Clinical trial NCT01556243: Breast-Conserving Surgery and Radiation Therapy in Patients With Multiple Ipsilateral Breast Cancer
Official title: Impact of Breast Conservation Surgery on Surgical Outcomes and Cosmesis in Patients With Multiple Ipsilateral Breast Cancers (MIBC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: stage IA breast cancer
stage IB breast cancer
stage II breast cancer
ductal breast carcinoma in situ
lobular breast carcinoma in situ
Lead sponsor: Alliance for Clinical Trials in Oncology
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-03-16
Enrollment: 270
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

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 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.

Primary outcomes:
measure: Local Recurrence
timeFrame: 5 years
Secondary outcomes:
measure: Conversion Rate to Mastectomy
timeFrame: 5 years
measure: 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
timeFrame: Up to 30 days post-treatment
measure: Radiation-related Side Effects
timeFrame: 17 months
measure: Patient's Perception of Cosmesis
timeFrame: 24 months
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: CHI Saint Vincent Cancer Center Hot Springs
state: Arkansas
city: Dublin
country: United States
facility: Epic Care-Dublin
state: California
city: Emeryville
country: United States
facility: Bay Area Breast Surgeons, Incorporated
state: California
city: Emeryville
country: United States
facility: Epic Care Partners in Cancer Care
state: California
city: La Jolla
country: United States
facility: UC San Diego Moores Cancer Center
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Martinez
country: United States
facility: Contra Costa Regional Medical Center
state: California
city: Oakland
country: United States
facility: Alta Bates Summit Medical Center-Summit Campus
state: California
city: Oakland
country: United States
facility: Bay Area Tumor Institute
state: California
city: Palo Alto
country: United States
facility: Stanford Cancer Institute
state: California
city: San Diego
country: United States
facility: Naval Medical Center-San Diego
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center-Anschutz Cancer Pavilion
state: Colorado
city: Englewood
country: United States
facility: Catholic Health Initiatives NCORP
state: Colorado
city: Hartford
country: United States
facility: Smilow Cancer Hospital Care Center at Saint Francis
state: Connecticut
city: Lewes
country: United States
facility: Beebe Medical Center
state: Delaware
city: Newark
country: United States
facility: Christiana Gynecologic Oncology LLC
state: Delaware
city: Newark
country: United States
facility: Delaware Clinical and Laboratory Physicians PA
state: Delaware
city: Newark
country: United States
facility: Helen F. Graham Cancer Center
state: Delaware
city: Newark
country: United States
facility: Medical Oncology Hematology Consultants PA
state: Delaware
city: Newark
country: United States
facility: Regional Hematology and Oncology PA
state: Delaware
city: Newark
country: United States
facility: Christiana Care Health System-Christiana Hospital
state: Delaware
city: Rehoboth Beach
country: United States
facility: Beebe Health Campus
state: Delaware
city: Seaford
country: United States
facility: Nanticoke Memorial Hospital
state: Delaware
city: Wilmington
country: United States
facility: Christiana Care Health System-Wilmington Hospital
state: Delaware
city: Clearwater
country: United States
facility: Morton Plant Hospital
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: Miami
country: United States
facility: University of Miami Miller School of Medicine-Sylvester Cancer Center
state: Florida
city: Savannah
country: United States
facility: Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
state: Georgia
city: 'Aiea
country: United States
facility: Oncare Hawaii, Incorporated-Pali Momi
state: Hawaii
city: 'Aiea
country: United States
facility: Pali Momi Medical Center
state: Hawaii
city: 'Ewa Beach
country: United States
facility: The Cancer Center of Hawaii-Leeward
state: Hawaii
city: Honolulu
country: United States
facility: Oncare Hawaii Inc-POB II
state: Hawaii
city: Honolulu
country: United States
facility: Queen's Medical Center
state: Hawaii
city: Honolulu
country: United States
facility: Straub Clinic and Hospital
state: Hawaii
city: Honolulu
country: United States
facility: University of Hawaii Cancer Center
state: Hawaii
city: Honolulu
country: United States
facility: Kuakini Medical Center
state: Hawaii
city: Honolulu
country: United States
facility: OnCare Hawaii, Incorporated-Kuakini
state: Hawaii
city: Honolulu
country: United States
facility: OnCare Hawaii-Liliha
state: Hawaii
city: Honolulu
country: United States
facility: The Cancer Center of Hawaii-Liliha
state: Hawaii
city: Honolulu
country: United States
facility: Kapiolani Medical Center for Women and Children
state: Hawaii
city: Lihue
country: United States
facility: Wilcox Memorial Hospital and Kauai Medical Clinic
state: Hawaii
city: Boise
country: United States
facility: Saint Alphonsus Cancer Care Center-Boise
state: Idaho
city: Coeur d'Alene
country: United States
facility: Kootenai Medical Center
state: Idaho
city: Post Falls
country: United States
facility: Kootenai Cancer Center
state: Idaho
city: Sandpoint
country: United States
facility: Kootenai Cancer Clinic
state: Idaho
city: Bloomington
country: United States
facility: Saint Joseph Medical Center
state: Illinois
city: Bloomington
country: United States
facility: Illinois CancerCare-Bloomington
state: Illinois
city: Canton
country: United States
facility: Illinois CancerCare-Canton
state: Illinois
city: Carbondale
country: United States
facility: Memorial Hospital of Carbondale
state: Illinois
city: Carthage
country: United States
facility: Illinois CancerCare-Carthage
state: Illinois
city: Centralia
country: United States
facility: Centralia Oncology Clinic
state: Illinois
city: Chicago
country: United States
facility: University of Illinois
state: Illinois
city: Decatur
country: United States
facility: Cancer Care Specialists of Central Illinois
state: Illinois
city: Decatur
country: United States
facility: Decatur Memorial Hospital
state: Illinois
city: Effingham
country: United States
facility: Crossroads Cancer Center
state: Illinois
city: Eureka
country: United States
facility: Illinois CancerCare-Eureka
state: Illinois
city: Galesburg
country: United States
facility: Illinois CancerCare-Galesburg
state: Illinois
city: Galesburg
country: United States
facility: Western Illinois Cancer Treatment Center
state: Illinois
city: Harvey
country: United States
facility: Ingalls Memorial Hospital
state: Illinois
city: Kewanee
country: United States
facility: Illinois CancerCare-Kewanee Clinic
state: Illinois
city: Macomb
country: United States
facility: Illinois CancerCare-Macomb
state: Illinois
city: Ottawa
country: United States
facility: Illinois CancerCare-Ottawa Clinic
state: Illinois
city: Ottawa
country: United States
facility: Radiation Oncology of Northern Illinois
state: Illinois
city: Pekin
country: United States
facility: OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
state: Illinois
city: Pekin
country: United States
facility: Illinois CancerCare-Pekin
state: Illinois
city: Peoria
country: United States
facility: Methodist Medical Center of Illinois
state: Illinois
city: Peoria
country: United States
facility: Illinois CancerCare-Peoria
state: Illinois
city: Peoria
country: United States
facility: OSF Saint Francis Radiation Oncology at Peoria Cancer Center
state: Illinois
city: Peoria
country: United States
facility: OSF Saint Francis Medical Center
state: Illinois
city: Peru
country: United States
facility: Illinois CancerCare-Peru
state: Illinois
city: Peru
country: United States
facility: Valley Radiation Oncology
state: Illinois
city: Princeton
country: United States
facility: Illinois CancerCare-Princeton
state: Illinois
city: Springfield
country: United States
facility: Central Illinois Hematology Oncology Center
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic
state: Illinois
city: Springfield
country: United States
facility: Memorial Medical Center
state: Illinois
city: Swansea
country: United States
facility: Cancer Care Specialists of Illinois-Swansea
state: Illinois
city: Avon
country: United States
facility: IU Health West Hospital
state: Indiana
city: Carmel
country: United States
facility: IU Health North Hospital
state: Indiana
city: Fishers
country: United States
facility: IU Health Central Indiana Cancer Centers-Fishers
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University-Melvin and Bren Simon Cancer Center
state: Indiana
city: Indianapolis
country: United States
facility: IU Health Methodist Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Sidney and Lois Eskenazi Hospital
state: Indiana
city: Mishawaka
country: United States
facility: Memorial Regional Cancer Center-Day Road
state: Indiana
city: Mishawaka
country: United States
facility: Saint Joseph Regional Medical Center-Mishawaka
state: Indiana
city: South Bend
country: United States
facility: Memorial Hospital of South Bend
state: Indiana
city: South Bend
country: United States
facility: Michiana Hematology Oncology PC-South Bend
state: Indiana
city: Ames
country: United States
facility: Mary Greeley Medical Center
state: Iowa
city: Ames
country: United States
facility: McFarland Clinic PC-William R Bliss Cancer Center
state: Iowa
city: Boone
country: United States
facility: McFarland Clinic PC-Boone
state: Iowa
city: Clive
country: United States
facility: Medical Oncology and Hematology Associates-West Des Moines
state: Iowa
city: Clive
country: United States
facility: Mercy Cancer Center-West Lakes
state: Iowa
city: Council Bluffs
country: United States
facility: Alegent Health Mercy Hospital
state: Iowa
city: Creston
country: United States
facility: Greater Regional Medical Center
state: Iowa
city: Des Moines
country: United States
facility: Iowa Methodist Medical Center
state: Iowa
city: Des Moines
country: United States
facility: Iowa-Wide Oncology Research Coalition NCORP
state: Iowa
city: Des Moines
country: United States
facility: Medical Oncology and Hematology Associates-Des Moines
state: Iowa
city: Des Moines
country: United States
facility: Medical Oncology and Hematology Associates-Laurel
state: Iowa
city: Des Moines
country: United States
facility: Mercy Medical Center-Des Moines
state: Iowa
city: Des Moines
country: United States
facility: Iowa Lutheran Hospital
state: Iowa
city: Fort Dodge
country: United States
facility: McFarland Clinic PC-Trinity Cancer Center
state: Iowa
city: Jefferson
country: United States
facility: McFarland Clinic PC-Jefferson
state: Iowa
city: Marshalltown
country: United States
facility: McFarland Clinic PC-Marshalltown
state: Iowa
city: West Des Moines
country: United States
facility: Mercy Medical Center-West Lakes
state: Iowa
city: West Des Moines
country: United States
facility: Methodist West Hospital
state: Iowa
city: Overland Park
country: United States
facility: Menorah Medical Center
state: Kansas
city: Overland Park
country: United States
facility: Saint Luke's South Hospital
state: Kansas
city: Prairie Village
country: United States
facility: Kansas City NCI Community Oncology Research Program
state: Kansas
city: Bardstown
country: United States
facility: Flaget Memorial Hospital
state: Kentucky
city: Corbin
country: United States
facility: Commonwealth Cancer Center-Corbin
state: Kentucky
city: Edgewood
country: United States
facility: Saint Elizabeth Medical Center South
state: Kentucky
city: Fort Thomas
country: United States
facility: Saint Elizabeth-Fort Thomas
state: Kentucky
city: Lexington
country: United States
facility: Saint Joseph Radiation Oncology Resource Center
state: Kentucky
city: Lexington
country: United States
facility: Saint Joseph Hospital East
state: Kentucky
city: Louisville
country: United States
facility: Jewish Hospital
state: Kentucky
city: Louisville
country: United States
facility: The James Graham Brown Cancer Center at University of Louisville
state: Kentucky
city: Louisville
country: United States
facility: Saints Mary and Elizabeth Hospital
state: Kentucky
city: Louisville
country: United States
facility: Jewish Hospital Medical Center Northeast
state: Kentucky
city: Shepherdsville
country: United States
facility: Jewish Hospital Medical Center South
state: Kentucky
city: Bangor
country: United States
facility: Eastern Maine Medical Center
state: Maine
city: Brewer
country: United States
facility: Eastern Maine Medical Center Cancer Care
state: Maine
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore
state: Maryland
city: Baltimore
country: United States
facility: Saint Agnes Hospital
state: Maryland
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: South Weymouth
country: United States
facility: Dana-Farber/Brigham and Women's Cancer Center at South Shore
state: Massachusetts
city: Ann Arbor
country: United States
facility: Saint Joseph Mercy Hospital
state: Michigan
city: Battle Creek
country: United States
facility: Bronson Battle Creek
state: Michigan
city: Dearborn
country: United States
facility: Oakwood Hospital and Medical Center
state: Michigan
city: Detroit
country: United States
facility: Wayne State University/Karmanos Cancer Institute
state: Michigan
city: Detroit
country: United States
facility: Saint John Hospital and Medical Center
state: Michigan
city: Flint
country: United States
facility: Genesys Hurley Cancer Institute
state: Michigan
city: Flint
country: United States
facility: Hurley Medical Center
state: Michigan
city: Grand Rapids
country: United States
facility: Mercy Health Saint Mary's
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health at Butterworth Campus
state: Michigan
city: Jackson
country: United States
facility: Allegiance Health
state: Michigan
city: Kalamazoo
country: United States
facility: Borgess Medical Center
state: Michigan
city: Kalamazoo
country: United States
facility: Bronson Methodist Hospital
state: Michigan
city: Kalamazoo
country: United States
facility: West Michigan Cancer Center
state: Michigan
city: Lansing
country: United States
facility: Sparrow Hospital
state: Michigan
city: Livonia
country: United States
facility: Saint Mary Mercy Hospital
state: Michigan
city: Muskegon
country: United States
facility: Mercy Health Mercy Campus
state: Michigan
city: Pontiac
country: United States
facility: Saint Joseph Mercy Oakland
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital-Royal Oak
state: Michigan
city: Saginaw
country: United States
facility: Saint Mary's of Michigan
state: Michigan
city: Traverse City
country: United States
facility: Munson Medical Center
state: Michigan
city: Troy
country: United States
facility: William Beaumont Hospital-Troy
state: Michigan
city: Warren
country: United States
facility: Saint John Macomb-Oakland Hospital
state: Michigan
city: Burnsville
country: United States
facility: Fairview Ridges Hospital
state: Minnesota
city: Coon Rapids
country: United States
facility: Mercy Hospital
state: Minnesota
city: Edina
country: United States
facility: Fairview-Southdale Hospital
state: Minnesota
city: Fridley
country: United States
facility: Unity Hospital
state: Minnesota
city: Maplewood
country: United States
facility: Minnesota Oncology Hematology PA-Maplewood
state: Minnesota
city: Maplewood
country: United States
facility: Saint John's Hospital-Healtheast
state: Minnesota
city: Minneapolis
country: United States
facility: Abbott-Northwestern Hospital
state: Minnesota
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Minneapolis
country: United States
facility: Health Partners Inc
state: Minnesota
city: New Ulm
country: United States
facility: New Ulm Medical Center
state: Minnesota
city: Robbinsdale
country: United States
facility: North Memorial Medical Health Center
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Cancer Center
state: Minnesota
city: Saint Cloud
country: United States
facility: Coborn Cancer Center at Saint Cloud Hospital
state: Minnesota
city: Saint Cloud
country: United States
facility: Saint Cloud Hospital
state: Minnesota
city: Saint Louis Park
country: United States
facility: Metro Minnesota Community Oncology Research Consortium
state: Minnesota
city: Saint Louis Park
country: United States
facility: Park Nicollet Clinic-Saint Louis Park
state: Minnesota
city: Saint Paul
country: United States
facility: Regions Hospital
state: Minnesota
city: Saint Paul
country: United States
facility: United Hospital
state: Minnesota
city: Shakopee
country: United States
facility: Saint Francis Regional Medical Center
state: Minnesota
city: Stillwater
country: United States
facility: Lakeview Hospital
state: Minnesota
city: Waconia
country: United States
facility: Ridgeview Medical Center
state: Minnesota
city: Willmar
country: United States
facility: Rice Memorial Hospital
state: Minnesota
city: Woodbury
country: United States
facility: Minnesota Oncology and Hematology PA-Woodbury
state: Minnesota
city: Bonne Terre
country: United States
facility: Parkland Health Center-Bonne Terre
state: Missouri
city: Cape Girardeau
country: United States
facility: Saint Francis Medical Center
state: Missouri
city: Cape Girardeau
country: United States
facility: Southeast Cancer Center
state: Missouri
city: Independence
country: United States
facility: Centerpoint Medical Center LLC
state: Missouri
city: Jefferson City
country: United States
facility: Capital Region Medical Center-Goldschmidt Cancer Center
state: Missouri
city: Kansas City
country: United States
facility: Saint Luke's Hospital of Kansas City
state: Missouri
city: Kansas City
country: United States
facility: Heartland Hematology and Oncology Associates Incorporated
state: Missouri
city: Kansas City
country: United States
facility: Research Medical Center
state: Missouri
city: Lee's Summit
country: United States
facility: Saint Luke's East-Lee's Summit
state: Missouri
city: Liberty
country: United States
facility: Liberty Radiation Oncology Center
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Saint Louis
country: United States
facility: Missouri Baptist Medical Center
state: Missouri
city: Sainte Genevieve
country: United States
facility: Sainte Genevieve County Memorial Hospital
state: Missouri
city: Sullivan
country: United States
facility: Missouri Baptist Sullivan Hospital
state: Missouri
city: Sunset Hills
country: United States
facility: Missouri Baptist Outpatient Center-Sunset Hills
state: Missouri
city: Billings
country: United States
facility: Montana Cancer Consortium NCORP
state: Montana
city: Billings
country: United States
facility: Saint Vincent Healthcare
state: Montana
city: Billings
country: United States
facility: Billings Clinic Cancer Center
state: Montana
city: Bozeman
country: United States
facility: Bozeman Deaconess Hospital
state: Montana
city: Butte
country: United States
facility: Saint James Community Hospital and Cancer Treatment Center
state: Montana
city: Great Falls
country: United States
facility: Benefis Healthcare-Sletten Cancer Institute
state: Montana
city: Helena
country: United States
facility: Saint Peter's Community Hospital
state: Montana
city: Kalispell
country: United States
facility: Kalispell Regional Medical Center
state: Montana
city: Missoula
country: United States
facility: Community Medical Hospital
state: Montana
city: Missoula
country: United States
facility: Saint Patrick Hospital-Community Hospital
state: Montana
city: Grand Island
country: United States
facility: CHI Health Saint Francis
state: Nebraska
city: Kearney
country: United States
facility: Heartland Hematology and Oncology
state: Nebraska
city: Kearney
country: United States
facility: CHI Health Good Samaritan
state: Nebraska
city: Lincoln
country: United States
facility: Saint Elizabeth Regional Medical Center
state: Nebraska
city: Omaha
country: United States
facility: Alegent Health Immanuel Medical Center
state: Nebraska
city: Omaha
country: United States
facility: Hematology and Oncology Consultants PC
state: Nebraska
city: Omaha
country: United States
facility: Alegent Health Bergan Mercy Medical Center
state: Nebraska
city: Omaha
country: United States
facility: Alegent Health Lakeside Hospital
state: Nebraska
city: Omaha
country: United States
facility: Creighton University Medical Center
state: Nebraska
city: Papillion
country: United States
facility: Midlands Community Hospital
state: Nebraska
city: Henderson
country: United States
facility: Cancer and Blood Specialists-Henderson
state: Nevada
city: Henderson
country: United States
facility: Comprehensive Cancer Centers of Nevada-Henderson
state: Nevada
city: Henderson
country: United States
facility: Las Vegas Cancer Center-Henderson
state: Nevada
city: Henderson
country: United States
facility: 21st Century Oncology-Henderson
state: Nevada
city: Henderson
country: United States
facility: Comprehensive Cancer Centers of Nevada-Southeast Henderson
state: Nevada
city: Las Vegas
country: United States
facility: University Medical Center of Southern Nevada
state: Nevada
city: Las Vegas
country: United States
facility: Cancer and Blood Specialists-Shadow
state: Nevada
city: Las Vegas
country: United States
facility: Nevada Cancer Research Foundation NCORP
state: Nevada
city: Las Vegas
country: United States
facility: Radiation Oncology Centers of Nevada Central
state: Nevada
city: Las Vegas
country: United States
facility: 21st Century Oncology-Fort Apache
state: Nevada
city: Las Vegas
country: United States
facility: 21st Century Oncology
state: Nevada
city: Las Vegas
country: United States
facility: HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
state: Nevada
city: Las Vegas
country: United States
facility: HealthCare Partners Medical Group Oncology/Hematology-San Martin
state: Nevada
city: Las Vegas
country: United States
facility: Radiation Oncology Centers of Nevada Southeast
state: Nevada
city: Las Vegas
country: United States
facility: Cancer Therapy and Integrative Medicine
state: Nevada
city: Las Vegas
country: United States
facility: 21st Century Oncology-Vegas Tenaya
state: Nevada
city: Las Vegas
country: United States
facility: Cancer and Blood Specialists-Tenaya
state: Nevada
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada-Northwest
state: Nevada
city: Las Vegas
country: United States
facility: HealthCare Partners Medical Group Oncology/Hematology-Tenaya
state: Nevada
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada-Summerlin
state: Nevada
city: Las Vegas
country: United States
facility: Cancer and Blood Specialists-Fort Apache
state: Nevada
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Las Vegas
country: United States
facility: Las Vegas Cancer Center-Medical Center
state: Nevada
city: Las Vegas
country: United States
facility: HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
state: Nevada
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada-Central Valley
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Cancer Center-Basking Ridge
state: New Jersey
city: New Brunswick
country: United States
facility: Saint Peter's University Hospital
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico Cancer Center
state: New Mexico
city: Albuquerque
country: United States
facility: Lovelace Women's Hospital
state: New Mexico
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center-Commack
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Cancer Center-West Harrison
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New Hyde Park
country: United States
facility: North Shore-LIJ Health System/Center for Advanced Medicine
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Poughkeepsie
country: United States
facility: Vassar Brothers Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Cancer Center-Rockville Centre
state: New York
city: Sleepy Hollow
country: United States
facility: Memorial Sloan Kettering Cancer Center-Sleepy Hollow
state: New York
city: Asheboro
country: United States
facility: Randolph Hospital
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas Medical Center/Levine Cancer Institute
state: North Carolina
city: Charlotte
country: United States
facility: Levine Cancer Institute-Tryon
state: North Carolina
city: Charlotte
country: United States
facility: Novant Health Presbyterian Medical Center
state: North Carolina
city: Charlotte
country: United States
facility: Carolina Surgical Clinic of Charlotte PA
state: North Carolina
city: Charlotte
country: United States
facility: Oncology Specialists of Charlotte
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas Medical Center/Levine Cancer Institute-Pineville
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas Medical Center/Levine Cancer Institute-University
state: North Carolina
city: Charlotte
country: United States
facility: Southern Oncology Specialists-Charlotte
state: North Carolina
city: Charlotte
country: United States
facility: Levine Cancer Institute-Ballantyne
state: North Carolina
city: Gastonia
country: United States
facility: CaroMont Breast Surgical Specialists-Gastonia
state: North Carolina
city: Gastonia
country: United States
facility: CaroMont Regional Medical Center
state: North Carolina
city: Greensboro
country: United States
facility: Cone Health Cancer Center
state: North Carolina
city: Huntersville
country: United States
facility: Lake Norman Hematology Oncology Specialists-Huntersville
state: North Carolina
city: Huntersville
country: United States
facility: Southern Oncology Specialists-Huntersville
state: North Carolina
city: Matthews
country: United States
facility: Matthews Radiation Oncology Center
state: North Carolina
city: Matthews
country: United States
facility: Novant Health Cancer Specialists-Matthews
state: North Carolina
city: Monroe
country: United States
facility: Carolinas HealthCare System Union
state: North Carolina
city: Mooresville
country: United States
facility: Lake Norman Hematology Oncology Specialists-Mooresville
state: North Carolina
city: Reidsville
country: United States
facility: Annie Penn Memorial Hospital
state: North Carolina
city: Belpre
country: United States
facility: Strecker Cancer Center-Belpre
state: Ohio
city: Chillicothe
country: United States
facility: Adena Regional Medical Center
state: Ohio
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Good Samaritan Hospital-Cincinnati
state: Ohio
city: Cincinnati
country: United States
facility: Bethesda North Hospital
state: Ohio
city: Cincinnati
country: United States
facility: TriHealth Cancer Institute-Westside
state: Ohio
city: Cincinnati
country: United States
facility: TriHealth Cancer Institute-Anderson
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Columbus
country: United States
facility: Mount Carmel East Hospital
state: Ohio
city: Columbus
country: United States
facility: Columbus Oncology and Hematology Associates Inc
state: Ohio
city: Columbus
country: United States
facility: Riverside Methodist Hospital
state: Ohio
city: Columbus
country: United States
facility: Columbus NCI Community Oncology Research Program
state: Ohio
city: Columbus
country: United States
facility: Grant Medical Center
state: Ohio
city: Columbus
country: United States
facility: The Mark H Zangmeister Center
state: Ohio
city: Columbus
country: United States
facility: Mount Carmel Health Center West
state: Ohio
city: Columbus
country: United States
facility: Doctors Hospital
state: Ohio
city: Delaware
country: United States
facility: Delaware Health Center-Grady Cancer Center
state: Ohio
city: Delaware
country: United States
facility: Delaware Radiation Oncology
state: Ohio
city: Delaware
country: United States
facility: Grady Memorial Hospital
state: Ohio
city: Lancaster
country: United States
facility: Fairfield Medical Center
state: Ohio
city: Mansfield
country: United States
facility: OhioHealth MedCentral Hospital
state: Ohio
city: Marietta
country: United States
facility: Marietta Memorial Hospital
state: Ohio
city: Marion
country: United States
facility: OhioHealth Marion General Hospital
state: Ohio
city: Mount Vernon
country: United States
facility: Knox Community Hospital
state: Ohio
city: Newark
country: United States
facility: Licking Memorial Hospital
state: Ohio
city: Newark
country: United States
facility: Newark Radiation Oncology
state: Ohio
city: Portsmouth
country: United States
facility: Southern Ohio Medical Center
state: Ohio
city: Springfield
country: United States
facility: Springfield Regional Medical Center
state: Ohio
city: West Chester
country: United States
facility: University Pointe
state: Ohio
city: Westerville
country: United States
facility: Saint Ann's Hospital
state: Ohio
city: Zanesville
country: United States
facility: Genesis Healthcare System Cancer Care Center
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: Mercy Hospital Oklahoma City
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Allentown
country: United States
facility: Lehigh Valley Hospital-Cedar Crest
state: Pennsylvania
city: Bethlehem
country: United States
facility: Lehigh Valley Hospital-Muhlenberg
state: Pennsylvania
city: Bryn Mawr
country: United States
facility: Bryn Mawr Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Cancer Institute (UPCI)
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Medical Center
state: Pennsylvania
city: Providence
country: United States
facility: Roger Williams Medical Center
state: Rhode Island
city: Hilton Head Island
country: United States
facility: Hilton Head Regional Medical Center
state: South Carolina
city: Rock Hill
country: United States
facility: Levine Cancer Institute-Rock Hill
state: South Carolina
city: West Columbia
country: United States
facility: Lexington Medical Center
state: South Carolina
city: Sioux Falls
country: United States
facility: Avera Cancer Institute
state: South Dakota
city: Chattanooga
country: United States
facility: Memorial Hospital
state: Tennessee
city: Hixson
country: United States
facility: Pulmonary Medicine Center of Chattanooga-Hixson
state: Tennessee
city: Ooltewah
country: United States
facility: Memorial GYN Plus
state: Tennessee
city: Amarillo
country: United States
facility: Texas Tech University Health Sciences Center-Amarillo
state: Texas
city: Dallas
country: United States
facility: Parkland Memorial Hospital
state: Texas
city: Dallas
country: United States
facility: UT Southwestern/Simmons Cancer Center-Dallas
state: Texas
city: Houston
country: United States
facility: M. D. Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital System
state: Texas
city: Laredo
country: United States
facility: Doctor's Hospital of Laredo
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute/University of Utah
state: Utah
city: Berlin
country: United States
facility: Central Vermont Medical Center
state: Vermont
city: Burlington
country: United States
facility: University of Vermont College of Medicine
state: Vermont
city: Saint Johnsbury
country: United States
facility: Norris Cotton Cancer Center-North
state: Vermont
city: Fredericksburg
country: United States
facility: Mary Washington Hospital
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University/Massey Cancer Center
state: Virginia
city: Bremerton
country: United States
facility: Harrison HealthPartners Hematology and Oncology-Bremerton
state: Washington
city: Bremerton
country: United States
facility: Harrison Medical Center
state: Washington
city: Burien
country: United States
facility: Highline Medical Center-Main Campus
state: Washington
city: Enumclaw
country: United States
facility: Saint Elizabeth Hospital
state: Washington
city: Federal Way
country: United States
facility: Saint Francis Hospital
state: Washington
city: Lakewood
country: United States
facility: Saint Clare Hospital
state: Washington
city: Poulsbo
country: United States
facility: Harrison HealthPartners Hematology and Oncology-Poulsbo
state: Washington
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Tacoma
country: United States
facility: Franciscan Research Center-Northwest Medical Plaza
state: Washington
city: Tacoma
country: United States
facility: Northwest Medical Specialties PLLC
state: Washington
city: Green Bay
country: United States
facility: Green Bay Oncology at Saint Vincent Hospital
state: Wisconsin
city: Green Bay
country: United States
facility: Saint Vincent Hospital
state: Wisconsin
city: Green Bay
country: United States
facility: Green Bay Oncology Limited at Saint Mary's Hospital
state: Wisconsin
city: Green Bay
country: United States
facility: Saint Mary's Hospital
state: Wisconsin
city: Green Bay
country: United States
facility: Aurora BayCare Medical Center
state: Wisconsin
city: La Crosse
country: United States
facility: Gundersen Lutheran Medical Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora Saint Luke's Medical Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Froedtert and the Medical College of Wisconsin
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora Sinai Medical Center
state: Wisconsin
city: New Richmond
country: United States
facility: Westfields Hospital/Cancer Center of Western Wisconsin
state: Wisconsin
city: Oshkosh
country: United States
facility: Vince Lombardi Cancer Clinic-Oshkosh
state: Wisconsin
city: Summit
country: United States
facility: Aurora Medical Center in Summit
state: Wisconsin
city: West Allis
country: United States
facility: Aurora West Allis Medical Center
state: Wisconsin
city: Cody
country: United States
facility: Big Horn Basin Cancer Center
state: Wyoming
city: Cody
country: United States
facility: Billings Clinic-Cody
state: Wyoming
city: Sheridan
country: United States
facility: Welch Cancer Center
state: Wyoming
Study officials:
affiliation: Mayo Clinic
name: Judy Boughey, MD
role: STUDY_CHAIR
References:
citation: Cuttino LW, McCall L, Kubicky C, Ballman KV, Le-Petross H, Hunt KK, Haffty B, Rosenkranz KM, Boughey JC. The Feasibility of Radiation Therapy after Breast-Conserving Surgery for Multiple Ipsilateral Breast Cancer: An Initial Report from ACOSOG Z11102 (Alliance) Trial. Int J Radiat Oncol Biol Phys. 2022 Mar 1;112(3):636-642. doi: 10.1016/j.ijrobp.2021.09.054. Epub 2021 Oct 8.
citation: Rosenkranz KM, Ballman K, McCall L, McCarthy C, Kubicky CD, Cuttino L, Hunt KK, Giuliano A, Van Zee KJ, Haffty B, Boughey JC. Cosmetic Outcomes Following Breast-Conservation Surgery and Radiation for Multiple Ipsilateral Breast Cancer: Data from the Alliance Z11102 Study. Ann Surg Oncol. 2020 Nov;27(12):4650-4661. doi: 10.1245/s10434-020-08893-w. Epub 2020 Jul 22.
citation: Rosenkranz KM, Ballman K, McCall L, Kubicky C, Cuttino L, Le-Petross H, Hunt KK, Giuliano A, Van Zee KJ, Haffty B, Boughey JC. The Feasibility of Breast-Conserving Surgery for Multiple Ipsilateral Breast Cancer: An Initial Report from ACOSOG Z11102 (Alliance) Trial. Ann Surg Oncol. 2018 Oct;25(10):2858-2866. doi: 10.1245/s10434-018-6583-6. Epub 2018 Jul 9.