Cixutumumab and Temsirolimus in Treating Patients With Locally Recurrent or Metastatic Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00699491
First received: June 17, 2008
Last updated: June 9, 2014
Last verified: June 2014
  Purpose

This phase I/II trial is studying the side effects and best dose of IMC-A12 when given together with temsirolimus and to see how well they work in treating patients with locally recurrent or metastatic breast cancer. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving IMC-A12 together with temsirolimus may kill more tumor cells.


Condition Intervention Phase
Male Breast Cancer
Recurrent Breast Cancer
Stage IV Breast Cancer
Biological: cixutumumab
Drug: temsirolimus
Other: laboratory biomarker analysis
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Trial of IMC-A12 in Combination With Temsirolimus in Patients With Metastatic Breast Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Recommended dose level for phase II testing (RPTD) (Phase I) [ Time Frame: During first course ] [ Designated as safety issue: Yes ]
    The RPTD is defined as the highest dose level at which at most one of 6 patients develops a dose limiting toxicity (DLT) during the first course of treatment. A two-stage Simon Phase II clinical trial design will be used to assess the toxicity profile of the combination of Temsirolimus and IMC-A12 at the recommended phase II dose in patients with metastatic breast cancer.

  • Tumor response rate (TRR) (Complete response [CR] or partial response [PR]) by the Response Evaluation Criteria in Solid Tumors (RECIST) (phase II) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    A two-stage Simon Phase II clinical trial design will be used to assess the anti-tumor activity of the combination of Temsirolimus and IMC-A12 at the recommended phase II dose in patients with metastatic breast cancer. A ninety percent confidence interval for the true tumor response rate will be calculated using the Duffy-Santer approach.


Secondary Outcome Measures:
  • Adverse events graded using the NCI CTCAE version. 3 (phase II) [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
    The maximum grade for each adverse event considered to be 'at least possibly related to treatment' will be recorded. Frequency tables will be constructed.

  • Duration of response (phase II) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Duration of response is defined for all evaluable patients with changes in disease burden that met the RECIST criteria for CR or PR on 2 consecutive evaluations at least 6-8 weeks apart as the date at which the CR or PR to the date progression is documented. The distribution of response durations will be estimated using the Kaplan-Meier method.

  • PFS (phase II) [ Time Frame: Time from registration to documentation of disease progression ] [ Designated as safety issue: No ]
    The distribution of PFS times will be estimated using the Kaplan-Meier method.

  • PFS rate [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
    A point and interval estimate of the 6 month PFS rate will be obtained using the Kaplan-Meier method.

  • Survival time (phase II) [ Time Frame: Time from registration to death due to any cause ] [ Designated as safety issue: No ]
    The distribution of survival time will be estimated using the method of Kaplan-Meier.


Enrollment: 48
Study Start Date: October 2008
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (monoclonal antibody and enzyme inhibitor therapy)

Phase I patients were accrued in 3 patient cohorts to assess toxicity. In sequence, each cohort received the following treatment:

  • temsirolimus IV over 30 minutes on days 1, 8, 15, and 22 (25 mg in cohort I, 20 mg in cohort 2, 15 mg in cohort 3, 4, and 5).
  • cixutumumab IV over 60 minutes on days 1, 8, 15, and 22 (3 mg/ks in cohort 1, 2, and 3; 4 mg/kg in cohort 4, and 5 mg/kg in cohort 5).

Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Phase II patients receive the recommended phase II dose determined in the phase I portion.

  • 15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
  • 4 mg/kg cixutumumab IV over 60 minues on days 1, 8, 15, and 22.

Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Biological: cixutumumab
Given IV
Other Names:
  • anti-IGF-1R recombinant monoclonal antibody IMC-A12
  • IMC-A12
Drug: temsirolimus
Given IV
Other Names:
  • CCI-779
  • cell cycle inhibitor 779
  • Torisel
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. To establish the recommended dose level of cixutumumab and temsirolimus for the phase II study in patients with metastatic breast cancer. (Phase I) II. To examine the safety profile of this combination in patients with metastatic breast cancer. (Phase I) III. To assess the anti-tumor activity (in terms of overall response rate) and toxicity profile of cixutumumab in combination with temsirolimus in patients with metastatic breast cancer. (Phase II)

SECONDARY OBJECTIVES:

I. To estimate the progression-free survival (PFS) and overall survival distributions (as well as the 6-month PFS rate).

II. To evaluate the in vivo mechanisms of action of temsirolimus in combination with cixutumumab and to examine potential biomarker predictors of treatment response.

OUTLINE: This is a dose-escalation study of cixutumumab. Patients receive temsirolimus IV over 30 minutes and cixutumumab IV over 60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Peripheral blood samples are collected periodically for circulating markers and mononuclear cells. Samples are analyzed for pharmacodynamic assessments via western blot and proteomic studies. If pre-existing tumor tissue is available, tissue is examined by immunohistochemical staining for markers (e.g., pIRS-1, pIGF-IR, pMAPK, pAKT [S473], pS6, PTEN, Stathmin). Fluorescence in situ hybridization is used to assess IGF-IR amplification. Gene resequencing is performed to identify mutations of PIK3CA (exons 9 and 20), AKT1, and other genes. Genes IGF-1, IGF-II, IGFBP-1, IGFBP-3, and others are analyzed by reverse transcriptase-polymerase chain reaction.

After completion of study treatment, patients are followed up periodically for up to 2 (phase I) or 5 (phase II) years.

  Eligibility

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

Inclusion Criteria:

  • Histologically confirmed diagnosis of breast cancer

    • Metastatic or locally recurrent disease (locally recurrent disease should be stage IV [e.g, chest wall involvement])
  • Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm by conventional techniques or as ≥ 10 mm by spiral CT scan (phase II only)
  • Must have received at least 1, but no more than 2, prior chemotherapy regimens in the setting of metastatic or locally recurrent (stage IV chest wall involvement) disease (phase II only)
  • No uncontrolled brain metastases

    • Brain metastases are not permitted on study unless the metastases have been treated by surgery or radiotherapy, and the patient has been neurologically stable and off of steroids for ≥ 12 weeks
  • ECOG performance status (PS) 0-1 OR Karnofsky PS 80-100%
  • Life expectancy > 12 weeks
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after completion of study treatment
  • Absolute neutrophil count ≥ 1,500/μL
  • Hemoglobin ≥ 8.5 g/dL
  • Platelets ≥ 100,000/μL
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 3 times ULN (5 times ULN if LFT elevations due to liver metastases)
  • Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
  • Fasting serum cholesterol ≤ 350 mg/dL (9.0 mmol/L)
  • Fasting triglycerides ≤ 400 mg/dL (4.56 mmol/L)
  • Albumin ≥ 3.4 mg/dL
  • Fasting serum glucose < 120 mg/dL
  • No baseline diabetes requiring oral hypoglycemics or insulin (phase I only)
  • No poorly controlled diabetes mellitus (phase II only)

    • Patients with a history of diabetes mellitus on oral hypoglycemics or insulin are allowed to participate, provided that their fasting blood glucose is < 120 mg/dL and that they are on a stable dietary or therapeutic regimen for this condition
  • No prior invasive non-breast malignancy, except for adequately treated basal cell or squamous cell carcinoma of the skin or other cancer from which the patient has been disease free for ≥ 5 years
  • No known hypersensitivity reactions to macrolide antibiotics (such as erythromycin, clarithromycin, and azithromycin)
  • No allergic reactions attributed to compounds of similar chemical or biologic composition toanti-IGF-1R recombinant monoclonal antibody IMC-A12 or temsirolimus
  • Known HIV-positive patients who have CD4 counts below the normal range are not eligible
  • No uncontrolled intercurrent illness including, but not limited to:

    • Ongoing or active infection
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Uncontrolled symptomatic cardiac arrhythmia
    • Psychiatric illness/social situations that would limit compliance with study requirements
  • No systemic anticancer therapy within the past 3 weeks
  • No radiotherapy within the past 2 weeks
  • No prior treatment with agents targeting the IGF-IR/IGFs or PI3K/Akt/mT OR pathway
  • Any number of prior therapy regimens allowed (phase I only)
  • No concurrent hormonal agents used for the treatment of breast cancer with the exception that premenopausal women who have been on a gonadotrophin-releasing hormone (GnRH)agonist and subsequently progressed may, at the discretion of the treating physician, continue on the GnRH agonist
  • No other concurrent investigational agents or herbal preparations
  • No concurrent oral corticosteroids except for replacement for adrenal insufficiency
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No concurrent enzyme-inducing antiepileptic drugs (EIAEDs) (e.g., phenytoin, carbamazepine, phenobarbital) or any other CYP3A4 inducer such as rifampin or Hypericum perforatum (St. John's wort)
  • No other concurrent chemotherapy 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: NCT00699491

  Hide Study Locations
Locations
United States, California
Palo Alto Medical Foundation Heath Care
Palo Alto, California, United States, 94301
Valley Medical Oncology Consultants
Pleasanton, California, United States, 94588
United States, Colorado
The Medical Center of Aurora
Aurora, Colorado, United States, 80012
Boulder Community Hospital
Boulder, Colorado, United States, 80301
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States, 80907
Rose Medical Center
Denver, Colorado, United States, 80220
Colorado Cancer Research Program CCOP
Denver, Colorado, United States, 80224-2522
Exempla Saint Joseph Hospital
Denver, Colorado, United States, 80218
Porter Adventist Hospital
Denver, Colorado, United States, 80210
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, United States, 80218
Swedish Medical Center
Englewood, Colorado, United States, 80113
North Colorado Medical Center
Greeley, Colorado, United States, 80631
Saint Anthony Hospital
Lakewood, Colorado, United States, 80228
Sky Ridge Medical Center
Lone Tree, Colorado, United States, 80124
Longmont United Hospital
Longmont, Colorado, United States, 80501
McKee Medical Center
Loveland, Colorado, United States, 80539
Saint Mary Corwin Medical Center
Pueblo, Colorado, United States, 81004
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States, 06105
United States, Delaware
Beebe Medical Center
Lewes, Delaware, United States, 19958
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States, 19718
United States, Florida
Florida Hospital
Orlando, Florida, United States, 32803
United States, Georgia
John B Amos Cancer Center
Columbus, Georgia, United States, 31904
United States, Hawaii
Oncare Hawaii Inc-Pali Momi
Aiea, Hawaii, United States, 96701
Pali Momi Medical Center
Aiea, Hawaii, United States, 96701
University of Hawaii
Honolulu, Hawaii, United States, 96813
Oncare Hawaii Inc-Kuakini
Honolulu, Hawaii, United States, 96817
Oncare Hawaii Inc-POB II
Honolulu, Hawaii, United States, 96813
Queen's Medical Center
Honolulu, Hawaii, United States, 96813
Straub Clinic and Hospital
Honolulu, Hawaii, United States, 96813
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826
Castle Medical Center
Kailua, Hawaii, United States, 96734
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, United States, 96766
United States, Idaho
Saint Alphonsus Regional Medical Center
Boise, Idaho, United States, 83706
United States, Illinois
Rush - Copley Medical Center
Aurora, Illinois, United States, 60504
Saint 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 Association
Canton, Illinois, United States, 61520
Illinois CancerCare-Carthage
Carthage, Illinois, United States, 62321
Memorial Hospital
Carthage, Illinois, United States, 62321
Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
University of Chicago
Chicago, Illinois, United States, 60637
Eureka Hospital
Eureka, Illinois, United States, 61530
Illinois CancerCare-Eureka
Eureka, Illinois, United States, 61530
Illinois CancerCare Galesburg
Galesburg, Illinois, United States, 61401
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Illinois CancerCare-Havana
Havana, Illinois, United States, 62644
Mason District Hospital
Havana, Illinois, United States, 62644
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, United States, 61443
Illinois CancerCare-Macomb
Macomb, Illinois, United States, 61455
Mcdonough District Hospital
Macomb, Illinois, United States, 61455
Holy Family Medical Center
Monmouth, Illinois, United States, 61462
Illinois CancerCare-Monmouth
Monmouth, Illinois, United States, 61462
Community Cancer Center Foundation
Normal, Illinois, United States, 61761
Bromenn Regional Medical Center
Normal, Illinois, United States, 61761
Illinois CancerCare-Community Cancer Center
Normal, Illinois, United States, 61761
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States, 61350
Ottawa Regional Hospital and Healthcare Center
Ottawa, Illinois, United States, 61350
Illinois CancerCare-Pekin
Pekin, Illinois, United States, 61603
Pekin Cancer Treatment Center
Pekin, Illinois, United States, 61554
Illinois CancerCare-Peoria
Peoria, Illinois, United States, 61615
Illinois Oncology Research Association CCOP
Peoria, Illinois, United States, 61615
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61637
Proctor Hospital
Peoria, Illinois, United States, 61614
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61603
Illinois Valley 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
Illinois CancerCare-Spring Valley
Spring Valley, Illinois, United States, 61362
Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Indiana
Franciscan Saint Francis Health-Indianapolis
Indianapolis, Indiana, United States, 46237
Reid Hospital and Health Care Services
Richmond, Indiana, United States, 47374
United States, Iowa
Siouxland Hematology Oncology Associates
Sioux City, Iowa, United States, 51101
Saint Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
Mercy Medical Center-Sioux City
Sioux City, Iowa, United States, 51104
United States, Kansas
Menorah Medical Center
Overland Park, Kansas, United States, 66209
Saint Luke's South Hospital
Overland Park, Kansas, United States, 66213
Kansas City CCOP
Prairie Village, Kansas, United States, 66208
United States, Maryland
Union Hospital of Cecil County
Elkton MD, Maryland, United States, 21921
United States, Michigan
Hickman Cancer Center
Adrian, Michigan, United States, 49221
Bixby Medical Center
Adrian, Michigan, United States, 49221
Michigan Cancer Research Consortium Community Clinical Oncology Program
Ann Arbor, Michigan, United States, 48106
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106-0995
Oakwood Hospital
Dearborn, Michigan, United States, 48124
Saint John Hospital and Medical Center
Detroit, Michigan, United States, 48236
Green Bay Oncology - Escanaba
Escanaba, Michigan, United States, 49431
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, United States, 48532
Hurley Medical Center
Flint, Michigan, United States, 48502
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Green Bay Oncology - Iron Mountain
Iron Mountain, Michigan, United States, 49801
Allegiance Health
Jackson, Michigan, United States, 49201
Sparrow Hospital
Lansing, Michigan, United States, 48912
Saint Mary Mercy Hospital
Livonia, Michigan, United States, 48154
Mercy Memorial Hospital
Monroe, Michigan, United States, 48162
Community Cancer Center of Monroe
Monroe, Michigan, United States, 48162
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341-2985
Saint Joseph Mercy Port Huron
Port Huron, Michigan, United States, 48060
Saint Mary's of Michigan
Saginaw, Michigan, United States, 48601
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States, 48093
United States, Minnesota
Miller-Dwan Hospital
Duluth, Minnesota, United States, 55805
Essentia Health Duluth Clinic CCOP
Duluth, Minnesota, United States, 55805
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, United States, 55805
Mayo Clinic
Rochester, Minnesota, United States, 55905
Saint Cloud Hospital
Saint Cloud, Minnesota, United States, 56303
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, United States, 56303
United States, Missouri
Heartland Hematology and Oncology Associates Incorporated
Kansas City, Missouri, United States, 64118
North Kansas City Hospital
Kansas City, Missouri, United States, 64116
Research Medical Center
Kansas City, Missouri, United States, 64132
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, United States, 64086
Saint Joseph Oncology Inc
Saint Joseph, Missouri, United States, 64507
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Nebraska
Nebraska Cancer Research Center
Lincoln, Nebraska, United States, 68510
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, United States, 68124
Alegent Health Immanuel Medical Center
Omaha, Nebraska, United States, 68122
Alegent Health Lakeside Hospital
Omaha, Nebraska, United States, 68130
Missouri Valley Cancer Consortium CCOP
Omaha, Nebraska, United States, 68106
Creighton University Medical Center
Omaha, Nebraska, United States, 68131
United States, New Jersey
Cooper Hospital University Medical Center
Camden, New Jersey, United States, 08103
United States, New York
Glens Falls Hospital
Glens Falls, New York, United States, 12801
United States, North Carolina
Randolph Hospital
Asheboro, North Carolina, United States, 27203
Wayne Memorial Hospital
Goldsboro, North Carolina, United States, 27534
Cone Health Cancer Center
Greensboro, North Carolina, United States, 27403
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, United States, 28791
Annie Penn Memorial Hospital
Reidsville, North Carolina, United States, 27320
United States, North Dakota
Bismarck Cancer Center
Bismarck, North Dakota, United States, 58501
Mid Dakota Clinic
Bismarck, North Dakota, United States, 58501
Saint Alexius Medical Center
Bismarck, North Dakota, United States, 58501
Altru Cancer Center
Grand Forks, North Dakota, United States, 58201
United States, Ohio
Toledo Clinic Cancer Centers-Bowling Green
Bowling Green, Ohio, United States, 43402
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
Mount Carmel Health Center West
Columbus, Ohio, United States, 43222
Columbus CCOP
Columbus, Ohio, United States, 43215
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Doctors Hospital
Columbus, Ohio, United States, 43228
Grant Medical Center
Columbus, Ohio, United States, 43215
Dayton CCOP
Dayton, Ohio, United States, 45420
Samaritan North Health Center
Dayton, Ohio, United States, 45415
Good Samaritan Hospital - Dayton
Dayton, Ohio, United States, 45406
Miami Valley Hospital
Dayton, Ohio, United States, 45409
Grandview Hospital
Dayton, Ohio, United States, 45405
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Hematology Oncology Center Incorporated
Elyria, Ohio, United States, 44035
Mercy Cancer Center-Elyria
Elyria, Ohio, United States, 44035
Blanchard Valley Hospital
Findlay, Ohio, United States, 45840
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, United States, 45005-1066
Wayne Hospital
Greenville, Ohio, United States, 45331
Kettering Medical Center
Kettering, Ohio, United States, 45429
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
Lima Memorial Hospital
Lima, Ohio, United States, 45804
Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
Toledo Clinic Cancer Centers-Maumee
Maumee, Ohio, United States, 43537
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
Maumee, Ohio, United States, 43537
Knox Community Hospital
Mount Vernon, Ohio, United States, 43050
Licking Memorial Hospital
Newark, Ohio, United States, 43055
Toledo Clinic Cancer Centers-Oregon
Oregon, Ohio, United States, 43616
Saint Charles Hospital
Oregon, Ohio, United States, 43616
Southern Ohio Medical Center
Portsmouth, Ohio, United States, 45662
Springfield Regional Medical Center
Springfield, Ohio, United States, 45505
Flower Hospital
Sylvania, Ohio, United States, 43560
Mercy Hospital of Tiffin
Tiffin, Ohio, United States, 44883
Toledo Community Hospital Oncology Program CCOP
Toledo, Ohio, United States, 43617
Saint Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
The Toledo Hospital/Toledo Children's Hospital
Toledo, Ohio, United States, 43606
Mercy Saint Anne Hospital
Toledo, Ohio, United States, 43623
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, United States, 43623
University of Toledo
Toledo, Ohio, United States, 43614
Upper Valley Medical Center
Troy, Ohio, United States, 45373
Fulton County Health Center
Wauseon, Ohio, United States, 43567
Saint Ann's Hospital
Westerville, Ohio, United States, 43081
Greene Memorial Hospital
Xenia, Ohio, United States, 45385
Genesis HealthCare System
Zanesville, Ohio, United States, 43701
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Natalie Warren Bryant Cancer Center at Saint Francis
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Legacy Mount Hood Medical Center
Gresham, Oregon, United States, 97030
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, United States, 97210
Legacy Meridian Park Hospital
Tualatin, Oregon, United States, 97062
United States, Virginia
Fredericksburg Oncology Inc
Fredericksburg, Virginia, United States, 22401
United States, Washington
Legacy Salmon Creek Hospital
Vancouver, Washington, United States, 98686
United States, Wisconsin
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301-3526
Saint Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301
Gundersen Lutheran
La Crosse, Wisconsin, United States, 54601
Holy Family Memorial Hospital
Manitowoc, Wisconsin, United States, 54221
Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Green Bay Oncology - Oconto Falls
Oconto Falls, Wisconsin, United States, 54154
Saint Nicholas Hospital
Sheboygan, Wisconsin, United States, 53081
Green Bay Oncology - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States, 54235
Sponsors and Collaborators
Investigators
Principal Investigator: Cynthia Ma Mayo Clinic
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00699491     History of Changes
Other Study ID Numbers: NCI-2009-00284, NCI-2009-00284, CDR0000598057, MC0736, 8129, P30CA015083, N01CM00099
Study First Received: June 17, 2008
Last Updated: June 9, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms, Male
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Sirolimus
Everolimus
Antibodies, Monoclonal
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014