AzTrials
AzTrials

Breast CancerPhase 3BETHNCT00625898

BETH Study: Treatment of HER2 Positive Breast Cancer With Chemotherapy Plus Trastuzumab vs Chemotherapy Plus Trastuzumab Plus Bevacizumab

A Phase 3 study testing Docetaxel, Trastuzumab and Carboplatin in people with Breast Cancer, run by NSABP Foundation Inc at 649 sites in 40 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The trial will determine the value of adding bevacizumab to chemotherapy plus trastuzumab in patients with resected node-positive or high risk node-negative, HER2-positive breast cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Docetaxel, Trastuzumab and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,509 participants
Where
649 sitesin 40 countries
Study dates
Apr 2008to Jul 2014
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Life expectancy of at least 10 years, excluding their diagnosis of breast cancer.
  • Women who have had breast reconstruction utilizing tissue expanders must be in agreement with delaying surgery to replace the tissue expanders with permanent implants until 3 months following the last dose of bevacizumab
  • Women of reproductive potential must agree to use an effective non-hormonal method of contraception (for example condoms, some intrauterine devices, diaphragms, vasectomized partner, or abstinence) during therapy and for at least 6 months after the last dose of bevacizumab and/or trastuzumab.
  • Submission of tumor samples from the breast surgery for central HER2 testing is required for all patients prior to enrollment in the BETH Trial
  • Signed and dated IRB/EC-approved consent
  • ECOG performance status of 0 or 1
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  • The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination.
  • The breast cancer must be HER2-positive based on test results as follows: Local testing (if available) should demonstrate that the tumor is IHC 2+ or 3+ or is considered to be HER2-positive for gene amplification by FISH, CISH, or other in situ hybridization (ISH) method. If local ISH test results are considered equivocal, the tumor can be submitted for central HER2 testing. (If local testing is not possible, the tumor can be submitted for central HER2 testing.) Central testing (a requirement for ALL patients) must demonstrate that the tumor is HER2-positive which is defined as FISH-positive and/or IHC 3+.
  • All of the following staging criteria (according to the 6th edition of the AJCC Cancer Staging Manual) must be met: By pathologic evaluation, primary tumor must be pT1-3; By pathologic evaluation, ipsilateral nodes must be pN0, pN1 (pN1mi, pN1a, pN1b, pN1c), pN2a, pN3a, or pN3b. If pN0, at least one of the following criteria must be met: Pathologic tumor size > 2.0 cm; ER negative and PgR negative; Histologic and/or nuclear grade 2 (intermediate) or 3 (high); or Age < 35 years
  • Patients must have undergone either a total mastectomy or breast conserving surgery (lumpectomy).
  • For patients who undergo lumpectomy, the margins of the resected specimen must be histologically free of invasive tumor and ductal carcinoma in situ (DCIS) as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional operative procedures may be performed to obtain clear margins. If tumor is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible. (Patients with margins positive for lobular carcinoma in situ [LCIS] are eligible without additional resection.)
  • For patients who undergo mastectomy, margins must be free of gross residual tumor. Patients with microscopic positive margins are eligible.
  • Patients must have completed one of the following procedures for evaluation of pathologic nodal status: Sentinel lymphadenectomy followed by removal of additional non-sentinel lymph nodes if the sentinel node (SN) is positive; Sentinel lymphadenectomy alone if pathologic nodal staging based on sentinel lymphadenectomy is pN0, pN1mi or pN1b; or Axillary lymphadenectomy without SN isolation procedure.
  • The interval between the last surgery for breast cancer (treatment or staging) and randomization must be at least 28 days but no more than 84 days.
  • Patients must have ER analysis performed on the primary tumor prior to randomization. If ER analysis is negative, then PgR analysis must also be performed.
  • The most recent postoperative blood counts, performed within 6 weeks prior to randomization, must meet the following criteria: ANC must be greater than or equal to 1200/mm3; Platelet count must be greater than or equal to 100,000/mm3; and Hemoglobin must be greater than or equal to 10 g/dL.
  • The following criteria for evidence of adequate hepatic function must be met based on the results of the most recent postoperative tests performed within 6 weeks prior to randomization: total bilirubin must be less than or equal to upper limit of normal (ULN) for the lab unless the patient has a bilirubin elevation > ULN to 1.5 x ULN due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and alkaline phosphatase must be less than or equal to 2.5 x ULN for the lab; and AST must be less than or equal to 1.5 x ULN for the lab. Alkaline phosphatase and AST may not both be > the ULN.
  • Patients with AST or alkaline phosphatase > ULN are eligible for inclusion in the study if liver imaging (CT, MRI, PET scan, or PET-CT scan performed within 3 months prior to randomization) does not demonstrate metastatic disease and the requirements for evidence of adequate hepatic function are met.
  • Patients with alkaline phosphatase that is > ULN but less than or equal to 2.5 x ULN are eligible for inclusion in the study if a bone scan,PET scan, or PET-CT scan (performed within 3 months prior to randomization) does not demonstrate metastatic disease.
  • The following criteria for renal function must be met based on the results of the most recent postoperative tests performed within 6 weeks prior to randomization: Serum creatinine must be less than or equal to ULN for the lab. Measured or calculated creatinine clearance must be > 60 mL/min.
  • A urine sample must be tested for protein by determination of the urine protein/creatinine (UPC) ratio or by urine dipstick. UPC ratio must be less than 1.0. Urine dipstick must indicate 0-1+ protein. If dipstick reading is greater than or equal to 2+, determine the UPC ratio, which must be less than 1.0, or collect a 24-hour urine specimen, which must demonstrate < 1.0 g of protein per 24 hours.
  • LVEF assessment must be performed within 3 months prior to randomization. The LVEF must be greater than or equal to 55% regardless of the cardiac imaging facility's lower limit of normal (LLN).
  • The ECG (performed within 3 months prior to randomization) must not have demonstrated any of the following conditions: ventricular arrhythmias except for benign premature ventricular contractions; supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication; and conduction abnormality requiring a pacemaker.

Who cannot join

  • Inflammatory breast cancer.
  • Definitive clinical or radiologic evidence of metastatic disease. (Chest imaging [mandatory for all patients] and other imaging [if required] must have been performed within 3 months prior to randomization.)
  • Synchronous or previous contralateral invasive breast cancer (Patients with synchronous or previous contralateral DCIS or LCIS are eligible).
  • History of ipsilateral invasive breast cancer regardless of treatment or ipsilateral DCIS treated with excision and RT. (Patients with history of ipsilateral LCIS are eligible.)
  • History of non-breast malignancies within the 5 years prior to study entry, except for the following: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinomas of the skin.
  • Previous therapy with anthracyclines, taxanes, carboplatin, trastuzumab, or bevacizumab for any malignancy.
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  • RT, chemotherapy, and/or targeted therapy, administered for the currently diagnosed breast cancer prior to randomization.
  • Continued therapy with any hormonal agent such as raloxifene or tamoxifen (or other SERM) or an aromatase inhibitor. (Patients are eligible if these medications are discontinued prior to randomization.)
  • Any sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy, etc. Patients are eligible if these medications are discontinued prior to randomization.
  • Cardiac disease (history of and/or active disease) that would preclude the use of the drugs included in the treatment regimens. This includes but is not confined to: Active cardiac disease - angina pectoris that requires the use of anti-anginal medication; ventricular arrhythmias except for benign premature ventricular contractions; supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication; conduction abnormality requiring a pacemaker; valvular disease with documented compromise in cardiac function; and symptomatic pericarditis. History of cardiac disease - myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LV function; history of documented CHF; and documented cardiomyopathy.
  • Uncontrolled hypertension defined as systolic blood pressure (BP) > 150 mmHg or diastolic BP > 90 mmHg, with or without anti-hypertensive medication. (BP must be assessed within 28 days prior to randomization.) Patients with initial BP elevations are eligible if initiation or adjustment of BP medication lowers pressure to meet entry criteria.
  • History of hypertensive crisis or hypertensive encephalopathy.
  • History of TIA or CVA.
  • History of any arterial thrombotic event within 12 months before randomization.
  • Symptomatic peripheral vascular disease.
  • Intrinsic lung disease resulting in dyspnea.
  • Unstable diabetes mellitus.
  • Active infection or chronic infection requiring chronic suppressive antibiotics.
  • Any significant bleeding within 6 months before randomization, exclusive of menorrhagia in premenopausal women.
  • Non-healing wound, skin ulcers, or incompletely healed bone fracture.
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to planned start of study therapy.
  • Anticipation of need for major surgical procedures during study therapy and for at least 3 months following completion of bevacizumab.
  • Gastroduodenal ulcer(s) documented by endoscopy to be active within 6 months before randomization.
  • History of GI perforation, abdominal fistulae, or intra-abdominal abscess.
  • Known bleeding diathesis or coagulopathy.
  • Requirement for therapeutic doses of coumadin or equivalent.
  • Sensory/motor neuropathy greater than or equal to grade 2, as defined by the NCI CTCAE v3.0.
  • Conditions that would prohibit administration of corticosteroids.
  • Chronic daily treatment with corticosteroids (dose of > 10 mg/day methylprednisolone equivalent) (excluding inhaled steroids).
  • History of hypersensitivity reaction to drugs formulated with polysorbate 80.
  • Pregnancy or lactation at the time of study entry. (Note: Pregnancy testing must be performed within 14 days prior to randomization according to institutional standards for women of child-bearing potential.)
  • Other non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up.
  • Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
  • Use of any investigational product within 4 weeks prior to enrollment in the study.

Trial locations and contacts

649 sites in 40 countries.

556 sites in 40 countries

United States300 sites

  • Bixby Medical Center

    Adrian, Michigan, 49221

  • Akron City Hospital

    Akron, Ohio, 44304

  • Akron General Medical Center

    Akron, Ohio, 44307

  • Phoebe Putney Memorial Hospital

    Albany, Georgia, 31701

  • New York Oncology Hematology PC-Albany

    Albany, New York, 12206

  • NY Oncology Hematology PC at Albany Medical Center

    Albany, New York, 12208

  • Central Hematology/Oncology Medical Group, Inc.

    Alhambra, California, 91801

  • Lehigh Valley Hospital

    Allentown, Pennsylvania, 18105

  • Alliance Cancer Center

    Alliance, Ohio, 44601

  • Amsterdam Community Cancer Program

    Amsterdam, New York, 12010

  • CCOP, St. Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106

  • Cancer Care & Hematology Specialists of Chicagoland

    Arlington, Illinois, 60005

  • Cancer Care of Western North Carolina

    Asheville, North Carolina, 28801

  • CCOP, Mission Hospitals, Inc.

    Asheville, North Carolina, 28801

  • Cancer Center of NC at Asheville

    Asheville, North Carolina, 28803

  • Northeast Georgia Cancer Care, LLC

    Athens, Georgia, 30607

  • Grady Healthsystem

    Atlanta, Georgia, 30303

  • Emory University

    Atlanta, Georgia, 30322

  • Augusta Oncology Associates

    Augusta, Georgia, 30901

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

  • Northwest Georgia Oncology Centers PC

    Austell, Georgia, 30106

  • Oncology Associates P.C.-Avon

    Avon, Connecticut, 06001

  • Comprehensive Blood and Cancer Center

    Bakersfield, California, 93309

  • Kaiser Permanente-Baldwin Park

    Baldwin Park, California, 91706

  • Mercy Medical Center

    Baltimore, Maryland, 21202

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

  • Franklin Square Hospital Center

    Baltimore, Maryland, 21237

  • Harry & Jeannette Weinberg Cancer Institute

    Baltimore, Maryland, 21237

  • Hematology-Oncology Associates

    Baltimore, Maryland, 21237

  • Eastern Maine Medical Center

    Bangor, Maine, 04401

  • Baton Rouge General Medical Center

    Baton Rouge, Louisiana, 70806

  • Battle Creek Health System

    Battle Creek, Michigan, 49016

  • Bay Regional Medical Center

    Bay City, Michigan, 48706

  • Dr. Cook and Abramson - Bay City

    Bay City, Michigan, 48706

  • Overlake Internal Medicine

    Bellevue, Washington, 98004

  • Kaiser Permanente-Bellflower

    Bellflower, California, 90706

  • Summit Medical Group

    Berkeley Heights, New Jersey, 07922

  • Carolyn Hendricks, MD

    Bethesda, Maryland, 20817

  • Suburban Hospital

    Bethesda, Maryland, 20817

  • Hematology and Medical Oncology Consultants-Bettendorf

    Bettendorf, Iowa, 52722

  • Hematology Oncology Centers of the Northern Rockies

    Billings, Montana, 59101

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Cancer Care of Southern Indiana

    Bloomington, Indiana, 47403

  • Lynn Cancer Institute

    Boca Raton, Florida, 33428

  • Florida Cancer Specialists-Bonita Springs

    Bonita Springs, Florida, 34135

  • Florida Cancer Specialists-Bradenton

    Bradenton, Florida, 34209

  • Florida Cancer Specialists, Brandon

    Brandon, Florida, 33511

  • Medical Specialists of SWIM

    Bridgeport, Connecticut, 06606

  • Bridgeport Hospital

    Bridgeport, Connecticut, 06610

  • St. Joseph Mercy Woodland Health Center

    Brighton, Michigan, 48114

  • Josephone Ford Cancer Center

    Brownstown, Michigan, 48183

  • Providence Saint Joseph Medical Center

    Burbank, California, 91505

  • Oncology Alliance-Burlington

    Burlington, Wisconsin, 53105

  • Minnesota Oncology Hematology-Burnsville

    Burnsville, Minnesota, 55337

  • Park Nicollet Clinic

    Burnsville, Minnesota, 55337

  • Interlakes Oncology & Hematology, P.C.

    Canandaigua, New York, 14424

  • Aultman Hospital

    Canton, Ohio, 44710

  • Tri County Hematology/Oncology

    Canton, Ohio, 44781

  • Florida Cancer Specialists-Cape Coral Parkway

    Cape Coral, Florida, 33914

  • Florida Cancer Specialists-Cape Coral Del Prado

    Cape Coral, Florida, 33990

  • Northwest Georgia Oncology Centers PC

    Carrollton, Georgia, 30117

  • Northwest Georgia Oncology Centers PC

    Cartersville, Georgia, 30121

  • Carolinas Hematology-Oncology Associates - Tyron St

    Charlotte, North Carolina, 28203

  • Carolinas Medical Center - Blumenthal Cancer Center

    Charlotte, North Carolina, 28204

  • CCOP Presbyterian Hospital

    Charlotte, North Carolina, 28204

  • Mecklenburg Medical Group - Morehead Medical Dr

    Charlotte, North Carolina, 28204

  • Mecklenburg Medical Group - Cameron Valley Pkwy

    Charlotte, North Carolina, 28211

  • Carolinas Hematology Oncology Associates - Harris Blvd.

    Charlotte, North Carolina, 28262

  • Carolinas Hematology-Oncology - John J. Delaney

    Charlotte, North Carolina, 28277

  • The Office of Frederik Smith

    Chevy Chase, Maryland, 20815

  • Washington Oncology-Hematology Center, PC-Chevy Chase

    Chevy Chase, Maryland, 20815

  • MBCCOP, John H. Stroger, JR., Hospital of Cook County-Chicago

    Chicago, Illinois, 60612

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Kenwood Office

    Cincinnati, Ohio, 45236

  • Oncology/Hematology Care Clinical Trials LLC

    Cincinnati, Ohio, 45236

  • North Treatment Center - Blue Ash Medical Center

    Cincinnati, Ohio, 45242

  • Oncology/Hematology Care Clinical Trials LLC, Cincinnati, OH Blue Ash Med. Cntr. (Administrative Only)

    Cincinnati, Ohio, 45242

  • Oncology/Hematology Care Clinical Trials LLC

    Cincinnati, Ohio, 45242

  • Florida Cancer Specialists

    Clearwater, Florida, 33756

  • Case Western Reserve/University Hospitals-Ireland Cancer Cntr.

    Cleveland, Ohio, 44106

  • Kootenai Cancer Center

    Coeur d'Alene, Idaho, 83814

  • Penrose Cancer Center

    Colorado Springs, Colorado, 80907

  • University of Missouri-Ellis Fischel

    Columbia, Missouri, 65203

  • Hubert H. Humphrey Cancer Center - Coon Rapids

    Coon Rapids, Minnesota, 55433

  • Corydon Hospital Medical Plaza

    Corydon, Indiana, 47112

  • Texas Oncology- Sammons CC

    Dallas, Texas, 75246

  • Geisinger Clinic

    Danville, Pennsylvania, 17882-2170

  • Hematology and Medical Oncology Consultants-Davenport

    Davenport, Iowa, 52804

  • Dayton Physicians-LLC-Hematology & Medical Oncology Division

    Dayton, Ohio, 45415

  • Henry Ford Medical Center-Fairlane

    Dearborn, Michigan, 48126

  • Clearview Cancer Institute-Decatur

    Decatur, Alabama, 35601

  • Crossroads Cancer Center

    Decatur, Illinois, 62401

  • Cancer Care Specialists-Central Illinois

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Kaiser Permanente-Franklin

    Denver, Colorado, 80205

  • Cypress Hematology/Oncology

    Denver, Colorado, 80210

  • Rocky Mountain Cancer Center - Midtown

    Denver, Colorado, 80218

  • CCOP-Colorado Cancer Research Prog. Inc.(Administrative Only)

    Denver, Colorado, 80224

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Hematology Oncology Associates of NE PA

    Donora, Pennsylvania, 18142

  • Hematology Oncology Assaociates of CNY, CCOP

    East Syracuse, New York, 12010

  • Minnesota Oncology Hematology-Edina

    Edina, Minnesota, 55435

  • Fairview Southdale Medical Oncology Clinic

    Edina, Minnesota, 55455

  • Shaw Regional Cancer Center

    Edwards, Colorado, 81632

  • Elkhart Clinic

    Elkhart, Indiana, 46514

  • Michiana Hematology-Oncology, P.C. (Elkhart)

    Elkhart, Indiana, 46514

  • Hematology-Encinitas

    Encinitas, California, 92024

  • Scripps Clinic Encinitas

    Encinitas, California, 92024

  • Florida Cancer Specialists-Englewood

    Englewood, Florida, 34223

  • Drs. Forte, Schleider, Attas and Condemi, PA

    Englewood, New Jersey, 07631

  • Ephrata Cancer Center at Ephrata Community Hospital

    Ephrata, Pennsylvania, 17522

  • UP Hematology/Oncology Assoc.-Doctor's Park Family Physicians

    Escanaba, Michigan, 49829

  • Medical Specialists of Fairfield

    Fairfield, Connecticut, 06824

  • Oncology Associates of Bridgeport-Fairfield

    Fairfield, Connecticut, 06824

  • Healthplex

    Fairfield, Ohio, 45014

  • Northern Arizona Hematology & Onclogy Associates

    Flagstaff, Arizona, 86001

  • CCOP Hurley Medical Center

    Flint, Michigan, 48503

  • Genesys Hurley

    Flint, Michigan, 48503

  • Sing and Arora

    Flint, Michigan, 48532

  • Kaiser Permanente-Fontana

    Fontana, California, 92335

  • Florida Cancer Specialists-Fort Myers Broadway

    Fort Myers, Florida, 33901

  • Florida Cancer Specialists-Fort Myers Summerlin

    Fort Myers, Florida, 33908

  • The Center for Cancer and Blood Disorders

    Fort Worth, Texas, 76104

  • Oncology Alliance-Franklin

    Franklin, Wisconsin, 53132

  • Hubert H. Humphrey Cancer Center - Fridley

    Fridley, Minnesota, 55432

  • St. Jude Heritage Healthcare

    Fullerton, California, 92835

  • Robert R. Carroll, MD, PA

    Gainesville, Florida, 32605

  • Waverly Hematology Oncology

    Gary, Indiana, 27518

  • Oncology Alliance

    Glendale, Wisconsin, 53212

  • CCOP, Wayne Memorial Hospital

    Goldsboro, North Carolina, 27534

  • Genesys Regional Medical Center

    Grand Blanc, Michigan, 48439

  • Grand Rapids Clinical Oncology Program

    Grand Rapids, Michigan, 49503

  • Spectrum Health Hospitals

    Grand Rapids, Michigan, 49503

  • St. Mary's Health Services

    Grand Rapids, Michigan, 49503

  • North Colorado Medical Center

    Greeley, Colorado, 80631

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

  • Moses Cone Regional Cancer Center

    Greensboro, North Carolina, 27403

  • UPMC Cancer Centers Arnold Palmer Pavilion-Mountainview

    Greensburg, Pennsylvania, 15601

  • UPMC Cancer Centers Arnold Palmer-Oakbrook

    Greensburg, Pennsylvania, 15601

  • Dayton Physicians, LLC - Greenville

    Greenville, Ohio, 45331

  • CCOP, St. John Hospital and Medical Center

    Grosse Pointe Woods, Michigan, 19229

  • Cancer Institute of New Jersey at Hamilton

    Hamilton, New Jersey, 08690

  • Hamilton Office

    Hamilton, Ohio, 45013

  • Portage Internal Medical Associates

    Hancock, Michigan, 49935

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Connecticut Multi Specialty Group-Hartford

    Hartford, Connecticut, 06106

  • Oncology Associates P.C.-Hartford

    Hartford, Connecticut, 06106

  • Breastlink Medical Group, Inc

    Hawthorne, California, 90250

  • Comprehensive Cancer Centers of Nevada (Siena)

    Henderson, Nevada, 89052

  • Northwestern Carolina Oncology & Hematology, PA

    Hickory, North Carolina, 28603

  • Oncare Hawaii, Inc-POB2

    Honolulu, Hawaii, 96813

  • Straub Clinic and Hospital

    Honolulu, Hawaii, 96813

  • University of Hawaii

    Honolulu, Hawaii, 96813

  • Oncare Hawaii, Inc-KMP

    Honolulu, Hawaii, 96817

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Ben Taub General Hospital

    Houston, Texas, 77030

  • NY Oncology Hematology PC-Hudson Carvell Cancer Tx Prog.

    Hudson, New York, 12534

  • Carolina BioOncology Institute

    Huntersville, North Carolina, 28078

  • Pacific Shores Medical Group

    Huntington Beach, California, 92648

  • Clearview Cancer Institute

    Huntsville, Alabama, 35801

  • Clearview Cancer Institute- Huntsville

    Huntsville, Alabama, 35805

  • UPMC Cancer Centers-Indiana

    Indiana, Pennsylvania, 15701

  • University of Iowa

    Iowa City, Iowa, 52242

  • UP Hematology/Oncology Associates

    Iron Mountain, Michigan, 49801

  • UP Hematology/Oncology Associates-Gogebic Range

    Ironwood, Michigan, 49938

  • Kaiser Permanente-Irvine

    Irvine, California, 92618

  • Integrated Community Oncology Network

    Jacksonville, Florida, 32258

  • Clark Medical Building

    Jeffersonville, Indiana, 47130

  • UPMC Cancer Centers-John P. Murtha Cancer Center

    Johnstown, Pennsylvania, 15901

  • Freeman Cancer Institute

    Joplin, Missouri, 64804

  • St. John's Regional Health Center-Joplin

    Joplin, Missouri, 64804

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Saint Luke's Hospital

    Kansas City, Missouri, 64111

  • CCOP, Kansas City (Administrative Only)

    Kansas City, Missouri, 64131

  • Oncology Alliance-Kenosha South

    Kenosha, Wisconsin, 53143

  • Oncology Alliance-Kenosha North

    Kenosha, Wisconsin, 53144

  • Dayton Clinical Oncology Program-Kettering

    Kettering, Ohio, 45429

  • Marian A. Llenado Lee, MD, Inc.

    Kettering, Ohio, 45429

  • Thompson Oncology Group-Blount

    Knoxville, Tennessee, 37804

  • Thompson Cancer Survival Center-Dowell Springs

    Knoxville, Tennessee, 37909

  • Thompson Cancer Survival Center

    Knoxville, Tennessee, 37916

  • Thompson Oncology Group-West

    Knoxville, Tennessee, 37932

  • Howard Regional Health System

    Kokomo, Indiana, 46904

  • Hematology-La Jolla

    La Jolla, California, 92037

  • Sabina R. Wallach, MD., AMC

    La Jolla, California, 92037

  • Scripps Cancer Center-San Diego

    La Jolla, California, 92037

  • Michiana Hematology-Oncology, P.C. (LaPorte)

    La Porte, Indiana, 46350

  • Kaiser Permanente Rock Creek

    Lafayette, Colorado, 80026

  • Lakeland Regional Cancer Center

    Lakeland, Florida, 33805

  • Hematology/Oncology Associates of OH and MI, PC

    Lambertville, Michigan, 48144

  • Antelope Valley Cancer Center

    Lancaster, California, 93534

  • CCOP, Sparrow Health System

    Lansing, Michigan, 48909

  • Michigan State University - Breslin Cancer Center

    Lansing, Michigan, 48910

  • Hematology Oncology-Lapeer

    Lapeer, Michigan, 48446

  • Lapeer Regional Hospital

    Lapeer, Michigan, 48446

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • Cancer and Blood Specialists- Shadow Lane

    Las Vegas, Nevada, 89106

  • Cancer Consultants

    Las Vegas, Nevada, 89106

  • Nevada Cancer Institute

    Las Vegas, Nevada, 89135

  • NY Oncology Hematology PC- Latham- Capital District Oncology Hematology

    Latham, New York, 12110

  • Keewanaw Memorial Hospital

    Laurium, Michigan, 49913

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Suburban Hematology-Oncology Associates

    Lawrenceville, Georgia, 30045

  • University of Kentucky Medical Center

    Lexington, Kentucky, 40536

  • St. Mary Mercy Hospital - Livonia

    Livonia, Michigan, 48154

  • Monmouth Medical Center

    Long Branch, New Jersey, 07740

  • Kaiser Permanente-Sunset

    Los Angeles, California, 90027

  • Kaiser Permanente-West Los Angeles

    Los Angeles, California, 90034

  • NortonHealthcare Pavillion

    Louisville, Kentucky, 40202

  • Norton Medical Plaza II

    Louisville, Kentucky, 40207

  • Norton Medical Plaza West

    Louisville, Kentucky, 40217

  • Old Brownsboro Crossing

    Louisville, Kentucky, 40241

  • McKee Medical Center

    Loveland, Colorado, 80538

  • Covenant Health System dba Joe Arrington Cancer Research & Treatment Center

    Lubbock, Texas, 79410

  • Central Georgia Cancer Care

    Macon, Georgia, 31201

  • Georgia Cancer Specialists

    Macon, Georgia, 31217

  • Minnesota Oncology Hematology PA - Maplewood

    Maplewood, Minnesota, 55109

  • Georgia Cancer Specialists

    Marietta, Georgia, 30060

  • Marquette General Hospital

    Marquette, Michigan, 49855

  • Upper Peninsula Hematology/Oncology Associates

    Marquette, Michigan, 49855

  • CCOP, Marshfield Clinic

    Marshfield, Wisconsin, 54449

  • Northwest Ohio Oncology Center

    Maumee, Ohio, 43537

  • UPMC Cancer Centers - McKeesport Hospital

    McKeesport, Pennsylvania, 15132

  • Riddle Memorial Hospital

    Media, Pennsylvania, 19063

  • The West Clinic

    Memphis, Tennessee, 38120

  • Oncology Alliance-Menomonee Falls

    Menomonee Falls, Wisconsin, 53051

  • Oncology Alliance-Mequon

    Mequon, Wisconsin, 53092

  • Medical Oncology and Hematology, P.C.

    Meriden, Connecticut, 06451

  • Mountain States Tumor Institute

    Meridian, Idaho, 83642

  • Oncology Alliance-South

    Milwaukee, Wisconsin, 53215

  • Minnesota Oncology Hematology-Minneapolis

    Minneapolis, Minnesota, 55407

  • West Virginia University Hospitals Inc.

    Morgantown, West Virginia, 26506-9162

  • Morristown Memorial Hospital

    Morristown, New Jersey, 07960

  • Community Cancer Care Specialists-Mt. Clemens

    Mount Clemens, Michigan, 48043

  • Mount Clemens Regional Medical Center

    Mount Clemens, Michigan, 48043

  • UPMC Cancer Centers Arnold Palmer-Mt. Pleasant

    Mount Pleasant, Pennsylvania, 15666

  • Intermountain Medical Center

    Murray, Utah, 84107

  • Hackley Hospital

    Muskegon, Michigan, 49443

  • Edward Hospital

    Naperville, Illinois, 60540

  • Florida Cancer Specialists-Naples Goodlette

    Naples, Florida, 34102

  • Florida Cancer Specialists-NAPA Ridge

    Naples, Florida, 34119

  • Cancer Care Center

    New Albany, Indiana, 47150

  • Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

  • Beth Israel Medical Center

    New York, New York, 10003

  • St. Luke's-Roosevelt Hospital Center

    New York, New York, 10019

  • CCOP, Christiana Care Health Services Inc.

    Newark, Delaware, 19718

  • University of Medicine and Dentistry of New Jersey

    Newark, New Jersey, 07103-2425

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

  • Michiana Hematology-Oncology PC

    Niles, Michigan, 49120

  • Berkshire Hematology Oncology, P.C.-North Adams

    North Adams, Massachusetts, 01247

  • Eastern Connecticut Hematology & Oncology Associates

    Norwich, Connecticut, 06360

  • Kaiser Permanente-Oakland

    Oakland, California, 94611

  • North County Oncology Medical Clinic, Inc.

    Oceanside, California, 92056

  • McKay-Dee Hospital

    Ogden, Utah, 84403

  • UHHS - Chagrin Highlands

    Orange, Ohio, 44122

  • Integrated Community Oncology Network

    Orange Park, Florida, 32073

  • Florida Hospital Cancer Institute

    Orlando, Florida, 32804

  • Florida Cancer Specialists, Cornerstone

    Palm Harbor, Florida, 34684

  • Kaiser Permanente-Panorama City

    Panorama City, California, 91042

  • Kaiser Permanente-Orange County

    Panorama City, California, 92807

  • Wilshire Oncology Medical Group

    Pasadena, California, 91750

  • Kimmel Cancer Center at Jefferson

    Philadelphia, Pennsylvania, 19107

  • Cancer Center at Center One

    Philadelphia, Pennsylvania, 19115

  • Albert Einstein Healthcare Network

    Philadelphia, Pennsylvania, 19141-3098

  • Allegheny General Hospital/Allegheny-Singer Research Institute

    Pittsburgh, Pennsylvania, 15212

  • NSABP Foundation, Inc

    Pittsburgh, Pennsylvania, 15212

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • UPMC Cancer Centers - UPMC St. Margaret

    Pittsburgh, Pennsylvania, 15215

  • Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • UPMC Cancer Centers - UPMC Passavant

    Pittsburgh, Pennsylvania, 15237

  • Berkshire Hematology Oncology, P.C.

    Pittsfield, Massachusetts, 01201

  • Edward Cancer Center Plainfield

    Plainfield, Illinois, 60585

  • North Texas Regional Cancer Center

    Plano, Texas, 75075

  • Michiana Hematology-Oncology PC

    Plymouth, Indiana, 46563

  • Oncology, P.C. Plymouth

    Plymouth, Indiana, 46563

  • Florida Cancer Specialists-Port Charlotte

    Port Charlotte, Florida, 33980

  • Northwest Cancer Specialists-Portland

    Portland, Oregon, 97213

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Adventist Medical Center

    Portland, Oregon, 97216

  • Northwest Cancer Specialists-Adventist Office

    Portland, Oregon, 97216

  • CCOP, Columbia River Oncology

    Portland, Oregon, 97225

  • Providence Oncology and Hematology Care Clinic

    Portland, Oregon, 97225

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

  • Utah Valley Regional Medical Center

    Provo, Utah, 84604

  • Oncology Alliance-Racine

    Racine, Wisconsin, 53406

  • Cancer Care Associates Medical Group, Inc.

    Redondo Beach, California, 90277

  • Renown Regional Medical Center

    Reno, Nevada, 89502

  • Alpine Hematology-Oncology

    Reno, Nevada, 89503

  • Riverview Cancer Care Medical Association

    Rexford, New York, 12148

  • VCU Massey Cancer Center at Stony Point

    Richmond, Virginia, 23235

  • MBCCOP, Virginia Commonwealth University

    Richmond, Virginia, 23298

  • Kaiser Permanente-Riverside

    Riverside, California, 92505

  • Hubert H. Humphrey Cancer Center-Robbinsdale

    Robbinsdale, Minnesota, 55422

  • Associates in Oncology/Hematology

    Rockville, Maryland, 20850

  • Hematology Oncology Associates of CNY, CCOP

    Rome, New York, 13440

  • Kaiser Permanente-Roseville

    Roseville, California, 95661

  • Sutter Roseville Medical Center

    Roseville, California, 95661

  • Kaiser Permanente-Sacramento

    Roseville, California, 95825

  • CCOP, William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • Sutter Medical Center

    Sacramento, California, 95816

Other trials in United States

Spain38 sites

  • Complejo Hospitalario Universitario A Coruna

    A Coruña, 15006

  • Centro Oncologico de Galicia

    A Coruña, 15009

  • Fundacion Hospitalaria de Alcorcon

    Alcorcón, 28922

  • Hospital General de Alicante

    Alicante, 03010

  • Hospital Perpetuo Socorro

    Badajoz, 6010

  • Hospital Germans Trias l Pujol

    Badalona (Barcelona), 08916

  • Hospital Comarcal de Barbastro

    Barbastro, 22300

  • Hospital Del Mar

    Barcelona, 08003

  • Hospital Santa Crue l San Pau

    Barcelona, 08025

  • Hospital Clinic i Provincial

    Barcelona, 08036

  • Consorci Sanitari de Terrassa

    Barcelona, 08227

  • Althaia Xarxa Assistencial de Manresa

    Barcelona, 08243

  • Hospital Espiritu Santo

    Barcelona, 08923

  • Hospital De San Pedro de Alcantara

    Cáceres, 10003

  • Instituto Oncologico de Guipuzcoa

    Donostia / San Sebastian

  • Hospital Gral. De Elche

    Elche, 03202

  • Hospital de Cabueñes, Oncologia Médica

    Gijón, 33394

  • Instituto Catalan Oncologia de Girona

    Girona, 17007

  • Complejo Hospitalario de Jaen

    Jaén, 23007

  • Hospital Universitario Insular de Gran Canaria

    Las Palmas, Canary Islands, 33106

  • Hospital Xera Calde

    Lugo

  • Hospital Universitario Gregorio Maranon

    Madrid, 28007

  • Hospital Ruber International

    Madrid, 28034

  • Fundacion Jimenez Diaz

    Madrid, 28040

  • Hospital Universitario San Carlos

    Madrid, 28040

  • Centro Integral de Oncologia "Clara Campal"

    Madrid, 28050

  • Hospital Clinico Virgen de la Victoria

    Málaga, 29010

  • Hospital Univesitario Carlos Haya

    Málaga, 29010

  • Hospital Santa Maria Nai Dr. Cabaleiro

    Ourense

  • Complejo Hospitalario de Pontevedra

    Pontevedra, 36001

  • Hospital del Parc Tauli

    Sabadell, 08208

  • Hospital Universitario de Salamanca

    Salamanca, 37007

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, 38320

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Torrevieja Salud, UTE

    Torrevieja, 03186

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

  • Hospital Clinico Universitario Lozano Blesa

    Zaragoza, 50009

  • Hospital U. Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Germany27 sites

  • Klinikum St. Marien Amberg

    Amberg, 92224

  • Hochwaldkrankenhaus

    Bad Nauheim, 61231

  • Klinikverbund Suedwest - Sindelfingen-Böeblingen Clinical Centre

    Böeblingen, 71032

  • Klinikum Chemnitz

    Chemnitz, 09116

  • Universitaetsklinikum Dresden

    Dresden, 01307

  • Luisenkrankenhaus

    Düsseldorf, 40235

  • Universitaetsfrauenklinik

    Essen, 45122

  • Zentrum fur Frauenheilkunde und Geburtshilfe

    Frankfurt, D-60590

  • Medizinisches Versorgungszentrum Osthessen

    Fulda, 36043

  • Kreiskrankenhaus Hameln

    Hamelin, 31785

  • Klinikum Stadt Hanau

    Hanau, 63450

  • Klinikum Hannover Nordstadt

    Hanover, 30167

  • Universitat Frauenklinik Jena

    Jena, 07743

  • Onkologische schwerpunktpraxis

    Leer, 26789

  • Klinikum Lippe Lemgo

    Lemgo, D-32657

  • Asklepios Kliniken Lich GmbH

    Lich, 35423

  • Universitaetsklinikum Mainz

    Mainz, 55101

  • St. Vincenz u. Elisabeth Hospital

    Mainz, 55131

  • Ev Krankenhaus Bethesda

    Mönchengladbach, 41061

  • RotKreuzKlinikum München GmbH

    Munich, 80637

  • Universitaetsklinikum Munster

    Münster, 48129

  • Praxis und Tagesklinik fuer Onkologie und

    Recklinghausen, 45657

  • Klinikum Rosenheim

    Rosenheim, 83022

  • Klinikum Schaumburg

    Stadhagen, 31655

  • Johanniter Krankenhaus

    Stendal, D-39576

  • Robert-Bosch-Krankenhaus

    Stuttgart, 70376

  • Fachärzte fürlnnere Medizin, Hämatologie

    Traunstein, 83278

Other trials in Germany

France22 sites

  • CHU D'Amiens

    Amiens, 80054

  • CH-Service Hemato-Oncologie

    Beauvais, 60000

  • Clinique Bordeaux Nord Aquitaine

    Bordeaux, 33300

  • CHU Morvan

    Brest, 29609

  • Hopital Pasteur

    Colmar, 68024

  • Ch intercommunal de creteil

    Créteil, 94000

  • Centre Leonard de Vinci

    Dechy, 59187

  • Institut Daniel Hollard

    Grenoble, 38028

  • CHD les Oudairies

    La Roche-sur-Yon, 85925

  • Clinique Francois Chenieux

    Limoges, 87039

  • CHU Dupuytren

    Limoges, 87042

  • Hopital St. Joseph

    Marseille, 13008

  • Centre Regional de Lutte contre le Cancer (CRLC) Val d'Aurelle

    Montpellier, 34298

  • Centre Catherine de Sienne

    Nantes, 44202

  • Clinique Hartmann

    Neuilly-sur-Seine, 92200

  • CHU Hotel Dieu

    Paris, 75004

  • Hopital St. Antoine

    Paris, 75571

  • Clinique Saint Hilaire

    Rouen, 76000

  • Pole de cancerologie prive

    Strasbourg, 67000

  • CLCC Paul Strauss

    Strasbourg, 67085

  • Polyclinique du Parc

    Toulous, 31400

  • Institution Claudius Regaud

    Toulouse, 31052

Other trials in France

Canada19 sites

  • William Osler Health Center

    Brampton, Ontario, L6R 3J7

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute, Dept of Medicine

    Edmonton, Alberta, T6G 1Z2

  • Hopital Charles LeMoyne

    Greenfield Park, Quebec, J4V 2H1

  • Credit Valley Hospital

    Mississauga, Ontario, L5M 2N1

  • Hopital Maisonneuve Rosemont

    Montreal, Quebec, H1T 2M4

  • Royal Victoria Hospital

    Montreal, Quebec, H3A 1A1

  • Montreal General Hospital

    Montreal, Quebec, H3G 1A4

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • Hospital du Sacre-Coeur

    Montreal, Quebec, H4J 1C5

  • University of Montreal Hospital Group

    Montreal, Quebec

  • Southlake Regional Health Centre

    Newmarket, Ontario, L3Y 2P9

  • Lion's Gate Hospital

    North Vancouver, British Columbia, V7L 2L7

  • Ottawa Hospital Regional Cancer Centre

    Ottawa, Ontario, K1H 8L6

  • Centre Hospitalier Affilie Universitaire De Quebec, Hospital du St-Sacrement

    Québec, Quebec, G1S 4L8

  • Dr. H. Bliss Murphy Cancer Centre

    St. John's, Newfoundland and Labrador, AIB 3V6

  • St. Michaels Hospital

    Toronto, Ontario, M5B 1W8

  • Humber River Regional Hospital

    Weston, Ontario, M9N 1N8

  • Windsor Regional Cancer Centre

    Windsor, Ontario, N8W 2X3

Other trials in Canada

Australia14 sites

  • Ashford Cancer Center

    Ashford, South Australia, 5035

  • Flinders Medical Centre

    Bedford, South Australia, 5042

  • Macarthur Cancer Center

    Campbelltown, New South Wales, 2560

  • Frankston Hospital

    Frankston, Victoria, 3199

  • Royal Brisbane & Women's Hospital

    Herston, Queensland, 4029

  • St. George Hospital

    Kogarah, New South Wales, 2217

  • Cancer Therapy Center

    Liverpool, New South Wales, 1871

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Mount Medical Center

    Perth, Western Australia, 6000

  • Mater Adult Hospital

    South Brisbane, Queensland, 4101

  • North Shore Private Hospital

    St Leonards, New South Wales, 2065

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

  • Berdat Family Comprehensive Cancer Centre

    Subiaco, Western Australia, 6008

  • Southern Medical Day Care

    Wollongong, New South Wales, 2500

Other trials in Australia

Austria13 sites

  • Krankenhaus Barmherzige Brueder Graz, Medizinische Abteilung

    Graz, 8020

  • Universitatsfrauenklinik Graz

    Graz, 8036

  • Medizinische Universitat Graz - Onkologie

    Graz, A-8036

  • AI University Hospital Innsbruck

    Innsbruck, A-6020

  • Bezirkskrankenhaus Kufstein, Innere Medizin

    Kufstein, 6330

  • Landeskrankenhaus Leoben, Abteilung fur Haemato-Onkologie

    Leoben, 8700

  • Krankenhaus Barmherzige Schwestern Linz, Kooperative Studiengruppe, Chirurgie

    Linz, 4010

  • AI Universitätsklinikum der PMU Landeskliniken

    Salzburg, 5020

  • AKH Vienna

    Vienna, 1090

  • Medizinische Universitaet Wien-Allgemeines Krankenhaus, Onkologie

    Vienna, 1090

  • Krankenhaus Hietzing, Gynaekologische Abteilung

    Vienna, 1130

  • Landeskrankenhaus Voecklabruck, 2. Medizinische Abteilung

    Vöcklabruck, 4840

  • Klinikum Wels-Grieskirchen, Kooperative Gruppe Wels/4. Medizinische Abteilung

    Wels, 4600

Other trials in Austria

Brazil13 sites

  • Lifecenter Sistema de Saude S/A

    Belo Horizonte, Minas Gerais, 30110-090

  • Centro Goiano de oncologia

    Goiânia, Goiás, 74075-040

  • Assoiacao hospital de caridade de ijui

    Ijuí, Rio Grande do Sul, 98700-000

  • Fundacao Dr. Amaral Carvalho

    Jaú, São Paulo, 17210-080

  • Instituto de Oncologia Clinica de Piracicaba

    Piracicaba, São Paulo, 13419-155

  • Hospital Das Clinicas de Porto Alegre-HCPA

    Porto Alegre, Rio Grande do Sul, 90035-003

  • Irmandade da Santa Casa de Misericoria de Porto Alegre Nucleo de Novos Tratamentos

    Porto Alegre, Rio Grande do Sul, 90050-170

  • Clinica de Oncologia de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90430-090

  • Instituto Nacional de Cancer

    Rio de Janeiro, Rio de Janeiro, 20560-120

  • Clinica Oncologistas Associados

    Rio de Janeiro, Rio de Janeiro, 22260-020

  • Centro de Oncologia e Hematologia da Faculdade de Medicina do ABC

    Santo André, São Paulo, 09060-650

  • Instituto do Cancer de Sao Paulo

    São Paulo, São Paulo, 01246-000

  • Conjunto Hospitalar de Sorocaba

    Sorocaba, 18030-075

Other trials in Brazil

Italy11 sites

  • Humanitas Centro Catanese

    Catania, 95126

  • (Azienda u.s.I. chieti) - Policinico Ospedaliero

    Chieti, 66100

  • Ospedale vito fazzi

    Lecce

  • Ospedale di Mirano

    Mirano

  • IRCCS - Instituto Nazionale per lo Studio e la Cura

    Naples, 80131

  • Fondazione Salvatore Maugeri

    Pavia, 27100

  • Ospedale S. Filippo Neri

    Roma, 00135

  • Regina Elena Cancer Institute

    Rome

  • Ospedale casa sollievo della sofferenza

    San Giovanni

  • Universita-istituto Clinica Medica

    Sassari, 07100

  • Asl n. 5 -Ospedale s. Vincenzo

    Taormina

Other trials in Italy

China10 sites

  • Chinese Academy of Medical Science

    Beijing, 100021

  • The Pla 307 Hospital

    Beijing, 100071

  • Chinese PLA General Hospital

    Beijing, 100853

  • Jilin Cancer Hospital

    Changchun, 130012

  • West China Hospital, Sichuan University

    Chengdu, 610041

  • Fuzhou General Hospital of Nanjing Military Area

    Fuzhou, 354200

  • Sun Yat-sen University Hospital

    Guangzhou, 510060

  • 1st Affiliated Hospital of Zhejiang University

    Hangzhou, 310003

  • Zhejiang Tumor Hospital

    Hangzhou, 310022

  • Tianjin Cancer Hospital

    Tianjin, 300060

Other trials in China

Ireland10 sites

  • Cork University Hospital

    Cork

  • Beaumont Hospital

    Dublin, 0009

  • St. James's Hospital

    Dublin, 8

  • Adelaide and Meath National Childrens Hospital

    Dublin

  • Institute for Cancer Research

    Dublin

  • Mater Private Hospital

    Dublin

  • St. Vincent's University Hospital

    Dublin

  • University College Hospital Galway

    Galway

  • Midwestern Regional Hospital

    Limerick

  • Sligo General Hospital

    Sligo

Other trials in Ireland

United Kingdom7 sites

  • Royal Bournemouth Hospital

    Bournemouth, BH7 7DW

  • Bristol Hematology - Oncology Centre

    Bristol, BS2 8ED

  • Ipswich Hospital

    Ipswich, IP4 5PD

  • Christie Hospital NHS Trust

    Manchester, M20 4BX

  • Nottingham City Hospital

    Nottingham, NG5 1PB

  • Peterborough District Hospital

    Peterborough, PE3 6DA

  • Sunrise Cancer Centre

    Truro, TR1 3IJ

Other trials in United Kingdom

Israel6 sites

  • The Lady Davis Carmel Medical Center/Lynn

    Haifa

  • Meir Medical Center

    Kfar, 13100

  • Kaplan Medical Center

    Rehovot

  • Ziv Medical Center

    Safed

  • Sourasky (Ichilov) Medical Center

    Tel Aviv

  • Assaf Harofeh Medical Center

    Tsrifin

Other trials in Israel

Poland6 sites

  • Regional Oncology Center

    Bialystok

  • Centrum Onkologii Instytut im. M.

    Gliwice, 44-101

  • ZOZ MSWiA z Warminsko-Mazurskim Centrum

    Olsztyn, 10-228

  • Olsztynski Osrodek Onkologiczny "Kopernik"

    Olsztyn, 10-513

  • Samodzielny Publiczny Zaklad Opieki

    Rybnik, 44-200

  • Breast Cancer Clinic

    Warsaw, 02-781

Other trials in Poland

Taiwan6 sites

  • Changhua Christian Hospital

    Changhua, 500

  • Kaohsiung Medical University Chung

    Kaohsiung City, 807

  • National Cheng Kung University

    Tainan, 704

  • Sun Yat-Sen Cancer Center

    Taipei, 112

  • Taipei Veterans General Hospital

    Taipei, 112

  • Chang Gung Memorial Hospital

    Taoyuan, 3330

Other trials in Taiwan

Argentina5 sites

  • Hospital Britanico de Buenos Aires

    Buenos Aires, C1280AEB

  • CEMIC

    Buenos Aires, C1431FWO

  • Breast Clinica de la mama

    La Plata, Buenos Aires, B1902CMV

  • Hospital Universitario Austral

    Presidente Derqui, Buenos Aires, B1629ODT

  • Centro Oncologico Rosario (COR)

    Rosario, Sante Fe, S2000DSK

Other trials in Argentina

South Korea5 sites

  • Seoul National University Bundang Hospital

    Gyeonggi-do, 463-707

  • Seoul National University Hospital

    Seoul, 110-744

  • Severance Hospital

    Seoul, 120-752

  • Samsung Medical Center

    Seoul, 135-710

  • Asan Medical Center

    Seoul, 138-736

Other trials in South Korea

Belgium4 sites

  • AZ Klina

    Brasschaat, 2930

  • C. H. Notre-Dame and Reine Fabiola

    Charleroi, 6000

  • Clinique St Pierre

    Ottignies, 1340

  • Medical Institute St. Augustinus

    Wilrijk, 2610

Other trials in Belgium

Hungary4 sites

  • Semmelweis Egyetem Clinic of Radiology

    Budapest, 1082

  • DEOEC Onkologiai Tanszek

    Debrecen, 4012

  • Petz Aladar Megyei Oktato

    Győr

  • Kaposi Mor oktato korhaz Onkologiai tanszek

    Kaposvár, H-7400

Other trials in Hungary

Russia4 sites

  • State Medical Institution "Republican Clinical Oncology Dispensary Ministry of Health of Republic Tatarstan"

    Kazan'

  • State Institution "Russian Oncological Research Center n.a. N.N. Blokhin of RAMS"

    Moscow

  • Federal State Institution "Research Institute of Oncology n.a. N.N. Petrov Rosmedtechnologiy"

    Saint Petersburg

  • Saint-Petersburg State Medical Institution "City Clinical Oncology Dispensary"

    Saint Petersburg

Other trials in Russia

Romania3 sites

  • County Hospital Alba-Iulia

    Alba Iulia, 510000

  • Institute of Oncology "AI.Trestioreanu"

    Bucharest, 022338

  • Institutul Oncologic "Prof. Dr. I. Chiricuta" Cluj-Napoca

    Cluj-Napoca

Other trials in Romania

South Africa3 sites

  • Department of Oncotherapy National Hospital

    Bloemfontein, 9301

  • Hopelands Cancer Centre

    Durban, 4001

  • Johannesburg Hospital

    Johannesburg

Other trials in South Africa

Thailand3 sites

  • National Cancer Institute

    Bangkok, 10400

  • Chulalongkorn Hospital

    Patumwan, Bangkok, 10330

  • Songklanagarind Hospital

    Songkhla

Other trials in Thailand

Bulgaria2 sites

  • District Oncology Dispensary Plovdiv

    Plovdiv, 4000

  • MHAT "Tsaritsa Yoanna-ISUL" EOOD

    Sofia, 1527

Other trials in Bulgaria

Hong Kong2 sites

  • Prince of Wales Hospital

    Hong Kong

  • Queen Elizabeth Hospital

    Hong Kong

Other trials in Hong Kong

Peru2 sites

  • Hospital Nacional Carlos Alberto Seguin

    Arequipa

  • Hospital Nacional Edgardo Rebagliati Martins

    Lima, Lima 11

Other trials in Peru

Portugal2 sites

  • HUC

    Coimbra, 3000-073

  • IPO Francisco Gentil-Porto

    Porto, 4200-319

Other trials in Portugal

Serbia2 sites

  • Clinical Hospital Center Bezanijska Kosa

    Belgrade, 11080

  • Clinic of Oncology, Clinical Center nis

    Niš, 18000

Other trials in Serbia

Sweden2 sites

  • Sahlgrenska University Hospital

    Gothenburg, 41345

  • Karolinska University Hospital

    Stockholm, S-118

Other trials in Sweden

Bosnia and Herzegovina1 site

  • Clinical Centre University of Sarajevo

    Sarajevo, 71000

Other trials in Bosnia and Herzegovina

Chile1 site

  • Hospital Regional Rancagua

    Rancagua, Región del Libertador General Bernardo O’Higgins, 2820000

Other trials in Chile

Croatia1 site

  • University Hospital Zagreb

    Zagreb, 10000

Other trials in Croatia

Czechia1 site

  • FN Na Bulovce

    Prague, 180 81

Other trials in Czechia

Egypt1 site

  • National Cancer Institute

    Cairo, 11796

Other trials in Egypt

Estonia1 site

  • Tartu University Hospital Clinic of Hematology and Oncology

    Tartu, 51014

Other trials in Estonia

Greece1 site

  • P.G. Hospital of Thessaloniki "Papageorgiou"

    Thessaloniki, 56429

Other trials in Greece

Latvia1 site

  • P. Stradina Clinical University Hospital

    Riga

Other trials in Latvia

Mexico1 site

  • Opcion Oncologia

    Monterrey, 64060

Other trials in Mexico

Philippines1 site

  • Cebu Doctors University Hospital

    Cebu City, 6000

Other trials in Philippines

Slovenia1 site

  • University Clinical Centre

    Maribor, 2101

Other trials in Slovenia

About this study

Official title: A Multicenter Phase III Randomized Trial of Adjuvant Therapy for Patients With HER2-Positive Node-Positive or High Risk Node-Negative Breast Cancer Comparing Chemotherapy Plus Trastuzumab With Chemotherapy Plus Trastuzumab Plus Bevacizumab

The trial will determine the value of adding bevacizumab to chemotherapy plus trastuzumab in patients with resected node-positive or high risk node-negative, HER2-positive breast cancer.

Read the detailed description

This Phase III, randomized, open-label trial will determine whether the regimens of chemotherapy plus trastuzumab plus bevacizumab improve invasive disease-free survival (IDFS) relative to the regimens of chemotherapy plus trastuzumab. Secondary aims include determining whether the addition of bevacizumab to chemotherapy plus trastuzumab will improve disease-free survival (DFS), overall survival (OS), recurrence-free interval (RFI), and distant recurrence-free interval (DRFI). The benefit of adding bevacizumab for IDFS, DFS, OS, RFI, and DRFI will also be evaluated for each of the two chemotherapy regimens. The cardiac and non-cardiac toxicities of each of the regimens will also be evaluated.

Following local determination that the tumor is HER2-positive for gene amplification by in situ hybridization or is IHC 2+ or 3+, a tumor sample must be submitted for HER2 testing by a designated central laboratory. If central testing confirms that the tumor is HER2-positive (either positive by FISH or IHC 3+) and all other eligibility criteria have been met, the patient will be randomized to a regimen of chemotherapy and trastuzumab with or without bevacizumab.

Patients in the trial will be enrolled in one of two chemotherapy regimen cohorts. One cohort will receive 6 cycles of docetaxel/carboplatin plus trastuzumab (TCH) with or without bevacizumab; the other cohort will receive 3 cycles of docetaxel plus trastuzumab given with or without bevacizumab followed by 3 cycles of 5-Fluorouracil, Epirubicin, Cyclophosphamide (TH-FEC). With both regimens, patients will continue trastuzumab with or without bevacizumab following chemotherapy to complete 1 year of targeted therapy. Following completion of chemotherapy, patients will also receive adjuvant radiotherapy and endocrine therapy as clinically indicated.

The trial will be conducted by investigators affiliated with the Cancer International Research Group (CIRG) and the National Surgical Adjuvant Breast and Bowel Project (NSABP). CIRG and NSABP investigators will only enroll patients in the TCH regimen cohort. Additional investigators, referred to in the protocol as Independent Investigators, will enroll patients in both the TCH regimen or the TH-FEC regimen cohort depending on institutional preference for the one regimen that will be used by that institution for the duration of the trial.

Patients will be given the option of allowing their tumor samples to be used for the BETH translational research and correlative science studies. Also, patients will be asked to consent to the submission of blood and serum samples at scheduled time points during the study.

LVEF assessments will be performed before study entry and then at scheduled time points during therapy and at 18, 36, and 60 months following randomization.

The planned sample size for the trial is 3,000 patients randomized in the faster accruing cohort and a minimum of 3,500 patients overall.

Conditions
Breast Cancer
Keywords
HER2 positive breast cancer, invasive breast cancer, bevacizumab, NSABP, Roche, CIRG, trastuzumab, cyclophosphamide, docetaxel, carboplatin, 5-fluorouracil, epirubicin
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DocetaxelDrug

    Also called Taxotere

    75 mg/m2 IV on day 1 every 3 weeks for cycles 1-6, Arms 1A and 1B

    100 mg/m2 on day 1 every 3 weeks for cycles 1-3, Arms 2A and 2B

  • TrastuzumabDrug

    Also called Herceptin

    First dose: 8 mg/kg IV on day 1 of cycle 1 only. Subsequent doses: 6 mg/kg IV on day 1 every 3 weeks for cycles 2-6. Following completion of chemotherapy cycles: 6 mg/kg IV every 3 weeks until 1 year following first trastuzumab dose. Arms 1A and 1B

    First dose: 8 mg/kg IV on day 1 of cycle 1 only. Subsequent doses: 6 mg/kg IV on day 1 every 3 weeks for cycles 2-3. 21 days after last dose of FEC: 8 mg/kg IV first post-FEC dose only; subsequent doses 6 mg/kg IV every 3 weeks for a total of 1 year. Arms 2A and 2B

  • CarboplatinDrug

    6 mg/ml/min IV on day 1 every 3 weeks for cycles 1-6

  • BevacizumabDrug

    Also called Avastin

    15 mg/kg IV on day 1 every 3 weeks for cycles 1-6. Following completion of chemotherapy cycles: 15 mg/kg IV on day 1 every 3 weeks until 1 year following first bevacizumab dose. Arm 1B

    15 mg/kg IV on day 1 every 3 weeks for cycles 1-3. 21 days after the last dose of FEC: 15 mg/kg IV on day 1 every 3 weeks until 1 year following first bevacizumab dose. Arm 2B

  • 5-FluorouracilDrug

    600 mg/m2 IV on day 1 every 3 weeks for cycles 4-6

  • EpirubicinDrug

    90 mg/m2 IV on day 1 every 3 weeks for cycles 4-6

  • CyclophosphamideDrug

    600 mg/m2 IV on day 1 every 3 weeks for cycles 4-6

Study groups in NCT00625898
Study groupRoleWhat they receive
1A: TCH-HActive comparatorDocetaxel (T), Carboplatin (C), and Trastuzumab (H) followed by Trastuzumab (H)
Receives: Drug: Docetaxel; Drug: Trastuzumab; Drug: Carboplatin
1B: TCHB-HBExperimentalDocetaxel (T), Carboplatin (C), Trastuzumab (H), Bevacizumab (B) followed by Trastuzumab (T) and Bevacizumab (B)
Receives: Drug: Docetaxel; Drug: Trastuzumab; Drug: Carboplatin; Drug: Bevacizumab
2A: TH-FEC-HActive comparatorDocetaxel (T) and Trastuzumab (H) followed by 5-fluorouracil (F), Epirubicin (E), and Cyclophosphamide (C) followed by Trastuzumab (H)
Receives: Drug: Docetaxel; Drug: Trastuzumab; Drug: 5-Fluorouracil; Drug: Epirubicin; Drug: Cyclophosphamide
2B: THB-FEC-HBExperimentalDocetaxel (T), Trastuzumab (H), and Bevacizumab (B) followed by 5-Fluorouracil (F), Epirubicin (E), and Cyclophosphamide (C) followed by Trastuzumab (H) and Bevacizumab (B)
Receives: Drug: Docetaxel; Drug: Trastuzumab; Drug: Bevacizumab; Drug: 5-Fluorouracil; Drug: Epirubicin; Drug: Cyclophosphamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Invasive Disease-free Survival (IDFS)

    Measured: up to 10 years

Secondary outcomes (8)

  1. Invasive disease-free survival (IDFS) within chemotherapy cohorts

    Measured: up to 10 years

  2. Disease-free survival (DFS)

    Measured: up to 10 years

  3. Overall survival (OS)

    Measured: Time from randomization until death from any cause or up to a maximum of 10 years from study entry

  4. Recurrence-free interval (RFI)

    Measured: Time from randomization until local, regional or distant recurrence or up to a maximum of 10 years from study entry

  5. Distant recurrence-free interval (DRFI)

    Measured: Time from randomization until distant disease recurrence only or up to a maximum of 10 years from study entry

  6. Cardiac toxicity. Cumulative incidence of severe cardiac events defined as definite or probable cardiac death, or NYHA Class III or IV CHF

    Measured: 2-3 weeks after cycle 3; 2-3 weeks after last chemotherapy dose; 7, 10, 18, 36, and 60 months from randomization

  7. Non-cardiac toxicity. Frequencies of adverse events categorized using the NCI CTCAE v3.0.

    Measured: within 3 days of each chemotherapy cycle; 2-3 weeks following last chemotherapy dose; every 6 weeks during targeted therapy; every 6 months through year 5; every 12 months years 6 - 10

  8. Identification of biomarkers (from tumor and serum/plasma) predictive for the level of benefit from the addition of bevacizumab to standard adjuvant systemic treatment for HER2-positive breast cancer as well as for cardiac toxicity

    Measured: baseline, during therapy and follow-up, within 2 weeks of LVEF assessments, any protocol-specified cardiac event, and after diagnosis of recurrence

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Feb 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionJun 2013
  4. Study completionJul 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3,509 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00625898
Sponsor's protocol ID
NSABP B-44-I
Other IDs
CIRG (TRIO) 011, Roche BO20906, BETH
Acronym
BETH
Status last verified
Mar 2020
First submitted
21 Feb 2008
Last updated
10 Sep 2020
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Docetaxel, Trastuzumab and Carboplatin in people with Breast Cancer, run by NSABP Foundation Inc at 649 sites in 40 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 649 sites in United States, Spain, Germany, France, Canada and 35 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Invasive Disease-free Survival (IDFS) (time frame: up to 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00625898.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2020.

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