Trial record 1 of 1 for:    acosog Z11102
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Breast-Conserving Surgery and Radiation Therapy in Patients With Multiple Ipsilateral Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by Alliance for Clinical Trials in Oncology
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT01556243
First received: March 15, 2012
Last updated: August 12, 2015
Last verified: August 2015
  Purpose

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

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


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

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

Resource links provided by NLM:


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

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

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

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

Detailed Description:

OBJECTIVES:

Primary

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

Secondary

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

OUTLINE: This is a multicenter study.

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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Registration Inclusion Criteria:

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

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

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

  4. Foci of Breast Cancer

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

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

    No more than 2 quadrants with biopsy proven breast cancer.

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

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

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

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

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

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

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

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

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

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

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

Registration Exclusion Criteria:

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

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

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

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

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01556243

Contacts
Contact: Judy Boughey, MD (507) 284-3629

  Hide Study Locations
Locations
United States, California
Bay Area Breast Surgeons, Incorporated Recruiting
Emeryville, California, United States, 94608
Contact: James H. Feusner, MD    510-428-3689      
UC San Diego Moores Cancer Center Recruiting
La Jolla, California, United States, 92093
Contact: Sarah Blair, M.D.    858-822-5354      
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Armando Giuliano, M.D.    310-423-9331      
Contra Costa Regional Medical Center Recruiting
Martinez, California, United States, 94553-3156
Contact: James H. Feusner, MD    510-428-3689      
Alta Bates Summit Medical Center - Summit Campus Recruiting
Oakland, California, United States, 94609
Contact: James Feusner, M.D.    510-450-7600      
Bay Area Tumor Institute Recruiting
Oakland, California, United States, 94609
Contact: James H. Feusner, MD    510-428-3689      
United States, Colorado
University of Colorado Cancer Center - Anschutz Cancer Pavilion Recruiting
Aurora, Colorado, United States, 80045
Contact: Nicole Kounalakis, M.D.    720-848-0650      
United States, Delaware
Christiana Care Health System-Christiana Hospital Recruiting
Newark, Delaware, United States, 19718
Contact: Diana Witmer-Dickson, MD    302-623-4343      
Christiana Care Health System-Christiana Hospital Recruiting
Newark, Delaware, United States, 19718
Contact: Diana Dickson-Witmer, M.D.    302-733-6227      
Medical Oncology Hematology Consultants PA Recruiting
Newark, Delaware, United States, 19713
Contact: Diana Dickson-Witmer, MD    302-623-4343      
United States, Florida
Morton Plant Hospital Recruiting
Clearwater, Florida, United States, 33756
Contact: Peter W. Blumencranz, MD    727-462-2131      
University of Miami Sylvester Comprehensive Cancer Center Recruiting
Miami, Florida, United States, 33136
Contact: Eli Avisar, MD    305-243-3379      
Mount Sinai Medical Center Recruiting
Miami Beach, Florida, United States, 33140
Contact: Michael Schwartz, M.D.    305-674-2625      
United States, Hawaii
Oncare Hawaii, Incorporated - Pali Momi Recruiting
Aiea, Hawaii, United States, 96701
Contact: Jeffrey L. Berenberg, MD    808-433-4089      
Kapiolani Medical Center for Women and Children Recruiting
Honolulu, Hawaii, United States, 96826
Contact: Jeffrey L. Berenberg, MD    808-433-4089      
Oncare Hawaii Inc-POB II Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Jeffrey Berenberg, M.D.    808-586-2979      
OnCare Hawaii, Incorporated - Kuakini Recruiting
Honolulu, Hawaii, United States, 96817
Contact: Jeffrey L. Berenberg, MD    808-433-4089      
OnCare Hawaii-Liliha Recruiting
Honolulu, Hawaii, United States, 96817
Contact: Jeffrey Berenberg, M.D.    808-524-6115      
Queen's Medical Center Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Jeffrey Berenberg, M.D.    808-433-4089      
Straub Clinic and Hospital Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Jeffrey L. Berenberg, MD    808-433-4089      
University of Hawaii Cancer Center Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Jeffrey Berenberg, M.D.    808-433-4089      
Wilcox Memorial Hospital and Kauai Medical Clinic Recruiting
Lihue, Hawaii, United States, 96766
Contact: Jeffrey Berenberg, M.D.    808-433-4089      
United States, Idaho
Saint Alphonsus Cancer Care Center-Boise Recruiting
Boise, Idaho, United States, 83706
Contact: Philip Stella, M.D.    734-712-4931      
United States, Illinois
Springfield Clinic Recruiting
Springfield, Illinois, United States, 62703
Contact: James Wade, MD    217-876-6600      
United States, Indiana
Michiana Hematology-Oncology, PC - Elkhart Recruiting
Elkhart, Indiana, United States, 46514
Contact: Robin Zon, MD    574-296-6536      
IU Health Central Indiana Cancer Centers-Fishers Recruiting
Fishers, Indiana, United States, 46037
Contact: Linda Han, MD    317-274-3616      
IU Health Methodist Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Linda Han, M.D.    317-274-2552      
Michiana Hematology-Oncology, PC - South Bend Recruiting
Mishawaka, Indiana, United States, 46601
Contact: Robin Zon, MD    574-296-6536      
Saint Joseph Regional Medical Center-Mishawaka Recruiting
Mishawaka, Indiana, United States, 46545
Contact: Robin Zon, MD    574-296-6536      
Michiana Hematology Oncology PC - Plymouth Recruiting
Plymouth, Indiana, United States, 46563
Contact: Robin Zon, MD    574-296-6536      
Northern Indiana Cancer Research Consortium Recruiting
South Bend, Indiana, United States, 46628
Contact: Robin Zon, MD    574-296-6536      
Memorial Hospital of South Bend Recruiting
South Bend, Indiana, United States, 46601
Contact: Thomas Reid, MD    574-647-1100      
Michiana Hematology Oncology-PC Westville Recruiting
Westville, Indiana, United States, 46391
Contact: Robin Zon    574-647-6343      
United States, Iowa
McFarland Clinic PC-William R Bliss Cancer Center Recruiting
Ames, Iowa, United States, 50010
Contact: Joseph Merchant, MD    515-956-2759      
Medical Oncology and Hematology Associates - West Des Moines Recruiting
Clive, Iowa, United States, 50325
Contact: Mehmet Copur, MD    308-398-5450      
Mercy Cancer Center - West Lakes Recruiting
Clive, Iowa, United States, 50325
Contact: Mehmet Copur, MD    308-398-5450      
Mercy Medical Center - Des Moines Recruiting
Des Moines, Iowa, United States, 50314
Contact: Mehmet Copur, MD    308-398-5450      
Medical Oncology and Hematology Associates-Laurel Recruiting
Des Moines, Iowa, United States, 50314
Contact: Mehmet Copur, MD    308-398-5450      
United States, Kansas
Saint Luke's South Hospital Recruiting
Overland Park, Kansas, United States, 66213
Contact: Rakesh Gaur, MD    913-948-5588      
Menorah Medical Center Recruiting
Overland Park, Kansas, United States, 66209
Contact: Rakesh Gaur, MD    913-948-5588      
Kansas City NCI Community Oncology Research Program Recruiting
Prairie Village, Kansas, United States, 66208
Contact: Rakesh Gaur, MD    913-948-5588      
United States, Kentucky
Saint Elizabeth Medical Center South Recruiting
Edgewood, Kentucky, United States, 41017
Contact: Joseph Guenther, MD    859-301-9186      
United States, Maine
Eastern Maine Medical Center Recruiting
Bangor, Maine, United States, 04401
Contact: Thomas Openshaw, M.D.    207-973-7474      
United States, Maryland
Saint Agnes Hospital Recruiting
Baltimore, Maryland, United States, 21229
Contact: Richard Hudes, M.D.    410-368-2965      
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Katherina Calvillo, M.D.    781-624-4611      
Dana-Farber/Brigham and Women's Cancer Center at South Shore Recruiting
South Weymouth, Massachusetts, United States, 02190
Contact: Katherina Calvillo, M.D.    781-624-4611      
United States, Michigan
Saint Joseph Mercy Hospital Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Philip Stella, M.D.    734-712-4931      
Oakwood Hospital and Medical Center Recruiting
Dearborn, Michigan, United States, 48124
Contact: Philip Stella, M.D.    734-712-4931      
Saint John Hospital and Medical Center Recruiting
Detroit, Michigan, United States, 48236
Contact: Philip Stella, M.D.    734-712-4931      
Genesys Hurley Cancer Institute Recruiting
Flint, Michigan, United States, 48503
Contact: Philip Stella, M.D.    734-712-4931      
Hurley Medical Center Recruiting
Flint, Michigan, United States, 48503
Contact: Philip Stella, M.D.    734-712-4931      
Spectrum Health at Butterworth Campus Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Gilbert Padula, M.D.    616-752-6218      
Allegiance Health Recruiting
Jackson, Michigan, United States, 49201
Contact: Philip Stella, M.D.    734-712-4931      
Borgess Medical Center Recruiting
Kalamazoo, Michigan, United States, 49001
Contact: Sunil Nagpal, MD    269-382-2500      
Bronson Methodist Hospital Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Sunil Nagpal, M.D.    269-382-2500      
West Michigan Cancer Center Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Gilbert Padula, M.D.    616-752-6218      
Saint Mary Mercy Hospital Recruiting
Livonia, Michigan, United States, 48154
Contact: Philip Stella, M.D.    734-712-4931      
Saint Joseph Mercy Oakland Recruiting
Pontiac, Michigan, United States, 48341
Contact: Philip Stella, M.D.    734-712-4931      
William Beaumont Hospital-Royal Oak Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Nayana Dekhne    248-551-3300      
Saint Mary's of Michigan Recruiting
Saginaw, Michigan, United States, 48601
Contact: Philip Stella, M.D.    734-712-4931      
Lakeland Hospital Recruiting
Saint Joseph, Michigan, United States, 49085
Contact: Robin Zon, MD    574-296-6536      
Marie Yeager Cancer Center Recruiting
Saint Joseph, Michigan, United States, 49085
Contact: Robin Zon    574-647-6343      
Munson Medical Center Recruiting
Traverse City, Michigan, United States, 49684
Contact: Gilbert Padula, M.D.    616-752-6218      
William Beaumont Hospital - Troy Recruiting
Troy, Michigan, United States, 48098
Contact: Nayana Dekhne, M.D.    248-551-7695      
Saint John Macomb-Oakland Hospital Recruiting
Warren, Michigan, United States, 48093
Contact: Philip Stella, M.D.    734-712-4931      
United States, Minnesota
Fairview Ridges Hospital Recruiting
Burnsville, Minnesota, United States, 55337
Contact: Daniel M. Anderson    952-892-2000      
Mercy Hospital Recruiting
Coon Rapids, Minnesota, United States, 55433
Contact: Daniel Anderson, M.D.    952-993-1517      
Fairview-Southdale Hospital Recruiting
Edina, Minnesota, United States, 55435
Contact: Daniel Anderson, M.D.    952-993-1517      
Unity Hospital Recruiting
Fridley, Minnesota, United States, 55432
Contact: Daniel Anderson, M.D.    952-993-1517      
Minnesota Oncology Hematology PA-Maplewood Recruiting
Maplewood, Minnesota, United States, 55109
Contact: Daniel Anderson, M.D.    952-993-1517      
Saint John's Hospital - Healtheast Recruiting
Maplewood, Minnesota, United States, 55109
Contact: Daniel Anderson, M.D.    952-993-1517      
Hennepin County Medical Center Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: Daniel Anderson, M.D.    952-993-1517      
Abbott-Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Daniel Anderson, M.D.    952-993-1517      
North Memorial Medical Health Center Recruiting
Robbinsdale, Minnesota, United States, 55422
Contact: Daniel Anderson    952-993-1517      
Coborn Cancer Center at Saint Cloud Hospital Recruiting
Saint Cloud, Minnesota, United States, 56303
Contact: Donald J. Jurgens, MD    320-229-4907      
Saint Cloud Hospital Recruiting
Saint Cloud, Minnesota, United States, 56303
Contact: Donald Jurgens, M.D.    320-229-4907      
Park Nicollet Clinic - Saint Louis Park Recruiting
Saint Louis Park, Minnesota, United States, 55416
Contact: Daniel M. Anderson, MD    952-993-3248      
Regions Hospital Recruiting
Saint Paul, Minnesota, United States, 55101
Contact: Daniel Anderson, M.D.    952-993-1517      
United Hospital Recruiting
Saint Paul, Minnesota, United States, 55102
Contact: Daniel M. Anderson    651-241-8000      
Saint Francis Regional Medical Center Recruiting
Shakopee, Minnesota, United States, 55379
Contact: Daniel Anderson, M.D.    952-993-1517      
Ridgeview Medical Center Recruiting
Waconia, Minnesota, United States, 55387
Contact: Daniel M. Anderson    952-442-2191      
Rice Memorial Hospital Recruiting
Willmar, Minnesota, United States, 56201
Contact: Daniel Anderson, M.D.    952-993-1517      
Minnesota Oncology and Hematology PA-Woodbury Recruiting
Woodbury, Minnesota, United States, 55125
Contact: Daniel Anderson, M.D.    952-993-1517      
United States, Missouri
Southeast Cancer Center Recruiting
Cape Girardeau, Missouri, United States, 63703
Contact: James Wade, MD    217-876-6600      
Capital Region Medical Center-Goldschmidt Cancer Center Recruiting
Jefferson City, Missouri, United States, 65109
Contact: James Wade, M.D.    217-876-6600      
Heartland Hematology Oncology Associates, Incorporated Recruiting
Kansas City, Missouri, United States, 64118
Contact: Rakesh Gaur, MD    913-948-5588      
Research Medical Center Recruiting
Kansas City, Missouri, United States, 64132
Contact: Rakesh Gaur, MD    913-948-5588      
Saint Luke's East - Lee's Summit Recruiting
Lee's Summit, Missouri, United States, 64086
Contact: Rakesh Gaur, MD    913-948-5588      
Missouri Baptist Medical Center Recruiting
Saint Louis, Missouri, United States, 63131
Contact: James Wade, MD    217-876-6600      
United States, Montana
Billings Clinic Cancer Center Recruiting
Billings, Montana, United States, 59107
Contact: Benjamin Marchello, MD    406-238-6290      
Montana Cancer Consortium NCORP Recruiting
Billings, Montana, United States, 59101
Contact: Benjamin T. Marchello, MD    406-238-6290      
Benefis Sletten Cancer Institute Recruiting
Great Falls, Montana, United States, 59405
Contact: Benjamin T. Marchello, MD    406-238-6290      
United States, Nevada
Nevada Cancer Research Foundation NCORP Recruiting
Las Vegas, Nevada, United States, 89106
Contact: John Ellerton, M.D.    702-384-0808      
United States, New Hampshire
Dartmouth Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Kari Rosenkranz, M.D.    800-639-6918      
United States, New Jersey
Saint Peter's University Hospital Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Susan McManus, M.D.    732-745-8600 ext 6163      
United States, New Mexico
Lovelace Women's Hospital Recruiting
Albuquerque, New Mexico, United States, 87109
Contact: Calvin Ridgeway, M.D.    505-559-6100      
United States, New York
Vassar Brothers Medical Center Recruiting
Poughkeepsie, New York, United States, 12601
Contact: Gregory Zanieski, M.D.    845-483-6483      
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Kristin Skinner, M.D.    585-275-5830      
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: David Ollila, M.D.    877-668-0683      
Carolinas Medical Center/Levine Cancer Institute Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Richard L. White, MD    704-355-3809      
United States, Ohio
Adena Regional Medical Center Recruiting
Chillicothe, Ohio, United States, 54601
Contact: John Kuebler, MD, PhD    614-442-3130      
Riverside Methodist Hospital Cancer Care Recruiting
Columbus, Ohio, United States, 43214
Contact: John P. Kuebler, MD, PhD    614-442-3130      
Doctors Hospital Recruiting
Columbus, Ohio, United States, 43228
Contact: John Kuebler, MD    614-566-3275      
Grant Medical Center Cancer Care Recruiting
Columbus, Ohio, United States, 43215
Contact: John Kuebler, MD, PhD    614-488-2118      
Mount Carmel Health Center West Recruiting
Columbus, Ohio, United States, 43222
Contact: John Kuebler, M.D.    614-488-2118      
Columbus NCI Community Oncology Research Program Recruiting
Columbus, Ohio, United States, 43215
Contact: John Kuebler, M.D.    614-488-2118      
The Mark H Zangmeister Center Recruiting
Columbus, Ohio, United States, 43219
Contact: John Kuebler, M.D.    614-488-2118      
Grady Memorial Hospital Recruiting
Delaware, Ohio, United States, 43015
Contact: John Kuebler, MD, PhD    614-488-2118      
Marietta Memorial Hospital Recruiting
Marietta, Ohio, United States, 45750
Contact: John Kuebler, M.D.    614-566-3275      
Licking Memorial Hospital Recruiting
Newark, Ohio, United States, 43055
Contact: John Kuebler, MD, PhD    614-488-2118      
Southern Ohio Medical Center Recruiting
Portsmouth, Ohio, United States, 45662
Contact: John Kuebler, MD, PhD    614-442-3130      
Saint Ann's Hospital Recruiting
Westerville, Ohio, United States, 43081
Contact: John Kuebler, M.D.    614-488-2118      
Genesis Healthcare System Cancer Care Center Recruiting
Zanesville, Ohio, United States, 43701
Contact: John Kuebler, M.D.    614-566-3275      
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: William Dooley, M.D.    405-271-4272      
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Charlotte Kubicky, M.D.    503-494-1080      
United States, Pennsylvania
Lehigh Valley Hospital-Cedar Crest Recruiting
Allentown, Pennsylvania, United States, 18103
Contact: Suresh Nair, M.D.    610-402-7880      
Lehigh Valley Hospital - Muhlenberg Recruiting
Bethlehem, Pennsylvania, United States, 18017
Contact: Suresh Nair, M.D.    610-402-7880      
Bryn Mawr Hospital Recruiting
Bryn Mawr, Pennsylvania, United States, 19010
Contact: Albert DeNittis, M.D.    484-476-2433      
Lancaster General Hospital Recruiting
Lancaster, Pennsylvania, United States, 17604
Contact: Daleela G. Dodge    717-544-5511      
University of Pittsburgh Cancer Institute (UPCI) Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Gretchen Ahrendt, M.D.    412-647-2811      
Lankenau Medical Center Recruiting
Wynnewood, Pennsylvania, United States, 19096
Contact: Albert DeNittis, M.D.    484-476-2433      
United States, Rhode Island
Roger Williams Medical Center Recruiting
Providence, Rhode Island, United States, 02908
Contact: James Koness, M.D.    401-456-2268      
United States, South Carolina
Hilton Head Regional Medical Center Recruiting
Hilton Head Island, South Carolina, United States, 29926
Contact: Rochelle Ringer, M.D.    843-876-0179      
Lexington Medical Center Recruiting
West Columbia, South Carolina, United States, 29169
Contact: Lynn M. Tucker    803-791-2000      
United States, South Dakota
Avera Cancer Institute Recruiting
Sioux Falls, South Dakota, United States, 57105
Contact: Wade Dosch, M.D.    605-328-1367      
United States, Texas
The Methodist Hospital System Recruiting
Houston, Texas, United States, 77030
Contact: Barbara Bass, M.D.    713-441-5132      
M. D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Elizabeth Mittendorf, MD    713-792-2362      
Doctor's Hospital of Laredo Recruiting
Laredo, Texas, United States, 78045
Contact: Gary W. Unzeitig, MD    956-726-3691      
United States, Vermont
Central Vermont Medical Center Recruiting
Berlin, Vermont, United States, 05602
Contact: Michelle Sowden, M.D.       michelle.sowden@vtmednet.org   
University of Vermont College of Medicine Recruiting
Burlington, Vermont, United States, 05405
Contact: Michelle Sowden, M.D.    802-656-8990      
United States, Wisconsin
Green Bay Oncology at Saint Vincent Hospital Recruiting
Green Bay, Wisconsin, United States, 54301-3526
Contact: Anthony J. Jaslowski, MD, FACP    920-884-3135      
Green Bay Oncology at Saint Vincent Hospital Recruiting
Green Bay, Wisconsin, United States, 54301-3526
Contact: Anthony J. Jaslowski, MD    610-402-2273      
Green Bay Oncology Limited at Saint Mary's Hospital Recruiting
Green Bay, Wisconsin, United States, 54303
Contact: Anthony J. Jaslowski, MD, FACP    920-884-3135      
Saint Mary's Hospital Recruiting
Green Bay, Wisconsin, United States, 54303
Contact: Anthony J. Jaslowski, MD, FACP    920-884-3135      
Saint Vincent Hospital Recruiting
Green Bay, Wisconsin, United States, 54301
Contact: Anthony Jaslowski, MD, FACP    920-884-3135      
Aurora BayCare Medical Center Recruiting
Green Bay, Wisconsin, United States, 54311-6519
Contact: William Owens, M.D.    800-252-2990      
Gundersen Lutheran Medical Center Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Jeanne Johnson, MD    608-782-7300      
Froedtert and the Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Tina Yen, M.D.    414-805-4380      
Aurora Saint Luke's Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Judy Tjoe, M.D.    800-252-2990      
Aurora Sinai Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53233
Contact: Judy Tjoe, M.D.    800-252-2990      
Vince Lombardi Cancer Clinic - Oshkosh Recruiting
Oshkosh, Wisconsin, United States, 54904
Contact: William Owens, M.D.    800-252-2990      
Aurora Medical Center in Summit Recruiting
Summit, Wisconsin, United States, 53066
Contact: William Owens, M.D.    800-252-2990      
Aurora West Allis Medical Center Recruiting
West Allis, Wisconsin, United States, 53227
Contact: Judy Tjoe, M.D.    800-252-2990      
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Investigators
Study Chair: Judy Boughey, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT01556243     History of Changes
Other Study ID Numbers: ACOSOG-Z11102, ACOSOG-Z11102, CDR0000728605
Study First Received: March 15, 2012
Last Updated: August 12, 2015
Health Authority: United States: NCI Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 01, 2015