Regional Radiation Therapy with or without Whole Breast Irradiation in Treating Patients with Estrogen Receptor Positive, HER2 Negative Low Risk Breast Cancer Who Have Undergone Breast Conserving Surgery or Mastectomy

Status: Active

Description

This randomized phase III trial studies if not giving regional radiotherapy is just as good as using regional radiotherapy in keeping breast cancer from coming back in patients with estrogen receptor (ER) positive, HER2 negative node positive low risk breast cancer who have undergone breast conserving surgery or mastectomy. Women with ER positive breast cancer normally will receive endocrine therapy and some may receive chemotherapy to help prevent the cancer from coming back. Many women will also receive radiotherapy to the whole breast / chest area and the surrounding lymph glands (called regional radiotherapy). Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. It is not known whether patients with low risk breast cancer need to receive regional radiotherapy. As a result, some women may be getting regional radiotherapy who do not need it and be exposed to the side effects of their treatment without benefit. This study will help to determine if regional radiotherapy can be omitted for low risk ER positive node positive breast cancer patients.

Eligibility Criteria

Inclusion Criteria

  • Patients must have newly diagnosed histologically proven invasive carcinoma of the breast with no evidence of metastases
  • Patients must have been treated by breast conserving surgery (BCS) or mastectomy
  • Patients treated by BCS or mastectomy and axillary dissection must have 1-3 positive axillary nodes (macrometastases, > 2 mm) * Note patients with additional nodal micrometastases (> 0.2-2 mm) or isolated tumor cells (=< 0.2 mm) are eligible; patients with nodal disease limited only to micrometastases or isolated tumor cells are not eligible
  • Patients treated by BCS and sentinel lymph node biopsy (SLNB) alone must have only 1-2 positive axillary nodes (macrometastases, > 2 mm) * Note patients with additional nodal micrometastases (> 0.2-2 mm) or isolated tumor cells (=< 0.2 mm) are eligible; patients with nodal disease limited only to micrometastases or isolated tumor cells are not eligible
  • Patients treated by mastectomy and SLNB alone must have only 1 positive axillary node (macrometastases, > 2 mm) * Note patients with additional nodal micrometastases (> 0.2-2 mm) or isolated tumor cells (=< 0.2 mm) are eligible; patients with nodal disease limited only to micrometastases or isolated tumor cells are not eligible
  • Patients must be ER >= 1% and HER2 negative on local testing
  • Patients must have an Oncotype DX recurrence score < 18 * If the patient does not already have Oncotype DX recurrence score, specimen (unstained blocks or slides) must be sent to the Genomic Health centralized laboratory in Redwood City, California; please see MA.39 trial specific website for instructions on ordering Oncotype DX test
  • Patient must consent to provision of, and investigator(s) must confirm access to and agree to submit to the Canadian Cancer Trials Group (CCTG) Central Tumour Bank, a representative formalin fixed paraffin block of tumor tissue in order that the specific correlative marker assays described in the protocol may be conducted; where tissue exists but local center regulations prohibit submission of blocks of tumor tissue, the approval of the CCTG must be sought prior to randomization of the first patient to allow cores (two 2 mm cores of tumor from the block) and slides (20 x 5 micro thick unstained slides) of representative tumor tissue to be substituted; where tumor tissue is available, failure to submit any tissue samples will result in the patient being considered ineligible
  • 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; endocrine therapy can be given concurrently or following RT
  • Patients may or may not have had adjuvant chemotherapy
  • RT must be administered within 12 weeks of definitive surgery if the patient is not treated with chemotherapy; if adjuvant chemotherapy is given, RT must begin within 2-8 weeks after the last dose
  • Patient’s Eastern Cooperative Oncology Group (ECOG) performance status must be 0, 1 or 2
  • Patient’s life expectancy is >= 10 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; the baseline assessment must be completed within required timelines, prior to registration/randomization; inability (lack of comprehension in English or French, or other equivalent reason such as cognitive issues or lack of competency) or refusal to complete the questionnaires will not make the patient ineligible for the study; participation in questionnaire completion is mandatory for centers, but optional for patients
  • Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements; each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate * A similar process must be followed for sites outside of Canada as per their respective cooperative group’s procedures
  • 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 3 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; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation, or vasectomy/vasectomized partner; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, she is responsible for beginning contraceptive measures * Women of childbearing potential will have a pregnancy test to determine eligibility as part of the pre-study evaluation; this may include an ultrasound to rule-out pregnancy if a false-positive is suspected; patient will be considered eligible if an ultrasound is negative for pregnancy

Exclusion Criteria

  • Patients with nodal disease limited to micrometastases (pN1Mi, > 0.2 mm and =< 2 mm) or isolated tumor cells (pN0i+ < 0.2 mm)
  • Any prior history, not including the index cancer, of ipsilateral invasive breast cancer or ipsilateral ductal breast carcinoma in situ (DCIS) treated with radiation therapy; (Patients with synchronous or previous ipsilateral lobular breast carcinoma in situ [LCIS] are eligible)
  • Synchronous or previous contralateral invasive breast cancer; (patients with contralateral DCIS not treated with radiation are eligible)
  • 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 with pT3 or pT4 disease
  • Patients who are pregnant
  • Patients that have had prior ipsilateral chestwall/thoracic radiation
  • Patients treated with neoadjuvant chemo or endocrine therapy for breast cancer
  • 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)

Locations & Contacts

Alaska

Fairbanks
Fairbanks Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 907-458-3043
Email: cancerresearch@foundationhealth.org

Arizona

Tucson
University of Arizona Cancer Center-North Campus
Status: Active
Contact: Site Public Contact
Phone: 800-327-2873
University of Arizona Cancer Center-Orange Grove Campus
Status: Active
Contact: Site Public Contact
Phone: 520-694-8900

Arkansas

Little Rock
University of Arkansas for Medical Sciences
Status: Active
Contact: Site Public Contact
Phone: 501-686-8274

California

Berkeley
Alta Bates Summit Medical Center-Herrick Campus
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-826-4673
Email: becomingapatient@coh.org
Fresno
Fresno Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Oakland
Kaiser Permanente Oakland-Broadway
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Rancho Cordova
Kaiser Permanente-Rancho Cordova Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Rohnert Park
Rohnert Park Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Roseville
The Permanente Medical Group-Roseville Radiation Oncology
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Santa Clara
Kaiser Permanente Medical Center - Santa Clara
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
South Pasadena
City of Hope South Pasadena
Status: Active
Contact: Site Public Contact
Phone: 800-826-4673
Email: becomingapatient@coh.org
South San Francisco
Kaiser Permanente Cancer Treatment Center
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Vallejo
Sutter Solano Medical Center / Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org

Colorado

Aurora
University of Colorado Hospital
Status: Active
Contact: Site Public Contact
Phone: 720-848-0650
Colorado Springs
Memorial Hospital North
Status: Active
Contact: Site Public Contact
Phone: 719-364-6700
Penrose-Saint Francis Healthcare
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
UCHealth Memorial Hospital Central
Status: Active
Contact: Site Public Contact
Phone: 719-365-2406
Fort Collins
Poudre Valley Hospital
Status: Active
Contact: Site Public Contact
Phone: 970-297-6150
Greeley
North Colorado Medical Center
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Loveland
McKee Medical Center
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org
Wheat Ridge
SCL Health Lutheran Medical Center
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org

Connecticut

Guilford
Yale-New Haven Shoreline Medical Center
Status: Active
Contact: Site Public Contact
Phone: 203-785-5702
Email: canceranswers@yale.edu
Hamden
Smilow Cancer Hospital-Hamden Care Center
Status: Active
Contact: Site Public Contact
Phone: 203-785-5702
Email: canceranswers@yale.edu
New Haven
Yale University
Status: Active
Contact: Site Public Contact
Phone: 203-785-5702
Email: canceranswers@yale.edu
Waterford
Lawrence and Memorial Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 203-785-5702
Email: canceranswers@yale.edu

Delaware

Newark
Christiana Care Health System-Christiana Hospital
Status: Active
Contact: Site Public Contact
Phone: 302-623-4450
Email: KDempsey@christianacare.org
Helen F Graham Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 302-623-4450
Email: KDempsey@christianacare.org

Florida

Coral Gables
UM Sylvester Comprehensive Cancer Center at Coral Gables
Status: Active
Contact: Site Public Contact
Phone: 305-243-2647
Deerfield Beach
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Status: Active
Contact: Site Public Contact
Phone: 305-243-2647
Fort Lauderdale
Broward Health Medical Center
Status: Active
Contact: Site Public Contact
Phone: 954-355-5346
Hollywood
Memorial Regional Hospital / Joe DiMaggio Children's Hospital
Status: Active
Contact: Site Public Contact
Phone: 954-265-1847
Email: OHR@mhs.net
Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 305-243-2647
Orlando
UF Cancer Center at Orlando Health
Status: Active
Contact: Site Public Contact
Phone: 321-841-7246
Email: CancerClinicalTrials@orlandohealth.com
Pembroke Pines
Memorial Hospital West
Status: Active
Contact: Site Public Contact
Phone: 954-265-4325
Tampa
Moffitt Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-679-0775
Email: canceranswers@moffitt.org

Georgia

Savannah
Lewis Cancer and Research Pavilion at Saint Joseph's / Candler
Status: Active
Contact: Site Public Contact
Phone: 912-819-5704
Email: underberga@sjchs.org

Idaho

Boise
Saint Alphonsus Cancer Care Center-Boise
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org

Illinois

Chicago
Advocate Illinois Masonic Medical Center
Status: Active
Contact: Site Public Contact
Phone: 773-296-5360
Northwestern University
Status: Active
Contact: Site Public Contact
Phone: 312-695-1301
Email: cancer@northwestern.edu
Rush University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 312-942-5498
Email: clinical_trials@rush.edu
Swedish Covenant Hospital
Status: Active
Contact: Site Public Contact
Phone: 773-878-8200
University of Illinois
Status: Active
Contact: Site Public Contact
Phone: 312-355-3046
Decatur
Decatur Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Lake Forest
Northwestern Medicine Lake Forest Hospital
Status: Active
Contact: Site Public Contact
Email: cancertrials@northwestern.edu
Peoria
OSF Saint Francis Medical Center
Status: Active
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Springfield
Memorial Medical Center
Status: Active
Contact: Site Public Contact
Phone: 217-788-3528
Urbana
Carle Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com

Indiana

Avon
IU Health West Hospital
Status: Active
Contact: Site Public Contact
Phone: 317-278-5632
Email: iutrials@iu.edu
Fishers
IU Health Central Indiana Cancer Centers-Fishers
Status: Active
Contact: Site Public Contact
Phone: 317-356-2422
Indianapolis
Community Cancer Center East
Status: Active
Contact: Site Public Contact
Phone: 317-497-2823
Email: lcheri@ecommunity.com
Community Cancer Center North
Status: Active
Contact: Site Public Contact
Phone: 317-497-2823
Email: lcheri@ecommunity.com
Community Cancer Center South
Status: Active
Contact: Site Public Contact
Phone: 317-497-2823
Email: lcheri@ecommunity.com
Indiana University / Melvin and Bren Simon Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 317-278-5632
Email: iutrials@iu.edu
IU Health Methodist Hospital
Status: Active
Contact: Site Public Contact
Phone: 317-278-5632
Email: iutrials@iu.edu
Muncie
IU Health Ball Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 765-751-5850

Iowa

Clive
Mercy Cancer Center-West Lakes
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Creston
Greater Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Des Moines
Iowa Methodist Medical Center
Status: Active
Contact: Site Public Contact
Phone: 515-241-6727
Mercy Medical Center - Des Moines
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org

Kansas

Kansas City
University of Kansas Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 913-945-7552
Email: ctnursenav@kumc.edu
Overland Park
University of Kansas Cancer Center-Overland Park
Status: Active
Contact: Site Public Contact
Phone: 913-945-7552
Email: ctnursenav@kumc.edu
Wichita
Ascension Via Christi Hospitals Wichita
Status: Active
Contact: Site Public Contact
Phone: 800-362-0070
Email: Keisha.humphries@ascension.org

Kentucky

Edgewood
Saint Elizabeth Medical Center South
Status: Active
Contact: Site Public Contact
Phone: 859-301-5473
Email: darla.hehman@stelizabeth.com
Louisville
The James Graham Brown Cancer Center at University of Louisville
Status: Active
Contact: Site Public Contact
Phone: 502-562-3429

Maine

Bath
MaineHealth Coastal Cancer Treatment Center
Status: Active
Contact: Site Public Contact
Phone: 888-823-5923
Email: ctsucontact@westat.com
Brewer
Lafayette Family Cancer Center-EMMC
Status: Active
Contact: Site Public Contact
Phone: 800-987-3005
Portland
Maine Medical Center-Bramhall Campus
Status: Active
Contact: Site Public Contact
Phone: 207-885-7565
Sanford
MaineHealth Cancer Care Center of York County
Status: Active
Contact: Site Public Contact
Phone: 207-459-1600
Scarborough
Maine Medical Center- Scarborough Campus
Status: Active
Contact: Site Public Contact
Phone: 207-396-8090
Email: wrighd@mmc.org

Maryland

Annapolis
Anne Arundel Medical Center
Status: Active
Contact: Site Public Contact
Phone: 443-481-1320
Email: kbodenhorn@aahs.org
Baltimore
Greater Baltimore Medical Center
Status: Active
Contact: Site Public Contact
Phone: 443-849-3706

Massachusetts

Boston
Beth Israel Deaconess Medical Center
Status: Active
Contact: Site Public Contact
Phone: 617-667-9925
Burlington
Lahey Hospital and Medical Center
Status: Active
Contact: Site Public Contact
Phone: 781-744-3421
Email: cancerclinicaltrials@lahey.org
Lowell
Lowell General Hospital
Status: Active
Contact: Site Public Contact
Phone: 978-788-7084
Email: ghincks@lowellgeneral.org
Springfield
Baystate Medical Center
Status: Active
Contact: Site Public Contact
Phone: 413-794-3565
Email: tamara.wrenn@baystatehealth.org

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-865-1125
Dearborn
Beaumont Hospital – Dearborn
Status: Active
Contact: Site Public Contact
Phone: 248-551-7695
Farmington Hills
Beaumont Hospital - Farmington Hills
Status: Active
Contact: Site Public Contact
Phone: 248-551-7695
Grand Rapids
Spectrum Health at Butterworth Campus
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Kalamazoo
West Michigan Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Muskegon
Mercy Health Mercy Campus
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Novi
Ascension Providence Hospitals - Novi
Status: Active
Contact: Site Public Contact
Phone: 248-849-5332
Email: karen.fife@ascension.org
Royal Oak
William Beaumont Hospital-Royal Oak
Status: Active
Contact: Site Public Contact
Phone: 248-551-7695
Southfield
Ascension Providence Hospitals - Southfield
Status: Active
Contact: Site Public Contact
Phone: 248-849-5332
Email: karen.fife@ascension.org
Traverse City
Munson Medical Center
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Troy
William Beaumont Hospital - Troy
Status: Active
Contact: Site Public Contact
Phone: 248-551-7695
Wyoming
Metro Health Hospital
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org

Minnesota

Bemidji
Sanford Joe Lueken Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 218-333-5000
Email: OncologyClinicalTrialsFargo@sanfordhealth.org
Minneapolis
Hennepin County Medical Center
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com

Mississippi

Southhaven
Baptist Memorial Hospital and Cancer Center-Desoto
Status: Active
Contact: Site Public Contact
Phone: 901-226-1366
Email: BCCclintrials@bmhcc.org

Missouri

Cape Girardeau
Saint Francis Medical Center
Status: Active
Contact: Site Public Contact
Phone: 573-334-2230
Email: sfmc@sfmc.net
Kansas City
The University of Kansas Cancer Center-North
Status: Active
Contact: Site Public Contact
Phone: 913-945-7552
Email: ctnursenav@kumc.edu
Lee's Summit
The University of Kansas Cancer Center-Lee's Summit
Status: Active
Contact: Site Public Contact
Phone: 913-945-7552
Email: ctnursenav@kumc.edu
Saint Louis
Missouri Baptist Medical Center
Status: Active
Contact: Site Public Contact
Phone: 314-996-5569

Montana

Butte
Saint James Community Hospital and Cancer Treatment Center
Status: Active
Contact: Site Public Contact
Phone: 406-723-2621
Great Falls
Benefis Healthcare- Sletten Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org

Nebraska

Omaha
University of Nebraska Medical Center
Status: Active
Contact: Site Public Contact
Phone: 402-559-6941
Email: unmcrsa@unmc.edu

New Hampshire

Concord
New Hampshire Oncology Hematology PA-Concord
Status: Active
Contact: Site Public Contact
Phone: 603-224-2556
Dover
Wentworth-Douglass Hospital
Status: Active
Contact: Site Public Contact
Phone: 603-740-2150
Hooksett
New Hampshire Oncology Hematology PA-Hooksett
Status: Active
Contact: Site Public Contact
Phone: 800-339-6484

New Jersey

Englewood
Englewood Hospital and Medical Center
Status: Active
Contact: Site Public Contact
Phone: 201-894-3456
Hamilton
The Cancer Institute of New Jersey Hamilton
Status: Active
Contact: Site Public Contact
Phone: 609-631-6946
New Brunswick
Rutgers Cancer Institute of New Jersey
Status: Active
Contact: Site Public Contact
Phone: 732-235-8675
Somerville
Robert Wood Johnson University Hospital Somerset
Status: Active
Contact: Site Public Contact
Phone: 908-685-2481
Toms River
Community Medical Center
Status: Active
Contact: Site Public Contact
Phone: 732-818-3882

New Mexico

Albuquerque
Lovelace Radiation Oncology
Status: Active
Contact: Site Public Contact
Phone: 505-272-0530
Email: AYost@nmcca.org
New Mexico Oncology Hematology Consultants
Status: Active
Contact: Site Public Contact
Phone: 505-272-0530
Email: CLee@nmcca.org
University of New Mexico Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 505-925-0366
Email: LByatt@nmcca.org
Las Cruces
Memorial Medical Center - Las Cruces
Status: Active
Contact: Site Public Contact
Phone: 575-556-6545
Email: Kim.Hoffman@lpnt.net

New York

Bronx
Montefiore Medical Center - Moses Campus
Status: Active
Contact: Site Public Contact
Phone: 718-379-6866
Email: aaraiza@montefiore.org
Montefiore Medical Center-Einstein Campus
Status: Active
Contact: Site Public Contact
Phone: 718-379-6866
Email: aaraiza@montefiore.org
Brooklyn
New York-Presbyterian / Brooklyn Methodist Hospital
Status: Active
Contact: Site Public Contact
Phone: 718-780-3677
Email: Adg9003@nyp.org
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: Active
Contact: Site Public Contact
Phone: 212-263-4434
Email: prmc.coordinator@nyumc.org
Mount Sinai Chelsea
Status: Active
Contact: Site Public Contact
Phone: 212-824-7309
Email: CCTO@mssm.edu
Mount Sinai Hospital
Status: Active
Contact: Site Public Contact
Phone: 212-824-7309
Email: CCTO@mssm.edu
Mount Sinai Union Square
Status: Active
Contact: Site Public Contact
Phone: 212-824-7309
Email: CCTO@mssm.edu
Stony Brook
Stony Brook University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 800-862-2215

North Carolina

Asheville
Hope Women's Cancer Centers-Asheville
Status: Active
Contact: Site Public Contact
Phone: 828-213-2539
Email: Karen.Smith3@HCAHealthcare.com
Mission Hospital
Status: Active
Contact: Site Public Contact
Phone: 828-213-2539
Email: Karen.Smith3@HCAHealthcare.com
Durham
Duke University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 888-275-3853
Gastonia
CaroMont Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 704-834-2810
Email: tammy.cozad@caromonthealth.org

North Dakota

Bismarck
Sanford Bismarck Medical Center
Status: Active
Contact: Site Public Contact
Phone: 701-323-5760
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

Ohio

Akron
Cleveland Clinic Akron General
Status: Active
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org
Canton
Aultman Health Foundation
Status: Active
Contact: Site Public Contact
Phone: 330-363-7274
Email: ClinicalReserachDept@aultman.com
Mercy Medical Center
Status: Active
Contact: Site Public Contact
Phone: 888-293-4673
Columbus
Ohio State University Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-293-5066
Email: Jamesline@osumc.edu
Riverside Methodist Hospital
Status: Active
Contact: Site Public Contact
Phone: 614-566-4475
Email: sheree@columbusccop.org
The Mark H Zangmeister Center
Status: Active
Contact: Site Public Contact
Phone: 614-488-2118
Email: sheree@columbusccop.org

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: Active
Contact: Site Public Contact
Phone: 405-271-8777
Email: ou-clinical-trials@ouhsc.edu

Oregon

Corvallis
Good Samaritan Hospital
Status: Active
Contact: Site Public Contact
Phone: 541-768-4352
Email: stmock@samhealth.org

Pennsylvania

Bryn Mawr
Bryn Mawr Hospital
Status: Active
Contact: Site Public Contact
Phone: 484-476-2649
Email: turzoe@mlhs.org
Chadds Ford
Christiana Care Health System-Concord Health Center
Status: Active
Contact: Site Public Contact
Phone: 302-623-4450
Email: KDempsey@christianacare.org
Erie
Saint Vincent Hospital
Status: Active
Contact: Site Public Contact
Phone: 814-452-5000
Jefferson Hills
Jefferson Hospital
Status: Active
Contact: Site Public Contact
Phone: 412-359-3043
Email: ddefazio@wpahs.org
Media
Riddle Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 484-476-2649
Email: turzoe@mlhs.org
Monroeville
Forbes Hospital
Status: Active
Contact: Site Public Contact
Phone: 412-858-7746
Newtown Square
Bryn Mawr Health Center
Status: Active
Contact: Site Public Contact
Phone: 484-476-2649
Email: turzoe@mlhs.org
Paoli
Paoli Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 484-476-2649
Email: turzoe@mlhs.org
Philadelphia
Thomas Jefferson University Hospital
Status: Active
Contact: Site Public Contact
Phone: 215-955-6084
Pittsburgh
Allegheny General Hospital
Status: Active
Contact: Site Public Contact
Phone: 877-284-2000
West Penn Hospital
Status: Active
Contact: Site Public Contact
Phone: 412-578-5000
West Reading
Reading Hospital
Status: Active
Contact: Site Public Contact
Phone: 610-988-9323
Wexford
Wexford Health and Wellness Pavilion
Status: Active
Contact: Site Public Contact
Phone: 412-359-3043
Email: ddefazio@wpahs.org
Wynnewood
Lankenau Medical Center
Status: Active
Contact: Site Public Contact
Phone: 484-476-2649
Email: turzoe@mlhs.org

Rhode Island

Providence
Women and Infants Hospital
Status: Active
Contact: Site Public Contact
Phone: 401-274-1122

South Carolina

Greenville
Prisma Health Cancer Institute - Eastside
Status: Active
Contact: Site Public Contact
Phone: 864-522-2066
Email: kim.williams3@prismahealth.org
Prisma Health Cancer Institute - Faris
Status: Active
Contact: Site Public Contact
Phone: 864-522-2066
Email: kim.williams3@prismahealth.org
Saint Francis Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 864-603-6213
Email: meissa_beckman@bshsi.org
Greer
Prisma Health Cancer Institute - Greer
Status: Active
Contact: Site Public Contact
Phone: 864-522-2066
Email: kim.williams3@prismahealth.org
Seneca
Prisma Health Cancer Institute - Seneca
Status: Active
Contact: Site Public Contact
Phone: 864-522-2066
Email: kim.williams3@prismahealth.org
Spartanburg
Prisma Health Cancer Institute - Spartanburg
Status: Active
Contact: Site Public Contact
Phone: 864-522-2066
Email: kim.williams3@prismahealth.org
West Columbia
Lexington Medical Center
Status: Active
Contact: Site Public Contact
Phone: 803-936-8050

South Dakota

Sioux Falls
Sanford USD Medical Center - Sioux Falls
Status: Active
Contact: Site Public Contact
Phone: 605-312-3320
Email: OncologyClinicalTrialsSF@SanfordHealth.org

Tennessee

Memphis
Baptist Memorial Hospital and Cancer Center-Memphis
Status: Active
Contact: Site Public Contact
Phone: 901-226-1366
Email: BCCclintrials@bmhcc.org

Texas

Dallas
Parkland Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 214-590-5582
Email: canceranswerline@UTSouthwestern.edu
UT Southwestern / Simmons Cancer Center-Dallas
Status: Active
Contact: Site Public Contact
Phone: 214-648-7097
Email: canceranswerline@UTSouthwestern.edu
San Antonio
University of Texas Health Science Center at San Antonio
Status: Active
Contact: Site Public Contact
Phone: 210-450-3800
Email: phoresearchoffice@uthscsa.edu

Utah

Farmington
Farmington Health Center
Status: Active
Contact: Site Public Contact
Phone: 888-424-2100
Email: cancerinfo@hci.utah.edu
Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: Active
Contact: Site Public Contact
Phone: 888-424-2100
Email: cancerinfo@hci.utah.edu
South Jordan
South Jordan Health Center
Status: Active
Contact: Site Public Contact
Phone: 888-424-2100
Email: cancerinfo@hci.utah.edu

Virginia

Fishersville
Augusta Health Center for Cancer and Blood Disorders
Status: Active
Contact: Site Public Contact
Phone: 540-332-5960

West Virginia

Morgantown
West Virginia University Healthcare
Status: Active
Contact: Site Public Contact
Phone: 304-293-7374
Email: cancertrialsinfo@hsc.wvu.edu

Wisconsin

Antigo
Langlade Hospital and Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 715-623-9869
Email: Juli.Alford@aspirus.org
Eau Claire
Marshfield Medical Center-EC Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Grafton
Aurora Cancer Care-Grafton
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Green Bay
Aurora BayCare Medical Center
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Saint Vincent Hospital Cancer Center at Saint Mary's
Status: Active
Contact: Site Public Contact
Phone: 920-433-8889
Email: Christy.Gilchrist@hshs.org
Saint Vincent Hospital Cancer Center Green Bay
Status: Active
Contact: Site Public Contact
Phone: 920-433-8889
Email: Christy.Gilchrist@hshs.org
Kenosha
Aurora Cancer Care-Kenosha South
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Madison
University of Wisconsin Hospital and Clinics
Status: Active
Contact: Site Public Contact
Phone: 800-622-8922
Marinette
Aurora Bay Area Medical Group-Marinette
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Marshfield
Marshfield Medical Center-Marshfield
Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Milwaukee
Aurora Saint Luke's Medical Center
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Aurora Sinai Medical Center
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Minocqua
Marshfield Clinic-Minocqua Center
Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Oshkosh
Vince Lombardi Cancer Clinic - Oshkosh
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Rice Lake
Marshfield Medical Center-Rice Lake
Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Sheboygan
HSHS Saint Nicholas Hospital
Status: Active
Contact: Site Public Contact
Phone: 920-433-8889
Email: Christy.Gilchrist@hshs.org
Vince Lombardi Cancer Clinic-Sheboygan
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Stevens Point
Marshfield Clinic Stevens Point Center
Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Sturgeon Bay
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Status: Active
Contact: Site Public Contact
Phone: 920-433-8889
Email: Christy.Gilchrist@hshs.org
Summit
Aurora Medical Center in Summit
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Two Rivers
Vince Lombardi Cancer Clinic-Two Rivers
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Wausau
Aspirus Regional Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-405-6866
West Allis
Aurora West Allis Medical Center
Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Email: ncorp@aurora.org
Weston
Diagnostic and Treatment Center
Status: Active
Contact: Site Public Contact
Phone: 888-799-3989
Email: oncology.clinical.trials@marshfieldresearch.org
Wisconsin Rapids
Aspirus UW Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 715-422-7718

Alberta

Calgary
Tom Baker Cancer Centre
Status: Active
Contact: Site Public Contact
Phone: 403-521-3433
Edmonton
Cross Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 780-432-8500

British Columbia

Abbotsford
BCCA-Abbotsford Cancer Centre
Status: Active
Contact: Site Public Contact
Phone: 604-851-4710
Kelowna
BCCA-Cancer Centre for the Southern Interior
Status: Active
Contact: Site Public Contact
Phone: 250-712-3900
Prince George
BCCA-Cancer Centre for the North
Status: Active
Contact: Site Public Contact
Phone: 855-775-7300
Surrey
BCCA-Fraser Valley Cancer Centre
Status: Active
Contact: Site Public Contact
Phone: 604-930-2098
Vancouver
BCCA-Vancouver Cancer Centre
Status: Active
Contact: Site Public Contact
Phone: 888-939-3333
Victoria
BCCA-Vancouver Island Cancer Centre
Status: Active
Contact: Site Public Contact
Phone: 604-877-6010

New Brunswick

Saint John
Atlantic Health Sciences Corporation-Saint John Regional Hospital
Status: Active
Contact: Site Public Contact
Phone: 506-648-6890

Newfoundland

St. John's
Doctor H. Bliss Murphy Cancer Centre
Status: Active
Contact: Site Public Contact
Phone: 709-777-7589

Nova Scotia

Halifax
QEII Health Sciences Centre / Nova Scotia Health Authority
Status: Active
Contact: Site Public Contact
Phone: 902-473-6000

Ontario

Barrie
Royal Victoria Regional Health Centre
Status: Active
Contact: Site Public Contact
Phone: 705-739-5661
Hamilton
Juravinski Cancer Centre at Hamilton Health Sciences
Status: Active
Contact: Site Public Contact
Phone: 905-387-9495
Kitchener
Grand River Regional Cancer Centre at Grand River Hospital
Status: Active
Contact: Site Public Contact
Phone: 519-749-4300ext2307
London
London Regional Cancer Program
Status: Active
Contact: Site Public Contact
Phone: 519-685-8600
Mississauga
Trillium Health Partners - Credit Valley Hospital
Status: Active
Contact: Site Public Contact
Phone: 905-813-4040
Ottawa
Ottawa Hospital and Cancer Center-General Campus
Status: Active
Contact: Site Public Contact
Phone: 613-761-4395
Saint Catharines
Niagara Health System-Saint Catharines General
Status: Active
Contact: Site Public Contact
Phone: 905-682-6451
Sault Ste Marie
Algoma District Cancer Program Sault Area Hospital
Status: Active
Contact: Site Public Contact
Phone: 705-759-3434
Sudbury
Health Sciences North
Status: Active
Contact: Site Public Contact
Phone: 706-522-6237ext2401
Email: japaquette@hrsrh.on.ca
Toronto
Odette Cancer Centre- Sunnybrook Health Sciences Centre
Status: Active
Contact: Site Public Contact
Phone: 416-480-5000
University Health Network-Princess Margaret Hospital
Status: Active
Contact: Site Public Contact
Phone: 416-946-4501
Email: clinical.trials@uhn.on.ca

Quebec

Greenfield Park
CSSS Champlain-Charles Le Moyne
Status: Active
Contact: Site Public Contact
Phone: 450-466-5065
Laval
Hopital de la Cite-de-la-Sante
Status: Active
Contact: Site Public Contact
Phone: 450-975-5359
Montreal
CHUM - Centre Hospitalier de l'Universite de Montreal
Status: Active
Contact: Site Public Contact
Phone: 514-890-8000ext12725
Email: info.cr.chum@ssss.gouv.qc.ca
CIUSSSEMTL-Hopital Maisonneuve-Rosemont
Status: Active
Contact: Site Public Contact
Phone: 514-252-3400ext3329
Jewish General Hospital
Status: Active
Contact: Site Public Contact
Phone: 514-340-8222ext8248
The Research Institute of the McGill University Health Centre (MUHC)
Status: Active
Contact: Site Public Contact
Phone: 514-934-1934ext48354
Email: evelyn.ortega@muhc.mcgill.ca
Quebec City
CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
Status: Active
Contact: Site Public Contact
Email: rechclinique@crchuq.ulaval.ca
Sherbrooke
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Status: Active
Contact: Site Public Contact
Phone: 819-820-6480
Email: crcinformation.chus@ssss.gouv.qc.ca

Saskatchewan

Regina
Allan Blair Cancer Centre
Status: Active
Contact: Site Public Contact
Phone: 306-766-2213
Saskatoon
Saskatoon Cancer Centre
Status: Active
Contact: Site Public Contact
Phone: 306-655-2914

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To compare the breast cancer recurrence-free interval (BCRFI) between patients that received regional radiation therapy (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 breast cancer (BC).

SECONDARY OBJECTIVES:

I. To compare the invasive disease-free survival (DFS) between patients that received regional RT or not.

II. To compare the breast cancer mortality between patients that received regional RT or not.

III. To compare the overall survival (OS) between patients that received regional RT or not.

IV. To compare the locoregional recurrence-free interval (LRRFI) between patients that received regional RT or not.

V. To compare the distant recurrence-free interval (DRFI) between patients that received regional RT or not.

VI. To compare the toxicity between patients that received regional RT or not.

VII. To compare arm volume and mobility measurements between patients that received regional RT or not.

VIII. To compare patient reported outcomes (PROs) and the quality of life (QOL) between patients that received regional RT or not.

IX. To compare the cost effectiveness between patients that received regional RT or not.

TERTIARY OBJECTIVES:

I. To establish a comprehensive tumor bank linked to a clinical database for the further study of predictive and prognostic biomarkers in breast cancer.

II. To evaluate the ability of intrinsic subtype measured by immunohistochemistry (IHC) to predict BCRFI, LRRFI, DRFI and the effect of regional RT on these outcomes.

III. To evaluate other radiation sensitivity signatures to prognosticate and predict effect of regional RT.

IV. To describe the prevalence of detectable baseline circulating tumor deoxyribonucleic acid (DNA) (ctDNA) in node positive low risk estrogen receptor (ER) positive breast cancer and evaluate its prognostic ability.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM 1: Following breast conserving surgery (BCS), patients receive whole breast irradiation (WBI) daily Monday to Friday for 16-21 or 25-32 fractions. Patients who underwent mastectomy do not receive RT.

ARM 2: Following BCS, patients receive WBI plus RT to the regional nodes (supraclavicular, non-dissected axillary, and internal mammary) daily Monday to Friday for 16-21 or 25-32 fractions. Patients who have had a mastectomy receive RT to the chest wall and regional nodes (supraclavicular, non-dissected axillary, and internal mammary).

After completion of study treatment, patients are followed up at 2 months (if not receiving RT), 6 and 12 months after randomization, and then annually thereafter for recurrence and toxicity.

Trial Phase & Type

Trial Phase

Phase III

Trial Type

Treatment

Lead Organization

Lead Organization
Canadian Cancer Trials Group

Principal Investigator
Timothy Joseph Whelan

Trial IDs

Primary ID CCTG MA.39
Secondary IDs NCI-2017-02047
Clinicaltrials.gov ID NCT03488693