AzTrials
AzTrials

Breast CancerPhase 3NCT00887536

A Clinical Trial Comparing the Combination of TC Plus Bevacizumab to TC Alone and to TAC for Women With Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer

A Phase 3 study testing bevacizumab, docetaxel and doxorubicin in people with Breast Cancer, run by NSABP Foundation Inc at 533 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The main purpose of this study is to learn if adding bevacizumab to standard treatment with chemotherapy (docetaxel, doxorubicin, and cyclophosphamide) for early stage HER2-negative breast cancer will prevent breast cancer from returning. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
bevacizumab, docetaxel and doxorubicin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,613 participants
Where
533 sitesin 2 countries
Study dates
May 2009to Feb 2018
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 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must be female.
  • The patient must be greater than or equal to 18 years of age and less than or equal to 70 years of age.
  • The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination.
  • The breast cancer must be HER2-negative based on current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) Guideline Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer. If the result of the in situ hybridization testing (FISH, chromagen in situ hybridization (CISH), or other) is equivocal, the patient is eligible if there is no plan to administer HER2-targeted therapy.
  • All of the following staging criteria (according to the 6th edition of the American Joint Committee on Cancer (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: ER negative and PgR negative; or Pathologic tumor size greater than 2.0 cm; or T1c (pathologic tumor size greater than 1.0 cm but less than or equal to 2.0 cm) and ER positive (PgR status may be positive or negative) and either Oncotype DX® Recurrence Score of greater than or equal to 25 or grade 3 histology.
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  • 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 DCIS as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional operative procedures must 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 histologically free of invasive tumor and DCIS.
  • Patients must have completed one of the following procedures for evaluation of pathologic nodal status: Sentinel lymphadenectomy alone if pathologic nodal staging based on sentinel lymphadenectomy is pN0, pN1mi, or pN1b; Sentinel lymphadenectomy followed by removal of additional non-sentinel lymph nodes if the sentinel node (SN) is positive; 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. (Either a core biopsy or surgical resection specimen can be used for ER/PgR testing.)
  • The most recent postoperative blood counts must meet the following criteria: 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; 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: total bilirubin must be less than or equal to upper limits of normal (ULN)for the lab unless the patient has a bilirubin elevation less than 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 aspartate transaminase (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 to 2.5 x ULN, then the AST must be less than or equal to the ULN. If the AST is greater than the ULN but less than or equal to 1.5 x ULN, then the alkaline phosphatase must be less than or equal to ULN.
  • Patients with AST or alkaline phosphatase greater than ULN are eligible for inclusion in the study if liver imaging (CT, MRI, PET-CT, or PET scan) does not demonstrate metastatic disease and the requirements for adequate hepatic function are met.
  • Patients with alkaline phosphatase that is greater than ULN but less than or equal to 2.5 x ULN are eligible for inclusion in the study if a bone scan, PET-CT, or PET scan does not demonstrate metastatic disease.
  • The most recent postoperative serum creatinine must be less than or equal to ULN for the lab.
  • A urine sample must be tested for proteinuria by the dipstick method. Eligibility must be based on the most recent postoperative test result(s) performed within 6 weeks prior to randomization. Urine dipstick must indicate 0-1+ protein. If dipstick reading is greater than or equal to 2+, a 24-hour urine specimen must be collected and must demonstrate less than 1 gram of protein.
  • Left ventricular ejection fraction (LVEF) assessment by 2-D echocardiogram or multigated acquisition (MUGA) scan must be performed within 90 days prior to randomization. The LVEF must be greater than or equal to 50% regardless of the facility's lower limits of normal (LLN).

Who cannot join

  • T4 tumors including inflammatory breast cancer.
  • Definitive clinical or radiologic evidence of metastatic disease.
  • Synchronous or metachronous contralateral invasive breast cancer. (Patients with synchronous and/or metachronous contralateral DCIS are eligible.)
  • Any history of ipsilateral invasive breast cancer or ipsilateral DCIS.
  • History of non-breast malignancies within 5 years prior to randomization, except for the following: carcinoma in situ of the cervix, colorectal carcinoma in situ, melanoma in situ, and basal cell and squamous cell carcinomas of the skin.
  • Previous therapy with anthracyclines, taxanes, or bevacizumab for any malignancy.
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  • Chemotherapy 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. Patients are eligible if these medications are discontinued prior to randomization.
  • Active hepatitis B or hepatitis C with abnormal liver function tests.
  • 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 1) 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, 2) History of cardiac disease: myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular (LV) function; history of documented congestive heart failure (CHF); and documented cardiomyopathy.
  • Uncontrolled hypertension defined as systolic BP greater than 150 mmHg or diastolic BP greater than 90 mmHg, with or without anti-hypertensive medication. 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 transient ischemic attack (TIA) or cerebrovascular accident (CVA).
  • History of any arterial thrombotic event within 12 months prior to randomization.
  • Symptomatic peripheral vascular disease.
  • Intrinsic lung disease resulting in dyspnea.
  • Unstable diabetes mellitus.
  • Active infection or chronic infection requiring suppressive antibiotics.
  • History of a major organ allograft or condition requiring chronic immunosuppression, e.g., kidney, liver, lung, heart, bone marrow transplant, or autoimmune diseases. (Patients who have received corneal transplants, cadaver skin, or bone transplants are eligible.)
  • Any significant bleeding within 180 days prior to 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 the 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 Common Terminology Criteria for Adverse Events (CTCAE) v3.0.
  • Conditions that would prohibit administration of corticosteroids.
  • Chronic daily treatment with corticosteroids (dose of greater than or equal to 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.
  • 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 randomization.

Trial locations and contacts

533 sites in 2 countries.

311 sites in 2 countries

United States300 sites

  • Texas Cancer Center - Abilene South

    Abilene, Texas, 79606-5208

  • Akron City Hospital

    Akron, Ohio, 44304

  • Phoebe Putney Memorial Hospital

    Albany, Georgia, 31703

  • New York Oncology Hematology PC-Albany

    Albany, New York, 12206

  • New York Oncology Hematology, PC at Albany Medical Center

    Albany, New York, 12208

  • Christus St. Frances Cabrini Hospital

    Alexandria, Louisiana, 71301

  • Central Hematology/Oncology Medical Group, Inc.

    Alhambra, California, 91801

  • Texas Oncology PA - Amarillo

    Amarillo, Texas, 79106

  • Amsterdam Community Cancer Program

    Amsterdam, New York, 12010

  • AnMed Health Cancer Center

    Anderson, South Carolina, 29621

  • CCOP, St. Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106

  • Kaiser Permanente Deer Valley Med Center

    Antioch, California, 94531

  • Cancer Care & Hematology Specialists of Chicagoland

    Arlington, Illinois, 60005

  • Texas Oncology PA - Arlington North

    Arlington, Texas, 76012

  • Texas Onclogy - Arlington South

    Arlington, Texas, 76014

  • Arlington Fairfax Hematology Oncology

    Arlington, Virginia, 22205

  • Medical Center of Aurora

    Aurora, Colorado, 80012

  • Rocky Mountain Cancer Center

    Aurora, Colorado, 80012

  • Northwest Georgia Oncology Centers

    Austell, Georgia, 30106

  • Texas Oncology Central Austin

    Austin, Texas, 78705

  • Texas Oncology Cancer Center - Balcones

    Austin, Texas, 78731

  • South Austin Cancer Center

    Austin, Texas, 78745

  • Southwest Regional Cancer Center- North

    Austin, Texas, 78759

  • Texas Oncology North Austin- Renfert

    Austin, Texas, 78759

  • Comp Blook and Cancer Center

    Bakersfield, California, 93309

  • Mercy Medical Center

    Baltimore, Maryland, 21202

  • St. Joseph's Medical Center

    Baltimore, Maryland, 21204-7582

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

  • Franklin Square Hospital Center

    Baltimore, Maryland, 21237

  • Eastern Maine Medical Center

    Bangor, Maine, 04401

  • Baton Rouge General Medical Center

    Baton Rouge, Louisiana, 70806

  • Bay Regional Medical Center

    Bay City, Michigan, 48706

  • Mamie McFaddin Ward Cancer Center

    Beaumont, Texas, 77702-1449

  • Raleigh Regional Cancer Center

    Beckley, West Virginia, 25801

  • Edwards Cancer Center - Bedford

    Bedford, Texas, 76022

  • Texas Oncology PA - Harris HEB

    Bedford, Texas, 76022

  • St. Charles Medical Center - Bend

    Bend, Oregon, 97701

  • Southwestern Regional Cancer Center (SWORD)

    Bennington, Vermont, 05201

  • Birmingham Hematology and Oncology

    Bessemer, Alabama, 35022

  • SCRI - Center for Cancer and Blood Disorders

    Bethesda, Maryland, 20817

  • Suburban Hospital

    Bethesda, Maryland, 20817

  • Birmingham Hematology and Oncology

    Birmingham, Alabama, 35205

  • Birmingham Hematology and Oncology - Brookwood

    Birmingham, Alabama, 35209

  • Birmingham Hematology and Oncology - Princeton

    Birmingham, Alabama, 35211

  • Birmingham Hematology and Oncology - Montclair

    Birmingham, Alabama, 35213

  • Birmingham Hematology and Oncology - Pilot

    Birmingham, Alabama, 35235

  • SCRI - Florida Cancer Specialists- Bonita Springs

    Bonita Springs, Florida, 34135

  • Rocky Mountain Cancer Centers - Boulder

    Boulder, Colorado, 80303

  • SCRI - Florida Cancer Specialists - Bradenton

    Bradenton, Florida, 34209

  • Florida Cancer Specialists

    Brandon, Florida, 33511

  • Interlakes Oncology Hematology PC

    Brockport, New York, 14420

  • Highline Medical Oncology

    Burien, Washington, 98166

  • Alamance Regional Medical Center

    Burlington, North Carolina, 27217

  • Minnesota Oncology Hematology-Burnsville

    Burnsville, Minnesota, 55337

  • Interlakes Oncology & Hematology, P.C.

    Canandaigua, New York, 14424

  • Aultman Hospital

    Canton, Ohio, 44710

  • SCRI Florida Cancer Specialists - Cape Coral (1708)

    Cape Coral, Florida, 33914

  • SCRI Florida Cancer Specialists - Cape Coral (811)

    Cape Coral, Florida, 33990

  • Central Indiana Cancer Centers

    Carmel, Indiana, 46032

  • Northwest Georgia Oncology Centers

    Carrollton, Georgia, 30117

  • Cancer Centers of North Carolina

    Cary, North Carolina, 27518

  • Sandra L. Maxwell Cancer Center

    Cedar City, Utah, 84720

  • Texas Oncology, PA - Cedar Park

    Cedar Park, Texas, 78613

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Roper Hosp & Med Asso (Care Alliance Health)

    Charleston, South Carolina, 29401

  • Medical University of South Carolina

    Charleston, South Carolina, 29425-0721

  • CAMC Health Education & Research Institute, Inc.

    Charleston, West Virginia, 25304

  • CCOP Carolinas HealthCare System

    Charlotte, North Carolina, 28232-2861

  • Presbyterian Hospital

    Charlotte, North Carolina, 28233

  • SCRI Chattanooga Oncol & Hematol Assoc, PC - Chattanooga

    Chattanooga, Tennessee, 37404

  • Virginia Oncology Associates - Medical Pkwy

    Chesapeake, Virginia, 23320

  • Chevy Chase Healthcare Management, LLC

    Chevy Chase, Maryland, 20815

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Marshfield Clinic Chippewa Falls Center

    Chippewa Falls, Wisconsin, 54729

  • Oncology and Hematology Associates of SW VA, Inc

    Christiansburg, Virginia, 24073

  • SCRI Oncology Hematology Care, Inc. - Cincinnati (TFT)

    Cincinnati, Ohio, 45219

  • SCRI Oncology Hematology Care, Inc - Cincinnati (AND)

    Cincinnati, Ohio, 45230

  • SCRI Oncology Hematology Care, Inc. - Cincinnati (KWD)

    Cincinnati, Ohio, 45236

  • SCRI Oncology Hematlogy Care, Inc. - Cincinnati (RPR)

    Cincinnati, Ohio, 45238

  • SCRI Oncology Hematology Care, Inc - Cincinnati (BAM)

    Cincinnati, Ohio, 45242

  • SCRI Oncology Hematology Care, Inc. Cincinnati (WST)

    Cincinnati, Ohio, 45248

  • Morton Plant Mease Health Care

    Clearwater, Florida, 33756

  • Penrose/St. Francis Healthcare System

    Colorado Springs, Colorado, 80907

  • Rocky Mountain Cancer Center at the Pivillion- Fontanero

    Colorado Springs, Colorado, 80907

  • Rocky Mountain Cancer Center - CO Springs

    Colorado Springs, Colorado, 80909

  • Maryland Oncology Hematology PA

    Columbia, Maryland, 21044

  • Missouri Cancer Associates

    Columbia, Missouri, 65201

  • University of Missouri-Ellis Fischel

    Columbia, Missouri, 65203

  • SCRI - South Carolina Oncology Associates - Stoneridge

    Columbia, South Carolina, 29210

  • Mercy and Unity Cancer Center at Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • SCRI Oncology Hematology Care, Inc. Crestview Hills (CVH)

    Crestview Hills, Kentucky, 41017

  • Texas Cancer Center at Medical City

    Dallas, Texas, 75230-2510

  • Texas Oncology PA- Presbyterian

    Dallas, Texas, 75231-4400

  • Methodist Charlton Cancer Center

    Dallas, Texas, 75237

  • Texas Oncology- Sammons CC

    Dallas, Texas, 75246

  • Geisinger Clinic

    Danville, Pennsylvania, 17882-2111

  • Genesis Medical Center

    Davenport, Iowa, 52803

  • Good Samaritan Hospital

    Dayton, Ohio, 45408

  • CCOP - Dayton

    Dayton, Ohio, 45429

  • CCOP - Oakwood Hospital and Medical Center

    Dearborn, Michigan, 48123-2500

  • Decatur Memorial Hospital Cancer Care Institute

    Decatur, Illinois, 62526

  • Texas Cancer Center

    Denton, Texas, 76210

  • Kaiser Permanente-Franklin

    Denver, Colorado, 80205

  • CCOP - Colorado Cancer Research Program, Inc.

    Denver, Colorado, 80209-5031

  • Porter Adventist Hospital

    Denver, Colorado, 80210

  • Exempla St. Joseph Hospital

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Center - Midtown

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Center - 9th Avenue

    Denver, Colorado, 80220

  • Rocky Mountain Cancer Center - Rose

    Denver, Colorado, 80220

  • University of Colorado

    Denver, Colorado, 80262

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • CCOP - St. John Hospital and Medical Center

    Detroit, Michigan, 48236-2172

  • Dublin Hematology/Oncology

    Dublin, Georgia, 31021

  • Oncology Hematology Associates of Northern PA

    DuBois, Pennsylvania, 15801

  • Finley Hospital

    Dubuque, Iowa, 52001-6314

  • St. Luke's Hospital

    Duluth, Minnesota, 55802

  • Regional Cancer Care, PA

    Durham, North Carolina, 27704

  • Cancer Centers of the Carolinas Easley, SC

    Easley, South Carolina, 29640

  • Michigan State University

    East Lansing, Michigan, 48824

  • Pocono Medical Center

    East Stroudsburg, Pennsylvania, 18301

  • Marshfield Clinic Regional CA Cntr - Sacred Heart Hospital

    Eau Claire, Wisconsin, 54701

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Minnesota Oncology Hematology-Edina

    Edina, Minnesota, 55435

  • Puget Sound Cancer Center- Edmonds

    Edmonds, Washington, 98026

  • Shaw Regional Cancer Center

    Edwards, Colorado, 81632

  • El Paso Cancer Treatment Center - West

    El Paso, Texas, 79902

  • El Paso Cancer Treatment Center - East

    El Paso, Texas, 79915

  • Virginia Oncology Associates

    Elizabeth City, North Carolina, 27909

  • Swedish Medical Center

    Englewood, Colorado, 80110

  • SCRI Florida Cancer Specialists - Englewood

    Englewood, Florida, 33990

  • Ephrata Community Hopital

    Ephrata, Pennsylvania, 17522-1002

  • Southwest Cancer Care (E. Grand)

    Escondido, California, 92025

  • Willamette Valley Cancer Institute and Research Center

    Eugene, Oregon, 97401

  • CCOP NorthShore University HealthSystem

    Evanston, Illinois, 60201

  • Fairfax Northern VA Hematology-Oncology PC

    Fairfax, Virginia, 22031

  • Fair Oaks Office

    Fairfax, Virginia, 22033

  • HemOnc Care, Inc.

    Fairfield, Ohio, 45014

  • Saint Anne's Hospital

    Fall River, Massachusetts, 02721

  • Innovis Health

    Fargo, North Dakota, 58103

  • University of Connecticut

    Farmington, Connecticut, 06032

  • Cape Fear Valley Medical Center Cancer Center

    Fayetteville, North Carolina, 28302-2000

  • Central Indiana Cancer Centers

    Fishers, Indiana, 46037

  • Northern Arizona Hematology & Onclogy Associates

    Flagstaff, Arizona, 86001

  • CCOP - Genesys Regional Hospital

    Flint, Michigan, 48503

  • CCOP - Hurley Medical Center

    Flint, Michigan, 48503

  • McLaren Regional Medical Center

    Flint, Michigan, 48532

  • Front Range Cancer Specialists

    Fort Collins, Colorado, 80524

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • SCRI Florida Cancer Specialists - Fort Myers (Hampshire)

    Fort Myers, Florida, 33908

  • SCRI Florida Cancer Specialists - Ft. Myers (Broadway)

    Fort Myers, Florida, 33908

  • SCRI Florida Cancer Specialists- Fort Myers (Veronica)

    Fort Myers, Florida, 33916

  • Texas Oncology - 8th Avenue

    Fort Worth, Texas, 76104

  • Texas Oncology at Klabzuba

    Fort Worth, Texas, 76104

  • Texas Oncology PA - 12th Avenue

    Fort Worth, Texas, 76104

  • Southwest Fort Worth Cancer Center

    Fort Worth, Texas, 76132

  • Atrium Medical Center - Middletown Regional Hosp

    Franklin, Ohio, 45005-1066

  • SCRI Tennessee Oncology - PLLC Franklin

    Franklin, Tennessee, 37067

  • Frederick Memorial Hospital

    Frederick, Maryland, 21701

  • San Antonio Tumor and Blood Clinic

    Fredericksburg, Texas, 78624

  • Kaiser Permanente Fremont

    Fremont, California, 94538

  • Unity Hospital

    Fridley, Minnesota, 55432

  • St. Jude Heritage Healthcare

    Fullerton, California, 92835

  • University of Florida Shands Cancer Center

    Gainesville, Florida, 32610-0232

  • Fairfax-Northern Virginia Hematology-Oncology PC

    Gainesville, Virginia, 20155

  • SCRI Tennessee Oncology- Gallatin

    Gallatin, Tennessee, 37066

  • Texas Oncology PA

    Garland, Texas, 75042-5788

  • Interlakes Oncology Hematology PC

    Geneva, New York, 14456

  • Georgetown Hospital System

    Georgetown, South Carolina, 29440

  • Cancer Center at Glens Falls Hospital

    Glens Falls, New York, 12801

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • St. Mary's Hospital and Medical Center

    Grand Junction, Colorado, 81502-1628

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

    Grand Junction, Colorado, 81502

  • Texas Oncology

    Grapevine, Texas, 76051

  • North Colorado Medical Center

    Greeley, Colorado, 80631

  • CCOP, St. Vincent Hospital

    Green Bay, Wisconsin, 54301

  • CCOP, St. Mary's Hospital Medical Center

    Green Bay, Wisconsin, 54303

  • Arizona Oncolocy (CASA-Green Valley)

    Green Valley, Arizona, 85614

  • Central Indiana Cancer Centers

    Greenfield, Indiana, 46140

  • CCOP, Moses Cone Health System-Regional CA Cntr

    Greensboro, North Carolina, 27401

  • East Carolina University

    Greenville, North Carolina, 27834

  • Wayne Hospital

    Greenville, Ohio, 45331

  • Cancer Centers of the Carolinas (Butternut)

    Greenville, South Carolina, 29605

  • Cancer Centers of the Carolinas-W. Faris Road

    Greenville, South Carolina, 29605

  • Cancer Centers of the Carolinas (International)

    Greenville, South Carolina, 29615

  • Cancer Institute of New Jersey at Hamilton

    Hamilton, New Jersey, 08690

  • SCRI Oncology Hematology Care, Inc. - Hamilton (HAM)

    Hamilton, Ohio, 45013

  • Virginia Oncology Associates

    Hampton, Virginia, 23606

  • Hartford Hospital

    Hartford, Connecticut, 06102-5037

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Kaiser Permanente Medical Center - Hayward

    Hayward, California, 94545

  • Geisinger Hazleton Cancer Center

    Hazleton, Pennsylvania, 18201

  • Comprehensive Cancer Centers of Nevada (Siena)

    Henderson, Nevada, 89052

  • US Oncology West Region Office (Horizon Ridge)

    Henderson, Nevada, 89052

  • Comprehensive Cancer Centers of Nevada (Wigwam)

    Henderson, Nevada, 89074

  • Margaret R. Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

  • SCRI Tennessee Oncology, PLLC Hermitage

    Hermitage, Tennessee, 37076

  • High Point Regional Hospital

    High Point, North Carolina, 27261

  • Hinsdale Hematology Oncology Associates

    Hinsdale, Illinois, 60521

  • SCRI Chattanooga Oncol & Hematol Assoc, PC Hixson

    Hixson, Tennessee, 37404

  • University of Hawaii

    Honolulu, Hawaii, 96813

  • Kaiser Permanente Hawaii - Moanalua Med Center

    Honolulu, Hawaii, 96819

  • Texas Oncology PA - Frostwood

    Houston, Texas, 77024

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Florida Cancer Institute - New Hope

    Hudson, Florida, 34667

  • New York Oncology Hematology, P.C. at Cavell Cancer Treatment Program

    Hudson, New York, 12534

  • Pacific Shores Medical Group

    Huntington Beach, California, 92648

  • Clearview Cancer Institute- Huntsville

    Huntsville, Alabama, 35805

  • Central Indiana Cancer Centers

    Indianapolis, Indiana, 46219

  • Central Indiana Cancer Centers (E. County)

    Indianapolis, Indiana, 46227

  • St. Vincent Hospital and Health Care Center

    Indianapolis, Indiana, 46260

  • University of Iowa

    Iowa City, Iowa, 52242

  • Southern California Permanente Medical Group

    Irvine, California, 92618

  • CCOP - Allegiance Health

    Jackson, Michigan, 49201

  • TORI-ICON - Shircl

    Jacksonville, Florida, 32204

  • Baptist Cancer Institute - Jacksonville

    Jacksonville, Florida, 32207

  • Integrated Community Oncology Network (ICON)

    Jacksonville, Florida, 32207

  • TORI-ICON St.Aug

    Jacksonville, Florida, 32258

  • CCOP, Jupiter Medical Cener

    Jupiter, Florida, 33458

  • Borgess Medical Center

    Kalamazoo, Michigan, 49001

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Kansas Cty Cancer Center - West

    Kansas City, Kansas, 66112

  • Kansas City Cancer Center - Central

    Kansas City, Missouri, 64111

  • Saint Luke's Hospital

    Kansas City, Missouri, 64111

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Kansas City Cancer Center - South

    Kansas City, Missouri, 64131

  • Research Medical Center

    Kansas City, Missouri, 64131

  • Research Medical Center

    Kansas City, Missouri, 64132

  • Kansas City Cancer Center - North

    Kansas City, Missouri, 64154

  • Columbia Basin Hematology and Oncology

    Kennewick, Washington, 99336

  • San Antonio Tumor and Blood Clinic

    Kerrville, Texas, 78028

  • Greater Dayton Cancer Center

    Kettering, Ohio, 45409

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • CCOP Holston Valley Medical Center

    Kingsport, Tennessee, 37662

  • Medical Oncology Associates

    Kingston, Pennsylvania, 18704

  • Wilshire Oncology Medical Group (Business Office)

    La Verne, California, 91750

  • Ocala Oncology Center - Lady Lake

    Lady Lake, Florida, 32159

  • Kaiser Permanente Rock Creek

    Lafayette, Colorado, 80026

  • Clarian Arnett Cancer Care

    Lafayette, Indiana, 47904

  • Rocky Mountain Cancer Center

    Lakewood, Colorado, 80228

  • Antelope Valley Cancer Center

    Lancaster, California, 93534

  • Ingham Regional Medical Center - Lansing

    Lansing, Michigan, 48910-0817

  • CCOP, Sparrow Health System

    Lansing, Michigan, 48910

  • Lapeer Regional Hospital

    Lapeer, Michigan, 48446

  • Texas Oncology PA Las Cruces

    Las Cruces, New Mexico, 88011

  • Comprehensive Cancer Centers of Nevada (Peak Dr.)

    Las Vegas, Nevada, 89128

  • Comprehensive Cancer Centers of Nevada (Southern Hills)

    Las Vegas, Nevada, 89148

  • Comprehensive Cancer Centers of Nevada (Twain)

    Las Vegas, Nevada, 89169

  • New York Oncology Hematology, PC

    Latham, New York, 12110

  • Suburban Hematology-Oncology Associates

    Lawrenceville, Georgia, 30045

  • SCRI Tennessee Oncology Lebanon

    Lebanon, Tennessee, 37087

  • Kansas City Cancer Centers - East

    Lee's Summit, Missouri, 64064

  • Fairfax-Northern Virginia Hematology-Oncology PC

    Leesburg, Virginia, 20176

  • Lake Vista Cancer Center

    Lewisville, Texas, 75067

  • University of Kentucky Medical Center

    Lexington, Kentucky, 40536

  • Nebraska Cancer Research Center

    Lincoln, Nebraska, 68510

  • St. Elizabeth Community Health Center

    Lincoln, Nebraska, 68510

  • Rocky Mountain Cancer Center - Dry Creek

    Littleton, Colorado, 80120-4413

  • CCOP - St. Mary Mercy Hospital - Livonia

    Livonia, Michigan, 48154

  • Rocky Mountain Cancer Center- Sky Ridge

    Lone Tree, Colorado, 80124

  • Breastlink Medical Group, Incorporated at Long Beach Memorial Medical Center

    Long Beach, California, 90806

  • Todd Cancer Institute at Long Beach Memorial Med Cent

    Long Beach, California, 90806

  • Pacific Shores Medical Group

    Long Beach, California, 90813

  • Rocky Mountain Cancer Center - Longmont

    Longmont, Colorado, 80501

  • Longview Cancer Center

    Longview, Texas, 75601

  • Pacific Shores Medical Group

    Los Alamitos, California, 90720

  • NortonHealtcare Inc.

    Louisville, Kentucky, 40202

  • Consultants in Blood Disorders and Cancer

    Louisville, Kentucky, 40207

  • McKee Medical Center

    Loveland, Colorado, 80539

  • Joe Arrington Cancer Research & Treatment Center

    Lubbock, Texas, 79410

  • CCOP - North Shore University Hospital

    Manhasset, New York, 11030

  • Minnesota Oncology Hematology PA - Maplewood

    Maplewood, Minnesota, 55109

  • St. John's Hospital Northeast/HealthEast, Inc.

    Maplewood, Minnesota, 55109

  • Northwest Georgia Oncology Centers

    Marietta, Georgia, 30060

  • Marquette General Hospital

    Marquette, Michigan, 49855

  • CCOP - Marshfield Clinic Research Foundation

    Marshfield, Wisconsin, 54449

  • South Texas Cancer Center - McAllen

    McAllen, Texas, 78503

  • SCRI Virginia Cancer Institute (Flank)

    Mechanicsville, Virginia, 23116

  • Riddle Memorial Hospital

    Media, Pennsylvania, 19063

  • Melbourne International Medicine Associates

    Melbourne, Florida, 32901

  • Texas Cancer Center of Mesquite

    Mesquite, Texas, 75150

  • Advanced Medical Specialties - AMS

    Miami, Florida, 33133

  • Advanced Medical Specialists- Sunset

    Miami, Florida, 33143

  • Advanced Medical Specialties - N Kendall (STE 300E)

    Miami, Florida, 33176

  • Advanced Medical Specialties - N. Kendall (STE 905E)

    Miami, Florida, 33176

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Allison Cancer Center

    Midland, Texas, 79701

  • SCRI Virginia Cancer Institute

    Midlothian, Virginia, 23114

  • Aurora Sinai Medical Center

    Milwaukee, Wisconsin, 53201-0342

  • Froedtert Hospital

    Milwaukee, Wisconsin, 53226

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Minnesota Oncology Hematology-Minneapolis

    Minneapolis, Minnesota, 55404

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center - Minneapolis

    Minneapolis, Minnesota, 55415

  • Marshfield Clinic Minocqua Center

    Minocqua, Wisconsin, 54548

  • TORI- N Valley Hematology Oncology Med Group

    Mission Hills, California, 91345

  • TORI - Oncology Care Medical Assoc.

    Montebello, California, 90640

  • West Virginia University Hospitals Inc.

    Morgantown, West Virginia, 26506-9162

  • Hematology-Oncology Associates of NNJ, PA

    Morristown, New Jersey, 07960

Other trials in United States

Ireland11 sites

  • Bon Secours Hospital

    Cork, CK

  • Mater Private Hospital

    Dublin, DN, 7

  • Beaumont Hospital

    Dublin, 9

  • St. Vincent's University Hospital

    Dublin, DN4

  • Mater Misericordiae

    Dublin, DN7

  • St James' Hospital

    Dublin, DN8

  • St. James' Hospital

    Dublin, DN8

  • University College Hospital

    Galway, GY

  • Letterkenny General Hospital

    Letterkenny, DL

  • Sligo General Hospital

    Sligo, CO Sligo

  • Waterford Regional Hospital

    Waterford, 0009

Other trials in Ireland

About this study

Official title: A Phase III Clinical Trial Comparing the Combination of TC Plus Bevacizumab to TC Alone and to TAC for Women With Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer

The main purpose of this study is to learn if adding bevacizumab to standard treatment with chemotherapy (docetaxel, doxorubicin, and cyclophosphamide) for early stage HER2-negative breast cancer will prevent breast cancer from returning. A second purpose of this study is to learn if adding bevacizumab to treatment with chemotherapy will help women with HER2-negative breast cancer live longer. The researchers also want to learn about the side effects of the combination of drugs used in this study.

Read the detailed description

The B-46-I/07132 study, a multicenter, open-label, randomized Phase III, adjuvant therapy trial, will compare the value of adding bevacizumab to a non-anthracycline-based chemotherapy regimen relative to the same chemotherapy without bevacizumab and relative to an anthracycline-based chemotherapy regimen in women with resected node-positive or high-risk node-negative, HER2-negative breast cancer. This trial will determine whether the addition of bevacizumab to a regimen of docetaxel and cyclophosphamide (TCB) improves invasive disease-free survival relative to docetaxel and cyclophosphamide alone (TC). A secondary aim will be to determine whether the addition of bevacizumab to TC improves invasive disease-free survival compared to a regimen of docetaxel, doxorubicin, and cyclophosphamide (TAC). Other secondary aims include whether TCB improves disease-free survival, overall survival, and recurrence-free interval relative to TC alone and to TAC. The toxicities of the three regimens will also be compared.

Patients in the B-46-I/07132 study will be randomized to one of three treatment regimens: Group 1 patients will receive 6 cycles of TAC administered every 21 days (docetaxel 75 mg/m2, doxorubicin 50 mg/m2, and cyclophosphamide 500 mg/m2); Group 2 patients will receive 6 cycles of TC administered every 21 days (docetaxel 75 mg/m2, cyclophosphamide 600 mg/m2); and Group 3 patients will receive 6 cycles of TCB every 21 days with bevacizumab therapy continuing every 21 days after completion of chemotherapy until 1 year following the first dose (docetaxel 75 mg/m2, cyclophosphamide 600 mg/m2, and bevacizumab 15 mg/kg). Primary prophylaxis with pegfilgrastim or filgrastim is required for Group 1 patients (optional for patients in Groups 2 and 3). Patients will also receive adjuvant radiation therapy as clinically indicated and endocrine therapy for hormone receptor-positive tumors.

Tumor samples will be submitted for correlative science studies to evaluate predictors of study therapy benefit. Submission of a tumor sample is a study requirement for all patients.

Conditions
Breast Cancer
Keywords
National Surgical Adjuvant Breast and Bowel Project (NSABP), Taxotere, Docetaxel, Doxorubicin, Cyclophosphamide, Bevacizumab, Breast Neoplasms, Adenocarcinoma, Breast Diseases, Carcinoma, HER2 negative, Node negative, High risk node positive, Adjuvant Therapy
Medical subject headings
Breast Neoplasms, Adenocarcinoma, Breast Diseases, Carcinoma

What participants receive

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

  • bevacizumabDrug

    bevacizumab 15 mg/kg IV every 21 days for 6 cycles followed by bevacizumab 15 mg/kg IV every 21 days until 1 year following the first dose of bevacizumab

  • docetaxelDrug

    Also called T

    docetaxel 75 mg/m2 IV every 21 days for 6 cycles

  • doxorubicinDrug

    Also called A

    doxorubicin 50 mg/m2 IV every 21 days for 6 cycles

  • cyclophosphamideDrug

    Also called C

    Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles

    Group 2 and 3: cyclophosphamide 600 mg/m2 IV every 21 days for 6 cycles

  • pegfilgrastimDrug

    pegfilgrastim 6 mg subcutaneous (SC) Day 2 every 21 days for 6 cycles [filgrastim (Neupogen®) 5 mcg/kg Days 2-10 may be given in lieu of pegfilgrastim (Neulasta®), but pegfilgrastim is preferred.]

Study groups in NCT00887536
Study groupRoleWhat they receive
Group 1: TAC then pegfilgrastimActive comparatordocetaxel, doxorubicin, cyclophosphamide, and pegfilgrastim/filgrastim
Receives: Drug: docetaxel; Drug: doxorubicin; Drug: cyclophosphamide; Drug: pegfilgrastim
Group 2: TCActive comparatordocetaxel and cyclophosphamide
Receives: Drug: docetaxel; Drug: cyclophosphamide
Group 3: TC + bevacizumabExperimentaldocetaxel, cyclophosphamide, and bevacizumab
Receives: Drug: bevacizumab; Drug: docetaxel; 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)relative to the TAC chemotherapy regimen alone

    Measured: Every 12 months until recurrence

Secondary outcomes (11)

  1. Invasive disease-free survival (IDFS) relative to the TAC chemotherapy regimen

    Measured: Every 12 months until recurrence

  2. Disease-free survival (DFS-DCIS) relative to the TC alone regimen

    Measured: Every 12 months until recurrence

  3. Overall survival (OS) relative to the TC alone regimen

    Measured: Every 12 months from randomization until death from any cause

  4. OS relative to the TAC regimen

    Measured: Every 12 months from randomization until death from any cause

  5. Recurrence-free interval (RFI) relative to the TC alone regimen

    Measured: Every 12 months, from randomization to local, regional, or distant recurrence

  6. RFI relative to the TAC regimen

    Measured: Every 12 months, from randomization to local, regional, or distant recurrence

  7. Develop molecular predictive markers for the degree of benefit from TCB over TC or TAC

    Measured: 6 years

  8. Provide the efficacy data from Group 1 patients and Group 2 patients enrolled in B-46-I/07132 to US Oncology Research, Inc. (USOR) for a planned combined analysis with efficacy data from patients receiving the same regimens in the USOR 06-090 trial

    Measured: 10 years

  9. Toxicity associated with each of the regimens

    Measured: Every 6 months

  10. Determine the role of topoisomerase II alpha (TOP2A) in prognosis and prediction of degree of benefit from TAC over TC

    Measured: 6 years

  11. Develop predictive markers for benefit from doxorubicin

    Measured: 6 years

Timeline

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

  1. First posted24 Apr 2009 (estimated)
  2. Study startMay 2009
  3. Primary completionFeb 2018
  4. Study completionFeb 2018

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
1,613 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00887536
Sponsor's protocol ID
NSABP B-46-I
Other IDs
USOR 07132
Status last verified
Apr 2022
First submitted
23 Apr 2009
Last updated
20 Apr 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • Geyer CE Jr, Blum JL, Yothers G, Asmar L, Flynn PJ, Robert NJ, Hopkins JO, O'Shaughnessy JA, Rastogi P, Puhalla SL, Hilton CJ, Dang CT, Gomez HL, Vukelja SJ, Lyss AP, Paul D, Brufsky AM, Colangelo LH, Swain SM, Mamounas EP, Wolmark N. Long-Term Follow-Up of the Anthracyclines in Early Breast Cancer Trials (USOR 06-090, NSABP B-46-I/USOR 07132, and NSABP B-49 [NRG Oncology]). J Clin Oncol. 2024 Apr 20;42(12):1344-1349. doi: 10.1200/JCO.23.01428. Epub 2024 Feb 9.

    PubMed 38335467

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing bevacizumab, docetaxel and doxorubicin in people with Breast Cancer, run by NSABP Foundation Inc at 533 sites in 2 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 19 inclusion and 36 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: finished, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 533 sites in United States, Ireland. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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)relative to the TAC chemotherapy regimen alone (time frame: Every 12 months until recurrence). 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 NCT00887536, which also lists 1 linked publication.

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 20 Apr 2022.

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