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

NCT ID: NCT01556243

Last Updated: 2023-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2023-04-15

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

therapeutic conventional surgery

Intervention Type: PROCEDURE

whole breast irradiation

Intervention Type: RADIATION

Interventions

therapeutic conventional surgery

Intervention Type: PROCEDURE

whole breast irradiation

Intervention Type: RADIATION

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Judy Boughey, MD

Role: STUDY_CHAIR

Mayo Clinic

Locations

CHI Saint Vincent Cancer Center Hot Springs

Hot Springs, Arkansas, United States

Epic Care-Dublin

Dublin, California, United States

Bay Area Breast Surgeons, Incorporated

Emeryville, California, United States

Epic Care Partners in Cancer Care

Emeryville, California, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Contra Costa Regional Medical Center

Martinez, California, United States

Alta Bates Summit Medical Center-Summit Campus

Oakland, California, United States

Bay Area Tumor Institute

Oakland, California, United States

Stanford Cancer Institute

Palo Alto, California, United States

Naval Medical Center-San Diego

San Diego, California, United States

University of Colorado Cancer Center-Anschutz Cancer Pavilion

Aurora, Colorado, United States

Catholic Health Initiatives NCORP

Englewood, Colorado, United States

Smilow Cancer Hospital Care Center at Saint Francis

Hartford, Connecticut, United States

Beebe Medical Center

Lewes, 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

Medical Oncology Hematology Consultants PA

Newark, Delaware, United States

Regional Hematology and Oncology PA

Newark, Delaware, United States

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

Beebe Health Campus

Rehoboth Beach, Delaware, United States

Nanticoke Memorial Hospital

Seaford, Delaware, United States

Christiana Care Health System-Wilmington Hospital

Wilmington, Delaware, United States

Morton Plant Hospital

Clearwater, Florida, 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

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Savannah, Georgia, United States

Oncare Hawaii Inc-POB II

Honolulu, Hawaii, United States

Queen's Medical Center

Honolulu, Hawaii, United States

Straub Clinic and Hospital

Honolulu, Hawaii, United States

University of Hawaii Cancer Center

Honolulu, Hawaii, United States

Kuakini Medical Center

Honolulu, Hawaii, United States

OnCare Hawaii, Incorporated-Kuakini

Honolulu, Hawaii, United States

OnCare Hawaii-Liliha

Honolulu, Hawaii, United States

The Cancer Center of Hawaii-Liliha

Honolulu, Hawaii, United States

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, United States

Wilcox Memorial Hospital and Kauai Medical Clinic

Lihue, Hawaii, 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

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, United States

Kootenai Medical Center

Coeur d'Alene, Idaho, United States

Kootenai Cancer Center

Post Falls, Idaho, United States

Kootenai Cancer Clinic

Sandpoint, Idaho, United States

Saint Joseph Medical Center

Bloomington, Illinois, United States

Illinois CancerCare-Bloomington

Bloomington, Illinois, United States

Illinois CancerCare-Canton

Canton, Illinois, United States

Memorial Hospital of Carbondale

Carbondale, Illinois, United States

Illinois CancerCare-Carthage

Carthage, Illinois, United States

Centralia Oncology Clinic

Centralia, Illinois, United States

University of Illinois

Chicago, Illinois, United States

Cancer Care Specialists of Central Illinois

Decatur, Illinois, United States

Decatur Memorial Hospital

Decatur, Illinois, United States

Crossroads Cancer Center

Effingham, Illinois, United States

Illinois CancerCare-Eureka

Eureka, Illinois, United States

Illinois CancerCare-Galesburg

Galesburg, Illinois, United States

Western Illinois Cancer Treatment Center

Galesburg, Illinois, United States

Ingalls Memorial Hospital

Harvey, Illinois, United States

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, United States

Illinois CancerCare-Macomb

Macomb, Illinois, United States

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, United States

Radiation Oncology of Northern Illinois

Ottawa, Illinois, United States

OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center

Pekin, Illinois, United States

Illinois CancerCare-Pekin

Pekin, Illinois, United States

Methodist Medical Center of Illinois

Peoria, Illinois, United States

Illinois CancerCare-Peoria

Peoria, Illinois, United States

OSF Saint Francis Radiation Oncology at Peoria Cancer Center

Peoria, Illinois, United States

OSF Saint Francis Medical Center

Peoria, Illinois, United States

Illinois CancerCare-Peru

Peru, Illinois, United States

Valley Radiation Oncology

Peru, Illinois, United States

Illinois CancerCare-Princeton

Princeton, Illinois, United States

Central Illinois Hematology Oncology Center

Springfield, Illinois, United States

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Springfield Clinic

Springfield, Illinois, United States

Memorial Medical Center

Springfield, Illinois, United States

Cancer Care Specialists of Illinois-Swansea

Swansea, Illinois, United States

IU Health West Hospital

Avon, Indiana, United States

IU Health North Hospital

Carmel, Indiana, United States

IU Health Central Indiana Cancer Centers-Fishers

Fishers, Indiana, 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

Memorial Regional Cancer Center-Day Road

Mishawaka, Indiana, United States

Saint Joseph Regional Medical Center-Mishawaka

Mishawaka, Indiana, United States

Memorial Hospital of South Bend

South Bend, Indiana, United States

Michiana Hematology Oncology PC-South Bend

South Bend, Indiana, United States

Mary Greeley Medical Center

Ames, Iowa, United States

McFarland Clinic PC-William R Bliss Cancer Center

Ames, Iowa, United States

McFarland Clinic PC-Boone

Boone, Iowa, United States

Medical Oncology and Hematology Associates-West Des Moines

Clive, Iowa, United States

Mercy Cancer Center-West Lakes

Clive, Iowa, United States

Alegent Health Mercy Hospital

Council Bluffs, Iowa, United States

Greater Regional Medical Center

Creston, 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

Iowa Lutheran Hospital

Des Moines, Iowa, United States

McFarland Clinic PC-Trinity Cancer Center

Fort Dodge, Iowa, United States

McFarland Clinic PC-Jefferson

Jefferson, Iowa, United States

McFarland Clinic PC-Marshalltown

Marshalltown, Iowa, United States

Mercy Medical Center-West Lakes

West Des Moines, Iowa, United States

Methodist West Hospital

West Des Moines, Iowa, United States

Menorah Medical Center

Overland Park, Kansas, United States

Saint Luke's South Hospital

Overland Park, Kansas, United States

Kansas City NCI Community Oncology Research Program

Prairie Village, Kansas, United States

Flaget Memorial Hospital

Bardstown, Kentucky, United States

Commonwealth Cancer Center-Corbin

Corbin, Kentucky, United States

Saint Elizabeth Medical Center South

Edgewood, Kentucky, United States

Saint Elizabeth-Fort Thomas

Fort Thomas, Kentucky, United States

Saint Joseph Radiation Oncology Resource Center

Lexington, Kentucky, United States

Saint Joseph Hospital East

Lexington, Kentucky, United States

Jewish Hospital

Louisville, Kentucky, United States

The James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, United States

Saints Mary and Elizabeth Hospital

Louisville, Kentucky, United States

Jewish Hospital Medical Center Northeast

Louisville, Kentucky, United States

Jewish Hospital Medical Center South

Shepherdsville, Kentucky, United States

Eastern Maine Medical Center

Bangor, Maine, United States

Eastern Maine Medical Center Cancer Care

Brewer, Maine, United States

Sinai Hospital of Baltimore

Baltimore, Maryland, United States

Saint Agnes Hospital

Baltimore, Maryland, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Dana-Farber/Brigham and Women's Cancer Center at South Shore

South Weymouth, Massachusetts, United States

Saint Joseph Mercy Hospital

Ann Arbor, Michigan, United States

Bronson Battle Creek

Battle Creek, Michigan, United States

Oakwood Hospital and Medical Center

Dearborn, Michigan, United States

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, United States

Saint John Hospital and Medical Center

Detroit, Michigan, United States

Genesys Hurley Cancer Institute

Flint, Michigan, United States

Hurley Medical Center

Flint, Michigan, United States

Mercy Health Saint Mary's

Grand Rapids, Michigan, United States

Spectrum Health at Butterworth Campus

Grand Rapids, Michigan, United States

Allegiance Health

Jackson, Michigan, United States

Borgess Medical Center

Kalamazoo, Michigan, United States

Bronson Methodist Hospital

Kalamazoo, Michigan, United States

West Michigan Cancer Center

Kalamazoo, Michigan, United States

Sparrow Hospital

Lansing, Michigan, United States

Saint Mary Mercy Hospital

Livonia, Michigan, United States

Mercy Health Mercy Campus

Muskegon, Michigan, United States

Saint Joseph Mercy Oakland

Pontiac, Michigan, United States

William Beaumont Hospital-Royal Oak

Royal Oak, Michigan, United States

Saint Mary's of Michigan

Saginaw, Michigan, United States

Munson Medical Center

Traverse City, Michigan, United States

William Beaumont Hospital-Troy

Troy, Michigan, United States

Saint John Macomb-Oakland Hospital

Warren, Michigan, United States

Fairview Ridges Hospital

Burnsville, Minnesota, United States

Mercy Hospital

Coon Rapids, Minnesota, United States

Fairview-Southdale Hospital

Edina, Minnesota, United States

Unity Hospital

Fridley, Minnesota, United States

Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, United States

Saint John's Hospital-Healtheast

Maplewood, Minnesota, United States

Abbott-Northwestern Hospital

Minneapolis, Minnesota, United States

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Health Partners Inc

Minneapolis, Minnesota, United States

New Ulm Medical Center

New Ulm, Minnesota, United States

North Memorial Medical Health Center

Robbinsdale, Minnesota, United States

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

Coborn Cancer Center at Saint Cloud Hospital

Saint Cloud, Minnesota, United States

Saint Cloud Hospital

Saint Cloud, Minnesota, 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

Saint Francis Regional Medical Center

Shakopee, Minnesota, United States

Lakeview Hospital

Stillwater, Minnesota, United States

Ridgeview Medical Center

Waconia, Minnesota, United States

Rice Memorial Hospital

Willmar, Minnesota, United States

Minnesota Oncology and Hematology PA-Woodbury

Woodbury, Minnesota, United States

Parkland Health Center-Bonne Terre

Bonne Terre, Missouri, United States

Saint Francis Medical Center

Cape Girardeau, Missouri, United States

Southeast Cancer Center

Cape Girardeau, Missouri, United States

Centerpoint Medical Center LLC

Independence, Missouri, United States

Capital Region Medical Center-Goldschmidt Cancer Center

Jefferson City, Missouri, United States

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, United States

Heartland Hematology and Oncology Associates Incorporated

Kansas City, Missouri, United States

Research Medical Center

Kansas City, Missouri, United States

Saint Luke's East-Lee's Summit

Lee's Summit, Missouri, United States

Liberty Radiation Oncology Center

Liberty, Missouri, United States

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Missouri Baptist Medical Center

St Louis, Missouri, United States

Missouri Baptist Sullivan Hospital

Sullivan, Missouri, United States

Missouri Baptist Outpatient Center-Sunset Hills

Sunset Hills, Missouri, United States

Montana Cancer Consortium NCORP

Billings, Montana, United States

Saint Vincent Healthcare

Billings, Montana, United States

Billings Clinic Cancer Center

Billings, Montana, United States

Bozeman Deaconess Hospital

Bozeman, Montana, United States

Saint James Community Hospital and Cancer Treatment Center

Butte, Montana, United States

Benefis Healthcare-Sletten Cancer Institute

Great Falls, Montana, United States

Saint Peter's Community Hospital

Helena, Montana, United States

Kalispell Regional Medical Center

Kalispell, Montana, United States

Community Medical Hospital

Missoula, Montana, United States

Saint Patrick Hospital-Community Hospital

Missoula, Montana, United States

CHI Health Saint Francis

Grand Island, Nebraska, United States

Heartland Hematology and Oncology

Kearney, Nebraska, United States

CHI Health Good Samaritan

Kearney, Nebraska, United States

Saint Elizabeth Regional Medical Center

Lincoln, Nebraska, United States

Alegent Health Immanuel Medical Center

Omaha, Nebraska, United States

Hematology and Oncology Consultants PC

Omaha, Nebraska, United States

Alegent Health Bergan Mercy Medical Center

Omaha, Nebraska, United States

Alegent Health Lakeside Hospital

Omaha, Nebraska, United States

Creighton University Medical Center

Omaha, Nebraska, United States

Midlands Community Hospital

Papillion, Nebraska, United States

Cancer and Blood Specialists-Henderson

Henderson, Nevada, United States

Comprehensive Cancer Centers of Nevada-Henderson

Henderson, Nevada, United States

Las Vegas Cancer Center-Henderson

Henderson, Nevada, United States

21st Century Oncology-Henderson

Henderson, Nevada, United States

Comprehensive Cancer Centers of Nevada-Southeast Henderson

Henderson, Nevada, United States

University Medical Center of Southern Nevada

Las Vegas, Nevada, United States

Cancer and Blood Specialists-Shadow

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

21st Century Oncology-Fort Apache

Las Vegas, Nevada, United States

21st Century Oncology

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

Radiation Oncology Centers of Nevada Southeast

Las Vegas, Nevada, United States

Cancer Therapy and Integrative Medicine

Las Vegas, Nevada, United States

21st Century Oncology-Vegas Tenaya

Las Vegas, Nevada, United States

Cancer and Blood Specialists-Tenaya

Las Vegas, Nevada, United States

Comprehensive Cancer Centers of Nevada-Northwest

Las Vegas, Nevada, United States

HealthCare Partners Medical Group Oncology/Hematology-Tenaya

Las Vegas, Nevada, United States

Comprehensive Cancer Centers of Nevada-Summerlin

Las Vegas, Nevada, United States

Cancer and Blood Specialists-Fort Apache

Las Vegas, Nevada, United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

Las Vegas Cancer Center-Medical Center

Las Vegas, Nevada, United States

HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills

Las Vegas, Nevada, United States

Comprehensive Cancer Centers of Nevada-Central Valley

Las Vegas, Nevada, United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Memorial Sloan Kettering Cancer Center-Basking Ridge

Basking Ridge, New Jersey, United States

Saint Peter's University Hospital

New Brunswick, New Jersey, United States

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Lovelace Women's Hospital

Albuquerque, New Mexico, United States

Memorial Sloan Kettering Cancer Center-Commack

Commack, New York, United States

Memorial Sloan Kettering Cancer Center-West Harrison

Harrison, New York, United States

North Shore University Hospital

Manhasset, New York, United States

North Shore-LIJ Health System/Center for Advanced Medicine

New Hyde Park, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Vassar Brothers Medical Center

Poughkeepsie, New York, United States

University of Rochester

Rochester, New York, United States

Memorial Sloan Kettering Cancer Center-Rockville Centre

Rockville Centre, New York, United States

Memorial Sloan Kettering Cancer Center-Sleepy Hollow

Sleepy Hollow, New York, United States

Randolph Hospital

Asheboro, North Carolina, United States

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, United States

Levine Cancer Institute-Tryon

Charlotte, North Carolina, United States

Novant Health Presbyterian Medical Center

Charlotte, North Carolina, United States

Carolina Surgical Clinic of Charlotte PA

Charlotte, North Carolina, United States

Oncology Specialists of Charlotte

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

Southern Oncology Specialists-Charlotte

Charlotte, North Carolina, United States

Levine Cancer Institute-Ballantyne

Charlotte, North Carolina, United States

CaroMont Breast Surgical Specialists-Gastonia

Gastonia, North Carolina, United States

CaroMont Regional Medical Center

Gastonia, North Carolina, United States

Cone Health Cancer Center

Greensboro, North Carolina, United States

Lake Norman Hematology Oncology Specialists-Huntersville

Huntersville, North Carolina, United States

Southern Oncology Specialists-Huntersville

Huntersville, North Carolina, United States

Matthews Radiation Oncology Center

Matthews, North Carolina, United States

Novant Health Cancer Specialists-Matthews

Matthews, North Carolina, United States

Carolinas HealthCare System Union

Monroe, North Carolina, United States

Lake Norman Hematology Oncology Specialists-Mooresville

Mooresville, North Carolina, United States

Annie Penn Memorial Hospital

Reidsville, North Carolina, United States

Strecker Cancer Center-Belpre

Belpre, Ohio, United States

Adena Regional Medical Center

Chillicothe, Ohio, United States

The Christ Hospital

Cincinnati, Ohio, United States

Good Samaritan Hospital-Cincinnati

Cincinnati, Ohio, United States

Bethesda North Hospital

Cincinnati, Ohio, United States

TriHealth Cancer Institute-Westside

Cincinnati, Ohio, United States

TriHealth Cancer Institute-Anderson

Cincinnati, Ohio, United States

University of Cincinnati

Cincinnati, Ohio, United States

Mount Carmel East Hospital

Columbus, Ohio, United States

Columbus Oncology and Hematology Associates Inc

Columbus, Ohio, United States

Riverside Methodist Hospital

Columbus, Ohio, United States

Columbus NCI Community Oncology Research Program

Columbus, Ohio, United States

Grant Medical Center

Columbus, Ohio, United States

The Mark H Zangmeister Center

Columbus, Ohio, United States

Mount Carmel Health Center West

Columbus, Ohio, United States

Doctors Hospital

Columbus, Ohio, 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

Fairfield Medical Center

Lancaster, Ohio, United States

OhioHealth MedCentral Hospital

Mansfield, Ohio, United States

Marietta Memorial Hospital

Marietta, Ohio, United States

OhioHealth Marion General Hospital

Marion, Ohio, United States

Knox Community Hospital

Mount Vernon, Ohio, United States

Licking Memorial Hospital

Newark, Ohio, United States

Newark Radiation Oncology

Newark, Ohio, United States

Southern Ohio Medical Center

Portsmouth, Ohio, United States

Springfield Regional Medical Center

Springfield, Ohio, United States

University Pointe

West Chester, Ohio, United States

Saint Ann's Hospital

Westerville, Ohio, United States

Genesis Healthcare System Cancer Care Center

Zanesville, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Mercy Hospital Oklahoma City

Oklahoma City, Oklahoma, United States

Oregon Health and Science University

Portland, Oregon, United States

Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, United States

Lehigh Valley Hospital-Muhlenberg

Bethlehem, Pennsylvania, United States

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, United States

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States

Lankenau Medical Center

Wynnewood, Pennsylvania, United States

Roger Williams Medical Center

Providence, Rhode Island, United States

Hilton Head Regional Medical Center

Hilton Head Island, South Carolina, United States

Levine Cancer Institute-Rock Hill

Rock Hill, South Carolina, United States

Lexington Medical Center

West Columbia, South Carolina, United States

Avera Cancer Institute

Sioux Falls, South Dakota, United States

Memorial Hospital

Chattanooga, Tennessee, United States

Pulmonary Medicine Center of Chattanooga-Hixson

Hixson, Tennessee, United States

Memorial GYN Plus

Ooltewah, Tennessee, United States

Texas Tech University Health Sciences Center-Amarillo

Amarillo, Texas, United States

Parkland Memorial Hospital

Dallas, Texas, United States

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, United States

M. D. Anderson Cancer Center

Houston, Texas, United States

The Methodist Hospital System

Houston, Texas, United States

Doctor's Hospital of Laredo

Laredo, Texas, United States

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States

Central Vermont Medical Center

Berlin Corners, Vermont, United States

University of Vermont College of Medicine

Burlington, Vermont, United States

Norris Cotton Cancer Center-North

Saint Johnsbury, Vermont, United States

Mary Washington Hospital

Fredericksburg, Virginia, United States

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, United States

Harrison HealthPartners Hematology and Oncology-Bremerton

Bremerton, Washington, United States

Harrison Medical Center

Bremerton, Washington, United States

Highline Medical Center-Main Campus

Burien, Washington, United States

Saint Elizabeth Hospital

Enumclaw, Washington, United States

Saint Francis Hospital

Federal Way, Washington, United States

Saint Clare Hospital

Lakewood, Washington, United States

Harrison HealthPartners Hematology and Oncology-Poulsbo

Poulsbo, Washington, United States

Virginia Mason Medical Center

Seattle, Washington, United States

Franciscan Research Center-Northwest Medical Plaza

Tacoma, Washington, United States

Northwest Medical Specialties PLLC

Tacoma, Washington, United States

Green Bay Oncology at Saint Vincent Hospital

Green Bay, Wisconsin, United States

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

Aurora BayCare Medical Center

Green Bay, Wisconsin, United States

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, United States

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, United States

Froedtert and the Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Aurora Sinai Medical Center

Milwaukee, Wisconsin, United States

Westfields Hospital/Cancer Center of Western Wisconsin

New Richmond, Wisconsin, United States

Vince Lombardi Cancer Clinic-Oshkosh

Oshkosh, Wisconsin, United States

Aurora Medical Center in Summit

Summit, Wisconsin, United States

Aurora West Allis Medical Center

West Allis, Wisconsin, United States

Big Horn Basin Cancer Center

Cody, Wyoming, United States

Billings Clinic-Cody

Cody, Wyoming, United States

Welch Cancer Center

Sheridan, Wyoming, United States

Countries

United States

References

Boughey JC, Rosenkranz KM, Ballman KV, McCall L, Haffty BG, Cuttino LW, Kubicky CD, Le-Petross HT, Giuliano AE, Van Zee KJ, Hunt KK, Hahn OM, Carey LA, Partridge AH. Local Recurrence After Breast-Conserving Therapy in Patients With Multiple Ipsilateral Breast Cancer: Results From ACOSOG Z11102 (Alliance). J Clin Oncol. 2023 Jun 10;41(17):3184-3193. doi: 10.1200/JCO.22.02553. Epub 2023 Mar 28.

Reference Type: DERIVED

PMID: 36977292 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34634438 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32699926 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29987605 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

ACOSOG-Z11102

Identifier Type: -

Identifier Source: secondary_id

CDR0000728605

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2012-00707

Identifier Type: REGISTRY

Identifier Source: secondary_id

ACOSOG-Z11102

Identifier Type: -

Identifier Source: org_study_id