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Breast-Conserving Surgery and Radiation Therapy in Patients With Multiple Ipsilateral Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT01556243
First received: March 15, 2012
Last updated: September 15, 2016
Last verified: September 2016
  Purpose

RATIONALE: Breast-conserving surgery is a less invasive type of surgery for breast cancer and may have fewer side effects and improve recovery. Radiation therapy uses high-energy x rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial studies how well breast-conserving surgery and radiation therapy work in treating patients with multiple ipsilateral breast cancer


Condition Intervention Phase
Breast Cancer
Procedure: therapeutic conventional surgery
Radiation: whole breast irradiation
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Impact of Breast Conservation Surgery on Surgical Outcomes and Cosmesis in Patients With Multiple Ipsilateral Breast Cancers (MIBC)

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Local recurrence defined as histologic evidence of ductal carcinoma in situ or invasive breast cancer in the ipsilateral breast or chest wall assessed up to 5 years [ Time Frame: Up to 5 years post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Conversion rate to mastectomy secondary to persistent positive margins assessed [ Time Frame: Up to 5 years post-treatment ] [ Designated as safety issue: No ]
  • Type and severity of adverse effects of breast-conserving surgery and radiation as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 30 days post-treatment ] [ Designated as safety issue: Yes ]
  • Radiation-related side effects of whole-breast radiation with a boost to 1 large or > 1 lumpectomy site as assessed by NCI CTCAE version 4.0 [ Time Frame: Up to 30 days post-treatment ] [ Designated as safety issue: Yes ]
  • Patient's perception of cosmesis assessed up to 24 months after WBI using the BREAST-Q© scoring module [ Time Frame: Up to 2 years post-treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 230
Study Start Date: July 2012
Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Breast conservation surgery and radiation therapy
Patients undergo breast conserving surgery. Patients receive adjuvant chemotherapy at the physician's discretion. Patients receiving chemotherapy will start treatment within 12 weeks following surgery. Patients receive radiation therapy within 8 weeks following the last dose of chemotherapy or within 10 weeks following surgery if not receiving chemotherapy. Patients receive endocrine therapy at the physician's discretion. Patient observation will occur every 6 months until 5 years after the end of radiation therapy.
Procedure: therapeutic conventional surgery Radiation: whole breast irradiation

Detailed Description:

OBJECTIVES:

Primary

  • To assess the local recurrence (LR) rate with breast-conservation in patients with multiple ipsilateral primary breast cancer (MIBC).

Secondary

  • To examine the conversion rate to mastectomy secondary to persistent positive margins; poor cosmesis within the first year of attempting breast-conservation surgery (BCS) or inability to satisfy the radiation dose constraints on the boost to the lumpectomy bed of each site of disease.
  • To assess whether patients who did not undergo re-excision for close margins (< 2 mm) have a higher local recurrence (LR) rate than patients for whom negative margins were achieved.
  • To assess patient's perception of cosmesis and incidence of breast lymphedema.
  • To assess incidence of breast lymphedema
  • To examine the type and severity of adverse effects of breast conserving surgery and radiation for women with multiple ipsilateral primary breast cancer (MIBC).
  • To examine the radiation-related side effects of whole-breast radiation with a boost to 1 large or > 1 lumpectomy site.

OUTLINE: This is a multicenter study.

Patients undergo breast-conserving surgery (BCS) with all lesions resected to negative margins using 1 lumpectomy or 2-3 separate lumpectomy incisions at the discretion of the surgeon. Patients receive adjuvant chemotherapy and/or endocrine therapy at the discretion of the treating medical oncologist based on tumor characteristics.

  Eligibility

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Registration Inclusion Criteria:

  1. Age ≥ 40 years per National Comprehensive Cancer Network (NCCN) recommendations for breast conservation.
  2. Life Expectancy of at least 5 years, excluding diagnosis of breast cancer (Comorbid conditions should be taken into consideration, but breast cancer diagnosis is not a consideration)
  3. Female Gender - Men are excluded from this study. Male breast cancer is a rare event.

    Men are rarely candidates for breast conservation surgery due to small breast size. Men are less likely to be candidates for breast conservation surgery if found to have MIBC.

    Men are rarely candidates for breast conservation surgery due to small breast size. Men are less likely to be candidates for breast conservation surgery if found to have MIBC.

  4. Foci of Breast Cancer

    4.1 Upon clinical exam and pre-operative imaging by mammogram +/- MRI, two or three foci of biopsy proven breast cancer separated by > 2 cm of normal breast tissue.

    4.2 Foci must include at least one focus of invasive breast carcinoma with another focus of either invasive breast carcinoma or ductal carcinoma in situ (DCIS).

    No more than 2 quadrants with biopsy proven breast cancer.

    4.3 Note: The shortest distance between lesions must be reported on mammogram +/- MRI and eligibility criteria must be met on both, if both are obtained.

    4.4 Note: Patient is eligible for study if lesion is not visualized on all imaging modalities (i.e., any of the lesion(s) is/are visualized on MRI but not on mammogram OR visualized on mammogram but not on MRI).

    4.5 Ultrasound cannot be used to determine patient eligibility; eligibility to be determined by bilateral mammogram +/- MRI only.

    4.6 Fine needle aspirate of the second or third lesion to document malignancy is allowed if the first focus is shown to be invasive by core needle biopsy.

    4.7 Patient may remain on study if, upon pathological assessment, two or three lesions identified on pre-operative imaging represent one contiguous lesion.

  5. Patients may be registered AFTER surgery and PRIOR TO radiation therapy if either of the criteria is met:

    5.1 An area of atypia > 2cm from the index lesion excised at the time of cancer operation is upgraded to DCIS or invasive carcinoma thereby identifying MIBC. OR

    5.2 Patient underwent resection of two or three foci of malignancy by breast conservation surgery with a minimum of one invasive focus of breast cancer and a minimum of 2 cm of normal breast tissue between the lesions on final pathology.

  6. Mammogram Imaging - Bilateral mammogram ≤ 90 days prior to date of surgery.

    6.1 Note: For patients undergoing more than 1 breast operation, this is the date of the first breast surgery for breast cancer treatment.

  7. Staging of Cancer - cN0 or cN1 disease
  8. ECOG Performance Status (PS) - 0, 1, or 2.
  9. Ability to Complete Questionnaires - Ability to complete questionnaire(s) by themselves or with assistance
  10. Ability to Provide Written Informed Consent
  11. Willing to Return to Enrolling Institution - Willing to return to enrolling institution for follow-up during the Active Monitoring Phase (the active treatment and observation portions) of the study. Patients are encouraged to return to the enrolling institution; however, patients may receive radiation therapy at a different institution other than the enrolling institution.

Registration Exclusion Criteria:

  1. Pregnancy, Nursing and Requirement for Contraception - Pregnant women, nursing women and women of childbearing potential who are unwilling to employ adequate contraception (as determined by the treating physician) are excluded from participation.

    This study involves radiation therapy (WBI) that has known genotoxic, mutagenic and teratogenic effects.

  2. Size of Single Focus of Disease on Preoperative Imaging - Largest single focus of disease > 5 centimeters by either mammogram or MRI or both. Note: Measurement of the largest single focus should include any satellite lesions within 1 centimeter of the index lesion.
  3. Prior Staging Procedure - Surgical axillary staging procedure prior to first definitive breast operation. Note: FNA or core needle biopsy of axillary node is permitted.
  4. Evidence of Metastatic Disease - Clinical or radiographic evidence of metastatic disease
  5. Prior History of Breast Cancer - Prior history of ipsilateral breast cancer [DCIS, LCIS (lobular cancer in situ) or invasive]
  6. Staging of Cancer - cNX, cN2, or cN3 disease
  7. Breast Implants - Breast implants at time of diagnosis. Note: Patients who have had implants previously removed prior to diagnosis are eligible.
  8. Systemic Illnesses or Concurrent Disease - Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would interfere significantly with whole breast irradiation (such as connective tissue disorders, lupus, scleroderma).
  9. Uncontrolled Intercurrent Illness - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  10. Bilateral Breast Cancer - Prior or current LCIS, DCIS or invasive breast cancer in the opposite breast (i.e., bilateral disease is not allowed).
  11. Disallowed Prior Treatments - Treatment including radiation therapy, chemotherapy, biotherapy, hormonal therapy for this cancer prior to surgery (i.e., any neoadjuvant chemotherapy or endocrine therapy is not allowed). Patients who undergo surgical resection with breast conservation and then are treated with adjuvant systemic therapy are eligible to enroll prior to the start of radiotherapy.
  12. Partial Breast Radiation - Planned partial breast radiation.
  13. Known BRCA Mutations - Patients with known BRCA mutations. Patients who are not tested or whose testing result is not returned at the time of registration are not excluded from registering to this study.
  14. Other Active Malignancies - Other active malignancy ≤ 5 years prior to registration.

14.1 Exceptions: Non-melanotic skin cancer or carcinoma-in-situ of the cervix.

14.2 Note: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer.

  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: NCT01556243

  Hide Study Locations
Locations
United States, Arkansas
CHI Saint Vincent Cancer Center Hot Springs
Hot Springs, Arkansas, United States, 71913
United States, California
Epic Care-Dublin
Dublin, California, United States, 94568
Bay Area Breast Surgeons, Incorporated
Emeryville, California, United States, 94608
Epic Care Partners in Cancer Care
Emeryville, California, United States, 94608
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Contra Costa Regional Medical Center
Martinez, California, United States, 94553
Alta Bates Summit Medical Center-Summit Campus
Oakland, California, United States, 94609
Bay Area Tumor Institute
Oakland, California, United States, 94609
Stanford Cancer Institute
Palo Alto, California, United States, 94304
Naval Medical Center-San Diego
San Diego, California, United States, 92134-3202
United States, Colorado
University of Colorado Cancer Center-Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045
Catholic Health Initiatives NCORP
Englewood, Colorado, United States, 80112
United States, Connecticut
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, United States, 06105
United States, Delaware
Beebe Medical Center
Lewes, Delaware, United States, 19958
Christiana Gynecologic Oncology LLC
Newark, Delaware, United States, 19713
Delaware Clinical and Laboratory Physicians PA
Newark, Delaware, United States, 19713
Helen F. Graham Cancer Center
Newark, Delaware, United States, 19713
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States, 19713
Regional Hematology and Oncology PA
Newark, Delaware, United States, 19713
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States, 19718
Beebe Health Campus
Rehoboth Beach, Delaware, United States, 19971
Nanticoke Memorial Hospital
Seaford, Delaware, United States, 19973
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware, United States, 19801
United States, Florida
Morton Plant Hospital
Clearwater, Florida, United States, 33756
Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
United States, Georgia
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, United States, 31405
United States, Hawaii
Oncare Hawaii, Incorporated-Pali Momi
Aiea, Hawaii, United States, 96701
Pali Momi Medical Center
Aiea, Hawaii, United States, 96701
The Cancer Center of Hawaii-Leeward
Ewa Beach, Hawaii, United States, 96706
Oncare Hawaii Inc-POB II
Honolulu, Hawaii, United States, 96813
Queen's Medical Center
Honolulu, Hawaii, United States, 96813
Straub Clinic and Hospital
Honolulu, Hawaii, United States, 96813
University of Hawaii Cancer Center
Honolulu, Hawaii, United States, 96813
Kuakini Medical Center
Honolulu, Hawaii, United States, 96817
OnCare Hawaii, Incorporated-Kuakini
Honolulu, Hawaii, United States, 96817
OnCare Hawaii-Liliha
Honolulu, Hawaii, United States, 96817
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii, United States, 96817
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, United States, 96766
United States, Idaho
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States, 83706
Kootenai Medical Center
Couer D'Alene, Idaho, United States, 83814
Kootenai Cancer Center
Post Falls, Idaho, United States, 83854
Kootenai Cancer Clinic
Sandpoint, Idaho, United States, 83864
United States, Illinois
Saint Joseph Medical Center
Bloomington, Illinois, United States, 61701
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States, 61704
Illinois CancerCare-Canton
Canton, Illinois, United States, 61520
Memorial Hospital of Carbondale
Carbondale, Illinois, United States, 62902
Illinois CancerCare-Carthage
Carthage, Illinois, United States, 62321
Centralia Oncology Clinic
Centralia, Illinois, United States, 62801
University of Illinois
Chicago, Illinois, United States, 60612
Cancer Care Specialists of Central Illinois
Decatur, Illinois, United States, 62526
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Crossroads Cancer Center
Effingham, Illinois, United States, 62401
Illinois CancerCare-Eureka
Eureka, Illinois, United States, 61530
Illinois CancerCare-Galesburg
Galesburg, Illinois, United States, 61401
Western Illinois Cancer Treatment Center
Galesburg, Illinois, United States, 61401
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, United States, 61443
Illinois CancerCare-Macomb
Macomb, Illinois, United States, 61455
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States, 61350
Radiation Oncology of Northern Illinois
Ottawa, Illinois, United States, 61350
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Pekin, Illinois, United States, 61554
Illinois CancerCare-Pekin
Pekin, Illinois, United States, 61603
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61603
Illinois CancerCare-Peoria
Peoria, Illinois, United States, 61615
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria, Illinois, United States, 61615
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61637
Illinois CancerCare-Peru
Peru, Illinois, United States, 61354
Valley Radiation Oncology
Peru, Illinois, United States, 61354
Illinois CancerCare-Princeton
Princeton, Illinois, United States, 61356
Central Illinois Hematology Oncology Center
Springfield, Illinois, United States, 62702
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62702
Springfield Clinic
Springfield, Illinois, United States, 62703
Memorial Medical Center
Springfield, Illinois, United States, 62781
Cancer Care Specialists of Illinois-Swansea
Swansea, Illinois, United States, 62226
United States, Indiana
IU Health West Hospital
Avon, Indiana, United States, 46123
IU Health North Hospital
Carmel, Indiana, United States, 46032
IU Health Central Indiana Cancer Centers-Fishers
Fishers, Indiana, United States, 46037
Indiana University-Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
IU Health Methodist Hospital
Indianapolis, Indiana, United States, 46202
Sidney and Lois Eskenazi Hospital
Indianapolis, Indiana, United States, 46202
Memorial Regional Cancer Center-Day Road
Mishawaka, Indiana, United States, 46544
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, United States, 46545
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
Michiana Hematology Oncology PC-South Bend
South Bend, Indiana, United States, 46601
United States, Iowa
Mary Greeley Medical Center
Ames, Iowa, United States, 50010
McFarland Clinic PC-William R Bliss Cancer Center
Ames, Iowa, United States, 50010
McFarland Clinic PC-Boone
Boone, Iowa, United States, 50036
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, United States, 50325
Mercy Cancer Center-West Lakes
Clive, Iowa, United States, 50325
Alegent Health Mercy Hospital
Council Bluffs, Iowa, United States, 51503
Greater Regional Medical Center
Creston, Iowa, United States, 50801
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Iowa-Wide Oncology Research Coalition NCORP
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, United States, 50314
Mercy Medical Center-Des Moines
Des Moines, Iowa, United States, 50314
Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
McFarland Clinic PC-Trinity Cancer Center
Fort Dodge, Iowa, United States, 50501
McFarland Clinic PC-Jefferson
Jefferson, Iowa, United States, 50129
McFarland Clinic PC-Marshalltown
Marshalltown, Iowa, United States, 50158
Mercy Medical Center-West Lakes
West Des Moines, Iowa, United States, 50266
Methodist West Hospital
West Des Moines, Iowa, United States, 50266
United States, Kansas
Menorah Medical Center
Overland Park, Kansas, United States, 66209
Saint Luke's South Hospital
Overland Park, Kansas, United States, 66213
Kansas City NCI Community Oncology Research Program
Prairie Village, Kansas, United States, 66208
United States, Kentucky
Flaget Memorial Hospital
Bardstown, Kentucky, United States, 40004
Commonwealth Cancer Center-Corbin
Corbin, Kentucky, United States, 40701
Saint Elizabeth Medical Center South
Edgewood, Kentucky, United States, 41017
Saint Elizabeth-Fort Thomas
Fort Thomas, Kentucky, United States, 41075
Saint Joseph Radiation Oncology Resource Center
Lexington, Kentucky, United States, 40504
Saint Joseph Hospital East
Lexington, Kentucky, United States, 40509
Jewish Hospital
Louisville, Kentucky, United States, 40202
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, United States, 40202
Saints Mary and Elizabeth Hospital
Louisville, Kentucky, United States, 40215
Jewish Hospital Medical Center Northeast
Louisville, Kentucky, United States, 40245
Jewish Hospital Medical Center South
Shepherdsville, Kentucky, United States, 40165
United States, Maine
Eastern Maine Medical Center
Bangor, Maine, United States, 04401
Eastern Maine Medical Center Cancer Care
Brewer, Maine, United States, 04412
United States, Maryland
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
Saint Agnes Hospital
Baltimore, Maryland, United States, 21229
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Dana-Farber/Brigham and Women's Cancer Center at South Shore
South Weymouth, Massachusetts, United States, 02190
United States, Michigan
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106
Bronson Battle Creek
Battle Creek, Michigan, United States, 49017
Oakwood Hospital and Medical Center
Dearborn, Michigan, United States, 48124
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Saint John Hospital and Medical Center
Detroit, Michigan, United States, 48236
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Hurley Medical Center
Flint, Michigan, United States, 48503
Mercy Health Saint Mary's
Grand Rapids, Michigan, United States, 49503
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States, 49503
Allegiance Health
Jackson, Michigan, United States, 49201
Borgess Medical Center
Kalamazoo, Michigan, United States, 49001
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
Sparrow Hospital
Lansing, Michigan, United States, 48912
Saint Mary Mercy Hospital
Livonia, Michigan, United States, 48154
Mercy Health Mercy Campus
Muskegon, Michigan, United States, 49444
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, United States, 48073
Saint Mary's of Michigan
Saginaw, Michigan, United States, 48601
Munson Medical Center
Traverse City, Michigan, United States, 49684
William Beaumont Hospital-Troy
Troy, Michigan, United States, 48098
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States, 48093
United States, Minnesota
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Fairview-Southdale Hospital
Edina, Minnesota, United States, 55435
Unity Hospital
Fridley, Minnesota, United States, 55432
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States, 55109
Saint John's Hospital-Healtheast
Maplewood, Minnesota, United States, 55109
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Health Partners Inc
Minneapolis, Minnesota, United States, 55454
New Ulm Medical Center
New Ulm, Minnesota, United States, 56073
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States, 55422
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, United States, 56303
Saint Cloud Hospital
Saint Cloud, Minnesota, United States, 56303
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park, Minnesota, United States, 55416
Park Nicollet Clinic-Saint Louis Park
Saint Louis Park, Minnesota, United States, 55416
Regions Hospital
Saint Paul, Minnesota, United States, 55101
United Hospital
Saint Paul, Minnesota, United States, 55102
Saint Francis Regional Medical Center
Shakopee, Minnesota, United States, 55379
Lakeview Hospital
Stillwater, Minnesota, United States, 55082
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Rice Memorial Hospital
Willmar, Minnesota, United States, 56201
Minnesota Oncology and Hematology PA-Woodbury
Woodbury, Minnesota, United States, 55125
United States, Missouri
Parkland Health Center-Bonne Terre
Bonne Terre, Missouri, United States, 63628
Saint Francis Medical Center
Cape Giradeau, Missouri, United States, 63703
Southeast Cancer Center
Cape Girardeau, Missouri, United States, 63703
Centerpoint Medical Center LLC
Independence, Missouri, United States, 64057
Capital Region Medical Center-Goldschmidt Cancer Center
Jefferson City, Missouri, United States, 65109
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
Heartland Hematology and Oncology Associates Incorporated
Kansas City, Missouri, United States, 64118
Research Medical Center
Kansas City, Missouri, United States, 64132
Saint Luke's East-Lee's Summit
Lee's Summit, Missouri, United States, 64086
Liberty Radiation Oncology Center
Liberty, Missouri, United States, 64068
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Missouri Baptist Medical Center
Saint Louis, Missouri, United States, 63131
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, United States, 63670
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, United States, 63080
Missouri Baptist Outpatient Center-Sunset Hills
Sunset Hills, Missouri, United States, 63127
United States, Montana
Montana Cancer Consortium NCORP
Billings, Montana, United States, 59101
Saint Vincent Healthcare
Billings, Montana, United States, 59101
Billings Clinic Cancer Center
Billings, Montana, United States, 59107
Bozeman Deaconess Hospital
Bozeman, Montana, United States, 59715
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, United States, 59701
Benefis Healthcare-Sletten Cancer Institute
Great Falls, Montana, United States, 59405
Saint Peter's Community Hospital
Helena, Montana, United States, 59601
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Community Medical Hospital
Missoula, Montana, United States, 59801
Saint Patrick Hospital-Community Hospital
Missoula, Montana, United States, 59802
United States, Nebraska
CHI Health Saint Francis
Grand Island, Nebraska, United States, 68803
Heartland Hematology and Oncology
Kearney, Nebraska, United States, 68845
CHI Health Good Samaritan
Kearney, Nebraska, United States, 68847
Saint Elizabeth Regional Medical Center
Lincoln, Nebraska, United States, 68510
Alegent Health Immanuel Medical Center
Omaha, Nebraska, United States, 68122
Hematology and Oncology Consultants PC
Omaha, Nebraska, United States, 68122
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, United States, 68124
Alegent Health Lakeside Hospital
Omaha, Nebraska, United States, 68130
Creighton University Medical Center
Omaha, Nebraska, United States, 68131
Midlands Community Hospital
Papillion, Nebraska, United States, 68046
United States, Nevada
Cancer and Blood Specialists-Henderson
Henderson, Nevada, United States, 89052
Comprehensive Cancer Centers of Nevada-Henderson
Henderson, Nevada, United States, 89052
Las Vegas Cancer Center-Henderson
Henderson, Nevada, United States, 89052
21st Century Oncology-Henderson
Henderson, Nevada, United States, 89074
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson, Nevada, United States, 89074
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States, 89102
Cancer and Blood Specialists-Shadow
Las Vegas, Nevada, United States, 89106
Nevada Cancer Research Foundation NCORP
Las Vegas, Nevada, United States, 89106
Radiation Oncology Centers of Nevada Central
Las Vegas, Nevada, United States, 89106
21st Century Oncology-Fort Apache
Las Vegas, Nevada, United States, 89109
21st Century Oncology
Las Vegas, Nevada, United States, 89109
HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
Las Vegas, Nevada, United States, 89109
HealthCare Partners Medical Group Oncology/Hematology-San Martin
Las Vegas, Nevada, United States, 89113
Radiation Oncology Centers of Nevada Southeast
Las Vegas, Nevada, United States, 89119
Cancer Therapy and Integrative Medicine
Las Vegas, Nevada, United States, 89121
21st Century Oncology-Vegas Tenaya
Las Vegas, Nevada, United States, 89128
Cancer and Blood Specialists-Tenaya
Las Vegas, Nevada, United States, 89128
Comprehensive Cancer Centers of Nevada-Northwest
Las Vegas, Nevada, United States, 89128
HealthCare Partners Medical Group Oncology/Hematology-Tenaya
Las Vegas, Nevada, United States, 89128
Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas, Nevada, United States, 89144
Cancer and Blood Specialists-Fort Apache
Las Vegas, Nevada, United States, 89148
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89148
Las Vegas Cancer Center-Medical Center
Las Vegas, Nevada, United States, 89148
HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
Las Vegas, Nevada, United States, 89149
Comprehensive Cancer Centers of Nevada-Central Valley
Las Vegas, Nevada, United States, 89169
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Memorial Sloan Kettering Cancer Center-Basking Ridge
Basking Ridge, New Jersey, United States, 07920
Saint Peter's University Hospital
New Brunswick, New Jersey, United States, 08901
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87102
Lovelace Women's Hospital
Albuquerque, New Mexico, United States, 87109
United States, New York
Memorial Sloan Kettering Cancer Center-Commack
Commack, New York, United States, 11725
North Shore University Hospital
Manhasset, New York, United States, 11030
North Shore-LIJ Health System/Center for Advanced Medicine
New Hyde Park, New York, United States, 11040
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Vassar Brothers Medical Center
Poughkeepsie, New York, United States, 12601
University of Rochester
Rochester, New York, United States, 14642
Memorial Sloan Kettering Cancer Center-Rockville Centre
Rockville Centre, New York, United States, 11570
Memorial Sloan Kettering Cancer Center-Sleepy Hollow
Sleepy Hollow, New York, United States, 10591
Memorial Sloan Kettering Cancer Center-West Harrison
West Harrison, New York, United States, 10604
United States, North Carolina
Randolph Hospital
Asheboro, North Carolina, United States, 27203
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, United States, 28203
Levine Cancer Institute-Tryon
Charlotte, North Carolina, United States, 28203
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States, 28204
Carolina Surgical Clinic of Charlotte PA
Charlotte, North Carolina, United States, 28207
Oncology Specialists of Charlotte
Charlotte, North Carolina, United States, 28207
Carolinas Medical Center/Levine Cancer Institute-Pineville
Charlotte, North Carolina, United States, 28210
Carolinas Medical Center/Levine Cancer Institute-University
Charlotte, North Carolina, United States, 28262
Southern Oncology Specialists-Charlotte
Charlotte, North Carolina, United States, 28262
Levine Cancer Institute-Ballantyne
Charlotte, North Carolina, United States, 28277
CaroMont Breast Surgical Specialists-Gastonia
Gastonia, North Carolina, United States, 28054
CaroMont Regional Medical Center
Gastonia, North Carolina, United States, 28054
Cone Health Cancer Center
Greensboro, North Carolina, United States, 27403
Lake Norman Hematology Oncology Specialists-Huntersville
Huntersville, North Carolina, United States, 28078
Southern Oncology Specialists-Huntersville
Huntersville, North Carolina, United States, 28078
Matthews Radiation Oncology Center
Matthews, North Carolina, United States, 28105
Novant Health Cancer Specialists-Matthews
Matthews, North Carolina, United States, 28105
Carolinas HealthCare System Union
Monroe, North Carolina, United States, 28112
Lake Norman Hematology Oncology Specialists-Mooresville
Mooresville, North Carolina, United States, 28117
Annie Penn Memorial Hospital
Reidsville, North Carolina, United States, 27320
United States, Ohio
Strecker Cancer Center-Belpre
Belpre, Ohio, United States, 45714
Adena Regional Medical Center
Chillicothe, Ohio, United States, 54601
The Christ Hospital
Cincinnati, Ohio, United States, 45219
Good Samaritan Hospital-Cincinnati
Cincinnati, Ohio, United States, 45220
Bethesda North Hospital
Cincinnati, Ohio, United States, 45242
TriHealth Cancer Institute-Westside
Cincinnati, Ohio, United States, 45247
TriHealth Cancer Institute-Anderson
Cincinnati, Ohio, United States, 45255
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Mount Carmel East Hospital
Columbus, Ohio, United States, 43213
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio, United States, 43214
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Columbus NCI Community Oncology Research Program
Columbus, Ohio, United States, 43215
Grant Medical Center
Columbus, Ohio, United States, 43215
The Mark H Zangmeister Center
Columbus, Ohio, United States, 43219
Mount Carmel Health Center West
Columbus, Ohio, United States, 43222
Doctors Hospital
Columbus, Ohio, United States, 43228
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, United States, 43015
Delaware Radiation Oncology
Delaware, Ohio, United States, 43015
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
OhioHealth MedCentral Hospital
Mansfield, Ohio, United States, 44903
Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
OhioHealth Marion General Hospital
Marion, Ohio, United States, 43302
Knox Community Hospital
Mount Vernon, Ohio, United States, 43050
Licking Memorial Hospital
Newark, Ohio, United States, 43055
Newark Radiation Oncology
Newark, Ohio, United States, 43055
Southern Ohio Medical Center
Portsmouth, Ohio, United States, 45662
Springfield Regional Medical Center
Springfield, Ohio, United States, 45505
University Pointe
West Chester, Ohio, United States, 45069
Saint Ann's Hospital
Westerville, Ohio, United States, 43081
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio, United States, 43701
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, United States, 73120
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, United States, 18103
Lehigh Valley Hospital-Muhlenberg
Bethlehem, Pennsylvania, United States, 18017
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States, 19010
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
Lankenau Medical Center
Wynnewood, Pennsylvania, United States, 19096
United States, Rhode Island
Roger Williams Medical Center
Providence, Rhode Island, United States, 02908
United States, South Carolina
Hilton Head Regional Medical Center
Hilton Head Island, South Carolina, United States, 29926
Levine Cancer Institute-Rock Hill
Rock Hill, South Carolina, United States, 29732
Lexington Medical Center
West Columbia, South Carolina, United States, 29169
United States, South Dakota
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
United States, Tennessee
Memorial Hospital
Chattanooga, Tennessee, United States, 37404
Pulmonary Medicine Center of Chattanooga-Hixson
Hixson, Tennessee, United States, 37343
Memorial GYN Plus
Ooltewah, Tennessee, United States, 37363
United States, Texas
Texas Tech University Health Sciences Center-Amarillo
Amarillo, Texas, United States, 79106
Parkland Memorial Hospital
Dallas, Texas, United States, 75235
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States, 75390
M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
The Methodist Hospital System
Houston, Texas, United States, 77030
Doctor's Hospital of Laredo
Laredo, Texas, United States, 78045
United States, Utah
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
United States, Vermont
Central Vermont Medical Center
Berlin, Vermont, United States, 05602
University of Vermont College of Medicine
Burlington, Vermont, United States, 05405
Norris Cotton Cancer Center-North
Saint Johnsbury, Vermont, United States, 05819
United States, Virginia
Mary Washington Hospital
Fredericksburg, Virginia, United States, 22401
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States, 23298
United States, Washington
Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton, Washington, United States, 98310
Harrison Medical Center
Bremerton, Washington, United States, 98310
Highline Medical Center-Main Campus
Burien, Washington, United States, 98166
Saint Elizabeth Hospital
Enumclaw, Washington, United States, 98022
Saint Francis Hospital
Federal Way, Washington, United States, 98003
Saint Clare Hospital
Lakewood, Washington, United States, 98499
Harrison HealthPartners Hematology and Oncology-Poulsbo
Poulsbo, Washington, United States, 98370
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Franciscan Research Center-Northwest Medical Plaza
Tacoma, Washington, United States, 98405
Northwest Medical Specialties PLLC
Tacoma, Washington, United States, 98405
United States, Wisconsin
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301
Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Saint Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Aurora BayCare Medical Center
Green Bay, Wisconsin, United States, 54311-6519
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Aurora Sinai Medical Center
Milwaukee, Wisconsin, United States, 53233
Westfields Hospital/Cancer Center of Western Wisconsin
New Richmond, Wisconsin, United States, 54017
Vince Lombardi Cancer Clinic-Oshkosh
Oshkosh, Wisconsin, United States, 54904
Aurora Medical Center in Summit
Summit, Wisconsin, United States, 53066
Aurora West Allis Medical Center
West Allis, Wisconsin, United States, 53227
United States, Wyoming
Big Horn Basin Cancer Center
Cody, Wyoming, United States, 82414
Billings Clinic-Cody
Cody, Wyoming, United States, 82414
Welch Cancer Center
Sheridan, Wyoming, United States, 82801
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
Study Chair: Judy Boughey, MD Mayo Clinic
  More Information

Additional Information:
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT01556243     History of Changes
Other Study ID Numbers: ACOSOG-Z11102  CDR0000728605 
Study First Received: March 15, 2012
Last Updated: September 15, 2016
Health Authority: United States: NCI Institutional Review Board

Keywords provided by Alliance for Clinical Trials in Oncology:
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
ductal breast carcinoma in situ
lobular breast carcinoma in situ

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

ClinicalTrials.gov processed this record on September 23, 2016