Brostallicin and Cisplatin in Treating Patients With Metastatic Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01091454
First received: March 18, 2010
Last updated: March 24, 2012
Last verified: March 2012
  Purpose

RATIONALE: Drugs used in chemotherapy, such as brostallicin and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving brostallicin together with cisplatin may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving brostallicin together with cisplatin works in treating patients with metastatic breast cancer.


Condition Intervention Phase
Breast Cancer
Drug: brostallicin
Drug: cisplatin
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Brostallicin and Cisplatin in Patients With Metastatic Triple Negative Breast Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 3-month progression-free survival (PFS) rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Confirmed response rate (complete or partial response) [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]
  • 6-month PFS rate [ Designated as safety issue: No ]
  • Time to disease progression [ Designated as safety issue: No ]
  • Survival time [ Designated as safety issue: No ]
  • Glutathione/glutathione levels measured at baseline and at 22-26 hours after cisplatin administration (before brostallicin administration) [ Designated as safety issue: No ]
  • Correlation of increased glutathione/glutathione levels and primary and secondary endpoints [ Designated as safety issue: No ]
  • Correlation of BRCA1 mutation and 3-month PFS [ Designated as safety issue: No ]

Estimated Enrollment: 46
Study Start Date: July 2010
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To identify any clinical efficacy of treatment with brostallicin and cisplatin, as measured by progression-free survival (PFS) at 3 months, in patients with triple-negative metastatic breast cancer.

Secondary

  • To describe the confirmed tumor response rate in these patients.
  • To describe the duration of response in these patients.
  • To describe the 6-month PFS of these patients.
  • To describe the overall survival of these patients.
  • To evaluate the adverse event profile of this regimen according to the current version of NCI CTCAE.

Tertiary

  • To assess the baseline glutathione levels in whole blood (before the administration of cisplatin) in these patients and to correlate those levels with the primary and secondary endpoints. (Translational research)
  • To evaluate whether cisplatin administered the day before the administration of brostallicin leads to an increased level of glutathione/glutathione S-transferase levels in vivo and whether such increase is associated with improvement of the primary and secondary endpoints. (Translational research)
  • To assess the prevalence of BCRA-1 mutation by IHC on the primary or metastatic tumor in these patients. (Translational research)
  • To assess the association of BRCA-1 mutation by IHC with the primary and secondary endpoints. (Translational research)
  • To bank paraffin-embedded tissue blocks or slides and blood products for future studies as part of ongoing research for NCCTG breast studies. (Translational research)

OUTLINE: This is a multicenter study.

Patients receive cisplatin IV over 2 hours on day 1 and brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Blood samples are collected periodically for translational research studies. Tumor tissue samples may also be collected for research studies.

After completion of study therapy, patients are followed up every 3 months until disease progression and then every 6 months for up to 5 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed adenocarcinoma of the breast

    • Clinical evidence of metastatic disease
  • Measurable disease according to RECIST criteria
  • Triple-negative breast cancer, defined as the following:

    • HER2-negative (according to active ASCO/CAP guidelines)
    • Estrogen receptor- and progesterone receptor-negative tumor defined as ≤ 1% by IHC
  • No evidence of active brain metastasis including leptomeningeal involvement

    • CNS metastasis allowed provided it is controlled after prior surgery and/or radiotherapy, as defined by the following criteria:

      • No symptoms for ≥ 2 months
      • No evidence of progression before study entry
      • Corticosteroid therapy to control brain edema has been discontinued

PATIENT CHARACTERISTICS:

  • Any menopausal status allowed
  • ECOG performance status 0-2
  • Life expectancy > 3 months
  • ANC ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 10.0 g/dL
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • SGOT and SGPT ≤ 3 times ULN (≤ 5 times ULN if the elevation is due to liver metastases)
  • Alkaline phosphatase ≤ 2.5 times ULN (≤ 5 times ULN if the elevations are due to liver metastases)
  • Serum creatinine ≤ 1.5 mg/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 30 days after completion of study treatment
  • Willing to return to NCCTG enrolling institution for treatment and follow-up
  • Willing to provide blood samples for research purposes
  • No other stage III or IV invasive malignancy within the past 5 years
  • No pre-existing peripheral neuropathy ≥ grade 2 (according to the active version of NCI CTCAE criteria)
  • No active, unresolved infection
  • No clinically significant cardiovascular or cerebrovascular disease within the past 6 months, including any of the following:

    • Myocardial infarction
    • Unstable angina
    • NYHA class II-IV congestive heart failure
    • Uncontrolled or clinically significant cardiac arrhythmia (patients with controlled atrial fibrillation are eligible)
  • Not immunocompromised (unless related to the use of corticosteroids), including known HIV-positivity with an AIDS-defining illness

    • HIV-positive patients whose CD4 count is normal and who have no history of an AIDS-defining illness are eligible
  • No concurrent uncontrolled illness including, but not limited to, psychiatric illness or social situation, co-morbid systemic illness, or other severe concurrent disease that, in the judgement of the investigator, would make the patient inappropriate for study entry, would interfere significantly with the proper assessment of safety of the prescribed treatment, would limit compliance with study requirements, or would make it undesirable for the patient to participate in the study
  • No history of allergy or hypersensitivity to the study drugs or to their excipients, including platinum compounds (e.g., cisplatin, carboplatin)

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No more than 4 prior chemotherapy regimens in the metastatic setting
  • More than 4 weeks since prior major surgery
  • More than 3 weeks since prior chemotherapy or immunologic therapy
  • More than 2 weeks since prior radiotherapy (except for radiotherapy to a non-target lesion) and recovered (acute adverse events ≤ grade 1 according to the current version of NCI CTCAE)

    • Prior radiotherapy to a target lesion allowed provided there has been clear progression of the lesion since radiotherapy was completed
    • Patients who receive a single dose of radiotherapy for palliation or radiotherapy to a non-target lesion may proceed to study registration without waiting 2 weeks
  • No concurrent treatment in another clinical study in which investigational procedures are performed or investigational therapies are administered

    • Patients may not enroll in such clinical trials while participating in this study
    • Exception may be granted for trials related to symptom management (cancer control) that do not employ hormonal treatments or treatments that may block the path of the targeted agents used in this study
  • No other concurrent chemotherapeutic agents, biologic agents, or radiotherapy
  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: NCT01091454

  Hide Study Locations
Locations
United States, Arizona
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
United States, Colorado
Aurora Presbyterian Hospital
Aurora, Colorado, United States, 80012
Boulder Community Hospital
Boulder, Colorado, United States, 80301-9019
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, United States, 80933
Presbyterian - St. Luke's Medical Center
Denver, Colorado, United States, 80218
Rose Medical Center
Denver, Colorado, United States, 80220
Porter Adventist Hospital
Denver, Colorado, United States, 80210
CCOP - Colorado Cancer Research Program
Denver, Colorado, United States, 80224-2522
St. Anthony Central Hospital
Denver, Colorado, United States, 80204
St. Joseph Hospital
Denver, Colorado, United States, 80218
Swedish Medical Center
Englewood, Colorado, United States, 80110
Front Range Cancer Specialists
Fort Collins, Colorado, United States, 80528
Poudre Valley Hospital
Fort Collins, Colorado, United States, 80524
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
Grand Junction, Colorado, United States, 81502
North Colorado Medical Center
Greeley, Colorado, United States, 80631
Sky Ridge Medical Center
Lone Tree, Colorado, United States, 80124
Hope Cancer Care Center at Longmont United Hospital
Longmont, Colorado, United States, 80501
McKee Medical Center
Loveland, Colorado, United States, 80539
St. Mary - Corwin Regional Medical Center
Pueblo, Colorado, United States, 81004
North Suburban Medical Center
Thornton, Colorado, United States, 80229
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States, 06105
United States, Florida
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, United States, 32207
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
United States, Hawaii
Kapiolani Medical Center at Pali Momi
Aiea, Hawaii, United States, 96701
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States, 96813
Hawaii Medical Center - East
Honolulu, Hawaii, United States, 96817
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826
OnCare Hawaii, Incorporated - Kuakini
Honolulu, Hawaii, United States, 96817
OnCare Hawaii, Incorporated - Lusitana
Honolulu, Hawaii, United States, 96813
Straub Clinic and Hospital, Incorporated
Honolulu, Hawaii, United States, 96813
Queen's Cancer Institute at Queen's Medical Center
Honolulu, Hawaii, United States, 96813
Kauai Medical Clinic
Lihue, Hawaii, United States, 96766
Maui Memorial Medical Center
Wailuku, Hawaii, United States, 96793
United States, Illinois
Rush-Copley Cancer Care Center
Aurora, Illinois, United States, 60504
St. Joseph Medical Center
Bloomington, Illinois, United States, 61701
Illinois CancerCare - Bloomington
Bloomington%, Illinois, United States, 61701
Illinois CancerCare - Canton
Canton, Illinois, United States, 61520
Graham Hospital
Canton, Illinois, United States, 61520
Illinois CancerCare - Carthage
Carthage, Illinois, United States, 62321
Illinois CancerCare - Eureka
Eureka, Illinois, United States, 61530
Eureka Community Hospital
Eureka, Illinois, United States, 61530
Galesburg Clinic, PC
Galesburg, Illinois, United States, 61401
Illinois CancerCare - Galesburg
Galesburg, Illinois, United States, 61401
Mason District Hospital
Havana, Illinois, United States, 62644
Illinois CancerCare - Havana
Havana, Illinois, United States, 62644
Illinois CancerCare - Kewanee Clinic
Kewanee, Illinois, United States, 61443
McDonough District Hospital
Macomb, Illinois, United States, 61455
Illinois CancerCare - Macomb
Macomb, Illinois, United States, 61455
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
Moline, Illinois, United States, 61265
Moline, Illinois, United States, 61265
Illinois CancerCare - Monmouth
Monmouth, Illinois, United States, 61462
OSF Holy Family Medical Center
Monmouth, Illinois, United States, 61462
Community Cancer Center
Normal, Illinois, United States, 61761
Illinois CancerCare - Community Cancer Center
Normal, Illinois, United States, 61761
BroMenn Regional Medical Center
Normal, Illinois, United States, 61761
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Ottawa, Illinois, United States, 61350
Community Hospital of Ottawa
Ottawa, Illinois, United States, 61350
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, United States, 61554
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61615
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, United States, 61615
OSF St. Francis Medical Center
Peoria, Illinois, United States, 61637
Proctor Hospital
Peoria, Illinois, United States, 61614
Illinois Valley Community Hospital
Peru, Illinois, United States, 61354
Illinois CancerCare - Peru
Peru, Illinois, United States, 61354
Illinois CancerCare - Princeton
Princeton, Illinois, United States, 61356
Perry Memorial Hospital
Princeton, Illinois, United States, 61356
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Indiana
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, United States, 46107
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States, 46360
Reid Hospital & Health Care Services
Richmond, Indiana, United States, 47374
United States, Iowa
McFarland Clinic, PC
Ames, Iowa, United States, 50010
Bettendorf, Iowa, United States, 52722
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa, United States, 52403
Mercy Regional Cancer Center at Mercy Medical Center
Cedar Rapids, Iowa, United States, 52403
Medical Oncology and Hematology Associates - West Des Moines
Clive, Iowa, United States, 50325
Mercy Cancer Center - West Lakes
Clive, Iowa, United States, 50325
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa, United States, 50314
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa, United States, 50309
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States, 51102
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States, 51101
St. Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
Methodist West Hospital
West Des Moines, Iowa, United States, 50266-7700
United States, Kansas
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States, 66701
Cancer Center of Kansas-Independence
Independence, Kansas, United States, 67301
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, United States, 67068
Lawrence Memorial Hospital
Lawrence, Kansas, United States, 66044
Cancer Center of Kansas, PA - Liberal
Liberal, Kansas, United States, 67901
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States, 67114
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States, 67357
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States, 67401
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States, 67152
CCOP - Wichita
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States, 67214
Associates in Womens Health, PA - North Review
Wichita, Kansas, United States, 67208
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States, 67208
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States, 67156
United States, Michigan
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, United States, 49221
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, United States, 48106-0995
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
Battle Creek Health System Cancer Care Center
Battle Creek, Michigan, United States, 49017
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, United States, 48123-2500
Green Bay Oncology, Limited - Escanaba
Escanaba, Michigan, United States, 49431
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Hurley Medical Center
Flint, Michigan, United States, 48503
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids, Michigan, United States, 49503
CCOP - Grand Rapids
Grand Rapids, Michigan, United States, 49503
Butterworth Hospital at Spectrum Health
Grand Rapids, Michigan, United States, 49503
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States, 48236
Dickinson County Healthcare System
Iron Mountain, Michigan, United States, 49801
Foote Memorial Hospital
Jackson, Michigan, United States, 49201
Sparrow Regional Cancer Center
Lansing, Michigan, United States, 48912-1811
St. Mary Mercy Hospital
Livonia, Michigan, United States, 48154
Mercy Memorial Hospital - Monroe
Monroe, Michigan, United States, 48162
Community Cancer Center of Monroe
Monroe, Michigan, United States, 48162
Mercy General Health Partners
Muskegon, Michigan, United States, 49443
St. Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341-2985
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan, United States, 48060
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan, United States, 48601
Munson Medical Center
Traverse City, Michigan, United States, 49684
St. John Macomb Hospital
Warren, Michigan, United States, 48093
United States, Minnesota
Alexandria, Minnesota, United States, 56308
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Miller - Dwan Medical Center
Duluth, Minnesota, United States, 55805
Duluth Clinic Cancer Center - Duluth
Duluth, Minnesota, United States, 55805-1983
CCOP - Duluth
Duluth, Minnesota, United States, 55805
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States, 55432
Hutchinson Area Health Care
Hutchinson, Minnesota, United States, 55350
Minnesota Oncology Hematology, PA - Maplewood
Maplewood, Minnesota, United States, 55109
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota, United States, 55109
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55415
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, United States, 55422-2900
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
Coborn Cancer Center
Saint Cloud, Minnesota, United States, 56303
CentraCare Clinic - River Campus
Saint Cloud, Minnesota, United States, 56303
Park Nicollet Cancer Center
Saint Louis Park, Minnesota, United States, 55416
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
United Hospital
Saint Paul, Minnesota, United States, 55102
St. Francis Cancer Center at St. Francis Medical Center
Shakopee, Minnesota, United States, 55379
Regions Hospital Cancer Care Center
St. Paul, Minnesota, United States, 55101
Lakeview Hospital
Stillwater, Minnesota, United States, 55082
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Willmar Cancer Center at Rice Memorial Hospital
Willmar, Minnesota, United States, 56201
Minnesota Oncology Hematology, PA - Woodbury
Woodbury, Minnesota, United States, 55125
United States, Missouri
Southeast Cancer Center
Cape Girardeau, Missouri, United States, 63703
Goldschmidt Cancer Center
Jefferson City, Missouri, United States, 65109
Missouri Baptist Cancer Center
Saint Louis, Missouri, United States, 63131
Comprehensive Cancer Care, PC
Saint Louis, Missouri, United States, 63141
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65802
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States, 65807
St. John's Regional Health Center
Springfield, Missouri, United States, 65804
United States, Montana
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, United States, 59102
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
Billings Clinic - Downtown
Billings, Montana, United States, 59107-7000
Bozeman Deaconess Cancer Center
Bozeman, Montana, United States, 59715
St. James Healthcare Cancer Care
Butte, Montana, United States, 59701
Great Falls Clinic - Main Facility
Great Falls, Montana, United States, 59405
Big Sky Oncology
Great Falls, Montana, United States, 59405-5309
Sletten Cancer Institute at Benefis Healthcare
Great Falls, Montana, United States, 59405
Northern Montana Hospital
Havre, Montana, United States, 59501
St. Peter's Hospital
Helena, Montana, United States, 59601
Glacier Oncology, PLLC
Kalispell, Montana, United States, 59901
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Kalispell Medical Oncology at KRMC
Kalispell, Montana, United States, 59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States, 59807
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States, 59807-7877
United States, Nebraska
Cancer Resource Center - Lincoln
Lincoln, Nebraska, United States, 68510
Immanuel Medical Center
Omaha, Nebraska, United States, 68122
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
Creighton University Medical Center
Omaha, Nebraska, United States, 68131-2197
Alegant Health Cancer Center at Bergan Mercy Medical Center
Omaha, Nebraska, United States, 68124
Lakeside Hospital
Omaha, Nebraska, United States, 68130
United States, New Mexico
Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital
Albuquerque, New Mexico, United States, 87110
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87131-5636
United States, North Dakota
Mid Dakota Clinic, PC
Bismarck, North Dakota, United States, 58501
Bismarck Cancer Center
Bismarck, North Dakota, United States, 58501
Medcenter One Hospital Cancer Care Center
Bismarck, North Dakota, United States, 58501
St. Alexius Medical Center Cancer Center
Bismarck, North Dakota, United States, 58502
Altru Cancer Center at Altru Hospital
Grand Forks, North Dakota, United States, 58201
United States, Ohio
Wood County Oncology Center
Bowling Green, Ohio, United States, 43402
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
Doctors Hospital at Ohio Health
Columbus, Ohio, United States, 43228
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States, 43214-3998
Grant Medical Center Cancer Care
Columbus, Ohio, United States, 43215
CCOP - Columbus
Columbus, Ohio, United States, 43215
Mount Carmel Health - West Hospital
Columbus, Ohio, United States, 43222
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States, 45409
CCOP - Dayton
Dayton, Ohio, United States, 45420
Good Samaritan Hospital
Dayton, Ohio, United States, 45406
Samaritan North Cancer Care Center
Dayton, Ohio, United States, 45415
Grandview Hospital
Dayton, Ohio, United States, 45405
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Hematology Oncology Center
Elyria, Ohio, United States, 44035
Community Cancer Center
Elyria, Ohio, United States, 44035
Blanchard Valley Medical Associates
Findlay, Ohio, United States, 45840
Middletown Regional Hospital
Franklin, Ohio, United States, 45005-1066
Wayne Hospital
Greenville, Ohio, United States, 45331
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States, 45429
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
Lima Memorial Hospital
Lima, Ohio, United States, 45804
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
Northwest Ohio Oncology Center
Maumee, Ohio, United States, 43537-1839
Knox Community Hospital
Mount Vernon, Ohio, United States, 43050
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, United States, 43055
Fisher-Titus Medical Center
Norwalk, Ohio, United States, 44857
Toledo Clinic - Oregon
Oregon, Ohio, United States, 43616
St. Charles Mercy Hospital
Oregon, Ohio, United States, 43616
Southern Ohio Medical Center Cancer Center
Portsmouth, Ohio, United States, 45662
Community Hospital of Springfield and Clark County
Springfield, Ohio, United States, 45505
Flower Hospital Cancer Center
Sylvania, Ohio, United States, 43560
Mercy Hospital of Tiffin
Tiffin, Ohio, United States, 44883
CCOP - Toledo Community Hospital
Toledo, Ohio, United States, 43617
St. Anne Mercy Hospital
Toledo, Ohio, United States, 43623
Medical University of Ohio Cancer Center
Toledo, Ohio, United States, 43614
St. Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
Toledo Clinic, Incorporated - Main Clinic
Toledo, Ohio, United States, 43623
Toledo Hospital
Toledo, Ohio, United States, 43606
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States, 45373-1300
Fulton County Health Center
Wauseon, Ohio, United States, 43567
Mount Carmel St. Ann's Cancer Center
Westerville, Ohio, United States, 43081
United States Air Force Medical Center - Wright-Patterson
Wright-Patterson Afb, Ohio, United States, 45433-5529
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, United States, 45385
Genesis - Good Samaritan Hospital
Zanesville, Ohio, United States, 43701
United States, Oklahoma
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, United States, 74136
United States, Pennsylvania
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, United States, 17822-0001
Geisinger Hazleton Cancer Center
Hazleton, Pennsylvania, United States, 18201
Geisinger Medical Group - Scenery Park
State College, Pennsylvania, United States, 16801
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States, 18711
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57701
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, United States, 57117-5039
United States, Virginia
Fredericksburg Oncology, Incorporated
Fredericksburg, Virginia, United States, 22401
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
United States, Wisconsin
Marshfield Clinic - Chippewa Center
Chippewa Falls, Wisconsin, United States, 54729
Center for Cancer Treatment & Prevention at Sacred Heart Hospital
Eau Claire, Wisconsin, United States, 54701
Marshfield Clinic Cancer Care at Regional Cancer Center
Eau Claire, Wisconsin, United States, 54701
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, United States, 54303
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54301-3526
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54307-3508
Holy Family Memorial Medical Center Cancer Care Center
Manitowoc, Wisconsin, United States, 54221-1450
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States, 54449
Marshfield Clinic - Lakeland Center
Minocqua, Wisconsin, United States, 54548
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls, Wisconsin, United States, 54154
Ministry Medical Group at Saint Mary's Hospital
Rhinelander, Wisconsin, United States, 54501
Marshfield Clinic - Indianhead Center
Rice Lake, Wisconsin, United States, 54868
St. Nicholas Hospital
Sheboygan, Wisconsin, United States, 53081
Marshfield Clinic at Saint Michael's Hospital
Stevens Point, Wisconsin, United States, 54481
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States, 54235
Marshfield Clinic - Weston Center
Weston, Wisconsin, United States, 54476
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, United States, 54494
United States, Wyoming
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan, Wyoming, United States, 82801
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Principal Investigator: Alvaro Moreno Aspitia, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Joseph L. Pater, Cancer Research Institute at Queen's University
ClinicalTrials.gov Identifier: NCT01091454     History of Changes
Other Study ID Numbers: CDR0000665441, NCCTG-N0937
Study First Received: March 18, 2010
Last Updated: March 24, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
triple-negative breast cancer
male breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2014