milton S Hershey Medical CenterRecruiting
- Jefferson HospitalRecruiting
- Sechler Family Cancer CenterRecruiting
- Geisinger Medical Oncology-LewisburgRecruiting
- Yolanda G Barco Oncology InstituteRecruiting
- Forbes HospitalRecruiting
- Allegheny Valley HospitalRecruiting
- Thomas Jefferson University HospitalRecruiting
- Fox Chase Cancer CenterRecruiting
- Jefferson Torresdale HospitalRecruiting
- Temple University HospitalRecruiting
- Allegheny General HospitalRecruiting
- West Penn HospitalRecruiting
- Geisinger Cancer Services-PottsvilleRecruiting
- Saint Luke's Hospital-Quakertown CampusRecruiting
- Guthrie Medical Group PC-Robert Packer HospitalRecruiting
- Grand View Hospital
- Wexford Health and Wellness PavilionRecruiting
- Geisinger Wyoming Valley/Henry Cancer CenterRecruiting
- Asplundh Cancer PavilionRecruiting
- WellSpan Health-York Cancer CenterRecruiting
- WellSpan Health-York HospitalRecruiting
- Rhode Island HospitalRecruiting
- Women and Infants HospitalRecruiting
- Kent HospitalRecruiting
- Smilow Cancer Hospital Care Center - WesterlyRecruiting
- Medical University of South CarolinaRecruiting
- McLeod Regional Medical CenterRecruiting
- Tidelands Georgetown Memorial HospitalRecruiting
- Carolina Regional Cancer CenterRecruiting
- Rock Hill Radiation Therapy CenterRecruiting
- Levine Cancer Institute-Rock HillRecruiting
- Sanford Cancer Center Oncology ClinicRecruiting
- Sanford USD Medical Center - Sioux FallsRecruiting
- The Children's Hospital at TriStar CentennialRecruiting
- Vanderbilt Breast Center at One Hundred OaksRecruiting
- Vanderbilt University/Ingram Cancer CenterRecruiting
- Hendrick Medical CenterRecruiting
- Houston Methodist San Jacinto HospitalRecruiting
- MD Anderson in The WoodlandsRecruiting
- Brooke Army Medical CenterRecruiting
- University of Texas Medical BranchRecruiting
- Houston Methodist HospitalRecruiting
- M D Anderson Cancer CenterRecruiting
- Methodist Willowbrook HospitalRecruiting
- MD Anderson West HoustonRecruiting
- Houston Methodist West HospitalRecruiting
- Doctor's Hospital of LaredoRecruiting
- MD Anderson League CityRecruiting
- UMC Cancer Center / UMC Health SystemRecruiting
- Texas Tech University Health Sciences Center-LubbockRecruiting
- Houston Methodist Saint John HospitalRecruiting
- MD Anderson in Sugar LandRecruiting
- Houston Methodist Sugar Land HospitalRecruiting
- Houston Methodist The Woodlands HospitalRecruiting
- Norris Cotton Cancer Center-NorthRecruiting
- Bon Secours Memorial Regional Medical CenterRecruiting
- VCU Massey Cancer Center at Hanover Medical ParkRecruiting
- Bon Secours Saint Francis Medical CenterRecruiting
- Naval Medical Center - PortsmouthRecruiting
- Bon Secours Saint Mary's HospitalRecruiting
- Bon Secours Cancer Institute at Reynolds CrossingRecruiting
- VCU Massey Cancer Center at Stony PointRecruiting
- Virginia Commonwealth University/Massey Cancer CenterRecruiting
- VCU Community Memorial Health CenterRecruiting
- PeaceHealth Saint Joseph Medical CenterRecruiting
- Harrison Medical CenterRecruiting
- Swedish Cancer Institute-IssaquahRecruiting
- Swedish Medical Center-Ballard CampusRecruiting
- Swedish Medical Center-First HillRecruiting
- Legacy Cancer Institute Medical Oncology and Day TreatmentRecruiting
- Legacy Salmon Creek HospitalRecruiting
- Edwards Comprehensive Cancer CenterRecruiting
- Langlade Hospital and Cancer CenterRecruiting
- ThedaCare Regional Cancer Center
- Aurora Cancer Care-Southern Lakes VLCCRecruiting
- HSHS Sacred Heart HospitalRecruiting
- Aurora Health Center-Fond du LacRecruiting
- Aurora Health Care Germantown Health CenterRecruiting
- Aurora Cancer Care-GraftonRecruiting
- Saint Vincent Hospital Cancer Center Green BayRecruiting
- Saint Vincent Hospital Cancer Center at Saint Mary'sRecruiting
- Aurora BayCare Medical CenterRecruiting
- UW Cancer Center Johnson CreekRecruiting
- Aurora Cancer Care-Kenosha SouthRecruiting
- Mayo Clinic Health System-Franciscan HealthcareRecruiting
- University of Wisconsin Carbone Cancer CenterRecruiting
- Aurora Bay Area Medical Group-MarinetteRecruiting
- Aspirus Medford HospitalRecruiting
- Froedtert Menomonee Falls HospitalRecruiting
- Aurora Cancer Care-MilwaukeeRecruiting
- Aurora Saint Luke's Medical CenterRecruiting
- Medical College of WisconsinRecruiting
- Aurora Sinai Medical CenterRecruiting
- ProHealth D N Greenwald CenterRecruiting
- Cancer Center of Western WisconsinRecruiting
- Drexel Town Square Health CenterRecruiting
- ProHealth Oconomowoc Memorial HospitalRecruiting
- Vince Lombardi Cancer Clinic - OshkoshRecruiting
- Aurora Cancer Care-RacineRecruiting
- Ascension Saint Mary's HospitalRecruiting
- Saint Vincent Hospital Cancer Center at SheboyganRecruiting
- Vince Lombardi Cancer Clinic-SheboyganRecruiting
- Ascension Saint Michael's HospitalRecruiting
- Saint Vincent Hospital Cancer Center at Sturgeon BayRecruiting
- Aurora Medical Center in SummitRecruiting
- Vince Lombardi Cancer Clinic-Two RiversRecruiting
- UW Cancer Center at ProHealth CareRecruiting
- Aspirus Regional Cancer CenterRecruiting
- Aurora Cancer Care-Milwaukee WestRecruiting
- Aurora West Allis Medical CenterRecruiting
- Froedtert West Bend Hospital/Kraemer Cancer CenterRecruiting
- Aspirus Cancer Care - Wisconsin RapidsRecruiting
- Atlantic Health Sciences Corporation-Saint John Regional HospitalRecruiting
- Kingston Health Sciences CentreRecruiting
- CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)Recruiting
- Saskatoon Cancer CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Arm 1: Breast Radiation Therapy + Endocrine Therapy
Arm 2: No Breast Radiation Therapy + Endocrine Therapy
Radiation therapy to the breast and hormonal drug for at least 5 years. Tamoxifen 20 mg daily Anastrozole 1 mg daily Letrozole 2.5 mg daily Exemestane 25 mg daily
No radiation therapy, only hormonal drug for at least 5 years. Tamoxifen 20 mg daily Anastrozole 1 mg daily Letrozole 2.5 mg daily Exemestane 25 mg daily