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

Breast Cancer Clinical Trial

Official title:

Impact of Breast Conservation Surgery on Surgical Outcomes and Cosmesis in Patients With Multiple Ipsilateral Breast Cancers (MIBC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01556243
• Other study ID #: ACOSOG-Z11102
• Secondary ID: ACOSOG-Z11102CDR
• Status: Completed
• Phase: Phase 2
• Start date: July 2012
• Est. completion date: April 15, 2023

Study information

• Verified date: November 2023
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: April 15, 2023
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• therapeutic conventional surgery

Radiation:
• whole breast irradiation

Locations

Country	Name	City	State
United States	Oncare Hawaii, Incorporated-Pali Momi	'Aiea	Hawaii
United States	Pali Momi Medical Center	'Aiea	Hawaii
United States	The Cancer Center of Hawaii-Leeward	'Ewa Beach	Hawaii
United States	Lovelace Women's Hospital	Albuquerque	New Mexico
United States	University of New Mexico Cancer Center	Albuquerque	New Mexico
United States	Lehigh Valley Hospital-Cedar Crest	Allentown	Pennsylvania
United States	Texas Tech University Health Sciences Center-Amarillo	Amarillo	Texas
United States	Mary Greeley Medical Center	Ames	Iowa
United States	McFarland Clinic PC-William R Bliss Cancer Center	Ames	Iowa
United States	Saint Joseph Mercy Hospital	Ann Arbor	Michigan
United States	Randolph Hospital	Asheboro	North Carolina
United States	University of Colorado Cancer Center-Anschutz Cancer Pavilion	Aurora	Colorado
United States	IU Health West Hospital	Avon	Indiana
United States	Saint Agnes Hospital	Baltimore	Maryland
United States	Sinai Hospital of Baltimore	Baltimore	Maryland
United States	Eastern Maine Medical Center	Bangor	Maine
United States	Flaget Memorial Hospital	Bardstown	Kentucky
United States	Memorial Sloan Kettering Cancer Center-Basking Ridge	Basking Ridge	New Jersey
United States	Bronson Battle Creek	Battle Creek	Michigan
United States	Strecker Cancer Center-Belpre	Belpre	Ohio
United States	Central Vermont Medical Center	Berlin	Vermont
United States	Lehigh Valley Hospital-Muhlenberg	Bethlehem	Pennsylvania
United States	Billings Clinic Cancer Center	Billings	Montana
United States	Montana Cancer Consortium NCORP	Billings	Montana
United States	Saint Vincent Healthcare	Billings	Montana
United States	Illinois CancerCare-Bloomington	Bloomington	Illinois
United States	Saint Joseph Medical Center	Bloomington	Illinois
United States	Saint Alphonsus Cancer Care Center-Boise	Boise	Idaho
United States	Parkland Health Center-Bonne Terre	Bonne Terre	Missouri
United States	McFarland Clinic PC-Boone	Boone	Iowa
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Bozeman Deaconess Hospital	Bozeman	Montana
United States	Harrison HealthPartners Hematology and Oncology-Bremerton	Bremerton	Washington
United States	Harrison Medical Center	Bremerton	Washington
United States	Eastern Maine Medical Center Cancer Care	Brewer	Maine
United States	Bryn Mawr Hospital	Bryn Mawr	Pennsylvania
United States	Highline Medical Center-Main Campus	Burien	Washington
United States	University of Vermont College of Medicine	Burlington	Vermont
United States	Fairview Ridges Hospital	Burnsville	Minnesota
United States	Saint James Community Hospital and Cancer Treatment Center	Butte	Montana
United States	Illinois CancerCare-Canton	Canton	Illinois
United States	Saint Francis Medical Center	Cape Girardeau	Missouri
United States	Southeast Cancer Center	Cape Girardeau	Missouri
United States	Memorial Hospital of Carbondale	Carbondale	Illinois
United States	IU Health North Hospital	Carmel	Indiana
United States	Illinois CancerCare-Carthage	Carthage	Illinois
United States	Centralia Oncology Clinic	Centralia	Illinois
United States	Carolina Surgical Clinic of Charlotte PA	Charlotte	North Carolina
United States	Carolinas Medical Center/Levine Cancer Institute	Charlotte	North Carolina
United States	Carolinas Medical Center/Levine Cancer Institute-Pineville	Charlotte	North Carolina
United States	Carolinas Medical Center/Levine Cancer Institute-University	Charlotte	North Carolina
United States	Levine Cancer Institute-Ballantyne	Charlotte	North Carolina
United States	Levine Cancer Institute-Tryon	Charlotte	North Carolina
United States	Novant Health Presbyterian Medical Center	Charlotte	North Carolina
United States	Oncology Specialists of Charlotte	Charlotte	North Carolina
United States	Southern Oncology Specialists-Charlotte	Charlotte	North Carolina
United States	Memorial Hospital	Chattanooga	Tennessee
United States	University of Illinois	Chicago	Illinois
United States	Adena Regional Medical Center	Chillicothe	Ohio
United States	Bethesda North Hospital	Cincinnati	Ohio
United States	Good Samaritan Hospital-Cincinnati	Cincinnati	Ohio
United States	The Christ Hospital	Cincinnati	Ohio
United States	TriHealth Cancer Institute-Anderson	Cincinnati	Ohio
United States	TriHealth Cancer Institute-Westside	Cincinnati	Ohio
United States	University of Cincinnati	Cincinnati	Ohio
United States	Morton Plant Hospital	Clearwater	Florida
United States	Medical Oncology and Hematology Associates-West Des Moines	Clive	Iowa
United States	Mercy Cancer Center-West Lakes	Clive	Iowa
United States	Big Horn Basin Cancer Center	Cody	Wyoming
United States	Billings Clinic-Cody	Cody	Wyoming
United States	Kootenai Medical Center	Coeur d'Alene	Idaho
United States	Columbus NCI Community Oncology Research Program	Columbus	Ohio
United States	Columbus Oncology and Hematology Associates Inc	Columbus	Ohio
United States	Doctors Hospital	Columbus	Ohio
United States	Grant Medical Center	Columbus	Ohio
United States	Mount Carmel East Hospital	Columbus	Ohio
United States	Mount Carmel Health Center West	Columbus	Ohio
United States	Riverside Methodist Hospital	Columbus	Ohio
United States	The Mark H Zangmeister Center	Columbus	Ohio
United States	Memorial Sloan Kettering Cancer Center-Commack	Commack	New York
United States	Mercy Hospital	Coon Rapids	Minnesota
United States	Commonwealth Cancer Center-Corbin	Corbin	Kentucky
United States	Alegent Health Mercy Hospital	Council Bluffs	Iowa
United States	Greater Regional Medical Center	Creston	Iowa
United States	Parkland Memorial Hospital	Dallas	Texas
United States	UT Southwestern/Simmons Cancer Center-Dallas	Dallas	Texas
United States	Oakwood Hospital and Medical Center	Dearborn	Michigan
United States	Cancer Care Specialists of Central Illinois	Decatur	Illinois
United States	Decatur Memorial Hospital	Decatur	Illinois
United States	Delaware Health Center-Grady Cancer Center	Delaware	Ohio
United States	Delaware Radiation Oncology	Delaware	Ohio
United States	Grady Memorial Hospital	Delaware	Ohio
United States	Iowa Lutheran Hospital	Des Moines	Iowa
United States	Iowa Methodist Medical Center	Des Moines	Iowa
United States	Iowa-Wide Oncology Research Coalition NCORP	Des Moines	Iowa
United States	Medical Oncology and Hematology Associates-Des Moines	Des Moines	Iowa
United States	Medical Oncology and Hematology Associates-Laurel	Des Moines	Iowa
United States	Mercy Medical Center-Des Moines	Des Moines	Iowa
United States	Saint John Hospital and Medical Center	Detroit	Michigan
United States	Wayne State University/Karmanos Cancer Institute	Detroit	Michigan
United States	Epic Care-Dublin	Dublin	California
United States	Saint Elizabeth Medical Center South	Edgewood	Kentucky
United States	Fairview-Southdale Hospital	Edina	Minnesota
United States	Crossroads Cancer Center	Effingham	Illinois
United States	Bay Area Breast Surgeons, Incorporated	Emeryville	California
United States	Epic Care Partners in Cancer Care	Emeryville	California
United States	Catholic Health Initiatives NCORP	Englewood	Colorado
United States	Saint Elizabeth Hospital	Enumclaw	Washington
United States	Illinois CancerCare-Eureka	Eureka	Illinois
United States	Saint Francis Hospital	Federal Way	Washington
United States	IU Health Central Indiana Cancer Centers-Fishers	Fishers	Indiana
United States	Genesys Hurley Cancer Institute	Flint	Michigan
United States	Hurley Medical Center	Flint	Michigan
United States	McFarland Clinic PC-Trinity Cancer Center	Fort Dodge	Iowa
United States	Saint Elizabeth-Fort Thomas	Fort Thomas	Kentucky
United States	Mary Washington Hospital	Fredericksburg	Virginia
United States	Unity Hospital	Fridley	Minnesota
United States	Illinois CancerCare-Galesburg	Galesburg	Illinois
United States	Western Illinois Cancer Treatment Center	Galesburg	Illinois
United States	CaroMont Breast Surgical Specialists-Gastonia	Gastonia	North Carolina
United States	CaroMont Regional Medical Center	Gastonia	North Carolina
United States	CHI Health Saint Francis	Grand Island	Nebraska
United States	Mercy Health Saint Mary's	Grand Rapids	Michigan
United States	Spectrum Health at Butterworth Campus	Grand Rapids	Michigan
United States	Benefis Healthcare-Sletten Cancer Institute	Great Falls	Montana
United States	Aurora BayCare Medical Center	Green Bay	Wisconsin
United States	Green Bay Oncology at Saint Vincent Hospital	Green Bay	Wisconsin
United States	Green Bay Oncology Limited at Saint Mary's Hospital	Green Bay	Wisconsin
United States	Saint Mary's Hospital	Green Bay	Wisconsin
United States	Saint Vincent Hospital	Green Bay	Wisconsin
United States	Cone Health Cancer Center	Greensboro	North Carolina
United States	Memorial Sloan Kettering Cancer Center-West Harrison	Harrison	New York
United States	Smilow Cancer Hospital Care Center at Saint Francis	Hartford	Connecticut
United States	Ingalls Memorial Hospital	Harvey	Illinois
United States	Saint Peter's Community Hospital	Helena	Montana
United States	21st Century Oncology-Henderson	Henderson	Nevada
United States	Cancer and Blood Specialists-Henderson	Henderson	Nevada
United States	Comprehensive Cancer Centers of Nevada-Henderson	Henderson	Nevada
United States	Comprehensive Cancer Centers of Nevada-Southeast Henderson	Henderson	Nevada
United States	Las Vegas Cancer Center-Henderson	Henderson	Nevada
United States	Hilton Head Regional Medical Center	Hilton Head Island	South Carolina
United States	Pulmonary Medicine Center of Chattanooga-Hixson	Hixson	Tennessee
United States	Kapiolani Medical Center for Women and Children	Honolulu	Hawaii
United States	Kuakini Medical Center	Honolulu	Hawaii
United States	Oncare Hawaii Inc-POB II	Honolulu	Hawaii
United States	OnCare Hawaii, Incorporated-Kuakini	Honolulu	Hawaii
United States	OnCare Hawaii-Liliha	Honolulu	Hawaii
United States	Queen's Medical Center	Honolulu	Hawaii
United States	Straub Clinic and Hospital	Honolulu	Hawaii
United States	The Cancer Center of Hawaii-Liliha	Honolulu	Hawaii
United States	University of Hawaii Cancer Center	Honolulu	Hawaii
United States	CHI Saint Vincent Cancer Center Hot Springs	Hot Springs	Arkansas
United States	M. D. Anderson Cancer Center	Houston	Texas
United States	The Methodist Hospital System	Houston	Texas
United States	Lake Norman Hematology Oncology Specialists-Huntersville	Huntersville	North Carolina
United States	Southern Oncology Specialists-Huntersville	Huntersville	North Carolina
United States	Centerpoint Medical Center LLC	Independence	Missouri
United States	Indiana University-Melvin and Bren Simon Cancer Center	Indianapolis	Indiana
United States	IU Health Methodist Hospital	Indianapolis	Indiana
United States	Sidney and Lois Eskenazi Hospital	Indianapolis	Indiana
United States	Allegiance Health	Jackson	Michigan
United States	McFarland Clinic PC-Jefferson	Jefferson	Iowa
United States	Capital Region Medical Center-Goldschmidt Cancer Center	Jefferson City	Missouri
United States	Borgess Medical Center	Kalamazoo	Michigan
United States	Bronson Methodist Hospital	Kalamazoo	Michigan
United States	West Michigan Cancer Center	Kalamazoo	Michigan
United States	Kalispell Regional Medical Center	Kalispell	Montana
United States	Heartland Hematology and Oncology Associates Incorporated	Kansas City	Missouri
United States	Research Medical Center	Kansas City	Missouri
United States	Saint Luke's Hospital of Kansas City	Kansas City	Missouri
United States	CHI Health Good Samaritan	Kearney	Nebraska
United States	Heartland Hematology and Oncology	Kearney	Nebraska
United States	Illinois CancerCare-Kewanee Clinic	Kewanee	Illinois
United States	Gundersen Lutheran Medical Center	La Crosse	Wisconsin
United States	UC San Diego Moores Cancer Center	La Jolla	California
United States	Saint Clare Hospital	Lakewood	Washington
United States	Fairfield Medical Center	Lancaster	Ohio
United States	Sparrow Hospital	Lansing	Michigan
United States	Doctor's Hospital of Laredo	Laredo	Texas
United States	21st Century Oncology	Las Vegas	Nevada
United States	21st Century Oncology-Fort Apache	Las Vegas	Nevada
United States	21st Century Oncology-Vegas Tenaya	Las Vegas	Nevada
United States	Cancer and Blood Specialists-Fort Apache	Las Vegas	Nevada
United States	Cancer and Blood Specialists-Shadow	Las Vegas	Nevada
United States	Cancer and Blood Specialists-Tenaya	Las Vegas	Nevada
United States	Cancer Therapy and Integrative Medicine	Las Vegas	Nevada
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	Comprehensive Cancer Centers of Nevada-Central Valley	Las Vegas	Nevada
United States	Comprehensive Cancer Centers of Nevada-Northwest	Las Vegas	Nevada
United States	Comprehensive Cancer Centers of Nevada-Summerlin	Las Vegas	Nevada
United States	HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills	Las Vegas	Nevada
United States	HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway	Las Vegas	Nevada
United States	HealthCare Partners Medical Group Oncology/Hematology-San Martin	Las Vegas	Nevada
United States	HealthCare Partners Medical Group Oncology/Hematology-Tenaya	Las Vegas	Nevada
United States	Las Vegas Cancer Center-Medical Center	Las Vegas	Nevada
United States	Nevada Cancer Research Foundation NCORP	Las Vegas	Nevada
United States	Radiation Oncology Centers of Nevada Central	Las Vegas	Nevada
United States	Radiation Oncology Centers of Nevada Southeast	Las Vegas	Nevada
United States	University Medical Center of Southern Nevada	Las Vegas	Nevada
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Saint Luke's East-Lee's Summit	Lee's Summit	Missouri
United States	Beebe Medical Center	Lewes	Delaware
United States	Saint Joseph Hospital East	Lexington	Kentucky
United States	Saint Joseph Radiation Oncology Resource Center	Lexington	Kentucky
United States	Liberty Radiation Oncology Center	Liberty	Missouri
United States	Wilcox Memorial Hospital and Kauai Medical Clinic	Lihue	Hawaii
United States	Saint Elizabeth Regional Medical Center	Lincoln	Nebraska
United States	Saint Mary Mercy Hospital	Livonia	Michigan
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Jewish Hospital	Louisville	Kentucky
United States	Jewish Hospital Medical Center Northeast	Louisville	Kentucky
United States	Saints Mary and Elizabeth Hospital	Louisville	Kentucky
United States	The James Graham Brown Cancer Center at University of Louisville	Louisville	Kentucky
United States	Illinois CancerCare-Macomb	Macomb	Illinois
United States	North Shore University Hospital	Manhasset	New York
United States	OhioHealth MedCentral Hospital	Mansfield	Ohio
United States	Minnesota Oncology Hematology PA-Maplewood	Maplewood	Minnesota
United States	Saint John's Hospital-Healtheast	Maplewood	Minnesota
United States	Marietta Memorial Hospital	Marietta	Ohio
United States	OhioHealth Marion General Hospital	Marion	Ohio
United States	McFarland Clinic PC-Marshalltown	Marshalltown	Iowa
United States	Contra Costa Regional Medical Center	Martinez	California
United States	Matthews Radiation Oncology Center	Matthews	North Carolina
United States	Novant Health Cancer Specialists-Matthews	Matthews	North Carolina
United States	University of Miami Miller School of Medicine-Sylvester Cancer Center	Miami	Florida
United States	Mount Sinai Medical Center	Miami Beach	Florida
United States	Aurora Saint Luke's Medical Center	Milwaukee	Wisconsin
United States	Aurora Sinai Medical Center	Milwaukee	Wisconsin
United States	Froedtert and the Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Abbott-Northwestern Hospital	Minneapolis	Minnesota
United States	Health Partners Inc	Minneapolis	Minnesota
United States	Hennepin County Medical Center	Minneapolis	Minnesota
United States	Memorial Regional Cancer Center-Day Road	Mishawaka	Indiana
United States	Saint Joseph Regional Medical Center-Mishawaka	Mishawaka	Indiana
United States	Community Medical Hospital	Missoula	Montana
United States	Saint Patrick Hospital-Community Hospital	Missoula	Montana
United States	Carolinas HealthCare System Union	Monroe	North Carolina
United States	Lake Norman Hematology Oncology Specialists-Mooresville	Mooresville	North Carolina
United States	Knox Community Hospital	Mount Vernon	Ohio
United States	Mercy Health Mercy Campus	Muskegon	Michigan
United States	Saint Peter's University Hospital	New Brunswick	New Jersey
United States	North Shore-LIJ Health System/Center for Advanced Medicine	New Hyde Park	New York
United States	Westfields Hospital/Cancer Center of Western Wisconsin	New Richmond	Wisconsin
United States	New Ulm Medical Center	New Ulm	Minnesota
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Christiana Care Health System-Christiana Hospital	Newark	Delaware
United States	Christiana Gynecologic Oncology LLC	Newark	Delaware
United States	Delaware Clinical and Laboratory Physicians PA	Newark	Delaware
United States	Helen F. Graham Cancer Center	Newark	Delaware
United States	Licking Memorial Hospital	Newark	Ohio
United States	Medical Oncology Hematology Consultants PA	Newark	Delaware
United States	Newark Radiation Oncology	Newark	Ohio
United States	Regional Hematology and Oncology PA	Newark	Delaware
United States	Alta Bates Summit Medical Center-Summit Campus	Oakland	California
United States	Bay Area Tumor Institute	Oakland	California
United States	Mercy Hospital Oklahoma City	Oklahoma City	Oklahoma
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Alegent Health Bergan Mercy Medical Center	Omaha	Nebraska
United States	Alegent Health Immanuel Medical Center	Omaha	Nebraska
United States	Alegent Health Lakeside Hospital	Omaha	Nebraska
United States	Creighton University Medical Center	Omaha	Nebraska
United States	Hematology and Oncology Consultants PC	Omaha	Nebraska
United States	Memorial GYN Plus	Ooltewah	Tennessee
United States	Vince Lombardi Cancer Clinic-Oshkosh	Oshkosh	Wisconsin
United States	Illinois CancerCare-Ottawa Clinic	Ottawa	Illinois
United States	Radiation Oncology of Northern Illinois	Ottawa	Illinois
United States	Menorah Medical Center	Overland Park	Kansas
United States	Saint Luke's South Hospital	Overland Park	Kansas
United States	Stanford Cancer Institute	Palo Alto	California
United States	Midlands Community Hospital	Papillion	Nebraska
United States	Illinois CancerCare-Pekin	Pekin	Illinois
United States	OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center	Pekin	Illinois
United States	Illinois CancerCare-Peoria	Peoria	Illinois
United States	Methodist Medical Center of Illinois	Peoria	Illinois
United States	OSF Saint Francis Medical Center	Peoria	Illinois
United States	OSF Saint Francis Radiation Oncology at Peoria Cancer Center	Peoria	Illinois
United States	Illinois CancerCare-Peru	Peru	Illinois
United States	Valley Radiation Oncology	Peru	Illinois
United States	University of Pittsburgh Cancer Institute (UPCI)	Pittsburgh	Pennsylvania
United States	Saint Joseph Mercy Oakland	Pontiac	Michigan
United States	Oregon Health and Science University	Portland	Oregon
United States	Southern Ohio Medical Center	Portsmouth	Ohio
United States	Kootenai Cancer Center	Post Falls	Idaho
United States	Vassar Brothers Medical Center	Poughkeepsie	New York
United States	Harrison HealthPartners Hematology and Oncology-Poulsbo	Poulsbo	Washington
United States	Kansas City NCI Community Oncology Research Program	Prairie Village	Kansas
United States	Illinois CancerCare-Princeton	Princeton	Illinois
United States	Roger Williams Medical Center	Providence	Rhode Island
United States	Beebe Health Campus	Rehoboth Beach	Delaware
United States	Annie Penn Memorial Hospital	Reidsville	North Carolina
United States	Virginia Commonwealth University/Massey Cancer Center	Richmond	Virginia
United States	North Memorial Medical Health Center	Robbinsdale	Minnesota
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	University of Rochester	Rochester	New York
United States	Levine Cancer Institute-Rock Hill	Rock Hill	South Carolina
United States	Memorial Sloan Kettering Cancer Center-Rockville Centre	Rockville Centre	New York
United States	William Beaumont Hospital-Royal Oak	Royal Oak	Michigan
United States	Saint Mary's of Michigan	Saginaw	Michigan
United States	Coborn Cancer Center at Saint Cloud Hospital	Saint Cloud	Minnesota
United States	Saint Cloud Hospital	Saint Cloud	Minnesota
United States	Norris Cotton Cancer Center-North	Saint Johnsbury	Vermont
United States	Missouri Baptist Medical Center	Saint Louis	Missouri
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Metro Minnesota Community Oncology Research Consortium	Saint Louis Park	Minnesota
United States	Park Nicollet Clinic-Saint Louis Park	Saint Louis Park	Minnesota
United States	Regions Hospital	Saint Paul	Minnesota
United States	United Hospital	Saint Paul	Minnesota
United States	Sainte Genevieve County Memorial Hospital	Sainte Genevieve	Missouri
United States	Huntsman Cancer Institute/University of Utah	Salt Lake City	Utah
United States	Naval Medical Center-San Diego	San Diego	California
United States	Kootenai Cancer Clinic	Sandpoint	Idaho
United States	Lewis Cancer and Research Pavilion at Saint Joseph's/Candler	Savannah	Georgia
United States	Nanticoke Memorial Hospital	Seaford	Delaware
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Saint Francis Regional Medical Center	Shakopee	Minnesota
United States	Jewish Hospital Medical Center South	Shepherdsville	Kentucky
United States	Welch Cancer Center	Sheridan	Wyoming
United States	Avera Cancer Institute	Sioux Falls	South Dakota
United States	Memorial Sloan Kettering Cancer Center-Sleepy Hollow	Sleepy Hollow	New York
United States	Memorial Hospital of South Bend	South Bend	Indiana
United States	Michiana Hematology Oncology PC-South Bend	South Bend	Indiana
United States	Dana-Farber/Brigham and Women's Cancer Center at South Shore	South Weymouth	Massachusetts
United States	Central Illinois Hematology Oncology Center	Springfield	Illinois
United States	Memorial Medical Center	Springfield	Illinois
United States	Southern Illinois University School of Medicine	Springfield	Illinois
United States	Springfield Clinic	Springfield	Illinois
United States	Springfield Regional Medical Center	Springfield	Ohio
United States	Lakeview Hospital	Stillwater	Minnesota
United States	Missouri Baptist Sullivan Hospital	Sullivan	Missouri
United States	Aurora Medical Center in Summit	Summit	Wisconsin
United States	Missouri Baptist Outpatient Center-Sunset Hills	Sunset Hills	Missouri
United States	Cancer Care Specialists of Illinois-Swansea	Swansea	Illinois
United States	Franciscan Research Center-Northwest Medical Plaza	Tacoma	Washington
United States	Northwest Medical Specialties PLLC	Tacoma	Washington
United States	Munson Medical Center	Traverse City	Michigan
United States	William Beaumont Hospital-Troy	Troy	Michigan
United States	Ridgeview Medical Center	Waconia	Minnesota
United States	Saint John Macomb-Oakland Hospital	Warren	Michigan
United States	Aurora West Allis Medical Center	West Allis	Wisconsin
United States	University Pointe	West Chester	Ohio
United States	Lexington Medical Center	West Columbia	South Carolina
United States	Mercy Medical Center-West Lakes	West Des Moines	Iowa
United States	Methodist West Hospital	West Des Moines	Iowa
United States	Saint Ann's Hospital	Westerville	Ohio
United States	Rice Memorial Hospital	Willmar	Minnesota
United States	Christiana Care Health System-Wilmington Hospital	Wilmington	Delaware
United States	Minnesota Oncology and Hematology PA-Woodbury	Woodbury	Minnesota
United States	Lankenau Medical Center	Wynnewood	Pennsylvania
United States	Genesis Healthcare System Cancer Care Center	Zanesville	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local Recurrence	Local recurrence(LR) 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. The estimated 5-year cumulative incidence of LR will be reported as a percentage of patients expected to experience a LR at 5 years.	5 years
Secondary	Conversion Rate to Mastectomy	The conversion rate to mastectomy secondary to persistent positive margins; poor cosmesis within the first year of attempting BCS; or inability to satisfy the radiation dose constraints on the boost to the lumpectomy bed of each site of disease.	5 years
Secondary	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		Up to 30 days post-treatment
Secondary	Radiation-related Side Effects	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.	17 months
Secondary	Patient's Perception of Cosmesis	Patient's perception of cosmesis will be assessed at their initial post-operative visit as well as 24 months following completion of WBI using the BREAST-Q subscales: satisfaction with breasts, satisfaction with overall outcome, and physical well-being. Patients registered after surgery will not partake in the pre-operative assessment but will be asked to complete subsequent cosmesis surveys. The total score for each of these subscales will be determined using the BREAST-Q scoring module (http://www.mskcc.org/mskcc/shared/Breast-Q/scoreBQ.html). The BREAST-Q has multiple domains, and each domain score is obtained by transforming the raw scale item responses with the Q-Score software program. Each domain results in an independent score from 0 to 100 (higher scores indicate greater satisfaction or quality of life).	24 months