Breast Cancer Clinical Trial
— TAILOR RTOfficial title:
TAILOR RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low-Risk Node Positive and T3N0 Breast Cancer
The purpose of this study is to compare the effects on low risk breast cancer receiving usual care that includes regional radiation therapy, with receiving no regional radiation therapy. Researchers want to see if not giving this type of radiation treatment works as well at preventing breast cancer from coming back.
Status | Recruiting |
Enrollment | 2140 |
Est. completion date | December 30, 2027 |
Est. primary completion date | September 1, 2027 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 35 Years and older |
Eligibility | Inclusion Criteria: - Patients must be women with newly diagnosed histologically proven invasive carcinoma of the breast with no evidence of metastases, staged as per site standard of care. - Patients must have been treated by BCS or mastectomy with clear margins of excision. Post-mastectomy positive margins for invasive disease and/or DCIS is not allowed. Multifocal disease (i.e. the presence of two or more foci or breast cancer within the same breast quadrant) and multicentric disease (i.e. the presence of two or more foci of breast cancer in different quadrants of the same breast) are allowed. - Patients with T3N0 disease are eligible. - Patients with disease limited to nodal micrometastases are eligible - Patients with nodal macrometastases (>2mm) treated by axillary dissection must have 1-3 positive axillary nodes (macrometastases, > 2 mm). - Patients treated by mastectomy and SLNB alone must have only 1-2 positive axillary nodes (macrometastases, > 2 mm). - Patients must be ER = 1% and HER2 negative on local testing - Patients must have an Oncotype DX recurrence score =25 obtained from testing of breast tumour tissue from a core biopsy or from the surgical specimen. - Patient must consent to provision of, and investigator(s) must agree to submit to the CCTG Central Tumour Bank, a representative formalin fixed paraffin block of tumour tissue in order that the specific correlative marker assays described in the protocol may be conducted - Patient must consent to provision of samples of blood in order that the specific correlative marker assays described in the protocol may be conducted. - Patients must have had endocrine therapy initiated or planned for = 5 years. Premenopausal women will receive ovarian ablation plus aromatase inhibitor therapy or tamoxifen if adjuvant chemotherapy was not administered. For all patients, endocrine therapy can be given concurrently or following RT. - Patients may or may not have had adjuvant chemotherapy. - RT must commence within 16 weeks of definitive surgery if the patient is not treated with chemotherapy. If adjuvant chemotherapy is given, RT must begin within 12 weeks after the last dose. (Note: adjuvant chemotherapy may be ongoing at the time of randomization). Definitive surgery is defined as the last breast cancer-related surgery. - Patient's ECOG performance status must be 0, 1 or 2. - Patient's age must be = 35 years. - For the first 736 eligible English or French-speaking subjects who have agreed to optional questionnaire completion: Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life, health utilities and lost productivity questionnaires in either English or French (note: enrollment completed 2022Aug02) - Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements - Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients randomized on this trial will be available for complete documentation of the treatment, adverse events, and follow-up. - In accordance with CCTG policy, protocol treatment is to begin within 6 weeks of patient randomization. - Women of childbearing potential must have agreed to use an effective contraceptive method. A woman is considered to be of "childbearing potential" if she has had menses at any time in the preceding 12 consecutive months. Exclusion Criteria: - Patients with nodal disease limited to isolated tumour cells (pN0i+ < 0.2 mm). - Patients with pT3N1 and pT4 disease (Note: patients with T3N0 are eligible). - Any prior history, not including the index cancer, of ipsilateral invasive breast cancer or ipsilateral DCIS treated with radiation therapy. (Patients with synchronous or previous ipsilateral LCIS are eligible.) - Synchronous or previous contralateral invasive breast cancer. (Patients with contralateral DCIS are eligible unless previously treated with radiation.) - History of non-breast malignancies except adequately treated non-melanoma skin cancers, in situ cancers treated by local excision or other cancers curatively treated with no evidence of disease for = 5 years. - Patients who are pregnant. - Patients that have had prior ipsilateral chestwall/thoracic radiation. - Patients treated with chemo or endocrine therapy administered in the neoadjuvant setting for breast cancer. Endocrine therapy exposure 12 weeks or less prior to surgery is permitted. - Patients with serious non-malignant disease (e.g. cardiovascular, scleroderma etc.) which would preclude RT. - Patients with any serious active or co-morbid medical conditions, laboratory abnormality, psychiatric illness, active or uncontrolled infections, or serious illnesses or medical conditions that would prevent the patient from participating or to be managed according to the protocol (according to investigator's decision). |
Country | Name | City | State |
---|---|---|---|
Canada | BCCA-Abbotsford Cancer Centre | Abbotsford | British Columbia |
Canada | Royal Victoria Regional Health Centre | Barrie | Ontario |
Canada | Tom Baker Cancer Centre | Calgary | Alberta |
Canada | Cross Cancer Institute | Edmonton | Alberta |
Canada | CSSS Champlain-Charles Le Moyne | Greenfield Park | Quebec |
Canada | QEII Health Sciences Centre/Nova Scotia Health Authority | Halifax | Nova Scotia |
Canada | Juravinski Cancer Centre at Hamilton Health Sciences | Hamilton | Ontario |
Canada | BCCA-Cancer Centre for the Southern Interior | Kelowna | British Columbia |
Canada | Kingston Health Sciences Centre | Kingston | Ontario |
Canada | Grand River Regional Cancer Centre at Grand River Hospital | Kitchener | Ontario |
Canada | Hopital de la Cite-de-la-Sante | Laval | Quebec |
Canada | London Regional Cancer Program | London | Ontario |
Canada | Trillium Health Partners - Credit Valley Hospital | Mississauga | Ontario |
Canada | CHUM - Centre Hospitalier de l'Universite de Montreal | Montreal | Quebec |
Canada | CIUSSSEMTL-Hopital Maisonneuve-Rosemont | Montreal | Quebec |
Canada | Jewish General Hospital | Montreal | Quebec |
Canada | The Research Institute of the McGill University Health Centre (MUHC) | Montreal | Quebec |
Canada | Ottawa Hospital and Cancer Center-General Campus | Ottawa | Ontario |
Canada | BCCA-Cancer Centre for the North | Prince George | British Columbia |
Canada | CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ) | Quebec City | Quebec |
Canada | Allan Blair Cancer Centre | Regina | Saskatchewan |
Canada | Niagara Health System-Saint Catharines General | Saint Catharines | Ontario |
Canada | Atlantic Health Sciences Corporation-Saint John Regional Hospital | Saint John | New Brunswick |
Canada | Saskatoon Cancer Centre | Saskatoon | Saskatchewan |
Canada | Algoma District Cancer Program Sault Area Hospital | Sault Ste Marie | Ontario |
Canada | Centre Hospitalier Universitaire de Sherbrooke-Fleurimont | Sherbrooke | Quebec |
Canada | Doctor H. Bliss Murphy Cancer Centre | St. John's | Newfoundland and Labrador |
Canada | Health Sciences North | Sudbury | Ontario |
Canada | BCCA-Fraser Valley Cancer Centre | Surrey | British Columbia |
Canada | Odette Cancer Centre- Sunnybrook Health Sciences Centre | Toronto | Ontario |
Canada | University Health Network-Princess Margaret Hospital | Toronto | Ontario |
Canada | BCCA-Vancouver Cancer Centre | Vancouver | British Columbia |
Canada | BCCA-Vancouver Island Cancer Centre | Victoria | British Columbia |
Canada | CancerCare Manitoba | Winnipeg | Manitoba |
United States | Cleveland Clinic Akron General | Akron | Ohio |
United States | Lovelace Radiation Oncology | Albuquerque | New Mexico |
United States | New Mexico Oncology Hematology Consultants | Albuquerque | New Mexico |
United States | University of New Mexico Cancer Center | Albuquerque | New Mexico |
United States | American Fork Hospital / Huntsman Intermountain Cancer Center | American Fork | Utah |
United States | Kaiser Permanente-Anaheim | Anaheim | California |
United States | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan |
United States | Anne Arundel Medical Center | Annapolis | Maryland |
United States | Langlade Hospital and Cancer Center | Antigo | Wisconsin |
United States | ThedaCare Regional Cancer Center | Appleton | Wisconsin |
United States | Hope Women's Cancer Centers-Asheville | Asheville | North Carolina |
United States | Mission Hospital | Asheville | North Carolina |
United States | Mount Sinai Queens | Astoria | New York |
United States | MultiCare Auburn Medical Center | Auburn | Washington |
United States | UCHealth University of Colorado Hospital | Aurora | Colorado |
United States | IU Health West Hospital | Avon | Indiana |
United States | UH Seidman Cancer Center at UH Avon Health Center | Avon | Ohio |
United States | Greater Baltimore Medical Center | Baltimore | Maryland |
United States | Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland |
United States | MedStar Franklin Square Medical Center/Weinberg Cancer Institute | Baltimore | Maryland |
United States | MedStar Good Samaritan Hospital | Baltimore | Maryland |
United States | Saint Agnes Hospital | Baltimore | Maryland |
United States | University of Maryland/Greenebaum Cancer Center | Baltimore | Maryland |
United States | Memorial Sloan Kettering Basking Ridge | Basking Ridge | New Jersey |
United States | MaineHealth Coastal Cancer Treatment Center | Bath | Maine |
United States | McLaren Cancer Institute-Bay City | Bay City | Michigan |
United States | Houston Methodist San Jacinto Hospital | Baytown | Texas |
United States | UHHS-Chagrin Highlands Medical Center | Beachwood | Ohio |
United States | Sanford Joe Lueken Cancer Center | Bemidji | Minnesota |
United States | Saint Charles Health System | Bend | Oregon |
United States | Alta Bates Summit Medical Center-Herrick Campus | Berkeley | California |
United States | Central Vermont Medical Center/National Life Cancer Treatment | Berlin | Vermont |
United States | Suburban Hospital | Bethesda | Maryland |
United States | Billings Clinic Cancer Center | Billings | Montana |
United States | Sanford Bismarck Medical Center | Bismarck | North Dakota |
United States | Saint Joseph's/Candler - Bluffton Campus | Bluffton | South Carolina |
United States | Boca Raton Regional Hospital | Boca Raton | Florida |
United States | Prisma Health Cancer Institute - Spartanburg | Boiling Springs | South Carolina |
United States | Saint Alphonsus Cancer Care Center-Boise | Boise | Idaho |
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Massachusetts General Hospital Cancer Center | Boston | Massachusetts |
United States | Rocky Mountain Cancer Centers-Boulder | Boulder | Colorado |
United States | Lafayette Family Cancer Center-EMMC | Brewer | Maine |
United States | Montefiore Medical Center - Moses Campus | Bronx | New York |
United States | Montefiore Medical Center-Einstein Campus | Bronx | New York |
United States | Maimonides Medical Center | Brooklyn | New York |
United States | New York-Presbyterian/Brooklyn Methodist Hospital | Brooklyn | New York |
United States | Bryn Mawr Hospital | Bryn Mawr | Pennsylvania |
United States | Lahey Hospital and Medical Center | Burlington | Massachusetts |
United States | University of Vermont Medical Center | Burlington | Vermont |
United States | Saint James Community Hospital and Cancer Treatment Center | Butte | Montana |
United States | Aultman Health Foundation | Canton | Ohio |
United States | Cleveland Clinic Mercy Hospital | Canton | Ohio |
United States | Saint Francis Medical Center | Cape Girardeau | Missouri |
United States | Carlisle Regional Cancer Center | Carlisle | Pennsylvania |
United States | IU Health North Hospital | Carmel | Indiana |
United States | Sandra L Maxwell Cancer Center | Cedar City | Utah |
United States | Saint Luke's Hospital | Cedar Rapids | Iowa |
United States | Christiana Care Health System-Concord Health Center | Chadds Ford | Pennsylvania |
United States | UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina |
United States | Geauga Hospital | Chardon | Ohio |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | Advocate Illinois Masonic Medical Center | Chicago | Illinois |
United States | Northwestern University | Chicago | Illinois |
United States | Rush University Medical Center | Chicago | Illinois |
United States | Swedish Covenant Hospital | Chicago | Illinois |
United States | University of Chicago Comprehensive Cancer Center | Chicago | Illinois |
United States | University of Illinois | Chicago | Illinois |
United States | McLaren Cancer Institute-Clarkston | Clarkston | Michigan |
United States | Morton Plant Hospital | Clearwater | Florida |
United States | Case Western Reserve University | Cleveland | Ohio |
United States | MetroHealth Medical Center | Cleveland | Ohio |
United States | Mercy Cancer Center-West Lakes | Clive | Iowa |
United States | Kootenai Health - Coeur d'Alene | Coeur d'Alene | Idaho |
United States | Memorial Hospital North | Colorado Springs | Colorado |
United States | Penrose-Saint Francis Healthcare | Colorado Springs | Colorado |
United States | Saint Francis Cancer Center | Colorado Springs | Colorado |
United States | UCHealth Memorial Hospital Central | Colorado Springs | Colorado |
United States | MU Health - University Hospital/Ellis Fischel Cancer Center | Columbia | Missouri |
United States | Grant Medical Center | Columbus | Ohio |
United States | Ohio State University Comprehensive Cancer Center | Columbus | Ohio |
United States | Riverside Methodist Hospital | Columbus | Ohio |
United States | The Mark H Zangmeister Center | Columbus | Ohio |
United States | Memorial Sloan Kettering Commack | Commack | New York |
United States | New Hampshire Oncology Hematology PA-Concord | Concord | New Hampshire |
United States | MD Anderson in The Woodlands | Conroe | Texas |
United States | Mary Imogene Bassett Hospital | Cooperstown | New York |
United States | UM Sylvester Comprehensive Cancer Center at Coral Gables | Coral Gables | Florida |
United States | City of Hope Corona | Corona | California |
United States | Good Samaritan Hospital | Corvallis | Oregon |
United States | Greater Regional Medical Center | Creston | Iowa |
United States | Parkland Memorial Hospital | Dallas | Texas |
United States | UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas |
United States | Beaumont Hospital - Dearborn | Dearborn | Michigan |
United States | Decatur Memorial Hospital | Decatur | Illinois |
United States | UM Sylvester Comprehensive Cancer Center at Deerfield Beach | Deerfield Beach | Florida |
United States | Northwestern Medicine Cancer Center Kishwaukee | DeKalb | Illinois |
United States | Porter Adventist Hospital | Denver | Colorado |
United States | UCHealth - Cherry Creek | Denver | Colorado |
United States | Iowa Methodist Medical Center | Des Moines | Iowa |
United States | Mercy Medical Center - Des Moines | Des Moines | Iowa |
United States | Wentworth-Douglass Hospital | Dover | New Hampshire |
United States | City of Hope Comprehensive Cancer Center | Duarte | California |
United States | Dublin Methodist Hospital | Dublin | Ohio |
United States | Kaiser Permanente Dublin | Dublin | California |
United States | Duke University Medical Center | Durham | North Carolina |
United States | University of Maryland Shore Medical Center at Easton | Easton | Maryland |
United States | HSHS Sacred Heart Hospital | Eau Claire | Wisconsin |
United States | Marshfield Medical Center-EC Cancer Center | Eau Claire | Wisconsin |
United States | Saint Elizabeth Healthcare Edgewood | Edgewood | Kentucky |
United States | Crossroads Cancer Center | Effingham | Illinois |
United States | Mercy Cancer Center-Elyria | Elyria | Ohio |
United States | Englewood Hospital and Medical Center | Englewood | New Jersey |
United States | Saint Vincent Hospital | Erie | Pennsylvania |
United States | UPMC Hillman Cancer Center Erie | Erie | Pennsylvania |
United States | NorthShore University HealthSystem-Evanston Hospital | Evanston | Illinois |
United States | Exeter Hospital | Exeter | New Hampshire |
United States | Fairbanks Memorial Hospital | Fairbanks | Alaska |
United States | Farmington Health Center | Farmington | Utah |
United States | Beaumont Hospital - Farmington Hills | Farmington Hills | Michigan |
United States | UPMC Cancer Center at UPMC Horizon | Farrell | Pennsylvania |
United States | IU Health Central Indiana Cancer Centers-Fishers | Fishers | Indiana |
United States | Augusta Health Center for Cancer and Blood Disorders | Fishersville | Virginia |
United States | McLaren Cancer Institute-Flint | Flint | Michigan |
United States | Poudre Valley Hospital | Fort Collins | Colorado |
United States | Broward Health Medical Center | Fort Lauderdale | Florida |
United States | Saint Elizabeth Fort Thomas | Fort Thomas | Kentucky |
United States | Fresno Cancer Center | Fresno | California |
United States | University of Texas Medical Branch | Galveston | Texas |
United States | CaroMont Regional Medical Center | Gastonia | North Carolina |
United States | Northwestern Medicine Cancer Center Delnor | Geneva | Illinois |
United States | MultiCare Gig Harbor Medical Park | Gig Harbor | Washington |
United States | UM Baltimore Washington Medical Center/Tate Cancer Center | Glen Burnie | Maryland |
United States | NorthShore University HealthSystem-Glenbrook Hospital | Glenview | Illinois |
United States | SCL Health Cancer Centers of Colorado - Lutheran Medical Center | Golden | Colorado |
United States | Aurora Cancer Care-Grafton | Grafton | Wisconsin |
United States | Altru Cancer Center | Grand Forks | North Dakota |
United States | Spectrum Health at Butterworth Campus | Grand Rapids | Michigan |
United States | Trinity Health Grand Rapids Hospital | Grand Rapids | Michigan |
United States | Benefis Healthcare- Sletten Cancer Institute | Great Falls | Montana |
United States | North Colorado Medical Center | Greeley | Colorado |
United States | UCHealth Greeley Hospital | Greeley | Colorado |
United States | Aurora BayCare Medical Center | Green Bay | Wisconsin |
United States | Bellin Memorial Hospital | Green Bay | Wisconsin |
United States | Saint Vincent Hospital Cancer Center at Saint Mary's | Green Bay | Wisconsin |
United States | Saint Vincent Hospital Cancer Center Green Bay | Green Bay | Wisconsin |
United States | UPMC Cancer Centers - Arnold Palmer Pavilion | Greensburg | Pennsylvania |
United States | Prisma Health Cancer Institute - Eastside | Greenville | South Carolina |
United States | Prisma Health Cancer Institute - Faris | Greenville | South Carolina |
United States | Saint Francis Cancer Center | Greenville | South Carolina |
United States | Self Regional Healthcare | Greenwood | South Carolina |
United States | Prisma Health Cancer Institute - Greer | Greer | South Carolina |
United States | Mount Carmel Grove City Hospital | Grove City | Ohio |
United States | Smilow Cancer Hospital Care Center - Guilford | Guilford | Connecticut |
United States | Smilow Cancer Hospital-Hamden Care Center | Hamden | Connecticut |
United States | The Cancer Institute of New Jersey Hamilton | Hamilton | New Jersey |
United States | UPMC Pinnacle Cancer Center/Community Osteopathic Campus | Harrisburg | Pennsylvania |
United States | Memorial Sloan Kettering Westchester | Harrison | New York |
United States | Penn State Milton S Hershey Medical Center | Hershey | Pennsylvania |
United States | NorthShore University HealthSystem-Highland Park Hospital | Highland Park | Illinois |
United States | UCHealth Highlands Ranch Hospital | Highlands Ranch | Colorado |
United States | The Radiation Oncology Center-Hilton Head/Bluffton | Hilton Head Island | South Carolina |
United States | Memorial Regional Hospital/Joe DiMaggio Children's Hospital | Hollywood | Florida |
United States | Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center | Houston | Texas |
United States | Houston Methodist Hospital | Houston | Texas |
United States | Houston Methodist West Hospital | Houston | Texas |
United States | M D Anderson Cancer Center | Houston | Texas |
United States | MD Anderson West Houston | Houston | Texas |
United States | Methodist Willowbrook Hospital | Houston | Texas |
United States | IRMC Cancer Center | Indiana | Pennsylvania |
United States | Community Cancer Center East | Indianapolis | Indiana |
United States | Community Cancer Center North | Indianapolis | Indiana |
United States | Community Cancer Center South | Indianapolis | Indiana |
United States | Indiana University/Melvin and Bren Simon Cancer Center | Indianapolis | Indiana |
United States | IU Health Methodist Hospital | Indianapolis | Indiana |
United States | City of Hope at Irvine Lennar | Irvine | California |
United States | Mayo Clinic in Florida | Jacksonville | Florida |
United States | Capital Region Southwest Campus | Jefferson City | Missouri |
United States | Jefferson Hospital | Jefferson Hills | Pennsylvania |
United States | UW Cancer Center Johnson Creek | Johnson Creek | Wisconsin |
United States | West Michigan Cancer Center | Kalamazoo | Michigan |
United States | University of Kansas Cancer Center | Kansas City | Kansas |
United States | University of Kansas Cancer Center - North | Kansas City | Missouri |
United States | Aurora Cancer Care-Kenosha South | Kenosha | Wisconsin |
United States | Gundersen Lutheran Medical Center | La Crosse | Wisconsin |
United States | Northwestern Medicine Lake Forest Hospital | Lake Forest | Illinois |
United States | City of Hope Antelope Valley | Lancaster | California |
United States | Lancaster General Ann B Barshinger Cancer Institute | Lancaster | Pennsylvania |
United States | Lancaster General Hospital | Lancaster | Pennsylvania |
United States | Karmanos Cancer Institute at McLaren Greater Lansing | Lansing | Michigan |
United States | Doctor's Hospital of Laredo | Laredo | Texas |
United States | Memorial Medical Center - Las Cruces | Las Cruces | New Mexico |
United States | MD Anderson League City | League City | Texas |
United States | Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center | Lebanon | New Hampshire |
United States | University of Kansas Cancer Center - Lee's Summit | Lee's Summit | Missouri |
United States | Saint Joseph Hospital East | Lexington | Kentucky |
United States | Saint Joseph Radiation Oncology Resource Center | Lexington | Kentucky |
United States | University of Kentucky/Markey Cancer Center | Lexington | Kentucky |
United States | University of Arkansas for Medical Sciences | Little Rock | Arkansas |
United States | Littleton Adventist Hospital | Littleton | Colorado |
United States | Logan Regional Hospital | Logan | Utah |
United States | Kaiser Permanente Los Angeles Medical Center | Los Angeles | California |
United States | Los Angeles General Medical Center | Los Angeles | California |
United States | USC / Norris Comprehensive Cancer Center | Los Angeles | California |
United States | The James Graham Brown Cancer Center at University of Louisville | Louisville | Kentucky |
United States | McKee Medical Center | Loveland | Colorado |
United States | Lowell General Hospital | Lowell | Massachusetts |
United States | University of Wisconsin Carbone Cancer Center | Madison | Wisconsin |
United States | Solinsky Center for Cancer Care | Manchester | New Hampshire |
United States | Aurora Bay Area Medical Group-Marinette | Marinette | Wisconsin |
United States | Marshfield Medical Center-Marshfield | Marshfield | Wisconsin |
United States | Loyola University Medical Center | Maywood | Illinois |
United States | UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion | Mechanicsburg | Pennsylvania |
United States | Riddle Memorial Hospital | Media | Pennsylvania |
United States | Baptist Memorial Hospital and Cancer Center-Memphis | Memphis | Tennessee |
United States | Froedtert Menomonee Falls Hospital | Menomonee Falls | Wisconsin |
United States | UH Seidman Cancer Center at Lake Health Mentor Campus | Mentor | Ohio |
United States | Miami Cancer Institute | Miami | Florida |
United States | University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida |
United States | UH Seidman Cancer Center at Southwest General Hospital | Middleburg Heights | Ohio |
United States | Memorial Sloan Kettering Monmouth | Middletown | New Jersey |
United States | Aurora Saint Luke's Medical Center | Milwaukee | Wisconsin |
United States | Aurora Sinai Medical Center | Milwaukee | Wisconsin |
United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
United States | NYU Winthrop Hospital | Mineola | New York |
United States | Abbott-Northwestern Hospital | Minneapolis | Minnesota |
United States | Hennepin County Medical Center | Minneapolis | Minnesota |
United States | Marshfield Clinic-Minocqua Center | Minocqua | Wisconsin |
United States | Forbes Hospital | Monroeville | Pennsylvania |
United States | UPMC Cancer Center - Monroeville | Monroeville | Pennsylvania |
United States | Memorial Sloan Kettering Bergen | Montvale | New Jersey |
United States | West Virginia University Healthcare | Morgantown | West Virginia |
United States | McLaren Cancer Institute-Macomb | Mount Clemens | Michigan |
United States | ProHealth D N Greenwald Center | Mukwonago | Wisconsin |
United States | IU Health Ball Memorial Hospital | Muncie | Indiana |
United States | Intermountain Medical Center | Murray | Utah |
United States | Trinity Health Muskegon Hospital | Muskegon | Michigan |
United States | Providence Queen of The Valley | Napa | California |
United States | Houston Methodist Saint John Hospital | Nassau Bay | Texas |
United States | Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey |
United States | Saint Peter's University Hospital | New Brunswick | New Jersey |
United States | Yale University | New Haven | Connecticut |
United States | UC Comprehensive Cancer Center at Silver Cross | New Lenox | Illinois |
United States | Cancer Center of Western Wisconsin | New Richmond | Wisconsin |
United States | Laura and Isaac Perlmutter Cancer Center at NYU Langone | New York | New York |
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
United States | Mount Sinai Chelsea | New York | New York |
United States | Mount Sinai Hospital | New York | New York |
United States | Mount Sinai Union Square | New York | New York |
United States | Mount Sinai West | New York | New York |
United States | NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York |
United States | Christiana Care Health System-Christiana Hospital | Newark | Delaware |
United States | Helen F Graham Cancer Center | Newark | Delaware |
United States | Bryn Mawr Health Center | Newtown Square | Pennsylvania |
United States | Norwalk Hospital | Norwalk | Connecticut |
United States | Ascension Providence Hospitals - Novi | Novi | Michigan |
United States | Nyack Hospital | Nyack | New York |
United States | Drexel Town Square Health Center | Oak Creek | Wisconsin |
United States | Kaiser Permanente Oakland-Broadway | Oakland | California |
United States | ProHealth Oconomowoc Memorial Hospital | Oconomowoc | Wisconsin |
United States | McKay-Dee Hospital Center | Ogden | Utah |
United States | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
United States | Alegent Health Bergan Mercy Medical Center | Omaha | Nebraska |
United States | University of Nebraska Medical Center | Omaha | Nebraska |
United States | Saint Joseph Hospital - Orange | Orange | California |
United States | UC Irvine Health/Chao Family Comprehensive Cancer Center | Orange | California |
United States | University of Chicago Medicine-Orland Park | Orland Park | Illinois |
United States | Orlando Health Cancer Institute | Orlando | Florida |
United States | Vince Lombardi Cancer Clinic - Oshkosh | Oshkosh | Wisconsin |
United States | University of Kansas Cancer Center-Overland Park | Overland Park | Kansas |
United States | Owensboro Health Mitchell Memorial Cancer Center | Owensboro | Kentucky |
United States | Desert Regional Medical Center | Palm Springs | California |
United States | Paoli Memorial Hospital | Paoli | Pennsylvania |
United States | Advocate Lutheran General Hospital | Park Ridge | Illinois |
United States | University Hospitals Parma Medical Center | Parma | Ohio |
United States | Memorial Hospital West | Pembroke Pines | Florida |
United States | OSF Saint Francis Medical Center | Peoria | Illinois |
United States | McLaren Cancer Institute-Northern Michigan | Petoskey | Michigan |
United States | Jefferson Torresdale Hospital | Philadelphia | Pennsylvania |
United States | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania |
United States | Allegheny General Hospital | Pittsburgh | Pennsylvania |
United States | UPMC-Magee Womens Hospital | Pittsburgh | Pennsylvania |
United States | UPMC-Passavant Hospital | Pittsburgh | Pennsylvania |
United States | UPMC-Saint Clair Hospital Cancer Center | Pittsburgh | Pennsylvania |
United States | UPMC-Saint Margaret | Pittsburgh | Pennsylvania |
United States | UPMC-Shadyside Hospital | Pittsburgh | Pennsylvania |
United States | West Penn Hospital | Pittsburgh | Pennsylvania |
United States | Miami Cancer Institute at Plantation | Plantation | Florida |
United States | McLaren-Port Huron | Port Huron | Michigan |
United States | Maine Medical Center-Bramhall Campus | Portland | Maine |
United States | Oregon Health and Science University | Portland | Oregon |
United States | Naval Medical Center - Portsmouth | Portsmouth | Virginia |
United States | Kootenai Clinic Cancer Services - Post Falls | Post Falls | Idaho |
United States | Women and Infants Hospital | Providence | Rhode Island |
United States | Utah Valley Regional Medical Center | Provo | Utah |
United States | Kaiser Permanente-Rancho Cordova Cancer Center | Rancho Cordova | California |
United States | University Hospitals Portage Medical Center | Ravenna | Ohio |
United States | Penn State Health Saint Joseph Medical Center | Reading | Pennsylvania |
United States | Marshfield Medical Center-Rice Lake | Rice Lake | Wisconsin |
United States | Riverton Hospital | Riverton | Utah |
United States | Rochester General Hospital | Rochester | New York |
United States | SwedishAmerican Regional Cancer Center/ACT | Rockford | Illinois |
United States | Rohnert Park Cancer Center | Rohnert Park | California |
United States | The Permanente Medical Group-Roseville Radiation Oncology | Roseville | California |
United States | William Beaumont Hospital-Royal Oak | Royal Oak | Michigan |
United States | Mercy Cancer Center - Sacramento | Sacramento | California |
United States | Saint George Regional Medical Center | Saint George | Utah |
United States | Saint Helena Hospital | Saint Helena | California |
United States | Norris Cotton Cancer Center-North | Saint Johnsbury | Vermont |
United States | Missouri Baptist Medical Center | Saint Louis | Missouri |
United States | Saint Anthony's Hospital Cancer Care Center | Saint Petersburg | Florida |
United States | Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah |
United States | LDS Hospital | Salt Lake City | Utah |
United States | University of Utah Sugarhouse Health Center | Salt Lake City | Utah |
United States | University of Texas Health Science Center at San Antonio | San Antonio | Texas |
United States | UH Seidman Cancer Center at Firelands Regional Medical Center | Sandusky | Ohio |
United States | MaineHealth Cancer Care Center of York County | Sanford | Maine |
United States | Kaiser Permanente Medical Center - Santa Clara | Santa Clara | California |
United States | Saint John's Cancer Institute | Santa Monica | California |
United States | Lewis Cancer and Research Pavilion at Saint Joseph's/Candler | Savannah | Georgia |
United States | Maine Medical Center- Scarborough Campus | Scarborough | Maine |
United States | Swedish Medical Center-First Hill | Seattle | Washington |
United States | Prisma Health Cancer Institute - Seneca | Seneca | South Carolina |
United States | Sidney Kimmel Cancer Center Washington Township | Sewell | New Jersey |
United States | HSHS Saint Nicholas Hospital | Sheboygan | Wisconsin |
United States | Vince Lombardi Cancer Clinic-Sheboygan | Sheboygan | Wisconsin |
United States | LSU Health Sciences Center at Shreveport | Shreveport | Louisiana |
United States | Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota |
United States | Robert Wood Johnson University Hospital Somerset | Somerville | New Jersey |
United States | South Jordan Health Center | South Jordan | Utah |
United States | City of Hope South Pasadena | South Pasadena | California |
United States | Kaiser Permanente Cancer Treatment Center | South San Francisco | California |
United States | Ascension Providence Hospitals - Southfield | Southfield | Michigan |
United States | Baptist Memorial Hospital and Cancer Center-Desoto | Southhaven | Mississippi |
United States | Spartanburg Medical Center | Spartanburg | South Carolina |
United States | Baystate Medical Center | Springfield | Massachusetts |
United States | Memorial Medical Center | Springfield | Illinois |
United States | Marshfield Medical Center-River Region at Stevens Point | Stevens Point | Wisconsin |
United States | Stony Brook University Medical Center | Stony Brook | New York |
United States | Saint Vincent Hospital Cancer Center at Sturgeon Bay | Sturgeon Bay | Wisconsin |
United States | Houston Methodist Sugar Land Hospital | Sugar Land | Texas |
United States | MD Anderson in Sugar Land | Sugar Land | Texas |
United States | Aurora Medical Center in Summit | Summit | Wisconsin |
United States | ProMedica Flower Hospital | Sylvania | Ohio |
United States | State University of New York Upstate Medical University | Syracuse | New York |
United States | MultiCare Tacoma General Hospital | Tacoma | Washington |
United States | Moffitt Cancer Center | Tampa | Florida |
United States | Saint Joseph's Hospital/Children's Hospital-Tampa | Tampa | Florida |
United States | Houston Methodist The Woodlands Hospital | The Woodlands | Texas |
United States | Community Medical Center | Toms River | New Jersey |
United States | City of Hope South Bay | Torrance | California |
United States | UM Saint Joseph Medical Center | Towson | Maryland |
United States | Munson Medical Center | Traverse City | Michigan |
United States | William Beaumont Hospital - Troy | Troy | Michigan |
United States | Smilow Cancer Hospital Care Center-Trumbull | Trumbull | Connecticut |
United States | University of Arizona Cancer Center-North Campus | Tucson | Arizona |
United States | University of Arizona Cancer Center-Orange Grove Campus | Tucson | Arizona |
United States | Vince Lombardi Cancer Clinic-Two Rivers | Two Rivers | Wisconsin |
United States | Memorial Sloan Kettering Nassau | Uniondale | New York |
United States | City of Hope Upland | Upland | California |
United States | Carle Cancer Center | Urbana | Illinois |
United States | Sutter Solano Medical Center/Cancer Center | Vallejo | California |
United States | University Hospitals Sharon Health Center | Wadsworth | Ohio |
United States | Northwestern Medicine Cancer Center Warrenville | Warrenville | Illinois |
United States | Kent Hospital | Warwick | Rhode Island |
United States | MedStar Georgetown University Hospital | Washington | District of Columbia |
United States | MedStar Washington Hospital Center | Washington | District of Columbia |
United States | Sibley Memorial Hospital | Washington | District of Columbia |
United States | UPMC Washington Hospital Radiation Oncology | Washington | Pennsylvania |
United States | Smilow Cancer Hospital Care Center - Waterford | Waterford | Connecticut |
United States | Aspirus Regional Cancer Center | Wausau | Wisconsin |
United States | Aurora West Allis Medical Center | West Allis | Wisconsin |
United States | Froedtert West Bend Hospital/Kraemer Cancer Center | West Bend | Wisconsin |
United States | Lexington Medical Center | West Columbia | South Carolina |
United States | Reading Hospital | West Reading | Pennsylvania |
United States | Saint Ann's Hospital | Westerville | Ohio |
United States | UH Seidman Cancer Center at Saint John Medical Center | Westlake | Ohio |
United States | UHHS-Westlake Medical Center | Westlake | Ohio |
United States | Cleveland Clinic-Weston | Weston | Florida |
United States | Diagnostic and Treatment Center | Weston | Wisconsin |
United States | Marshfield Medical Center - Weston | Weston | Wisconsin |
United States | Wexford Health and Wellness Pavilion | Wexford | Pennsylvania |
United States | SCL Health Lutheran Medical Center | Wheat Ridge | Colorado |
United States | Ascension Via Christi Hospitals Wichita | Wichita | Kansas |
United States | Asplundh Cancer Pavilion | Willow Grove | Pennsylvania |
United States | Aspirus Cancer Care - Wisconsin Rapids | Wisconsin Rapids | Wisconsin |
United States | Lankenau Medical Center | Wynnewood | Pennsylvania |
United States | University of Michigan Health - West | Wyoming | Michigan |
United States | UPMC Memorial | York | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Canadian Cancer Trials Group | Alliance for Clinical Trials in Oncology, Eastern Cooperative Oncology Group, NRG Oncology, SWOG Cancer Research Network |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | compare the breast cancer recurrence-free interval (BCRFI) between patients that received regional RT or not | Defined as time from randomization to time of invasive recurrent disease in the ipsilateral chestwall, breast, regional nodes, distant sites or death due to BC. | 9.5 years | |
Secondary | Compare the invasive disease-free survival between patients that received regional RT or not. | Defined as time from randomization to time of invasive recurrent disease in the ipsilateral chestwall, breast, regional nodes, distant sites or death due to BC | 9.5 years | |
Secondary | Compare the breast cancer mortality between patients that received regional RT or not. | Defined as death due to BC | 9.5 years | |
Secondary | Compare the overall survival (OS) between patients that received regional RT or not | Defined as the time from randomization to the time of death from any cause | 9.5 years | |
Secondary | Compare the locoregional recurrence-free interval (LRRFI) between patients that received regional RT or not. | Defined as time from randomization to time of invasive recurrent disease in the ipsilateral chestwall, breast or regional nodes, or death to due to BC | 9.5 years | |
Secondary | Compare the distant recurrence-free interval (DRFI) between patients that received regional RT or not. | Defined as time from randomization to time of invasive recurrent disease in distant sites or death due to BC | 9.5 years | |
Secondary | Number and severity of adverse events using the current CTCAE version 4 | 9.5 years | ||
Secondary | Compare arm volume and mobility measurements between patients that received regional RT or not | A Fisher's Exact Test will be used to compare lymphedema and arm abduction deficit between two arms. Defined as a difference in arm abduction of 10% or greater in the comparison of the ipsilateral to the contralateral arm. | 9.5 years | |
Secondary | Compare patient-reported outcomes (PROs) and the quality of life (QOL) between patients that received regional RT or not | using the NSABP Questionnaire for patients treated by BCS or mastectomy. | 9.5 years | |
Secondary | Compare the quality of life (QOL) between patients that received regional RT or not | Overall QOL (EORTC QLQ-C30) will be compared between the two treatment groups using a similar approach. | 9.5 years | |
Secondary | Compare the cost-effectiveness between patients that received regional RT or not | Costs will be expressed in $US and $CAN base currencies based on the final year of the study. An average cost per study subject by treatment arm for an overall mean cost per study arm will be generated | 9.5 years | |
Secondary | Compare the quality of life (QOL) between patients that received regional RT or not | breast symptoms (NSABP B32 Questionnaire) will be compared between the two treatment groups using a similar approach. | 9.5 years | |
Secondary | Compare the quality of life (QOL) between patients that received regional RT or not | skin symptoms and fatigue (EORTC QLQ-BR23) will be compared between the two treatment groups using a similar approach. | 9.5 years |
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