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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIBiomarker/Laboratory analysis, TreatmentActive40 and overNCI, OtherCDR0000728605
ACOSOG-Z11102, Z11102, NCT01556243

Trial Description

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

Further Study Information

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 patient's perception of cosmesis and incidence of breast lymphedema.
  • To examine the type and severity of adverse effects of BCS and radiation for women with MIBC.
  • To examine the radiation-related side effects of whole-breast radiation with a boost to 1 large or > 1 lumpectomy site.
  • To evaluate protein and gene expression patterns in tissue taken from each breast lesion and to evaluate the concordance of the findings between these lesions.
  • To compare the extent of disease described on imaging (mammography, bilateral breast magnetic resonance imaging [MRI] and other adjunctive imaging modalities) with surgical findings.

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.

Within 6-10 weeks after surgery or 8 weeks after completion of cytotoxic chemotherapy, patients undergo adjuvant whole-breast irradiation (WBI) with a boost to the lumpectomy bed of each site of disease 5 days a week for approximately 6 weeks.

Patients complete the Breast-Conserving Therapy Module (BREAST-Q© subscales) questionnaire 5-30 days after surgery and every 6 months for the first 2 years and the yearly for the next 3 years after WBI. Patients' surgeons also complete the questionnaire 5-30 days after performing final surgery to assess cosmetic outcomes.

Formalin-fixed paraffin-embedded (FFPE) tissue block from each site of disease are collected during BCS for protein and gene expression pattern studies. Blood samples may be also collected at baseline and during BCS.

After completion of study treatment, patients are followed up every 6 months for 2 years and then yearly for years 3-5.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Upon clinical exam and pre-operative imaging by MRI and mammogram both, two or three foci of biopsy-proven breast cancer separated by ≥ 3 cm of normal breast tissue on clinical exam and preoperative imaging; 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-positive breast cancer
  • Ultrasound cannot be used to determine patient eligibility; eligibility to be determined by bilateral mammogram and MRI only
  • Bilateral mammogram ≤ 60 days prior to registration
  • Bilateral breast MRI ≤ 45 days prior to registration
  • cN0 or cN1 disease
  • No cNX, cN2, or cN3 disease
  • Willing to provide tissue samples for correlative research purposes
  • Largest single focus of disease > 5 cm by either mammogram or MRI or both (measurement of the largest single focus should include any satellite lesions within 1 cm of the index lesion)
  • No clinical or radiographic evidence of metastatic disease
  • No prior or current lobular carcinoma in situ (LCIS), DCIS, or invasive breast cancer in the opposite breast (i.e., bilateral disease is not allowed)
  • No patients with known BRCA mutations

PATIENT CHARACTERISTICS:

  • 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)
  • Men are excluded from this study
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
  • Hemoglobin (Hgb) ≥ 8 g/dL
  • Peripheral platelet count (PLT) ≥ 50,000/mm³
  • Ability to complete questionnaire(s) by themselves or with assistance
  • Willing to return to enrolling institution for follow-up during the Active Monitoring Phase (the active treatment and observation portions) of the study
  • Negative serum or urine pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only
  • None of the following:
  • Pregnant women
  • Nursing women
  • Women of childbearing potential who are unwilling to employ adequate contraception (as determined by the treating physician)
  • No 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, or scleroderma)
  • No 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
  • No other active malignancy ≤ 5 years prior to registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix
  • If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer

PRIOR CONCURRENT THERAPY:

  • No surgical axillary staging procedure prior to study entry
  • Fine-needle aspiration (FNA) or core-needle biopsy of axillary node is permitted
  • No breast implants at time of diagnosis
  • Patients who have had implants previously removed prior to diagnosis are eligible
  • No treatment including radiation therapy, chemotherapy, biotherapy, or hormonal therapy for this cancer prior to registration
  • No neoadjuvant endocrine therapy or neoadjuvant hormonal therapy
  • No planned partial-breast radiation
  • No administration of any investigational agent ≤ 30 days prior to registration

Trial Contact Information

Trial Lead Organizations/Sponsors

American College of Surgeons

National Cancer Institute

Judy BougheyStudy Chair

Trial Sites

U.S.A.
California
  Castro Valley
 East Bay Radiation Oncology Center
 James H. Feusner Ph: 510-450-7600
  LA Jolla
 Rebecca and John Moores UCSD Cancer Center
 Sarah L Blair Ph: 858-822-5354
  Email: cancercto@ucsd.edu
  Los Angeles
 Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
 Armando E Giuliano Ph: 310-423-8965
  Martinez
 Contra Costa Regional Medical Center
 James H. Feusner Ph: 510-450-7600
  Mountain View
 El Camino Hospital Cancer Center
 James H. Feusner Ph: 510-450-7600
  Oakland
 Alta Bates Summit Medical Center - Summit Campus
 James H. Feusner Ph: 510-450-7600
 Bay Area Breast Surgeons, Incorporated
 James H. Feusner Ph: 510-450-7600
 CCOP - Bay Area Tumor Institute
 James H. Feusner Ph: 510-450-7600
 Larry G Strieff MD Medical Corporation
 James H. Feusner Ph: 510-450-7600
  San Diego
 Sharp Memorial Hospital Cancer Center
 Robert M. Barone Ph: 858-939-5015
  San Pablo
 Doctors Medical Center - San Pablo Campus
 James H. Feusner Ph: 510-450-7600
Delaware
  Lewes
 Tunnell Cancer Center at Beebe Medical Center
 Diana Dickson-Witmer Ph: 302-733-6227
  Newark
 Helen F. Graham Cancer Center at Christiana Hospital
 Diana Dickson-Witmer Ph: 302-733-6227
Florida
  Clearwater
 Morton Plant Hospital
 Peter William Blumencranz Ph: 727-461-8519
  Fort Lauderdale
 Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
 Michael Schwartz Ph: 305-674-2625
  Email: info@msccop.com
  Jupiter
 Ella Milbank Foshay Cancer Center at Jupiter Medical Center
 Michael Schwartz Ph: 305-674-2625
  Email: info@msccop.com
  Miami Beach
 CCOP - Mount Sinai Medical Center
 Michael Schwartz Ph: 305-674-2625
  Email: info@msccop.com
Georgia
  Decatur
 Charles B. Eberhart Cancer Center at DeKalb Medical Center
 John S. Kennedy Ph: 404-501-3279
Hawaii
  Aiea
 Kapiolani Medical Center at Pali Momi
 Jeffrey L. Berenberg Ph: 808-586-2979
 Jeffrey L. Berenberg Ph: 808-586-2979
  Honolulu
 Cancer Research Center of Hawaii
 Jeffrey L. Berenberg Ph: 808-586-2979
 Kapiolani Medical Center for Women and Children
 Jeffrey L. Berenberg Ph: 808-586-2979
 OnCare Hawaii, Incorporated - Kuakini
 Jeffrey L. Berenberg Ph: 808-586-2979
 Jeffrey L. Berenberg Ph: 808-586-2979
 OnCare Hawaii, Incorporated - Lusitana
 Jeffrey L. Berenberg Ph: 808-586-2979
 Queen's Cancer Institute at Queen's Medical Center
 Jeffrey L. Berenberg Ph: 808-586-2979
 Straub Clinic and Hospital, Incorporated
 Jeffrey L. Berenberg Ph: 808-586-2979
  Kailua
 Castle Medical Center
 Jeffrey L. Berenberg Ph: 808-586-2979
  Lihue
 Kauai Medical Clinic
 Jeffrey L. Berenberg Ph: 808-586-2979
Illinois
  Chicago
 Resurrection Medical Center
 Rabia Z Bhatti Ph: 773-792-5116
  Harvey
 Ingalls Cancer Care Center at Ingalls Memorial Hospital
 Mark F. Kozloff Ph: 708-915-4673
  Email: clinicaltrials@ingalls.org
Indiana
  Avon
 Clarian West Medical Center
 Linda K Han Ph: 317-274-2552
  Carmel
 IU Health North Hospital
 Linda K Han Ph: 317-274-2552
  Elkhart
 Elkhart Clinic, LLC
 Robin Zon Ph: 574-234-5123
 Elkhart General Hospital
 Robin Zon Ph: 574-234-5123
 Michiana Hematology-Oncology, PC - Elkhart
 Robin Zon Ph: 574-234-5123
  Indianapolis
 Indiana University Melvin and Bren Simon Cancer Center
 Linda K Han Ph: 317-274-2552
 Methodist Cancer Center at Methodist Hospital
 Linda K Han Ph: 317-274-2552
 William N. Wishard Memorial Hospital
 Linda K Han Ph: 317-274-2552
  Kokomo
 Community Cancer Care at Howard Regional Health System
 Robin Zon Ph: 574-234-5123
  La Porte
 Center for Cancer Therapy at LaPorte Hospital and Health Services
 Robin Zon Ph: 574-234-5123
  Mishawaka
 Michiana Hematology-Oncology, PC - Mishawaka
 Robin Zon Ph: 574-234-5123
 Saint Joseph's Medical Center
 Robin Zon Ph: 574-234-5123
  Plymouth
 Michiana Hematology Oncology PC - Plymouth
 Robin Zon Ph: 574-234-5123
  South Bend
 CCOP - Northern Indiana CR Consortium
 Robin Zon Ph: 574-234-5123
 Memorial Hospital of South Bend
 Robin Zon Ph: 574-234-5123
 Michiana Hematology-Oncology, PC - South Bend
 Robin Zon Ph: 574-234-5123
  Westville
 Michiana Hematology Oncology-PC Westville
 Robin Zon Ph: 574-234-5123
Iowa
  Ames
 McFarland Clinic, PC
 Joseph James Merchant Ph: 515-239-2621
  Clive
 Medical Oncology and Hematology Associates-West Des Moines
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 Mercy Cancer Center - West Lakes
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
  Des Moines
 CCOP - Iowa Oncology Research Association
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 John Stoddard Cancer Center at Iowa Lutheran Hospital
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 John Stoddard Cancer Center at Iowa Methodist Medical Center
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 Medical Oncology and Hematology Associates at John Stoddard Cancer Center
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 Medical Oncology and Hematology Associates at Mercy Cancer Center
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 Mercy Cancer Center at Mercy Medical Center - Des Moines
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
  West Des Moines
 Methodist West Hospital
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
Kansas
  Overland Park
 Menorah Medical Center
 Rakesh Gaur Ph: 913-948-5588
  Email: amy.krushelniski@hcahealthcare.com
 Saint Luke's Hospital - South
 Rakesh Gaur Ph: 913-948-5588
  Email: amy.krushelniski@hcahealthcare.com
  Prairie Village
 CCOP - Kansas City
 Rakesh Gaur Ph: 913-948-5588
  Email: amy.krushelniski@hcahealthcare.com
Kentucky
  Edgewood
 St. Elizabeth Medical Center
 Joseph Michael Guenther Ph: 859-301-5473
  Email: darla.hehman@stelizabeth.com
Maryland
  Elkton MD
 Union Hospital of Cecil County
 Diana Dickson-Witmer Ph: 302-733-6227
Michigan
  Saint Joseph
 Lakeside Cancer Specialists, PLLC
 Robin Zon Ph: 574-234-5123
  St. Joseph
 Lakeland Regional Cancer Care Center - St. Joseph
 Robin Zon Ph: 574-234-5123
Minnesota
  Bemidji
 MeritCare Bemidji
 Preston D. Steen Ph: 701-234-6161
  Duluth
 CCOP - Duluth
 Daniel Nikcevich Ph: 888-203-7267
 Essentia Health - Duluth Clinic
 Daniel Nikcevich Ph: 888-203-7267
 Miller - Dwan Medical Center
 Daniel Nikcevich Ph: 888-203-7267
  Rochester
 Mayo Clinic Cancer Center
 Judy C Boughey Ph: 507-538-7623
  Saint Cloud
 CentraCare Clinic - Women and Children
 Donald J Jurgens Ph: 877-229-4907
  Email: coborncancercenter@centracare.com
 Coborn Cancer Center
 Donald J Jurgens Ph: 877-229-4907
  Email: coborncancercenter@centracare.com
Missouri
  Cape Girardeau
 Southeast Cancer Center
 Alan Philip Lyss Ph: 800-392-0936
  Jefferson City
 Goldschmidt Cancer Center
 Alan Philip Lyss Ph: 800-392-0936
  Kansas City
 Heartland Hematology Oncology Associates, Incorporated
 Rakesh Gaur Ph: 913-948-5588
  Email: amy.krushelniski@hcahealthcare.com
 North Kansas City Hospital
 Rakesh Gaur Ph: 913-948-5588
  Email: amy.krushelniski@hcahealthcare.com
 Research Medical Center
 Rakesh Gaur Ph: 913-948-5588
  Email: amy.krushelniski@hcahealthcare.com
 Saint Luke's Hospital
 Rakesh Gaur Ph: 913-948-5588
  Email: amy.krushelniski@hcahealthcare.com
  Lee's Summit
 Saint Luke's East - Lee's Summit
 Rakesh Gaur Ph: 913-948-5588
  Email: amy.krushelniski@hcahealthcare.com
  Saint Joseph
 Heartland Regional Medical Center
 Rakesh Gaur Ph: 913-948-5588
  Email: amy.krushelniski@hcahealthcare.com
 Saint Joseph Oncology, Incorporated
 Rakesh Gaur Ph: 913-948-5588
  Email: amy.krushelniski@hcahealthcare.com
  Saint Louis
 Missouri Baptist Cancer Center
 Alan Philip Lyss Ph: 800-392-0936
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
 Julie A Margenthaler Ph: 800-600-3606
  Email: info@siteman.wustl.edu
Montana
  Billings
 Billings Clinic Cancer Center - 801 N 29th Street
 Benjamin Thomas Marchello Ph: 800-648-6274
 CCOP - Montana Cancer Consortium
 Benjamin Thomas Marchello Ph: 800-648-6274
  Great Falls
 Benefis Sletten Cancer Institute
 Benjamin Thomas Marchello Ph: 800-648-6274
New Hampshire
  Lebanon
 Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
 Kari M Rosenkranz Ph: 800-639-6918
  Email: cancer.research.nurse@dartmouth.edu
New Jersey
  Camden
 Cancer Institute of New Jersey at Cooper University Hospital - Camden
 Diana Dickson-Witmer Ph: 302-733-6227
  New Brunswick
 Saint Peter's University Hospital
 Susan A McManus Ph: 732-745-8600ext6163
  Email: kcovert@saintpetersuh.com
New York
  New York
 Memorial Sloan-Kettering Cancer Center
 Kimberly J Van Zee Ph: 212-639-7202
  Poughkeepsie
 Dyson Center for Cancer Care at Vassar Brothers Medical Center
 Gregory J Zanieski Ph: 845-483-6483
North Carolina
  Chapel Hill
 Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
 Keith D Amos Ph: 877-668-0683
  Charlotte
 Presbyterian Cancer Center at Presbyterian Hospital
 Justin P Favaro Ph: 704-384-5369
  Winston-Salem
 Wake Forest University Comprehensive Cancer Center
 Edward A. Levine Ph: 336-713-6771
North Dakota
  Fargo
 Roger Maris Cancer Center at MeritCare Hospital
 Preston D. Steen Ph: 701-234-6161
 Preston D. Steen Ph: 701-234-6161
 Sanford Clinic North-Fargo
 Preston D. Steen Ph: 701-234-6161
Ohio
  Chillicothe
 Adena Regional Medical Center
 J. Philip Kuebler Ph: 614-566-3275
  Columbus
 CCOP - Columbus
 J. Philip Kuebler Ph: 614-566-3275
 Doctors Hospital at Ohio Health
 J. Philip Kuebler Ph: 614-566-3275
 Grant Medical Center Cancer Care
 J. Philip Kuebler Ph: 614-566-3275
 Mount Carmel Health - West Hospital
 J. Philip Kuebler Ph: 614-566-3275
 Riverside Methodist Hospital Cancer Care
 J. Philip Kuebler Ph: 614-566-3275
 Zangmeister Center
 J. Philip Kuebler Ph: 614-566-3275
  Delaware
 Grady Memorial Hospital
 J. Philip Kuebler Ph: 614-566-3275
  Marietta
 Strecker Cancer Center at Marietta Memorial Hospital
 J. Philip Kuebler Ph: 614-566-3275
  Newark
 Licking Memorial Cancer Care Program at Licking Memorial Hospital
 J. Philip Kuebler Ph: 614-566-3275
  Portsmouth
 Southern Ohio Medical Center Cancer Center
 J. Philip Kuebler Ph: 614-566-3275
  Springfield
 Community Hospital of Springfield and Clark County
 J. Philip Kuebler Ph: 614-566-3275
  Westerville
 Mount Carmel St. Ann's Cancer Center
 J. Philip Kuebler Ph: 614-566-3275
  Zanesville
 Genesis - Good Samaritan Hospital
 J. Philip Kuebler Ph: 614-566-3275
Oklahoma
  Oklahoma City
 Mercy Health Center
 Alan B Hollingsworth Ph: 405-752-3388
 Oklahoma University Cancer Institute
 William C Dooley Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
Oregon
  Portland
 Knight Cancer Institute at Oregon Health and Science University
 Charlotte D Kubicky Ph: 503-494-1080
  Email: trials@ohsu.edu
Pennsylvania
  Allentown
 Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
 Lori C Alfonse Ph: 610-402-2273
  Bryn Mawr
 Bryn Mawr Hospital
 Ned Z. Carp Ph: 866-225-5654
  Email: wellenbachj@mlhs.org
  Gettysburg
 Adams Cancer Center
 Thomas L. Bauer Ph: 877-441-7957
  Hanover
 Cherry Tree Cancer Center
 Thomas L. Bauer Ph: 877-441-7957
  Lancaster
 Lancaster General Hospital
 Daleela G Dodge Ph: 717-544-5511
  Wynnewood
 Lankenau Cancer Center at Lankenau Hospital
 Ned Z. Carp Ph: 866-225-5654
  Email: wellenbachj@mlhs.org
  York
 WellSpan Health
 Thomas L. Bauer Ph: 877-441-7957
Rhode Island
  Providence
 Roger Williams Medical Center
 R. James Koness Ph: 401-456-2268
  Email: rdavies@rwmc.org
South Carolina
  Charleston
 Hollings Cancer Center at Medical University of South Carolina
 Megan K Baker Ruppel Ph: 843-792-9321
  Hilton Head Island
 Hilton Head Regional Medical Center
 Megan K Baker Ruppel Ph: 843-792-9321
  West Columbia
 Lexington Medical Center
 Lynn M Tucker Ph: 803-936-8050
South Dakota
  Sioux Falls
 Avera Cancer Institute
 Wade E Dosch Ph: 605-328-1367
 Sanford Cancer Center at Sanford USD Medical Center
 Miroslaw A Mazurczak Ph: 605-328-1367
 Miroslaw A Mazurczak Ph: 605-328-1367
Tennessee
  Nashville
 MBCCOP - Meharry Medical College - Nashville
 Kevin T Palka Ph: 615-327-5724
  Email: jmurray@mmc.edu
 Nashville Breast Center
 Kevin T Palka Ph: 615-327-5724
  Email: jmurray@mmc.edu
Texas
  Dallas
 Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
 Ann Marilyn Leitch Ph: 214-648-7097
  Houston
 Univeristy of Texas M.D. Anderson Cancer Center
 Elizabeth A Mittendorf Ph: 713-792-3245
  Laredo
 Doctor's Hospital of Laredo
 Gary W. Unzeitig
  Email: calgbco@calgb.org
Vermont
  Burlington
 Vermont Cancer Center at University of Vermont
 Michelle Sowden Ph: 802-656-8990
Wisconsin
  Appleton
 Fox Valley Surgical Associates at Appleton Medical Center
 Honnie R Bermas Ph: 800-574-3872
 Honnie R Bermas Ph: 800-574-3872
  Green Bay
 Green Bay Oncology, Limited at St. Mary's Hospital
 Anthony J. Jaslowski Ph: 800-432-6049
 Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
 Anthony J. Jaslowski Ph: 800-432-6049
 St. Mary's Hospital Medical Center - Green Bay
 Anthony J. Jaslowski Ph: 800-432-6049
 St. Vincent Hospital Regional Cancer Center
 Anthony J. Jaslowski Ph: 800-432-6049
 Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
 William L Owens Ph: 800-252-2990
  La Crosse
 Gundersen Lutheran Center for Cancer and Blood
 Jeanne M Johnson Ph: 608-775-2385
  Email: cancerctr@gundluth.org
  Madison
 University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
 Lee G Wilke Ph: 877-405-6866
  Mequon
 Columbia Saint Mary's Hospital - Ozaukee
 Charles H. I. Tiber Ph: 414-326-2675
  Email: clinicaltrials@columbia-stmarys.org
  Milwaukee
 Aurora Sinai Medical Center
 Judy A Tjoe Ph: 800-252-2990
 Columbia-Saint Mary's Cancer Care Center
 Charles H. I. Tiber Ph: 414-326-2675
  Email: clinicaltrials@columbia-stmarys.org
 Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
 Judy A Tjoe Ph: 800-252-2990
  Oshkosh
 Vince Lombardi Cancer Clinic - Oshkosh
 William L Owens Ph: 800-252-2990
  Summit
 Aurora Medical Center
 William L Owens Ph: 800-252-2990
  West Allis
 Aurora Women's Pavilion of West Allis Memorial Hospital
 Judy A Tjoe Ph: 800-252-2990

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01556243
Information obtained from ClinicalTrials.gov on April 04, 2013

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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