Standard or Comprehensive Radiation Therapy in Treating Patients With Early-Stage Breast Cancer Previously Treated With Chemotherapy and Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by NSABP Foundation Inc
Sponsor:
Collaborators:
Radiation Therapy Oncology Group
Information provided by (Responsible Party):
NSABP Foundation Inc
ClinicalTrials.gov Identifier:
NCT01872975
First received: June 3, 2013
Last updated: September 5, 2014
Last verified: September 2014
  Purpose

This randomized phase III trial studies standard or comprehensive radiation therapy in treating patients with early-stage breast cancer who have undergone surgery. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether comprehensive radiation therapy is more effective than standard radiation therapy in treating patients with breast cancer


Condition Intervention Phase
Stage IB Breast Cancer
Stage II Breast Cancer
Radiation: regional nodal XRT
Radiation: chestwall XRT
Radiation: WBI
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients With Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy

Resource links provided by NLM:


Further study details as provided by NSABP Foundation Inc:

Primary Outcome Measures:
  • IBC-RFI [ Time Frame: Time from randomization until invasive local, regional, or distant recurrence, or death from breast cancer, assessed up to 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • OS [ Time Frame: Time from randomization to death from any cause, assessed up to 10 years ] [ Designated as safety issue: No ]
  • LRRFI [ Time Frame: Time from randomization to recurrence of primary cancer w/in breast or lymph nodes in ipsilateral axilla, infraclavicular fossa, or ipsilateral internal mammary chain w/out evidence distant disease, or death due to breast cancer, assessed up to 10 years ] [ Designated as safety issue: No ]
  • DRFI [ Time Frame: Time from randomization to the development of tumor in all areas beyond local or regional limits, or death due to breast cancer, assessed up to 10 years ] [ Designated as safety issue: No ]
    .

  • DFS-DCIS [ Time Frame: Time from randomization to local recurrence post-mastectomy/in ipsilateral breast post-lumpectomy, regional/distant recurrence, contralateral disease, second primary cancer, or death from any cause prior to recurrence or SPC, assessed up to 10 years ] [ Designated as safety issue: No ]
  • Time to SPC [ Time Frame: Time from randomization to the development of a second primary invasive cancer of any site excluding squamous and basal cell carcinoma of the skin, assessed up to 10 years ] [ Designated as safety issue: No ]
  • Effect of radiation therapy on cosmetic outcome in mastectomy and lumpectomy patients as assessed by quality of life questionnaire [ Time Frame: Assessed prior to randomization, 3 months or at end of RT, and 6, 12, and 24 months from randomization ] [ Designated as safety issue: No ]
  • Frequencies of adverse events graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 30 days after completion of study treatment ] [ Designated as safety issue: Yes ]
  • Molecular predictors of recurrence [ Time Frame: Tissue samples collected after randomizaiton; the gene expression profiles are measured at the end of study ] [ Designated as safety issue: No ]
    To test the prognostic role of gene expression profiles in residual tumor tissue and to develop predictors of the degree of reduction of loco-regional recurrence.


Estimated Enrollment: 1636
Study Start Date: August 2013
Estimated Study Completion Date: August 2028
Estimated Primary Completion Date: August 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1A Lumpectomy: no regional nodal XRT with WBI
Lumpectomy patients undergo whole breast radiation therapy using IMRT or 3D-CRT once daily 5 days a week for 5 weeks followed by a radiation therapy boost to the lumpectomy cavity once daily 5 days a week for 1-1/2 weeks.
Radiation: WBI
Other Name: Whole Breast Irradiation (WBI)
No Intervention: Group 1B Mastectomy: No regional nodal or chestwall XRT
Mastectomy patients do not undergo radiation therapy.
Experimental: Group 2A lumpectomy: Regional nodal XRT with WBI
Lumpectomy patients undergo regional nodal radiation therapy with whole breast radiation therapy using IMRT or 3D-CRT once daily 5 days a week for 5 weeks followed by a radiation therapy boost to the lumpectomy cavity once daily 5 days a week for 1-1/2 weeks.
Radiation: regional nodal XRT
Other Name: XRT: External radiotherapy
Radiation: WBI
Other Name: Whole Breast Irradiation (WBI)
Experimental: Group 2B Mastectomy: Regional nodal XRT and chestwall XRT
Mastectomy patients undergo regional nodal radiation therapy using IMRT or 3D-CRT once daily 5 days a week for 5 weeks.
Radiation: regional nodal XRT
Other Name: XRT: External radiotherapy
Radiation: chestwall XRT
Other Name: XRT: External radiotherapy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient must have signed and dated an Institutional Review Board (IRB)-approved consent form that conforms to federal and institutional guidelines
  • The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Patient must have clinically T1-3, N1 breast cancer at the time of diagnosis (before neoadjuvant therapy); clinical axillary nodal involvement can be assessed by palpation, ultrasound, CT scan, magnetic resonance imaging (MRI), positron emission tomography (PET) scan, or PET/CT scan
  • Patient must have had pathologic confirmation of axillary nodal involvement at presentation (before neoadjuvant therapy) based on either a positive fine needle aspirate (FNA) (demonstrating malignant cells) or positive core needle biopsy (demonstrating invasive adenocarcinoma); the FNA or core needle biopsy can be performed either by palpation or by image guidance; documentation of axillary nodal positivity by sentinel node biopsy (before neoadjuvant therapy) is not permitted
  • Patients must have had estrogen receptor (ER) analysis performed on the primary breast tumor before neoadjuvant therapy according to current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guideline recommendations for hormone receptor testing; if negative for ER, assessment of progesterone receptor (PgR) must also be performed according to current ASCO/CAP guideline recommendations for hormone receptor testing (http://www.asco.org)
  • Patients must have had HER2 testing performed on the primary breast tumor before neoadjuvant chemotherapy according to the current ASCO/CAP guideline recommendations for human epidermal growth factor receptor 2 testing in Breast Cancer (http://www.asco.org); patients who have a primary tumor that is either HER2-positive or HER2-negative are eligible
  • Patient must have completed a minimum of 12 weeks of standard neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen
  • For patients who receive adjuvant chemotherapy after surgery, a maximum of 12 weeks of intended chemotherapy may be administered but must be completed before randomization; (if treatment delays occur, chemotherapy must be completed within 14 weeks); the dose and schedule of the adjuvant chemotherapy are at the investigator's discretion; Note: It is preferred that all intended chemotherapy be administered in the neoadjuvant setting
  • Patients with HER2-positive tumors must have received neoadjuvant trastuzumab or other anti-HER2 therapy (either with all or with a portion of the neoadjuvant chemotherapy regimen), unless medically contraindicated
  • At the time of definitive surgery, all removed axillary nodes must be histologically free from cancer; acceptable procedures for assessment of axillary nodal status at the time of surgery include:

    • Axillary node dissection
    • Sentinel node biopsy alone or
    • Sentinel node biopsy followed by axillary node dissection
    • Note: Patients are eligible whether there is residual invasive carcinoma in the surgical breast specimen or whether there is evidence of pathologic complete response; patients who are found to be pathologically node-positive at the time of surgery, based on sentinel node biopsy alone, are candidates for A011202, a study developed by the Alliance in Oncology, an NCI Cooperative Group; if A011202 is open at the investigator's institution, patients should be approached about participating in the A011202 study
  • Patients with pathologic staging of ypN0(i+) or ypN0(mol+) are eligible (Note: Postneoadjuvant therapy is designated with a "yp" prefix.)
  • Patient who have undergone either a total mastectomy or a lumpectomy are eligible
  • For patients who undergo lumpectomy, the margins of the resected specimen or re-excision must be histologically free of invasive tumor and DCIS as determined by the local pathologist; additional operative procedures may be performed to obtain clear margins; if tumor is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible; (patients with margins positive for lobular carcinoma in situ [LCIS] are eligible without additional resection)
  • For patients who undergo mastectomy, the margins must be histologically free of residual (microscopic or gross) tumor
  • The interval between the last surgery for breast cancer (including re-excision of margins) and randomization must be no more than 56 days; also, if adjuvant chemotherapy was administered, the interval between the last chemotherapy treatment and randomization must be no more than 56 days
  • The patient must have recovered from surgery with the incision completely healed and no signs of infection
  • If adjuvant chemotherapy was administered, chemotherapy-related toxicity that may interfere with delivery of radiation therapy should have resolved

Exclusion Criteria:

  • Definitive clinical or radiologic evidence of metastatic disease
  • T4 tumors including inflammatory breast cancer
  • Documentation of axillary nodal positivity before neoadjuvant therapy by sentinel node biopsy alone
  • N2 or N3 disease detected clinically or by imaging
  • Patients with histologically positive axillary nodes post neoadjuvant therapy
  • Patients with microscopic positive margins after definitive surgery
  • Synchronous or previous contralateral invasive breast cancer or DCIS; (patients with synchronous and/or previous contralateral LCIS 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)
  • 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 randomization
  • Any radiation therapy for the currently diagnosed breast cancer prior to randomization
  • Any continued use of sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy; patients are eligible if these medications are discontinued prior to randomization
  • Prior breast or thoracic radiation therapy (RT) for any condition
  • Active collagen vascular disease, specifically dermatomyositis with a creatinine phosphokinase (CPK) level above normal or with an active skin rash, systemic lupus erythematosus, or scleroderma
  • Pregnancy or lactation at the time of study entry; (Note: Pregnancy testing must be performed within 2 weeks prior to randomization according to institutional standards for women of childbearing potential)
  • Other non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up
  • Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01872975

  Hide Study Locations
Locations
United States, Alabama
University of South Alabama Mitchell Cancer Institute Recruiting
Mobile, Alabama, United States, 36688
Contact: John R. Russell    877-904-4367      
Principal Investigator: John R. Russell         
United States, Alaska
Providence Alaska Medical Center Recruiting
Anchorage, Alaska, United States, 99508
Contact: Alison K. Conlin    503-215-6412      
Principal Investigator: Alison K. Conlin         
United States, Arizona
Arizona Oncology Associates-West Orange Grove Recruiting
Tucson, Arizona, United States, 85704
Contact: Vivek S. Kavadi    281-277-5200      
Principal Investigator: Vivek S. Kavadi         
United States, California
California Cancer Center - North Fresno Recruiting
Fresno, California, United States, 93720
Contact: Uma G. Swamy    559-447-4050      
Principal Investigator: Uma G. Swamy         
Los Angeles County-USC Medical Center Recruiting
Los Angeles, California, United States, 90033
Contact: Eugene I. Chung    323-865-0451      
Principal Investigator: Eugene I. Chung         
University of Southern California/Norris Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Eugene I. Chung    323-865-0451      
Principal Investigator: Eugene I. Chung         
Saint Joseph Hospital - Orange Recruiting
Orange, California, United States, 92868
Contact: David A. Margileth    714-734-6220      
Principal Investigator: David A. Margileth         
Pomona Valley Hospital Medical Center Recruiting
Pomona, California, United States, 91767
Contact: Yallapragada S. Rao    909-865-9555      
Principal Investigator: Yallapragada S. Rao         
Kaiser Permanente-Roseville Recruiting
Roseville, California, United States, 95661
Contact: Louis Fehrenbacher    626-564-3455      
Principal Investigator: Louis Fehrenbacher         
University of California at Davis Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Jyoti S. Mayadev    916-734-3089      
Principal Investigator: Jyoti S. Mayadev         
Kaiser Permanente Medical Center - Santa Clara Recruiting
Santa Clara, California, United States, 95051
Contact: Louis Fehrenbacher    626-564-3455      
Principal Investigator: Louis Fehrenbacher         
Kaiser Permanente-South San Francisco Recruiting
South San Francisco, California, United States, 94080
Contact: Louis Fehrenbacher    626-564-3455      
Principal Investigator: Louis Fehrenbacher         
Stanford University Hospitals and Clinics Recruiting
Stanford, California, United States, 94305
Contact: Kathleen C. Horst    650-498-7061    ccto-office@stanford.edu   
Principal Investigator: Kathleen C. Horst         
Sutter Solano Medical Center Recruiting
Vallejo, California, United States, 94589
Contact: Ari D. Baron    415-600-1182    SchmidtJ@cpmcri.org   
Principal Investigator: Ari D. Baron         
United States, Colorado
University of Colorado Cancer Center - Anschutz Cancer Pavilion Recruiting
Aurora, Colorado, United States, 80045
Contact: Rachel A. Rabinovitch    720-848-0650      
Principal Investigator: Rachel A. Rabinovitch         
Rocky Mountain Cancer Centers-Boulder Recruiting
Boulder, Colorado, United States, 80304
Contact: Keren Sturtz    888-785-6789      
Principal Investigator: Keren Sturtz         
Penrose-Saint Francis Healthcare Recruiting
Colorado Springs, Colorado, United States, 80907
Contact: Keren Sturtz    888-785-6789      
Principal Investigator: Keren Sturtz         
Rocky Mountain Cancer Centers-Littleton Recruiting
Littleton, Colorado, United States, 80120
Contact: Keren Sturtz    888-785-6789      
Principal Investigator: Keren Sturtz         
Exempla Lutheran Medical Center Recruiting
Wheat Ridge, Colorado, United States, 80033
Contact: Keren Sturtz    888-785-6789      
Principal Investigator: Keren Sturtz         
United States, Connecticut
Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06102
Contact: Helaine F. Bertsch    860-545-5363      
Principal Investigator: Helaine F. Bertsch         
Yale-New Haven Hospital Saint Raphael Campus Withdrawn
Hew Haven, Connecticut, United States, 06511
The Hospital of Central Connecticut Recruiting
New Britain, Connecticut, United States, 06050
Contact: Neal B. Goldberg    860-224-5660      
Principal Investigator: Neal B. Goldberg         
Yale University Withdrawn
New Haven, Connecticut, United States, 06520
United States, District of Columbia
Lombardi Comprehensive Cancer Center at Georgetown University Recruiting
Washington, District of Columbia, United States, 20057
Contact: John L. Zapas    443-777-7364      
Principal Investigator: John L. Zapas         
Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: John L. Zapas    443-777-7364      
Principal Investigator: John L. Zapas         
United States, Florida
Memorial Healthcare System - Joe DiMaggio Children's Hospital Recruiting
Hollywood, Florida, United States, 33021
Contact: Srinath Sundararaman    954-265-2234      
Principal Investigator: Srinath Sundararaman         
Florida Hospital Recruiting
Orlando, Florida, United States, 32803
Contact: Carlos A. Alemany    407-303-5623      
Principal Investigator: Carlos A. Alemany         
UF Cancer Center at Orlando Health Recruiting
Orlando, Florida, United States, 32806
Contact: Tomas Dvorak    321-841-7246    CancerClinicalTrials@orlandohealth.com   
Principal Investigator: Tomas Dvorak         
21st Century Oncology-Palatka Recruiting
Palatka, Florida, United States, 32177
Contact: Mark E. Augspurger    904-202-7051      
Principal Investigator: Mark E. Augspurger         
United States, Georgia
Piedmont Hospital Recruiting
Atlanta, Georgia, United States, 30309
Contact: Adam W. Nowlan    404-425-7943    ORS@piedmont.org   
Principal Investigator: Adam W. Nowlan         
Emory University/Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30322
Contact: Mylin A. Torres    404-778-1868      
Principal Investigator: Mylin A. Torres         
Grady Health System Recruiting
Atlanta, Georgia, United States, 30303
Contact: Mylin A. Torres    404-778-1868      
Principal Investigator: Mylin A. Torres         
Dekalb Medical Center Recruiting
Decatur, Georgia, United States, 30033
Contact: Jayanthi Srinivasiah    404-501-3279      
Principal Investigator: Jayanthi Srinivasiah         
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Recruiting
Savannah, Georgia, United States, 31405
Contact: John A. Pablo    800-622-6877      
Principal Investigator: John A. Pablo         
United States, Hawaii
Queen's Medical Center Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Kenneth N. Sumida    808-586-2979    dorothy@crch.hawaii.edu   
Principal Investigator: Kenneth N. Sumida         
United States, Idaho
Saint Alphonsus Cancer Care Center-Boise Recruiting
Boise, Idaho, United States, 83706
Contact: Samir Narayan    734-712-4673      
Principal Investigator: Samir Narayan         
Kootenai Cancer Center Recruiting
Post Falls, Idaho, United States, 83854
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
United States, Illinois
John H Stroger Jr Hospital of Cook County Recruiting
Chicago, Illinois, United States, 60612-3785
Contact: Thomas E. Lad    312-864-6000      
Principal Investigator: Thomas E. Lad         
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Eric D. Donnelly    312-695-1301    cancer@northwestern.edu   
Principal Investigator: Eric D. Donnelly         
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Tarita O. Thomas    708-226-4357      
Principal Investigator: Tarita O. Thomas         
Advocate Lutheran General Hospital. Recruiting
Park Ridge, Illinois, United States, 60068
Contact: Jacob D. Bitran    847-384-3621      
Principal Investigator: Jacob D. Bitran         
Illinois CancerCare-Peoria Recruiting
Peoria, Illinois, United States, 61615
Contact: Nguyet A. Le-Lindqwister    800-793-2262      
Principal Investigator: Nguyet A. Le-Lindqwister         
OSF Saint Francis Medical Center Recruiting
Peoria, Illinois, United States, 61637
Contact: Nguyet A. Le-Lindqwister    800-793-2262      
Principal Investigator: Nguyet A. Le-Lindqwister         
United States, Indiana
Community Regional Cancer Care-East Radiation Oncology Recruiting
Indianapolis, Indiana, United States, 46219
Contact: Shih J. Wei    317-621-7104      
Principal Investigator: Shih J. Wei         
Community Regional Cancer Care-North Recruiting
Indianapolis, Indiana, United States, 46256
Contact: Shih J. Wei    317-621-7104      
Principal Investigator: Shih J. Wei         
IU Health Methodist Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Peter A. Johnstone    317-274-2552      
Principal Investigator: Peter A. Johnstone         
Memorial Hospital of South Bend Recruiting
South Bend, Indiana, United States, 46601
Contact: Thomas J. Reid    800-284-7370      
Principal Investigator: Thomas J. Reid         
United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Alexandra Thomas    800-237-1225      
Principal Investigator: Alexandra Thomas         
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Parvesh Kumar    913-588-4709      
Principal Investigator: Parvesh Kumar         
Kansas City Cancer Centers-Southwest Recruiting
Overland Park, Kansas, United States, 66210
Contact: Parvesh Kumar    913-588-4709      
Principal Investigator: Parvesh Kumar         
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: Edward H. Romond    859-257-3379      
Principal Investigator: Edward H. Romond         
United States, Louisiana
Ochsner Clinic CCOP Withdrawn
New Orleans, Louisiana, United States, 70121
Ochsner Medical Center Jefferson Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Mini J. Elnaggar    888-562-4763      
Principal Investigator: Mini J. Elnaggar         
United States, Maine
Eastern Maine Medical Center Recruiting
Bangor, Maine, United States, 04401
Contact: Thomas H. Openshaw    207-973-4274      
Principal Investigator: Thomas H. Openshaw         
United States, Maryland
Franklin Square Hospital Center Recruiting
Baltimore, Maryland, United States, 21237
Contact: John L. Zapas    443-777-7364      
Principal Investigator: John L. Zapas         
Tate Cancer Center Recruiting
Glen Burnie, Maryland, United States, 21061
Contact: Steven J. Feigenberg    800-888-8823      
Principal Investigator: Steven J. Feigenberg         
United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Ariel E. Hirsch    617-638-8265      
Principal Investigator: Ariel E. Hirsch         
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Faina Nakhlis    617-983-7000      
Principal Investigator: Faina Nakhlis         
Lowell General Hospital Recruiting
Lowell, Massachusetts, United States, 01854
Contact: Matthew S. Katz    978-788-7084    ghincks@lowellgeneral.org   
Principal Investigator: Matthew S. Katz         
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Thomas J. Doyle    313-916-1784      
Principal Investigator: Thomas J. Doyle         
Saint John Hospital and Medical Center Recruiting
Detroit, Michigan, United States, 48236
Contact: Samir Narayan    734-712-4673      
Principal Investigator: Samir Narayan         
William Beaumont Hospital-Royal Oak Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Nayana S. Dekhne    248-551-7695      
Principal Investigator: Nayana S. Dekhne         
William Beaumont Hospital - Troy Recruiting
Troy, Michigan, United States, 48098
Contact: Nayana S. Dekhne    248-551-7695      
Principal Investigator: Nayana S. Dekhne         
United States, Minnesota
Abbott-Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Patrick J. Flynn    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Patrick J. Flynn         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Robert W. Mutter    507-538-7623      
Principal Investigator: Robert W. Mutter         
United Hospital Recruiting
Saint Paul, Minnesota, United States, 55102
Contact: Patrick J. Flynn    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Patrick J. Flynn         
Ridgeview Medical Center Recruiting
Waconia, Minnesota, United States, 55387
Contact: Patrick J. Flynn    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Patrick J. Flynn         
United States, Missouri
Saint Luke's Hospital of Kansas City Recruiting
Kansas City, Missouri, United States, 64111
Contact: Rakesh Gaur    913-948-5588    aroland@kccop.org   
Principal Investigator: Rakesh Gaur         
Kansas City Cancer Center - South Recruiting
Kansas City, Missouri, United States, 64131
Contact: Parvesh Kumar    913-588-4709      
Principal Investigator: Parvesh Kumar         
Barnes-Jewish West County Hospital Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Maria A. Thomas    800-600-3606    info@siteman.wustl.edu   
Principal Investigator: Maria A. Thomas         
Siteman Cancer Center-South County Terminated
Saint Louis, Missouri, United States, 63129
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Maria A. Thomas    800-600-3606    info@siteman.wustl.edu   
Principal Investigator: Maria A. Thomas         
Siteman Cancer Center - Saint Peters Recruiting
Saint Peters, Missouri, United States, 63376
Contact: Maria A. Thomas    800-600-3606    info@siteman.wustl.edu   
Principal Investigator: Maria A. Thomas         
United States, Montana
Kalispell Regional Medical Center Recruiting
Kalispell, Montana, United States, 59901
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
United States, New Hampshire
Dartmouth Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Alan C. Hartford    800-639-6918    cancer.research.nurse@dartmouth.edu   
Principal Investigator: Alan C. Hartford         
United States, New Jersey
Saint Barnabas Medical Center Recruiting
Livingston, New Jersey, United States, 07039
Contact: Alison Grann    973-322-2470      
Principal Investigator: Alison Grann         
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County Recruiting
Mount Holly, New Jersey, United States, 08060
Contact: Lemuel S. Ariaratnam    888-847-8823      
Principal Investigator: Lemuel S. Ariaratnam         
UMDNJ - Robert Wood Johnson University Hospital Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Atif J. Khan    732-235-8675      
Principal Investigator: Atif J. Khan         
Valley Hospital Recruiting
Ridgewood, New Jersey, United States, 07450
Contact: Laura A. Klein    201-634-5792      
Principal Investigator: Laura A. Klein         
Sparta Cancer Treatment Center Recruiting
Sparta, New Jersey, United States, 07871
Contact: Pramila R. Anne    215-955-6084      
Principal Investigator: Pramila R. Anne         
Virtua West Jersey Hospital Voorhees Recruiting
Voorhees, New Jersey, United States, 08043
Contact: Lemuel S. Ariaratnam    888-847-8823      
Principal Investigator: Lemuel S. Ariaratnam         
United States, New York
Mary Imogene Bassett Hospital Recruiting
Cooperstown, New York, United States, 13326
Contact: Joy E. Anderson    607-547-3073    diana.crean@bassett.org   
Principal Investigator: Joy E. Anderson         
Vassar Brothers Medical Center Recruiting
Poughkeepsie, New York, United States, 12601
Contact: Gregory J. Zanieski    845-483-6483      
Principal Investigator: Gregory J. Zanieski         
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Timothy M. Zagar    877-668-0683    cancerclinicaltrials@med.unc.edu   
Principal Investigator: Timothy M. Zagar         
Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Hadley J. Sharp    704-355-2884      
Principal Investigator: Hadley J. Sharp         
Novant Health Presbyterian Medical Center Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Justin P. Favaro    704-384-5369      
Principal Investigator: Justin P. Favaro         
South Atlantic Radiation Oncology Recruiting
Supply, North Carolina, United States, 28462
Contact: Michael A. Papagikos    910-251-1839      
Principal Investigator: Michael A. Papagikos         
Coastal Carolina Radiation Oncology Recruiting
Wilmington, North Carolina, United States, 28401
Contact: Michael A. Papagikos    910-251-1839      
Principal Investigator: Michael A. Papagikos         
United States, North Dakota
Sanford Bismarck Medical Center Recruiting
Bismarck, North Dakota, United States, 58501
Contact: Preston D. Steen    701-234-6161      
Principal Investigator: Preston D. Steen         
United States, Ohio
Akron General Medical Center Recruiting
Akron, Ohio, United States, 44307
Contact: Andrew H. Fenton    330-344-6348      
Principal Investigator: Andrew H. Fenton         
Summa Akron City Hospital/Cooper Cancer Center Recruiting
Akron, Ohio, United States, 44304
Contact: Jennifer E. Payne    330-375-6101      
Principal Investigator: Jennifer E. Payne         
Summa Barberton Hospital Recruiting
Barberton, Ohio, United States, 44203
Contact: Jennifer E. Payne    330-375-6101      
Principal Investigator: Jennifer E. Payne         
Case Western Reserve University Recruiting
Cleveland, Ohio, United States, 44106
Contact: Robert R. Shenk    800-641-2422      
Principal Investigator: Robert R. Shenk         
Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Julia R. White    866-627-7616    osu@emergingmed.com   
Principal Investigator: Julia R. White         
Delaware Radiation Oncology Recruiting
Delaware, Ohio, United States, 43015
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Summa Health Center at Lake Medina Recruiting
Medina, Ohio, United States, 44256
Contact: Jennifer E. Payne    330-375-6101      
Principal Investigator: Jennifer E. Payne         
Lake University Ireland Cancer Center Recruiting
Mentor, Ohio, United States, 44060
Contact: Robert R. Shenk    800-641-2422      
Principal Investigator: Robert R. Shenk         
Southwest General Health Center Ireland Cancer Center Recruiting
Middleburg Heights, Ohio, United States, 44130
Contact: Robert R. Shenk    800-641-2422      
Principal Investigator: Robert R. Shenk         
UHHS-Chagrin Highlands Medical Center Recruiting
Orange Village, Ohio, United States, 44122
Contact: Robert R. Shenk    800-641-2422      
Principal Investigator: Robert R. Shenk         
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Terence S. Herman    405-271-4272    julie-traylor@ouhsc.edu   
Principal Investigator: Terence S. Herman         
Natalie Warren Bryant Cancer Center at Saint Francis Terminated
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Legacy Mount Hood Medical Center Recruiting
Gresham, Oregon, United States, 97030
Contact: Jay C. Andersen    800-220-4937      
Principal Investigator: Jay C. Andersen         
United States, Pennsylvania
Penn State Milton S Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033-0850
Contact: Henry Wagner    717-531-3779    CTO@hmc.psu.edu   
Principal Investigator: Henry Wagner         
Lancaster General Hospital Recruiting
Lancaster, Pennsylvania, United States, 17604
Contact: Jeffery S. Eshleman    717-544-5511      
Principal Investigator: Jeffery S. Eshleman         
Intercommunity Cancer Center Recruiting
Monroeville, Pennsylvania, United States, 15146
Contact: Thomas B. Julian    877-284-2000      
Principal Investigator: Thomas B. Julian         
Alle-Kiski Medical Center Recruiting
Natrona Heights, Pennsylvania, United States, 15065
Contact: Thomas B. Julian    877-284-2000      
Principal Investigator: Thomas B. Julian         
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Pramila R. Anne    215-955-6084      
Principal Investigator: Pramila R. Anne         
National Surgical Adjuvant Breast and Bowel Project Recruiting
Pittsburgh, Pennsylvania, United States, 15212-5234
Contact: Eleftherios (Terry) P. Mamounas    330-438-6281    tmamounas@aultman.com   
Principal Investigator: Eleftherios (Terry) P. Mamounas         
Allegheny Cancer Center at Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Thomas B. Julian    877-284-2000      
Principal Investigator: Thomas B. Julian         
Reading Hospital Recruiting
West Reading, Pennsylvania, United States, 19611
Contact: Terrence P. Cescon    610-988-9323      
Principal Investigator: Terrence P. Cescon         
WellSpan Health-York Hospital Recruiting
York, Pennsylvania, United States, 17405
Contact: L. Eamonn Boyle    877-441-7957      
Principal Investigator: L. Eamonn Boyle         
United States, South Carolina
Roper Hospital Recruiting
Charleston, South Carolina, United States, 29401
Contact: James M. Orcutt    843-720-8386    elizabeth.strojny@roperstfrancis.com   
Principal Investigator: James M. Orcutt         
United States, South Dakota
Avera Cancer Institute Recruiting
Sioux Falls, South Dakota, United States, 57105
Contact: Addison R. Tolentino    800-657-4377    Jan.Healy@avera.org   
Principal Investigator: Addison R. Tolentino         
United States, Tennessee
Thompson Cancer Survival Center Recruiting
Knoxville, Tennessee, United States, 37916
Contact: Daniel D. Scaperoth    865-541-1812      
Principal Investigator: Daniel D. Scaperoth         
United States, Texas
Texas Oncology-Arlington South Recruiting
Arlington, Texas, United States, 76014
Contact: Vivek S. Kavadi    281-277-5200      
Principal Investigator: Vivek S. Kavadi         
Texas Oncology PA - Bedford Recruiting
Bedford, Texas, United States, 76022
Contact: Vivek S. Kavadi    281-277-5200      
Principal Investigator: Vivek S. Kavadi         
The Klabzuba Cancer Center Recruiting
Fort Worth, Texas, United States, 76104
Contact: Vivek S. Kavadi    281-277-5200      
Principal Investigator: Vivek S. Kavadi         
Memorial Hermann Memorial City Medical Center Recruiting
Houston, Texas, United States, 77024
Contact: Vivek S. Kavadi    281-277-5200      
Principal Investigator: Vivek S. Kavadi         
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Simona F. Shaitelman    713-792-3245      
Principal Investigator: Simona F. Shaitelman         
Covenant Medical Center-Lakeside Recruiting
Lubbock, Texas, United States, 79410
Contact: Ibrahim A. Shalaby    806-725-8000    jaccresearch@covhs.org   
Principal Investigator: Ibrahim A. Shalaby         
Texas Oncology - Round Rock Cancer Center Recruiting
Round Rock, Texas, United States, 78681
Contact: Vivek S. Kavadi    281-277-5200      
Principal Investigator: Vivek S. Kavadi         
Texas Oncology Cancer Center Sugar Land Recruiting
Sugar Land, Texas, United States, 77479
Contact: Vivek S. Kavadi    281-277-5200      
Principal Investigator: Vivek S. Kavadi         
United States, Vermont
Norris Cotton Cancer Center-North Recruiting
Saint Johnsbury, Vermont, United States, 05819
Contact: Alan C. Hartford    800-639-6918    cancer.research.nurse@dartmouth.edu   
Principal Investigator: Alan C. Hartford         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Shayna L. Showalter    434-243-6143      
Principal Investigator: Shayna L. Showalter         
Sentara Cancer Institute at Sentara CarePlex Hospital Recruiting
Hampton, Virginia, United States, 23666
Contact: Mark E. Shaves    757-388-2406      
Principal Investigator: Mark E. Shaves         
Sentara Hospitals Recruiting
Norfolk, Virginia, United States, 23507
Contact: Mark E. Shaves    757-388-2406      
Principal Investigator: Mark E. Shaves         
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Harry D. Bear    804-628-1939      
Principal Investigator: Harry D. Bear         
Sentara Virginia Beach General Hospital Recruiting
Virginia Beach, Virginia, United States, 23454
Contact: Mark E. Shaves    757-388-2406      
Principal Investigator: Mark E. Shaves         
United States, Washington
Harrison Medical Center Recruiting
Bremerton, Washington, United States, 98310
Contact: Tanya A. Wahl    425-688-5407    patra.grevstad@swedish.org   
Principal Investigator: Tanya A. Wahl         
Good Samaritan Community Hospital Recruiting
Puyallup, Washington, United States, 98372
Contact: Yoshio Inoue    253-403-2394      
Principal Investigator: Yoshio Inoue         
Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98109
Contact: Janice N. Kim    800-804-8824      
Principal Investigator: Janice N. Kim         
Cancer Care Northwest - Spokane South Recruiting
Spokane, Washington, United States, 99202
Contact: Janice N. Kim    800-804-8824      
Principal Investigator: Janice N. Kim         
Multicare Health System Recruiting
Tacoma, Washington, United States, 98415
Contact: Yoshio Inoue    253-403-2394      
Principal Investigator: Yoshio Inoue         
Saint Joseph Medical Center Terminated
Tacoma, Washington, United States, 98405
United States, West Virginia
West Virginia University Healthcare Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Jessica F. Partin    304-293-2745    sfilburn@hsc.wvu.edu   
Principal Investigator: Jessica F. Partin         
United States, Wisconsin
Appleton Medical Center Recruiting
Appleton, Wisconsin, United States, 54911
Contact: Editha (Edie) A. Krueger    920-380-1500      
Principal Investigator: Editha (Edie) A. Krueger         
Fox Valley Surgical Associates Limited Recruiting
Appleton, Wisconsin, United States, 54911
Contact: Honnie R. Bermas    800-574-3872      
Principal Investigator: Honnie R. Bermas         
Sacred Heart Hospital Recruiting
Eau Claire, Wisconsin, United States, 54701
Contact: Jessica A. Wernberg    715-389-4457      
Principal Investigator: Jessica A. Wernberg         
Aurora Cancer Care-Grafton Recruiting
Grafton, Wisconsin, United States, 53024
Contact: Mitchell H. Pincus    800-252-2990      
Principal Investigator: Mitchell H. Pincus         
Gundersen Lutheran Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Kurt Oettel    608-775-2385    cancerctr@gundluth.org   
Principal Investigator: Kurt Oettel         
University of Wisconsin Hospital and Clinics Recruiting
Madison, Wisconsin, United States, 53792
Contact: Bethany M. Anderson    877-405-6866      
Principal Investigator: Bethany M. Anderson         
Saint Joseph's Hospital Recruiting
Marshfield, Wisconsin, United States, 54449
Contact: Jessica A. Wernberg    715-389-4457      
Principal Investigator: Jessica A. Wernberg         
Community Memorial Hospital Recruiting
Menomonee Falls, Wisconsin, United States, 53051
Contact: Adam D. Currey    414-805-4380      
Principal Investigator: Adam D. Currey         
Froedtert and the Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Adam D. Currey    414-805-4380      
Principal Investigator: Adam D. Currey         
Aurora Saint Luke's Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Mitchell H. Pincus    800-252-2990      
Principal Investigator: Mitchell H. Pincus         
Marshfield Clinic-Minocqua Center Recruiting
Minocqua, Wisconsin, United States, 54548
Contact: Jessica A. Wernberg    715-389-4457      
Principal Investigator: Jessica A. Wernberg         
Marshfield Clinic-Rice Lake Center Recruiting
Rice Lake, Wisconsin, United States, 54868
Contact: Jessica A. Wernberg    715-389-4457      
Principal Investigator: Jessica A. Wernberg         
Saint Michael's Hospital Recruiting
Stevens Point, Wisconsin, United States, 54481
Contact: Jessica A. Wernberg    715-389-4457      
Principal Investigator: Jessica A. Wernberg         
Aurora Medical Center in Summit Recruiting
Summit, Wisconsin, United States, 53066
Contact: Mitchell H. Pincus    800-252-2990      
Principal Investigator: Mitchell H. Pincus         
Aurora Cancer Care-Milwaukee West Recruiting
Wauwatosa, Wisconsin, United States, 53226
Contact: Mitchell H. Pincus    800-252-2990      
Principal Investigator: Mitchell H. Pincus         
Aurora West Allis Medical Center Recruiting
West Allis, Wisconsin, United States, 53227
Contact: Mitchell H. Pincus    800-252-2990      
Principal Investigator: Mitchell H. Pincus         
Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Keith Tankel    780-432-8500      
Principal Investigator: Keith Tankel         
Canada, Quebec
Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Richard G. Margolese    514-340-8222ext8248      
Principal Investigator: Richard G. Margolese         
Hopital Maisonneuve-Rosemont Recruiting
Montreal, Quebec, Canada, H1T 2M4
Contact: Michael Yassa    514-252-3400ext3329      
Principal Investigator: Michael Yassa         
CHUQ - Pavilion Hotel-Dieu de Quebec Recruiting
Quebec City, Quebec, Canada, G1R 2J6
Contact: Valerie Theberge    418-525-4444      
Principal Investigator: Valerie Theberge         
Sponsors and Collaborators
NSABP Foundation Inc
Radiation Therapy Oncology Group
Investigators
Principal Investigator: Norman Wolmark, MD NSABP Foundation Inc
  More Information

No publications provided

Responsible Party: NSABP Foundation Inc
ClinicalTrials.gov Identifier: NCT01872975     History of Changes
Other Study ID Numbers: NSABP-B-51/RTOG-1304, NCI-2012-03198, U10CA012027
Study First Received: June 3, 2013
Last Updated: September 5, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014