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 November 2013 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: November 20, 2013
Last verified: November 2013
  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 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Breast conservation surgery and radiation therapy
Patients undergo breast conserving surgery with all lesions resected to negative margins using one 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 with a boost to the lumpectomy bed of each site of disease 5 days per week for approximately 6 weeks.
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 examine the type and severity of adverse effects of BCS and radiation for women with MIBC.
  • To assess incidence of breast lymphedema
  • 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.

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 at the discretion of the surgeon.

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.

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

  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.

  4. Foci of Breast Cancer - Upon clinical exam and pre-operative imaging by both MRI and mammogram, two or three foci of biopsy proven breast cancer separated by > 2 cm of normal breast tissue. 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.

    Note: Patient is eligible for study if lesion is not visualized on both 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). Ultrasound cannot be used to determine patient eligibility; eligibility to be determined by bilateral mammogram and MRI only. Patient may remain on study if, upon pathological assessment, two or three lesions identified on pre-operative imaging represent one contiguous lesion.

  5. Mammogram Imaging - Bilateral mammogram ≤ 60 days prior to registration
  6. MRI Imaging - Bilateral breast MRI ≤ 60 days prior to registration
  7. Staging of Cancer - cN0 or cN1 disease
  8. ECOG Performance Status (PS) - 0, 1, or 2.

    Note: An ECOG PS scale is available on the Cancer Trial Support Unit (CTSU) website.

  9. Hemoglobin and Platelet Count - The following laboratory values obtained ≤ 21 days prior to registration:

    • Hemoglobin (Hgb) ≥ 8 g/dL
    • Peripheral platelet count (PLT) ≥ 50,000/mm3
  10. Pregnancy for Women of Childbearing Potential - Negative urine or serum pregnancy test result ≤ 7 days prior to registration for women of childbearing potential only.
  11. Ability to Complete Questionnaires by themselves or with assistance.
  12. Ability to Provide Written Informed Consent
  13. 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 Any of the following because this study involves radiation therapy (WBI) that has known genotoxic, mutagenic and teratogenic effects:

    • Pregnant women
    • Nursing women
    • Women of childbearing potential who are unwilling to employ adequate contraception (as determined by the treating physician)
  2. Size of Single Focus of Disease - 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 1centimeter of the index lesion.
  3. Prior Staging Procedure - Surgical axillary staging procedure prior to study entry.

    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 ipsilateral breast cancer [DCIS, LCIS (lobular cancer in situ) or invasive]
  6. Staging of Cancer - cNX, cN2, or cN3 disease
  7. 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 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 registration.
  12. Chemotherapy or Endocrine Therapy Prior to Surgery - Neoadjuvant chemotherapy or neoadjuvant endocrine therapy (in other words, no chemotherapy or endocrine therapy prior to surgery) for this cancer.
  13. Partial Breast Radiation - Planned partial breast radiation.
  14. Investigational Agents - Administration of any investigational agent ≤ 30 days prior to registration.
  15. Known BRCA Mutations - Patients with known BRCA mutations.
  16. Other Active Malignancies - Other active malignancy ≤ 5 years prior to registration.

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

  Hide Study Locations
Locations
United States, California
East Bay Radiation Oncology Center Recruiting
Castro Valley, California, United States, 94546
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      
El Camino Hospital Cancer Center Recruiting
Mountain View, California, United States, 94040
Contact: Clinical Trials Office - El Camino Hospital Cancer Center    650-988-7623      
CCOP - Bay Area Tumor Institute Recruiting
Oakland, California, United States, 94609
Contact: James H. Feusner, MD    510-428-3689      
Tom K Lee, Incorporated Recruiting
Oakland, California, United States, 94609
Contact: James H. Feusner, MD    510-428-3689      
Bay Area Breast Surgeons, Incorporated Recruiting
Oakland, California, United States, 94609
Contact: James H. Feusner, MD    510-428-3689      
Larry G Strieff MD Medical Corporation Recruiting
Oakland, California, United States, 94609
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      
Sutter Roseville Medical Center Recruiting
Roseville, California, United States, 95661
Contact: Jay Owens, M.D.    916-454-6500      
Sutter General Hospital Recruiting
Sacramento, California, United States, 95816
Contact: Jay Owens, M.D.    916-454-6500      
Sharp Memorial Hospital Recruiting
San Diego, California, United States, 92123
Contact: Robert M. Barone, MD, FACS    858-637-7888      
Doctors Medical Center - San Pablo Campus Recruiting
San Pablo, California, United States, 94806
Contact: James H. Feusner, MD    510-428-3689      
Stanford University Hospitals and Clinics Recruiting
Stanford, California, United States, 94305
Contact: Frederick Dirbas, M.D.    650-498-7061      
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, Connecticut
Saint Vincent's Medical Center Recruiting
Bridgeport, Connecticut, United States, 06606
Contact: Anthy Demestihas, M.D.    888-823-5923      
United States, Delaware
Tunnell Cancer Center at Beebe Medical Center Recruiting
Lewes, Delaware, United States, 19958
Contact: Clinical Trials Office - Tunnell Cancer Center    302-645-3171      
Christiana Care Health System-Christiana Hospital Recruiting
Newark, Delaware, United States, 19718
Contact: Diana Dickson-Witmer, M.D.    302-733-6227      
CCOP - Christiana Care Health Services Recruiting
Newark, Delaware, United States, 19713
Contact: Clinical Trial Office - CCOP - Christiana Care Health Services    302-623-4450      
United States, Florida
Morton Plant Hospital Recruiting
Clearwater, Florida, United States, 33756
Contact: Peter W. Blumencranz, MD    727-462-2131      
Holy Cross Hospital Recruiting
Fort Lauderdale, Florida, United States, 33308
Contact: Michael Schwartz, M.D.    305-674-2625      
Jupiter Medical Center Recruiting
Jupiter, Florida, United States, 33458
Contact: Michael Schwartz, M.D.    305-674-2625      
Mount Sinai Medical Center CCOP Recruiting
Miami Beach, Florida, United States, 33140
Contact: Michael Schwartz, M.D.    305-674-2625      
United States, Georgia
Dekalb Medical Center Recruiting
Decatur, Georgia, United States, 30033
Contact: John Kennedy, M.D.    404-501-3279      
United States, Hawaii
Oncare Hawaii, Incorporated - Pali Momi Recruiting
Aiea, Hawaii, United States, 96701
Contact: Jeffrey L. Berenberg, MD    808-433-4089      
Straub Clinic and Hospital, Incorporated Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Jeffrey L. Berenberg, MD    808-433-4089      
University of Hawaii Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Jeffrey Berenberg, M.D.    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      
Queen's Medical Center Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Jeffrey Berenberg, M.D.    808-433-4089      
OnCare Hawaii-Liliha Recruiting
Honolulu, Hawaii, United States, 96817
Contact: Jeffrey Berenberg, M.D.    808-524-6115      
OnCare Hawaii, Incorporated - Kuakini Recruiting
Honolulu, Hawaii, United States, 96817
Contact: Jeffrey L. Berenberg, MD    808-433-4089      
Castle Medical Center Recruiting
Kailua, Hawaii, United States, 96734
Contact: Jeffrey L. Berenberg, MD    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 Regional Medical Center Recruiting
Boise, Idaho, United States, 83706
Contact: Tari Stull, M.D.    734-712-3456      
United States, Illinois
Elmhurst Memorial Hospital Recruiting
Elmhurst, Illinois, United States, 60126
Contact: Lucio Di Nunno, MD    806-725-8000      
Ingalls Memorial Hospital Recruiting
Harvey, Illinois, United States, 60426
Contact: Mark F. Kozloff    708-339-4800      
Medical Arts Associates Ltd. Recruiting
Moline, Illinois, United States, 61265
Contact: David Spector, M.D.    309-779-4245      
United States, Indiana
Clarian West Medical Center Recruiting
Avon, Indiana, United States, 46123
Contact: Linda K. Han    317-217-3000      
Clarian North Medical Center Recruiting
Carmel, Indiana, United States, 46032
Contact: Linda K. Han    317-688-2000      
Elkhart Clinic, LLC Recruiting
Elkhart, Indiana, United States, 46514-2098
Contact: Robin Zon, MD    574-296-6536      
Elkhart General Hospital Recruiting
Elkhart, Indiana, United States, 46515
Contact: Robin Zon, MD    574-296-6536      
Michiana Hematology-Oncology, PC - Elkhart Recruiting
Elkhart, Indiana, United States, 46514
Contact: Robin Zon, MD    574-296-6536      
IU Health Methodist Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Linda Han, M.D.    317-274-2552      
Indiana University Melvin and Bren Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202-5289
Contact: Clinical Trials Office - Indiana University Cancer Center    317-274-2552      
William N. Wishard Memorial Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Linda K. Han    317-639-6671      
Howard Community Hospital Recruiting
Kokomo, Indiana, United States, 46904
Contact: Robin Zon, MD    574-296-6536      
Community Howard Regional Health Recruiting
Kokomo, Indiana, United States, 46904
Contact: Robin Zon    574-647-6343      
Principal Investigator: Robin Zon         
Center for Cancer Therapy at LaPorte Hospital and Health Services Recruiting
La Porte, Indiana, United States, 46350
Contact: Robin Zon, MD    574-296-6536      
Saint Joseph Regional Medical Center Recruiting
Mishawaka, Indiana, United States, 46545-1470
Contact: Robin Zon, MD    574-296-6536      
Michiana Hematology-Oncology, PC - South Bend Recruiting
Mishawaka, Indiana, United States, 46545-1470
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      
CCOP - Northern Indiana CR Consortium Recruiting
South Bend, Indiana, United States, 46601
Contact: Robin Zon, MD    574-296-6536      
Memorial Hospital of South Bend Recruiting
South Bend, Indiana, United States, 46601
Contact: Clinical Trials Office - Memorial Hospital of South Bend    800-284-7370      
Memorial Hospital of South Bend Recruiting
South Bend, Indiana, United States, 46601
Contact: Robin Zon    574-647-6343      
Michiana Hematology Oncology PC - La Porte Recruiting
Westville, Indiana, United States, 46391
Contact: Robin Zon, MD    574-296-6536      
Michiana Hematology Oncology-PC Westville Recruiting
Westville, Indiana, United States, 46391
Contact: Robin Zon    574-647-6343      
United States, Iowa
McFarland Clinic, PC Recruiting
Ames, Iowa, United States, 50010
Contact: Clinical Trials Office - McFarland Clinic, PC    515-239-2621      
Medical Oncology and Hematology Associates - West Des Moines Recruiting
Clive, Iowa, United States, 50325
Contact: Robert J. Behrens    515-875-9713      
Mercy Cancer Center - West Lakes Recruiting
Clive, Iowa, United States, 50325
Contact: Robert J. Behrens    515-643-8206      
Mercy Cancer Center at Mercy Medical Center - Des Moines Recruiting
Des Moines, Iowa, United States, 50314
Contact: Robert J. Behrens    515-643-8206      
John Stoddard Cancer Center at Iowa Methodist Medical Center Recruiting
Des Moines, Iowa, United States, 50309
Contact: Clinical Trials Office - John Stoddard Cancer Center at Iowa M    515-241-6727      
Medical Oncology and Hematology Associates at Mercy Cancer Center Recruiting
Des Moines, Iowa, United States, 50314
Contact: Robert J. Behrens    515-643-8740      
John Stoddard Cancer Center at Iowa Lutheran Hospital Recruiting
Des Moines, Iowa, United States, 50316
Contact: Clinical Trials Office - John Stoddard Cancer Center at Iowa L    515-241-8704      
Medical Oncology and Hematology Associates at John Stoddard Cancer Center Recruiting
Des Moines, Iowa, United States, 50309
Contact: Robert J. Behrens    515-282-2921      
CCOP - Iowa Oncology Research Association Recruiting
Des Moines, Iowa, United States, 50309
Contact: Robert J. Behrens    515-244-7586      
Mercy Medical Center-West Lakes Recruiting
West Des Moines, Iowa, United States, 50266
Contact: Robert Behrens, M.D.    515-244-7586      
Methodist West Hospital Recruiting
West Des Moines, Iowa, United States, 50266-7700
Contact: Robert J. Behrens    515-343-1000      
United States, Kansas
Menorah Medical Center Recruiting
Overland Park, Kansas, United States, 66209
Contact: Rakesh Gaur, MD    913-948-5588      
Saint Luke's Hospital - South Recruiting
Overland Park, Kansas, United States, 66213
Contact: Rakesh Gaur, MD    913-948-5588      
CCOP - Kansas City Recruiting
Prairie Village, Kansas, United States, 66208
Contact: Rakesh Gaur, MD    913-948-5588      
United States, Kentucky
St. Elizabeth Medical Center Recruiting
Edgewood, Kentucky, United States, 41017
Contact: Clinical Trials Office - St. Elizabeth Medical Center    859-301-2237      
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      
Union Hospital of Cecil County Recruiting
Elkton MD, Maryland, United States, 21921
Contact: Diana Dickson-Witmer    410-398-4000      
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Katherina Calvillo, M.D.    781-624-4611      
Brigham and Women's Hospital 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
Michigan Cancer Research Consortium Community Clinical Oncology Program Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Tari Stull, M.D.    734-712-3456      
Saint Joseph Mercy Hospital Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Tari Stull, M.D.    734-712-3456      
Oakwood Healthcare Inc Recruiting
Dearborn, Michigan, United States, 48124
Contact: Tari Stull, M.D.    734-712-3456      
Saint John Hospital and Medical Center Recruiting
Detroit, Michigan, United States, 48236
Contact: Tari Stull, M.D.    734-712-3456      
Hurley Medical Center Recruiting
Flint, Michigan, United States, 48503
Contact: Tari Stull, M.D.    734-712-3456      
Genesys Hurley Cancer Institute Recruiting
Flint, Michigan, United States, 48503
Contact: Tari Stull, M.D.    734-712-3456      
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: Tari Stull, M.D.    734-712-3456      
West Michigan Cancer Center Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Raymond Lord, M.D.    269-373-7464      
Borgess Medical Center Recruiting
Kalamazoo, Michigan, United States, 49001
Contact: Raymond S. Lord, MD    269-373-7458      
Bronson Methodist Hospital Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Raymond Lord, M.D.    269-373-7464      
Sparrow Hospital Recruiting
Lansing, Michigan, United States, 48912
Contact: Tari Stull, M.D.    734-712-3456      
Saint Mary Mercy Hospital Recruiting
Livonia, Michigan, United States, 48154
Contact: Tari Stull, M.D.    734-712-3456      
Saint Joseph Mercy Oakland Recruiting
Pontiac, Michigan, United States, 48341
Contact: Tari Stull, M.D.    734-712-3456      
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: Tari Stull, M.D.    734-712-3456      
Marie Yeager Cancer Center Recruiting
Saint Joseph, Michigan, United States, 49085
Contact: Robin Zon    574-647-6343      
Lakeland Regional Cancer Care Center - St. Joseph Recruiting
Saint Joseph, Michigan, United States, 49085
Contact: Robin Zon, MD    574-296-6536      
Lakeside Cancer Specialists, PLLC Recruiting
Saint Joseph, Michigan, United States, 49085
Contact: Robin Zon, MD    574-296-6536      
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: Tari Stull, M.D.    734-712-3456      
United States, Minnesota
Sanford Clinic North-Bemidji Recruiting
Bemidji, Minnesota, United States, 56601
Contact: Preston Steen, M.D.    701-234-6161      
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      
Essentia Health Duluth Clinic CCOP Recruiting
Duluth, Minnesota, United States, 55805
Contact: Daniel A. Nikcevich    610-402-2273      
Principal Investigator: Daniel A. Nikcevich         
Essentia Health Saint Mary's Medical Center Recruiting
Duluth, Minnesota, United States, 55805
Contact: Daniel A. Nikcevich    610-402-2273      
Principal Investigator: Daniel A. Nikcevich         
Miller - Dwan Medical Center Recruiting
Duluth, Minnesota, United States, 55805
Contact: Daniel Nikcevich, MD, PhD    218-786-3625      
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      
Saint John's Hospital - Healtheast Recruiting
Maplewood, Minnesota, United States, 55109
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      
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      
Mayo Clinic Cancer Center Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Office - All Mayo Clinic Locations    507-538-7623      
Saint Cloud Hospital Recruiting
Saint Cloud, Minnesota, United States, 56303
Contact: Donald Jurgens, M.D.    320-229-4907      
Coborn Cancer Center Recruiting
Saint Cloud, Minnesota, United States, 56303
Contact: Donald J. Jurgens    320-229-4907      
Metro-Minnesota CCOP Recruiting
Saint Louis Park, Minnesota, United States, 55416
Contact: Daniel Anderson, M.D.    952-993-1517      
Park Nicollet Cancer Center Recruiting
Saint Louis Park, Minnesota, United States, 55416
Contact: Daniel M. Anderson    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: Alan P. Lyss, MD    314-996-5514      
Capital Region Medical Center-Goldschmidt Cancer Center Recruiting
Jefferson City, Missouri, United States, 65109
Contact: Alan Lyss, M.D.    800-392-0936      
Research Medical Center Recruiting
Kansas City, Missouri, United States, 64132
Contact: Rakesh Gaur, MD    913-948-5588      
Heartland Hematology Oncology Associates, Incorporated Recruiting
Kansas City, Missouri, United States, 64118
Contact: Rakesh Gaur, MD    913-948-5588      
North Kansas City Hospital Recruiting
Kansas City, Missouri, United States, 64116
Contact: Rakesh Gaur, MD    913-948-5588      
Saint Luke's Cancer Institute at Saint Luke's Hospital Recruiting
Kansas City, Missouri, United States, 64111
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      
Saint Joseph Oncology, Incorporated Recruiting
Saint Joseph, Missouri, United States, 64507
Contact: Rakesh Gaur, MD    913-948-5588      
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Julie A. Margenthaler    314-747-7222      
Missouri Baptist Cancer Center Recruiting
Saint Louis, Missouri, United States, 63131
Contact: Alan Philip Lyss, MD    314-996-5514    alyss@bjc.org   
United States, Montana
CCOP - Montana Cancer Consortium Recruiting
Billings, Montana, United States, 59101
Contact: Benjamin T. Marchello, MD    406-238-6290      
Billings Clinic - Downtown Recruiting
Billings, Montana, United States, 59107-7000
Contact: Clinical Trials Office - Billings Clinic - Downtown    800-996-2663    research@billingsclinic.org   
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 CCOP 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
Cooper Hospital University Medical Center Recruiting
Camden, New Jersey, United States, 08103
Contact: Diana Dickson-Witmer, M.D.    302-733-6227      
Saint Peter's University Hospital Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Susan McManus, M.D.    732-745-8600 ext 6163      
Cancer Institute of New Jersey at Cooper - Voorhees Recruiting
Voorhees, New Jersey, United States, 08043
Contact: Clinical Trials Office - Cancer Institute of New Jersey at Coo    856-325-6757      
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
Mount Sinai Medical Center Recruiting
New York, New York, United States, 10029
Contact: Elisa Port, M.D.    212-241-3806      
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 Recruiting
Charlotte, North Carolina, United States, 28232-2861
Contact: Richard L. White, MD    704-355-3809      
Presbyterian Hospital Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Justin Favaro, M.D.    704-342-1900      
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Edward Levine, M.D.    336-713-6771      
United States, North Dakota
Sanford Clinic North-Fargo Recruiting
Fargo, North Dakota, United States, 58102
Contact: Preston Steen, M.D.    701-234-6161      
Sanford Roger Maris Cancer Center Recruiting
Fargo, North Dakota, United States, 58122
Contact: Preston Steen    701-234-6161      
Principal Investigator: Preston Steen         
Sanford Medical Center-Fargo Recruiting
Fargo, North Dakota, United States, 58122
Contact: Preston Steen, M.D.    701-234-6161      
United States, Ohio
Adena Regional Medical Center Recruiting
Chillicothe, Ohio, United States, 54601
Contact: J. P. Kuebler, MD, PhD    614-442-3130      
Riverside Methodist Hospital Cancer Care Recruiting
Columbus, Ohio, United States, 43214
Contact: J. P. Kuebler, MD, PhD    614-442-3130      
The Mark H Zangmeister Center Recruiting
Columbus, Ohio, United States, 43219
Contact: John Kuebler, M.D.    614-488-2118      
Columbus CCOP Recruiting
Columbus, Ohio, United States, 43215
Contact: John Kuebler, M.D.    614-488-2118      
Mount Carmel Health Center West Recruiting
Columbus, Ohio, United States, 43222
Contact: John Kuebler, M.D.    614-488-2118      
Doctors Hospital at Ohio Health Recruiting
Columbus, Ohio, United States, 43228
Contact: J. P. Kuebler, MD, PhD    614-442-3130      
Grant Medical Center Cancer Care Recruiting
Columbus, Ohio, United States, 43215
Contact: J. Philip Kuebler, MD, PhD    614-488-2118      
Grady Memorial Hospital Recruiting
Delaware, Ohio, United States, 43015
Contact: J. Philip 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 Cancer Care Program at Licking Memorial Hospital Recruiting
Newark, Ohio, United States, 43055
Contact: J. Philip Kuebler, MD, PhD    614-488-2118      
Southern Ohio Medical Center Cancer Center Recruiting
Portsmouth, Ohio, United States, 45662
Contact: J. Philip Kuebler, MD, PhD    614-442-3130      
Springfield Regional Medical Center Recruiting
Springfield, Ohio, United States, 45505
Contact: John Kuebler    614-442-3130      
Principal Investigator: John Kuebler         
Saint Ann's Hospital Recruiting
Westerville, Ohio, United States, 43081
Contact: John Kuebler, M.D.    614-488-2118      
Genesis HealthCare System-Good Samaritan 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      
Mercy Health Center Recruiting
Oklahoma City, Oklahoma, United States, 73120
Contact: Alan Hollingsworth, M.D.    405-752-3388      
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 Recruiting
Allentown, Pennsylvania, United States, 18105
Contact: Lori Alfonse, M.D.    610-402-2273      
Lehigh Valley Hospital - Muhlenberg Recruiting
Bethlehem, Pennsylvania, United States, 18017
Contact: Lori Alfonse, M.D.    610-402-2273      
Bryn Mawr Hospital Recruiting
Bryn Mawr, Pennsylvania, United States, 19010
Contact: Albert DeNittis, M.D.    484-476-2433      
Adams Cancer Center Recruiting
Gettysburg, Pennsylvania, United States, 17325
Contact: Thomas Bauer, M.D.    877-441-7957      
Cherry Tree Cancer Center Recruiting
Hanover, Pennsylvania, United States, 17331
Contact: Thomas Bauer, M.D.    877-441-7957      
Lancaster General Hospital Recruiting
Lancaster, Pennsylvania, United States, 17604
Contact: Daleela G. Dodge    717-544-5511      
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Gretchen Ahrendt, M.D.    412-647-2811      
Lankenau Hospital Recruiting
Wynnewood, Pennsylvania, United States, 19096
Contact: Albert DeNittis, M.D.    484-476-2433      
WellSpan Health-York Hospital Recruiting
York, Pennsylvania, United States, 17405
Contact: Thomas Bauer, M.D.    717-741-8170      
York Cancer Center at Apple Hill Medical Center Recruiting
York, Pennsylvania, United States, 17405
Contact: Thomas L. Bauer, MD    302-623-4530      
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
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Megan Baker Ruppel, M.D.    843-792-9321      
Hilton Head Regional Medical Center Recruiting
Hilton Head Island, South Carolina, United States, 29926
Contact: Megan Baker Ruppel, M.D.    843-792-9321      
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      
Sanford USD Medical Center - Sioux Falls Recruiting
Sioux Falls, South Dakota, United States, 57117
Contact: Miroslaw Mazurczak, M.D.    605-328-8000      
Sanford Cancer Center Oncology Clinic Recruiting
Sioux Falls, South Dakota, United States, 57104
Contact: Miroslaw Mazurczak    605-328-8000      
United States, Tennessee
Nashville Breast Center Recruiting
Nashville, Tennessee, United States, 37203
Contact: Kevin T. Palka    615-284-8229      
MBCCOP - Meharry Medical College - Nashville Recruiting
Nashville, Tennessee, United States, 37208-3599
Contact: Kevin T. Palka    615-327-6000      
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 at University of Texas Recruiting
Houston, Texas, United States, 77030-4009
Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U    713-792-3245      
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/National Life Cancer Treatment Recruiting
Berlin, Vermont, United States, 05602
Contact: Michelle Sowden, M.D.       michelle.sowden@vtmednet.org   
University of Vermont Recruiting
Burlington, Vermont, United States, 05401
Contact: Michelle Sowden, M.D.    802-656-8990      
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Laurie Cuttino, M.D.    804-628-1939      
United States, Wisconsin
Aurora BayCare Medical Center Recruiting
Green Bay, Wisconsin, United States, 54311
Contact: William Owens, M.D.    800-252-2990      
St. Vincent Hospital Regional Cancer Center Recruiting
Green Bay, Wisconsin, United States, 54307-3508
Contact: Clinical Trials Office - St. Vincent Hospital Regional Cancer    920-433-8889      
St. Mary's Hospital Medical Center - Green Bay Recruiting
Green Bay, Wisconsin, United States, 54303
Contact: Anthony J. Jaslowski, MD, FACP    920-884-3135      
Green Bay Oncology, Limited at St. Mary's Hospital Recruiting
Green Bay, Wisconsin, United States, 54303
Contact: Anthony J. Jaslowski, MD, FACP    920-884-3135      
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center 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    610-402-2273      
Principal Investigator: Anthony J. Jaslowski         
Gundersen Lutheran Center for Cancer and Blood Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Clinical Trials Office - Gundersen Lutheran Cancer Center    608-775-2385    cancerctr@gundluth.org   
Columbia Saint Mary's Hospital - Ozaukee Recruiting
Mequon, Wisconsin, United States, 53097
Contact: Charles H. I. Tiber, MD    414-291-1840      
Aurora Sinai Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53233
Contact: Judy Tjoe, M.D.    800-252-2990      
Columbia Saint Mary's Water Tower Medical Commons Recruiting
Milwaukee, Wisconsin, United States, 53211
Contact: Charles Tiber, M.D.    414-326-2675      
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      
Vince Lombardi Cancer Clinic - Oshkosh Recruiting
Oshkosh, Wisconsin, United States, 54904
Contact: William Owen, 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 Women's Pavilion of 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: CDR0000728605, ACOSOG-Z11102
Study First Received: March 15, 2012
Last Updated: November 20, 2013
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 October 23, 2014