AzTrials
AzTrials

Breast CancerPhase 3NCT00408408

Chemotherapy With or Without Bevacizumab in Treating Women With Stage I, Stage II, or Stage IIIA Breast Cancer That Can Be Removed By Surgery

A Phase 3 study testing bevacizumab, capecitabine and cyclophosphamide in people with Breast Cancer, run by NSABP Foundation Inc at 442 sites in 3 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Read more about this study

Who is it for?
Ages 18 to 120 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
bevacizumab, capecitabine and cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,206 participants
Where
442 sitesin 3 countries
Study dates
Nov 2006to Mar 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 120 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient must have consented to participate and must have signed and dated an appropriate Institutional Review Board (IRB)-approved consent form that conforms to federal and institutional guidelines for the study treatment and submission of pre-entry core biopsy material for correlative studies.
  • Patients must be female.
  • Patients must be 18 years of age or older.
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy.
  • The primary breast tumor must be palpable and measure greater than or equal to 2.0 cm on physical exam.
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  • All patients must have their left ventricular ejection fraction (LVEF) assessed by multigated acquisition (MUGA) scan or echocardiogram within 3 months prior to study entry. The LVEF must be greater than or equal to the lower limit of normal (LLN) for the cardiac imaging facility performing the study. Note: If the cardiac imaging facility cannot provide a LLN, use 50% as the LLN value.
  • Note: Since the pre-entry LVEF serves as the baseline for comparing subsequent LVEF assessments to determine if bevacizumab therapy can be continued, it is critical that this baseline study be an accurate assessment of the patient's LVEF. If the baseline LVEF is greater than 75%, the investigator should have the study reviewed for accuracy prior to study entry. Following study entry, the LVEF determination may be reviewed up until the time of the post-chemotherapy (preoperative) evaluation. Please note that if a more accurate value is obtained from the review of the baseline MUGA or echocardiogram, the correct value must be submitted to the NSABP before the post-chemotherapy (preoperative) MUGA or echocardiogram is performed or it cannot be used for managing postoperative bevacizumab.
  • All patients must have an EKG within 3 months prior to study entry.
  • At the time of randomization:
  • Absolute neutrophil count (ANC) must be greater than or equal to 1200/mm3.
  • Platelet count must be greater than or equal to 100,000/mm3.
  • Hemoglobin must be greater than or equal to 10 g/dL.
  • There must be evidence of adequate hepatic function by these criteria:
  • Total bilirubin must be less than or equal to the ULN for the lab unless the patient has a grade 1 bilirubin elevation (greater than ULN to 1.5 x ULN) resulting from Gilbert's disease or similar syndrome due to slow conjugation of bilirubin; and
  • Alkaline phosphatase must be less than or equal 2.5 x ULN for the lab; and
  • Aspartate Aminotransferase (AST) must be less than or equal to 1.5 x ULN for the lab.
  • Alkaline phosphatase and AST may not both be greater than the ULN. For example, if the alkaline phosphatase is greater than the ULN but less than or equal 2.5 x ULN, then the AST must be less than or equal the ULN. If the AST is greater than the ULN but less than or equal 1.5 x ULN, then the alkaline phosphatase must be less than or equal ULN.
  • Patients with either skeletal pain or alkaline phosphatase that is greater than ULN but less than or equal 2.5 x ULN are eligible for inclusion in the study if bone scans do not demonstrate metastatic disease. Suspicious findings on bone scan must be confirmed as benign by x-ray, MRI, or biopsy.
  • Patients with AST or alkaline phosphatase greater than ULN are eligible for inclusion in the study if liver imaging does not demonstrate metastatic disease and adequate bone marrow and liver function results as described above are met.
  • The following criteria for evidence of adequate renal function must be met:
  • Serum creatinine less than or equal ULN for the lab.
  • Calculated creatinine clearance must be greater than 50 mL/min.
  • Urine protein/urine creatinine (UPC) ratio must be less than 1.0.
  • Patient must be able to swallow oral medications.

Who cannot join

  • Tumor determined to be strongly human epidermal growth factor receptor 2 (HER2)-positive by immunohistochemistry (3+) or by fluorescent in situ hybridization (positive for gene amplification).
  • Excisional or incisional biopsy for this primary breast tumor.
  • Surgical axillary staging procedure prior to study entry. Exceptions: 1) Fine Needle Aspiration (FNA) or core biopsy of an axillary node is permitted for any patient, and 2) although not recommended, a pre-neoadjuvant therapy sentinel lymph node biopsy for patients with clinically negative axillary nodes is permitted.
  • Tumors clinically staged as T4.
  • Ipsilateral cN2b or cN3 disease. (Patients with cN1 or cN2a disease are eligible.)
  • Definitive clinical or radiologic evidence of metastatic disease.
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  • Synchronous bilateral breast cancer (invasive or DCIS).
  • Treatment including radiation therapy, chemotherapy, biotherapy, and/or hormonal therapy for the currently diagnosed breast cancer prior to study entry.
  • Any sex hormonal therapy, e.g., birth control pills, ovarian hormonal replacement therapy, etc. (These patients are eligible if this therapy is discontinued prior to randomization.)
  • Therapy with any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulator (SERM), either for osteoporosis or breast cancer prevention. (Patients are eligible only if these medications are discontinued prior to randomization.)
  • Prior history of breast cancer, including DCIS. (Patients with a history of lobular carcinoma in situ [LCIS] are eligible.)
  • Prior therapy with anthracyclines, taxanes, capecitabine, 5-FU (fluorouracil), gemcitabine, or bevacizumab for any malignancy.
  • Other malignancies unless the patient is considered to be disease-free for 5 or more years prior to randomization and is deemed by her physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.
  • Cardiac disease that would preclude the use of anthracyclines. This includes:
  • angina pectoris that requires the use of anti-anginal medication;
  • history of documented congestive heart failure;
  • serious cardiac arrhythmia requiring medication;
  • severe conduction abnormality;
  • valvular disease with documented cardiac function compromise; and
  • uncontrolled hypertension defined as BP greater than 150/90 on antihypertensive therapy. (Patients with hypertension that is well controlled on medication are eligible.)
  • History of myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LV function.
  • History of transient ischemic attack (TIA) or cerebrovascular accident (CVA).
  • History of other arterial thrombotic event within 12 months before study entry.
  • Symptomatic peripheral vascular disease.
  • Any significant non-traumatic bleeding within 6 months before study entry.
  • Serious or non-healing wound, skin ulcers, or incompletely healed bone fracture.
  • Gastroduodenal ulcer(s) determined by endoscopy to be active.
  • Invasive procedures defined as follows:
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to planned start of study therapy. (Note: Placement of a vascular access device is not considered a major surgical procedure.)
  • Anticipation of need for major surgical procedures (other than the required breast surgery) during the course of the study.
  • Known bleeding diathesis or coagulopathy. (Patients on warfarin with an in-range international normalized ratio [INR] [usually between 2 and 3] are eligible.)
  • Sensory/motor neuropathy greater than or equal grade 2, as defined by the NCI's Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0).
  • Other non-malignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude treatment with any of the treatment regimens or would prevent required follow-up.
  • Conditions that would prohibit administration of corticosteroids.
  • History of severe hypersensitivity reaction to drugs formulated with polysorbate 80.
  • Administration of any investigational agents within 30 days before study entry.
  • Pregnancy or lactation at the time of proposed randomization.

Trial locations and contacts

442 sites in 3 countries.

310 sites in 3 countries

United States300 sites

  • Kapiolani Medical Center at Pali Momi

    ‘Aiea, Hawaii, 96701

  • Hickman Cancer Center at Bixby Medical Center

    Adrian, Michigan, 49221

  • McDowell Cancer Center at Akron General Medical Center

    Akron, Ohio, 44307

  • Summa Center for Cancer Care at Akron City Hospital

    Akron, Ohio, 44309-2090

  • Phoebe Cancer Center at Phoebe Putney Memorial Hospital

    Albany, Georgia, 31701

  • Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest

    Allentown, Pennsylvania, 18105

  • Saint Anthony's Hospital at Saint Anthony's Health Center

    Alton, Illinois, 62002

  • American Fork Hospital

    American Fork, Utah, 84003

  • McFarland Clinic, PC

    Ames, Iowa, 50010

  • AnMed Cancer Center

    Anderson, South Carolina, 29621

  • Saint Joseph Mercy Cancer Center

    Ann Arbor, Michigan, 48106-0995

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • Randolph Hospital

    Asheboro, North Carolina, 27203-5400

  • Hope A Women's Cancer Center

    Asheville, North Carolina, 28816

  • Cancer Resource Center at King's Daughters Medical Center

    Ashland, Kentucky, 41101-0151

  • Auburn Regional Center for Cancer Care

    Auburn, Washington, 98002

  • Aurora Presbyterian Hospital

    Aurora, Colorado, 80012

  • Greenebaum Cancer Center at University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Greater Baltimore Medical Center Cancer Center

    Baltimore, Maryland, 21204

  • St. Agnes Hospital Cancer Center

    Baltimore, Maryland, 21229

  • Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center

    Baltimore, Maryland, 21237

  • Barberton Citizens Hospital

    Barberton, Ohio, 44203

  • Mary Bird Perkins Cancer Center - Baton Rouge

    Baton Rouge, Louisiana, 70809

  • Ochsner Health Center - Bluebonnet

    Baton Rouge, Louisiana, 70809

  • St. Francis Hospital and Health Centers - Beech Grove Campus

    Beech Grove, Indiana, 46107

  • Mountainview Medical

    Berlin Corners, Vermont, 05602

  • St. Luke's Cancer Network at St. Luke's Hospital

    Bethlehem, Pennsylvania, 18015

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Hematology-Oncology Centers of the Northern Rockies - Billings

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • St. Vincent Healthcare Cancer Care Services

    Billings, Montana, 59101

  • Billings Clinic - Downtown

    Billings, Montana, 59107-7000

  • Illinois CancerCare - Bloomington

    Bloomington, Illinois, 61701

  • St. Joseph Medical Center

    Bloomington, Illinois, 61701

  • Boulder Community Hospital

    Boulder, Colorado, 80301-9019

  • Wood County Oncology Center

    Bowling Green, Ohio, 43402

  • Bozeman Deaconess Cancer Center

    Bozeman, Montana, 59715

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Alamance Cancer Center at Alamance Regional Medical Center

    Burlington, North Carolina, 27216

  • Fletcher Allen Health Care - University Health Center Campus

    Burlington, Vermont, 05401

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • St. James Healthcare Cancer Care

    Butte, Montana, 59701

  • Graham Hospital

    Canton, Illinois, 61520

  • Illinois CancerCare - Canton

    Canton, Illinois, 61520

  • Aultman Cancer Center at Aultman Hospital

    Canton, Ohio, 44710-1799

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Illinois CancerCare - Carthage

    Carthage, Illinois, 62321

  • Memorial Hospital

    Carthage, Illinois, 62321

  • East Bay Radiation Oncology Center

    Castro Valley, California, 94546

  • Eden Medical Center

    Castro Valley, California, 94546

  • Valley Medical Oncology Consultants - Castro Valley

    Castro Valley, California, 94546

  • Sandra L. Maxwell Cancer Center

    Cedar City, Utah, 84720

  • Providence Centralia Hospital

    Centralia, Washington, 98531-9027

  • Cancer Center of Kansas, PA - Chanute

    Chanute, Kansas, 66720

  • Roper St. Francis Cancer Center at Roper Hospital

    Charleston, South Carolina, 29401

  • Hollings Cancer Center at Medical University of South Carolina

    Charleston, South Carolina, 29425

  • West Virginia University Health Sciences Center - Charleston

    Charleston, West Virginia, 25304

  • Blumenthal Cancer Center at Carolinas Medical Center

    Charlotte, North Carolina, 28232-2861

  • Presbyterian Cancer Center at Presbyterian Hospital

    Charlotte, North Carolina, 28233-3549

  • Mount Sinai Hospital Medical Center

    Chicago, Illinois, 60608

  • John H. Stroger, Jr. Hospital of Cook County

    Chicago, Illinois, 60612-3785

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Marshfield Clinic - Chippewa Center

    Chippewa Falls, Wisconsin, 54729

  • Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106-5065

  • North Coast Cancer Care - Clyde

    Clyde, Ohio, 43410

  • Kootenai Cancer Center - Coeur d'Alene

    Coeur d'Alene, Idaho, 83814

  • Memorial Hospital Cancer Center - Colorado Springs

    Colorado Springs, Colorado, 80909

  • Penrose Cancer Center at Penrose Hospital

    Colorado Springs, Colorado, 80933

  • Ellis Fischel Cancer Center at University of Missouri - Columbia

    Columbia, Missouri, 65203

  • Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210-1240

  • Batte Cancer Center at Northeast Medical Center

    Concord, North Carolina, 28025

  • Mercy and Unity Cancer Center at Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Geisinger Cancer Institute at Geisinger Health

    Danville, Pennsylvania, 17822-0001

  • Grandview Hospital

    Dayton, Ohio, 45405

  • Good Samaritan Hospital

    Dayton, Ohio, 45406

  • David L. Rike Cancer Center at Miami Valley Hospital

    Dayton, Ohio, 45409

  • Samaritan North Cancer Care Center

    Dayton, Ohio, 45415

  • CCOP - Dayton

    Dayton, Ohio, 45420

  • Herbert D. Kerman Regional Oncology Center - Daytona Beach

    Daytona Beach, Florida, 32114

  • Oakwood Cancer Center at Oakwood Hospital and Medical Center

    Dearborn, Michigan, 48123-2500

  • Decatur Memorial Hospital Cancer Care Institute

    Decatur, Illinois, 62526

  • St. Anthony Central Hospital

    Denver, Colorado, 80204

  • Kaiser Permanente - Denver

    Denver, Colorado, 80205

  • Porter Adventist Hospital

    Denver, Colorado, 80210

  • Presbyterian - St. Luke's Medical Center

    Denver, Colorado, 80218

  • St. Joseph Hospital

    Denver, Colorado, 80218

  • Rose Medical Center

    Denver, Colorado, 80220

  • CCOP - Colorado Cancer Research Program

    Denver, Colorado, 80224-2522

  • Josephine Ford Cancer Center at Henry Ford Hospital

    Detroit, Michigan, 48202

  • Cancer Center of Kansas, PA - Dodge City

    Dodge City, Kansas, 67801

  • Duluth Clinic Cancer Center - Duluth

    Duluth, Minnesota, 55805-1983

  • CCOP - Duluth

    Duluth, Minnesota, 55805

  • Miller - Dwan Medical Center

    Duluth, Minnesota, 55805

  • Marshfield Clinic Cancer Care at Regional Cancer Center

    Eau Claire, Wisconsin, 54701

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Cancer Center of Kansas, PA - El Dorado

    El Dorado, Kansas, 67042

  • Alexian Brothers Radiation Oncology

    Elk Grove Village, Illinois, 60007

  • Elkhart Clinic, LLC

    Elkhart, Indiana, 46514-2098

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Community Cancer Center

    Elyria, Ohio, 44035

  • Hematology Oncology Center

    Elyria, Ohio, 44035

  • Swedish Medical Center

    Englewood, Colorado, 80110

  • Eureka Community Hospital

    Eureka, Illinois, 61530

  • Illinois CancerCare - Eureka

    Eureka, Illinois, 61530

  • St. Francis Hospital

    Evanston, Illinois, 60202

  • Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center

    Farmington, Connecticut, 06360-2875

  • St. Francis Hospital

    Federal Way, Washington, 98003

  • Blanchard Valley Medical Associates

    Findlay, Ohio, 45840

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Great Lakes Cancer Institute at McLaren Regional Medical Center

    Flint, Michigan, 48532

  • Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Broward General Medical Center Cancer Center

    Fort Lauderdale, Florida, 33316

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

  • Fort Wayne Medical Oncology and Hematology

    Fort Wayne, Indiana, 46845

  • MetroWest Medical Center - Framingham Union Hospital

    Framingham, Massachusetts, 01702

  • Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Frederick Memorial Hospital Regional Cancer Therapy Center

    Frederick, Maryland, 21701

  • Fredericksburg Oncology, Incorporated

    Fredericksburg, Virginia, 22401

  • Kaiser Permanente - Fremont

    Fremont, California, 94538

  • Valley Medical Oncology

    Fremont, California, 94538

  • Cancer Care Associates

    Fresno, California, 93720

  • Mercy and Unity Cancer Center at Unity Hospital

    Fridley, Minnesota, 55432

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Galesburg Clinic, PC

    Galesburg, Illinois, 61401

  • Galesburg Cottage Hospital

    Galesburg, Illinois, 61401

  • Illinois CancerCare - Cottage

    Galesburg, Illinois, 61401

  • Illinois CancerCare - Galesburg

    Galesburg, Illinois, 61401

  • Charles R. Wood Cancer Center at Glens Falls Hospital

    Glens Falls, New York, 12801

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • Center for Cancer Care at Goshen General Hospital

    Goshen, Indiana, 46526

  • Altru Cancer Center at Altru Hospital

    Grand Forks, North Dakota, 58201

  • St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center

    Grand Junction, Colorado, 81502

  • Big Sky Oncology

    Great Falls, Montana, 59405-5309

  • Great Falls Clinic - Main Facility

    Great Falls, Montana, 59405

  • Sletten Cancer Institute at Benefis Healthcare

    Great Falls, Montana, 59405

  • Study site

    Great Falls, Montana, 59405

  • North Colorado Medical Center

    Greeley, Colorado, 80631

  • Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

  • Moses Cone Regional Cancer Center at Wesley Long Community Hospital

    Greensboro, North Carolina, 27403-1198

  • Wayne Hospital

    Greenville, Ohio, 45331

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • Van Elslander Cancer Center at St. John Hospital and Medical Center

    Grosse Pointe Woods, Michigan, 48236

  • Cancer Institute of New Jersey at Hamilton

    Hamilton, New Jersey, 08690

  • Cherry Tree Cancer Center

    Hanover, Pennsylvania, 17331

  • Helen and Harry Gray Cancer Center at Hartford Hospital

    Hartford, Connecticut, 06102-5037

  • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

    Hartford, Connecticut, 06105

  • Hattiesburg Clinic, PA at Forrest General

    Hattiesburg, Mississippi, 39401

  • Illinois CancerCare - Havana

    Havana, Illinois, 62644

  • Mason District Hospital

    Havana, Illinois, 62644

  • Kaiser Permanente Medical Center - Hayward

    Hayward, California, 94545

  • St. Peter's Hospital

    Helena, Montana, 59601

  • Penn State Cancer Institute at Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • Cancer Research Center of Hawaii

    Honolulu, Hawaii, 96813

  • OnCare Hawaii, Incorporated - Lusitana

    Honolulu, Hawaii, 96813

  • Queen's Cancer Institute at Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Straub Clinic and Hospital, Incorporated

    Honolulu, Hawaii, 96813

  • Hawaii Medical Center - East

    Honolulu, Hawaii, 96817

  • OnCare Hawaii, Incorporated - Kuakini

    Honolulu, Hawaii, 96817

  • Kaiser Permanente - Moanalua Medical Center and Clinic

    Honolulu, Hawaii, 96819

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

  • Hutchinson Area Health Care

    Hutchinson, Minnesota, 55350

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • St. Vincent Indianapolis Hospital

    Indianapolis, Indiana, 46260

  • Holden Comprehensive Cancer Center at University of Iowa

    Iowa City, Iowa, 52242-1002

  • Foote Memorial Hospital

    Jackson, Michigan, 49201

  • Baptist Cancer Institute - Jacksonville

    Jacksonville, Florida, 32207

  • St. John's Regional Medical Center

    Joplin, Missouri, 64804

  • Ella Milbank Foshay Cancer Center at Jupiter Medical Center

    Jupiter, Florida, 33458

  • Borgess Medical Center

    Kalamazoo, Michigan, 49001

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007-3731

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • Glacier Oncology, PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology at KRMC

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Truman Medical Center - Hospital Hill

    Kansas City, Missouri, 64108

  • Saint Luke's Cancer Institute at Saint Luke's Hospital

    Kansas City, Missouri, 64111

  • St. Joseph Medical Center

    Kansas City, Missouri, 64114

  • North Kansas City Hospital

    Kansas City, Missouri, 64116

  • Parvin Radiation Oncology

    Kansas City, Missouri, 64116

  • Heartland Hematology Oncology Associates, Incorporated

    Kansas City, Missouri, 64118

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Research Medical Center

    Kansas City, Missouri, 64132

  • Good Samaritan Cancer Center at Good Samaritan Hospital

    Kearney, Nebraska, 68848-1990

  • Charles F. Kettering Memorial Hospital

    Kettering, Ohio, 45429

  • Illinois CancerCare - Kewanee Clinic

    Kewanee, Illinois, 61443

  • Cancer Center of Kansas, PA - Kingman

    Kingman, Kansas, 67068

  • Thompson Cancer Survival Center

    Knoxville, Tennessee, 37916

  • Howard Community Hospital

    Kokomo, Indiana, 46904

  • Gundersen Lutheran Center for Cancer and Blood

    La Crosse, Wisconsin, 54601

  • Scripps Cancer Center - San Diego

    La Jolla, California, 92037

  • Center for Cancer Therapy at LaPorte Hospital and Health Services

    La Porte, Indiana, 46350

  • Kaiser Permanente - Lafayette

    Lafayette, Colorado, 80026

  • Haematology-Oncology Associates of Ohio and Michigan, PC

    Lambertville, Michigan, 48144

  • Breslin Cancer Center at Ingham Regional Medical Center

    Lansing, Michigan, 48910

  • Sparrow Regional Cancer Center

    Lansing, Michigan, 48912-1811

  • Lapeer Regional Hospital

    Lapeer, Michigan, 48446

  • Doctor's Hospital of Laredo

    Laredo, Texas, 78041

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Cleo Craig Cancer Research Clinic

    Lawton, Oklahoma, 73505

  • Saint Luke's East - Lee's Summit

    Lee's Summit, Missouri, 64086

  • Tunnell Cancer Center at Beebe Medical Center

    Lewes, Delaware, 19958

  • Lucille P. Markey Cancer Center at University of Kentucky

    Lexington, Kentucky, 40536-0093

  • Southwest Medical Center

    Liberal, Kansas, 67901

  • Liberty Hospital

    Liberty, Missouri, 64068

  • Lima Memorial Hospital

    Lima, Ohio, 45804

  • Cancer Resource Center - Lincoln

    Lincoln, Nebraska, 68510

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • St. Mary Mercy Hospital

    Livonia, Michigan, 48154

  • Loma Linda University Cancer Institute at Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Sky Ridge Medical Center

    Lone Tree, Colorado, 80124

  • Hope Cancer Care Center at Longmont United Hospital

    Longmont, Colorado, 80501

  • Louisville Oncology at Norton Cancer Institute - Louisville

    Louisville, Kentucky, 40202

  • James Graham Brown Cancer Center at University of Louisville

    Louisville, Kentucky, 40292

  • McKee Medical Center

    Loveland, Colorado, 80539

  • Illinois CancerCare - Macomb

    Macomb, Illinois, 61455

  • McDonough District Hospital

    Macomb, Illinois, 61455

  • HealthEast Cancer Care at St. John's Hospital

    Maplewood, Minnesota, 55109

  • Minnesota Oncology Hematology, PA - Maplewood

    Maplewood, Minnesota, 55109

  • Marshfield Clinic - Marshfield Center

    Marshfield, Wisconsin, 54449

  • Saint Joseph's Hospital

    Marshfield, Wisconsin, 54449

  • Contra Costa Regional Medical Center

    Martinez, California, 94553-3156

  • Northwest Ohio Oncology Center

    Maumee, Ohio, 43537-1839

  • St. Luke's Hospital

    Maumee, Ohio, 43537

  • Cardinal Bernardin Cancer Center at Loyola University Medical Center

    Maywood, Illinois, 60153

  • University of Tennessee Cancer Institute - Memphis

    Memphis, Tennessee, 38104

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Tucker Center for Cancer Care at Orange Regional Medical Center

    Middletown, New York, 10940-4199

  • Aurora Sinai Medical Center

    Milwaukee, Wisconsin, 53201-0342

  • Medical College of Wisconsin Cancer Center

    Milwaukee, Wisconsin, 53226

  • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center - Minneapolis

    Minneapolis, Minnesota, 55415

  • Marshfield Clinic - Lakeland Center

    Minocqua, Wisconsin, 54548

  • Community Medical Center

    Missoula, Montana, 59801

  • Guardian Oncology and Center for Wellness

    Missoula, Montana, 59804

  • Montana Cancer Specialists at Montana Cancer Center

    Missoula, Montana, 59807-7877

  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

    Missoula, Montana, 59807

  • Illinois CancerCare - Monmouth

    Monmouth, Illinois, 61462

  • OSF Holy Family Medical Center

    Monmouth, Illinois, 61462

  • Community Cancer Center of Monroe

    Monroe, Michigan, 48162

  • Mercy Memorial Hospital - Monroe

    Monroe, Michigan, 48162

  • Mary Babb Randolph Cancer Center at West Virginia University Hospitals

    Morgantown, West Virginia, 26506

  • Good Samaritan Regional Health Center

    Mount Vernon, Illinois, 62864

  • El Camino Hospital Cancer Center

    Mountain View, California, 94040

  • Community Hospital

    Munster, Indiana, 46321

  • Jon and Karen Huntsman Cancer Center at Intermountain Medical Center

    Murray, Utah, 84157

  • Edward Hospital Cancer Center

    Naperville, Illinois, 60540

  • Nashville Oncology Associates, PC

    Nashville, Tennessee, 37203

  • MBCCOP - Meharry Medical College - Nashville

    Nashville, Tennessee, 37208-3599

  • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08903

  • MBCCOP - LSU Health Sciences Center

    New Orleans, Louisiana, 70112

  • Medical Center of Louisiana - New Orleans

    New Orleans, Louisiana, 70112

  • CCOP - Ochsner

    New Orleans, Louisiana, 70121

  • Ochsner Cancer Institute at Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

  • Cancer Center of Kansas, PA - Newton

    Newton, Kansas, 67114

  • BroMenn Regional Medical Center

    Normal, Illinois, 61761

  • Community Cancer Center

    Normal, Illinois, 61761

  • Illinois CancerCare - Community Cancer Center

    Normal, Illinois, 61761

  • Fisher-Titus Medical Center

    Norwalk, Ohio, 44857

  • Eastern Connecticut Hematology and Oncology Associates

    Norwich, Connecticut, 06360

  • Highland General Hospital

    Oakland, California, 94602

  • Alta Bates Summit Medical Center - Summit Campus

    Oakland, California, 94609

  • Bay Area Breast Surgeons, Incorporated

    Oakland, California, 94609

  • CCOP - Bay Area Tumor Institute

    Oakland, California, 94609

  • Larry G Strieff MD Medical Corporation

    Oakland, California, 94609

  • Tom K Lee, Incorporated

    Oakland, California, 94609

  • Kaiser Permanente Medical Center - Oakland

    Oakland, California, 94611

  • Val and Ann Browning Cancer Center at McKay-Dee Hospital Center

    Ogden, Utah, 84403

  • Providence St. Peter Hospital Regional Cancer Center

    Olympia, Washington, 98506-5166

  • CCOP - Missouri Valley Cancer Consortium

    Omaha, Nebraska, 68106

  • Immanuel Medical Center

    Omaha, Nebraska, 68122

  • Alegant Health Cancer Center at Bergan Mercy Medical Center

    Omaha, Nebraska, 68124

  • Creighton University Medical Center

    Omaha, Nebraska, 68131-2197

  • St. Joseph Hospital Regional Cancer Center - Orange

    Orange, California, 92868

  • St. Charles Mercy Hospital

    Oregon, Ohio, 43616

  • Toledo Clinic - Oregon

    Oregon, Ohio, 43616

  • Florida Hospital Cancer Institute at Florida Hospital Orlando

    Orlando, Florida, 32803-1273

  • M.D. Anderson Cancer Center at Orlando

    Orlando, Florida, 32806

  • Vince Lombardi Cancer Clinic - Oshkosh

    Oshkosh, Wisconsin, 54904

  • Community Hospital of Ottawa

    Ottawa, Illinois, 61350

  • Oncology Hematology Associates of Central Illinois, PC - Ottawa

    Ottawa, Illinois, 61350

  • Menorah Medical Center

    Overland Park, Kansas, 66209

  • Saint Luke's Hospital - South

    Overland Park, Kansas, 66213

  • Desert Regional Medical Center Comprehensive Cancer Center

    Palm Springs, California, 92262

  • Cancer Center of Paoli Memorial Hospital

    Paoli, Pennsylvania, 19301-1792

  • Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital

    Parkersburg, West Virginia, 26102

  • Cancer Center of Kansas, PA - Parsons

    Parsons, Kansas, 67357

  • Illinois CancerCare - Pekin

    Pekin, Illinois, 61603

  • Proctor Hospital

    Peoria, Illinois, 61614

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois, 61615

  • Oncology Hematology Associates of Central Illinois, PC - Peoria

    Peoria, Illinois, 61615

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • OSF St. Francis Medical Center

    Peoria, Illinois, 61637

  • Illinois CancerCare - Peru

    Peru, Illinois, 61354

  • Illinois Valley Community Hospital

    Peru, Illinois, 61354

  • Allegheny Cancer Center at Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224-1791

  • UPMC Cancer Centers

    Pittsburgh, Pennsylvania, 15232

Other trials in United States

Canada9 sites

  • Hopital Notre-Dame du CHUM

    Montreal, Quebec, H2L 4M1

  • CHUM - Hotel Dieu Hospital

    Montreal, Quebec, H2W 1T8

  • CHUM - Hopital Saint-Luc

    Montreal, Quebec, H2X 3J4

  • Royal Victoria Hospital - Montreal

    Montreal, Quebec, H3A 1A1

  • Montreal General Hospital

    Montreal, Quebec, H3G 1A4

  • Jewish General Hospital - Montreal

    Montreal, Quebec, H3T 1E2

  • St. Mary's Hospital Center

    Montreal, Quebec, H3T 1M5

  • Hopital du Saint-Sacrement - Quebec

    Québec, Quebec, G1S 4L8

  • Edmond Odette Cancer Centre at Sunnybrook

    Toronto, Ontario, M4N 3M5

Other trials in Canada

Puerto Rico1 site

  • San Juan City Hospital

    San Juan, 00928

Other trials in Puerto Rico

About this study

Official title: A Randomized Phase III Trial of Neoadjuvant Therapy in Patients With Palpable and Operable Breast Cancer Evaluating the Effect on Pathologic Complete Response (pCR) of Adding Capecitabine or Gemcitabine to Docetaxel When Administered Before AC With or Without Bevacizumab and Correlative Science Studies Attempting to Identify Predictors of High Likelihood for pCR With Each of the Regimens

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as bevacizumab, 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. Bevacizumab may also stop the growth of breast cancer by blocking blood flow to the tumor. Giving chemotherapy and bevacizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving bevacizumab after surgery may kill any tumor cells that remain after surgery. It is not yet known which chemotherapy regimen is more effective with or without bevacizumab in treating breast cancer.

PURPOSE: This randomized phase III trial is studying six different chemotherapy regimens to compare how well they work with or without bevacizumab in treating women with stage I, stage II, or stage IIIA breast cancer that can be removed by surgery.

Read the detailed description

OBJECTIVES:

Primary

  • Compare the efficacy of docetaxel followed by doxorubicin hydrocloride and cyclophosphamide (AC) vs docetaxel and capecitabine followed by AC vs docetaxel and gemcitabine hydrochloride followed by AC, with or without bevacizumab, in terms of an increase in the rate of pathologic complete response (pCR) in the breast, in women with palpable or operable breast cancer.

Secondary

  • Compare docetaxel/capecitabine with AC vs docetaxel/gemcitabine hydrochloride with AC vs docetaxel with AC, with or without bevacizumab, in terms of the rate of pCR in the breast and all post-therapy lymph nodes evaluated histologically (pCR breast and nodes).
  • Determine whether the addition of bevacizumab to the docetaxel/anthracycline-based regimens (docetaxel with AC, docetaxel and capecitabine with AC, and docetaxel and gemcitabine hydrochloride with AC) will increase the rate of pCR of the breast and nodes compared to the same docetaxel/anthracycline-based regimens without bevacizumab in these patients.
  • Determine whether the addition of capecitabine or gemcitabine hydrochloride to docetaxel, with or without bevacizumab, will increase the rate of clinical overall response (cOR) compared to docetaxel alone with or without bevacizumab in these patients.
  • Determine whether the addition of bevacizumab to the docetaxel/anthracycline-based regimens will increase the rate of cOR compared to the same docetaxel/anthracycline-based regimens without bevacizumab in these patients.
  • Determine whether the addition of capecitabine or gemcitabine hydrochloride to docetaxel, with or without bevacizumab, will increase the rate of clinical complete response (cCR) compared to docetaxel alone with or without bevacizumab in these patients.
  • Determine whether the addition of bevacizumab to the docetaxel/anthracycline-based regimens (docetaxel with AC, docetaxel/capecitabine with AC, and docetaxel/gemcitabine hydrochloride with AC) will increase the rate of cCR compared to the same docetaxel/anthracycline-based regimens without bevacizumab in these patients.
  • Identify gene expression profiles that can predict pCR in patients treated with the different sequential docetaxel/anthracycline-based regimens with or without bevacizumab.
  • Identify gene expression profiles that can predict cOR in patients treated with docetaxel alone, docetaxel/capecitabine, or docetaxel/gemcitabine hydrochloride with or without bevacizumab.
  • Determine the accuracy of an in vitro chemoresponse assay (ChemoFx®) as a predictor of pCR in patients treated with the different sequential docetaxel/anthracycline-based regimens without bevacizumab.
  • Determine the accuracy of ChemoFx® as a predictor of cOR in patients treated with docetaxel alone, docetaxel/capecitabine, or docetaxel/gemcitabine hydrochloride without bevacizumab in these patients.
  • Determine the impact of preoperative bevacizumab and sequential chemotherapy regimens and postoperative bevacizumab therapy on cardiac function in these patients.
  • Determine the impact of bevacizumab on surgical complications in these patients.
  • Determine the toxicity of the preoperative regimens and the toxicity of postoperative bevacizumab in these patients.
  • Compare the docetaxel/anthracycline-based regimens with vs without bevacizumab, in terms of an increase in disease-free survival, of these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor size (2-4 cm vs > 4 cm), nodal status (negative vs positive), hormone receptor status (estrogen receptor [ER]-positive and/or progesterone-receptor [PgR]-positive vs ER- and PgR-negative), and age (< 50 years vs ≥ 50 years). Patients are randomized to 1 of 6 treatment arms.

Core needle biopsies are performed at baseline. Tumor tissue samples are also collected during definitive surgery. Samples are examined for gene expression and polymorphism by reverse transcriptase-polymerase chain reaction analysis and chemoresponse assay (ChemoFx®).

After completion of study therapy, patients are followed periodically for 10 years.

PROJECTED ACCRUAL: A total of 1,200 patients will be accrued for this study.

Conditions
Breast Cancer
Being tested
bevacizumab, capecitabine, cyclophosphamide, docetaxel, doxorubicin hydrochloride (Adriamycin)
Keywords
stage I breast cancer, stage II breast cancer, stage IIIA breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

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

Study groups in NCT00408408
Study groupRoleWhat they receive
Arm 1A: Docetaxel then ACActive comparatorPatients receive docetaxel IV on day 1 every 3 weeks for up to 4 cycles. Patients then receive AC IV every 3 weeks for up to 4 cycles. Patients then undergo surgery (lumpectomy or mastectomy).
Receives: Drug: cyclophosphamide; Drug: docetaxel; Drug: doxorubicin hydrochloride (Adriamycin)
Arm 1B Docetaxel + Bev then AC + BevExperimentalPatients receive bevacizumab (bev) IV on day 1 and docetaxel every 3 weeks for up to 4 cycles. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1A. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab IV every 3 weeks for up to 10 cycles in the absence of disease progression or unacceptable toxicity.
Receives: Biological: bevacizumab; Drug: cyclophosphamide; Drug: docetaxel; Drug: doxorubicin hydrochloride (Adriamycin)
Arm 2A: Docetaxel + Capecitabine then ACExperimentalPatients receive docetaxel as in Arm 1A and oral capecitabine (cape) twice daily on days 1-14 every 3 weeks for up to 4 cycles. Patients then receive AC as in Arm 1A. Patients then undergo surgery as in Arm 1A.
Receives: Drug: capecitabine; Drug: cyclophosphamide; Drug: docetaxel; Drug: doxorubicin hydrochloride (Adriamycin)
Arm 2B: Docetaxel + Cape + Bev then AC + BevExperimentalPatients receive bevacizumab as in Arm 1B and docetaxel and capecitabine as in Arm III. Treatment repeats every 3 weeks for up to 4 cycles. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1B. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm 1B.
Receives: Biological: bevacizumab; Drug: capecitabine; Drug: cyclophosphamide; Drug: docetaxel; Drug: doxorubicin hydrochloride (Adriamycin)
Arm 3A: Docetaxel + Gem then ACExperimentalPatients receive docetaxel as in Arm 1A and gemcitabine hydrochloride IV on days 1 and 8 of each cycle every 3 weeks for up to 4 cycles. Patients then receive AC as in Arm 1A. Patients then undergo surgery as in Arm 1A.
Receives: Drug: cyclophosphamide; Drug: docetaxel; Drug: doxorubicin hydrochloride (Adriamycin); Drug: gemcitabine hydrochloride
Arm 3B: Docetaxel + Gem + Bev then AC + BevExperimentalPatients receive docetaxel as in Arm 1A, gemcitabine hydrochloride as in Arm 3A, and bevacizumab as in Arm 1B. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1A. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm 1B.
Receives: Biological: bevacizumab; Drug: cyclophosphamide; Drug: docetaxel; Drug: doxorubicin hydrochloride (Adriamycin); Drug: gemcitabine hydrochloride

What is being measured

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

  1. Pathologic Complete Response (pCR) of the Primary Tumor in the Breast

    Percentage of patients absent of histologic evidence of invasive tumor cells in the surgical breast specimen.

    Measured: Time of surgery, on average 6 or 13 months

Secondary outcomes (9)

  1. pCR in the Breast and Nodes

    Percentage of patients absent of histologic evidence of invasive tumor cells in the surgical breast specimen and axillary lymph nodes.

    Measured: Time of surgery, on average 6 or 13 months

  2. Clinical Overall Response (cOR) Following Docetaxel Alone, Docetaxel/Capecitabine, and Docetaxel/Gemcitabine Hydrochloride, With or Without Bevacizumab, as Assessed by Physical Exam at the Completion of the Docetaxel-based Portion of Chemotherapy

    Percentages of patients assessed as Clinical Complete Response or Clinical Partial Response according to RECIST.

    Measured: Assessed at cycle 5 of chemotherapy, on average at 15 weeks

  3. Clinical Overall Response: cOR as Assessed by Physical Exam at the Completion of the Sequential Chemotherapy Regimens

    The percentage of patients assessed by physical exam as Clinical Complete Response or Clinical Partial Response according to RECIST.

    Measured: Three to four weeks after the last chemotherapy dose on average 6 or 13 months

  4. Clinical Complete Response (cCR) Following Docetaxel Alone, Docetaxel/Capecitabine, and Docetaxel/Gemcitabine Hydrochloride, With or Without Bevacizumab, as Assessed by Physical Exam at Completion of Therapy

    Percentages of patients assessed as Clinical Complete Response or Clinical Partial Response according to RECIST.

    Measured: Assessed at cycle 5 of chemotherapy, on average at 15 weeks

  5. Clinical Complete Resonse: cCR as Assessed by Physical Exam at the Completion of the Sequential Chemotherapy Regimens

    The percentage of patients assessed by physical exam as Clinical Complete Response according to RECIST.

    Measured: Three to four weeks after the last chemotherapy dose, on average at 6 or 13 months

  6. Percentage of Cardiac Events

    Measured: After each cycle, 3-5 weeks postoperative, 9 and 12 months from study entry, every 6 month years 2-5, and annually years 6-10, for postoperative bevacizumab patients, every 6 weeks during postoperative therapy and at 18 months following study entry.

  7. Surgical Complication

    Number of patients with Grade 4 or above surgery-related toxicities

    Measured: 24 months after study entry

  8. Toxicities Including Events Other Than Congestive Heart Failure, of Chemotherapy Alone, Bevacizumab With Chemotherapy, and Bevacizumab Alone

    The number of patients who experienced Grade 1 or above Adverse Events. Referring to the Adverse Events tables for specifics.

    Measured: 24 months after study entry

  9. Disease-free Survival (DFS)

    Percentage of patients free from local recurrence following mastectomy, local recurrence in the ipsilateral breast following lumpectomy, regional recurrence, distant recurrence, contralateral breast cancer, second primary cancer after 5 years.

    Measured: Measured through 5 years after study enrollment

Timeline

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

  1. First posted7 Dec 2006 (estimated)
  2. Study startNov 2006
  3. Primary completionMar 2011
  4. Study completionMar 2018 (estimated)

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
1,206 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00408408
Sponsor's protocol ID
NSABP B-40
Other IDs
NSABP B-40
Status last verified
Sep 2017
First submitted
6 Dec 2006
Last updated
18 Sep 2017
Data monitoring committee
Yes

Publications

  • Bear HD, Tang G, Rastogi P, Geyer CE Jr, Robidoux A, Atkins JN, Baez-Diaz L, Brufsky AM, Mehta RS, Fehrenbacher L, Young JA, Senecal FM, Gaur R, Margolese RG, Adams PT, Gross HM, Costantino JP, Swain SM, Mamounas EP, Wolmark N. Bevacizumab added to neoadjuvant chemotherapy for breast cancer. N Engl J Med. 2012 Jan 26;366(4):310-20. doi: 10.1056/NEJMoa1111097.

    PubMed 22276821

  • Bear HD, Tang G, Rastogi P, et al.: The effect on pCR of bevacizumab and/or antimetabolites added to standard neoadjuvant chemotherapy: NSABP protocol B-40. [Abstract] J Clin Oncol 29 (Suppl 15): A-LBA1005, 2011.

  • Bear HD, Tang G, Rastogi P, Geyer CE Jr, Liu Q, Robidoux A, Baez-Diaz L, Brufsky AM, Mehta RS, Fehrenbacher L, Young JA, Senecal FM, Gaur R, Margolese RG, Adams PT, Gross HM, Costantino JP, Paik S, Swain SM, Mamounas EP, Wolmark N. Neoadjuvant plus adjuvant bevacizumab in early breast cancer (NSABP B-40 [NRG Oncology]): secondary outcomes of a phase 3, randomised controlled trial. Lancet Oncol. 2015 Sep;16(9):1037-1048. doi: 10.1016/S1470-2045(15)00041-8. Epub 2015 Aug 10.

    PubMed 26272770

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing bevacizumab, capecitabine and cyclophosphamide in people with Breast Cancer, run by NSABP Foundation Inc at 442 sites in 3 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 25 inclusion and 37 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: status not confirmed, as of the sponsor's last update on 18 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 442 sites in United States, Canada, Puerto Rico. 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?

Yes. Results are posted in the registry (first posted 18 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Pathologic Complete Response (pCR) of the Primary Tumor in the Breast (time frame: Time of surgery, on average 6 or 13 months). 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 NCT00408408, which also lists 3 linked publications.

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 18 Sep 2017.

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