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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00887536
• Other study ID #: NSABP B-46-I
• Secondary ID: USOR 07132
• Status: Completed
• Phase: Phase 3
• Start date: May 2009
• Est. completion date: February 2018

Study information

• Verified date: April 2022
• Source: NSABP Foundation Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1613
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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.
• 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).

Exclusion Criteria:

• 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.
• 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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• bevacizumab
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
• docetaxel
docetaxel 75 mg/m2 IV every 21 days for 6 cycles
• doxorubicin
doxorubicin 50 mg/m2 IV every 21 days for 6 cycles
• cyclophosphamide
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
• pegfilgrastim
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.]

Locations

Country	Name	City	State
Ireland	Bon Secours Hospital	Cork	CK
Ireland	Beaumont Hospital	Dublin
Ireland	Mater Misericordiae	Dublin
Ireland	Mater Private Hospital	Dublin	DN
Ireland	St James' Hospital	Dublin
Ireland	St. James' Hospital	Dublin
Ireland	St. Vincent's University Hospital	Dublin
Ireland	University College Hospital	Galway
Ireland	Letterkenny General Hospital	Letterkenny	DL
Ireland	Sligo General Hospital	Sligo
Ireland	Waterford Regional Hospital	Waterford
United States	Texas Cancer Center - Abilene South	Abilene	Texas
United States	Akron City Hospital	Akron	Ohio
United States	New York Oncology Hematology PC-Albany	Albany	New York
United States	New York Oncology Hematology, PC at Albany Medical Center	Albany	New York
United States	Phoebe Putney Memorial Hospital	Albany	Georgia
United States	Christus St. Frances Cabrini Hospital	Alexandria	Louisiana
United States	Central Hematology/Oncology Medical Group, Inc.	Alhambra	California
United States	Texas Oncology PA - Amarillo	Amarillo	Texas
United States	Amsterdam Community Cancer Program	Amsterdam	New York
United States	AnMed Health Cancer Center	Anderson	South Carolina
United States	CCOP, St. Joseph Mercy Hospital	Ann Arbor	Michigan
United States	Kaiser Permanente Deer Valley Med Center	Antioch	California
United States	Arlington Fairfax Hematology Oncology	Arlington	Virginia
United States	Cancer Care & Hematology Specialists of Chicagoland	Arlington	Illinois
United States	Texas Onclogy - Arlington South	Arlington	Texas
United States	Texas Oncology PA - Arlington North	Arlington	Texas
United States	Medical Center of Aurora	Aurora	Colorado
United States	Rocky Mountain Cancer Center	Aurora	Colorado
United States	Northwest Georgia Oncology Centers	Austell	Georgia
United States	South Austin Cancer Center	Austin	Texas
United States	Southwest Regional Cancer Center- North	Austin	Texas
United States	Texas Oncology Cancer Center - Balcones	Austin	Texas
United States	Texas Oncology Central Austin	Austin	Texas
United States	Texas Oncology North Austin- Renfert	Austin	Texas
United States	Comp Blook and Cancer Center	Bakersfield	California
United States	Franklin Square Hospital Center	Baltimore	Maryland
United States	Greater Baltimore Medical Center	Baltimore	Maryland
United States	Mercy Medical Center	Baltimore	Maryland
United States	St. Joseph's Medical Center	Baltimore	Maryland
United States	Eastern Maine Medical Center	Bangor	Maine
United States	Baton Rouge General Medical Center	Baton Rouge	Louisiana
United States	Bay Regional Medical Center	Bay City	Michigan
United States	Mamie McFaddin Ward Cancer Center	Beaumont	Texas
United States	Raleigh Regional Cancer Center	Beckley	West Virginia
United States	Edwards Cancer Center - Bedford	Bedford	Texas
United States	Texas Oncology PA - Harris HEB	Bedford	Texas
United States	St. Charles Medical Center - Bend	Bend	Oregon
United States	Southwestern Regional Cancer Center (SWORD)	Bennington	Vermont
United States	Birmingham Hematology and Oncology	Bessemer	Alabama
United States	SCRI - Center for Cancer and Blood Disorders	Bethesda	Maryland
United States	Suburban Hospital	Bethesda	Maryland
United States	Birmingham Hematology and Oncology	Birmingham	Alabama
United States	Birmingham Hematology and Oncology - Brookwood	Birmingham	Alabama
United States	Birmingham Hematology and Oncology - Montclair	Birmingham	Alabama
United States	Birmingham Hematology and Oncology - Pilot	Birmingham	Alabama
United States	Birmingham Hematology and Oncology - Princeton	Birmingham	Alabama
United States	SCRI - Florida Cancer Specialists- Bonita Springs	Bonita Springs	Florida
United States	Rocky Mountain Cancer Centers - Boulder	Boulder	Colorado
United States	SCRI - Florida Cancer Specialists - Bradenton	Bradenton	Florida
United States	Florida Cancer Specialists	Brandon	Florida
United States	Interlakes Oncology Hematology PC	Brockport	New York
United States	Highline Medical Oncology	Burien	Washington
United States	Alamance Regional Medical Center	Burlington	North Carolina
United States	Minnesota Oncology Hematology-Burnsville	Burnsville	Minnesota
United States	Interlakes Oncology & Hematology, P.C.	Canandaigua	New York
United States	Aultman Hospital	Canton	Ohio
United States	SCRI Florida Cancer Specialists - Cape Coral (1708)	Cape Coral	Florida
United States	SCRI Florida Cancer Specialists - Cape Coral (811)	Cape Coral	Florida
United States	Central Indiana Cancer Centers	Carmel	Indiana
United States	Northwest Georgia Oncology Centers	Carrollton	Georgia
United States	Cancer Centers of North Carolina	Cary	North Carolina
United States	Sandra L. Maxwell Cancer Center	Cedar City	Utah
United States	Texas Oncology, PA - Cedar Park	Cedar Park	Texas
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	CAMC Health Education & Research Institute, Inc.	Charleston	West Virginia
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Roper Hosp & Med Asso (Care Alliance Health)	Charleston	South Carolina
United States	CCOP Carolinas HealthCare System	Charlotte	North Carolina
United States	Presbyterian Hospital	Charlotte	North Carolina
United States	SCRI Chattanooga Oncol & Hematol Assoc, PC - Chattanooga	Chattanooga	Tennessee
United States	Virginia Oncology Associates - Medical Pkwy	Chesapeake	Virginia
United States	Chevy Chase Healthcare Management, LLC	Chevy Chase	Maryland
United States	Rush University Medical Center	Chicago	Illinois
United States	Marshfield Clinic Chippewa Falls Center	Chippewa Falls	Wisconsin
United States	Oncology and Hematology Associates of SW VA, Inc	Christiansburg	Virginia
United States	SCRI Oncology Hematlogy Care, Inc. - Cincinnati (RPR)	Cincinnati	Ohio
United States	SCRI Oncology Hematology Care, Inc - Cincinnati (AND)	Cincinnati	Ohio
United States	SCRI Oncology Hematology Care, Inc - Cincinnati (BAM)	Cincinnati	Ohio
United States	SCRI Oncology Hematology Care, Inc. - Cincinnati (KWD)	Cincinnati	Ohio
United States	SCRI Oncology Hematology Care, Inc. - Cincinnati (TFT)	Cincinnati	Ohio
United States	SCRI Oncology Hematology Care, Inc. Cincinnati (WST)	Cincinnati	Ohio
United States	Morton Plant Mease Health Care	Clearwater	Florida
United States	Penrose/St. Francis Healthcare System	Colorado Springs	Colorado
United States	Rocky Mountain Cancer Center - CO Springs	Colorado Springs	Colorado
United States	Rocky Mountain Cancer Center at the Pivillion- Fontanero	Colorado Springs	Colorado
United States	Maryland Oncology Hematology PA	Columbia	Maryland
United States	Missouri Cancer Associates	Columbia	Missouri
United States	SCRI - South Carolina Oncology Associates - Stoneridge	Columbia	South Carolina
United States	University of Missouri-Ellis Fischel	Columbia	Missouri
United States	Mercy and Unity Cancer Center at Mercy Hospital	Coon Rapids	Minnesota
United States	SCRI Oncology Hematology Care, Inc. Crestview Hills (CVH)	Crestview Hills	Kentucky
United States	Methodist Charlton Cancer Center	Dallas	Texas
United States	Texas Cancer Center at Medical City	Dallas	Texas
United States	Texas Oncology PA- Presbyterian	Dallas	Texas
United States	Texas Oncology- Sammons CC	Dallas	Texas
United States	Geisinger Clinic	Danville	Pennsylvania
United States	Genesis Medical Center	Davenport	Iowa
United States	CCOP - Dayton	Dayton	Ohio
United States	Good Samaritan Hospital	Dayton	Ohio
United States	CCOP - Oakwood Hospital and Medical Center	Dearborn	Michigan
United States	Decatur Memorial Hospital Cancer Care Institute	Decatur	Illinois
United States	Texas Cancer Center	Denton	Texas
United States	CCOP - Colorado Cancer Research Program, Inc.	Denver	Colorado
United States	Exempla St. Joseph Hospital	Denver	Colorado
United States	Kaiser Permanente-Franklin	Denver	Colorado
United States	Porter Adventist Hospital	Denver	Colorado
United States	Rocky Mountain Cancer Center - 9th Avenue	Denver	Colorado
United States	Rocky Mountain Cancer Center - Midtown	Denver	Colorado
United States	Rocky Mountain Cancer Center - Rose	Denver	Colorado
United States	University of Colorado	Denver	Colorado
United States	CCOP - St. John Hospital and Medical Center	Detroit	Michigan
United States	Henry Ford Health System	Detroit	Michigan
United States	Dublin Hematology/Oncology	Dublin	Georgia
United States	Oncology Hematology Associates of Northern PA	DuBois	Pennsylvania
United States	Finley Hospital	Dubuque	Iowa
United States	St. Luke's Hospital	Duluth	Minnesota
United States	Regional Cancer Care, PA	Durham	North Carolina
United States	Cancer Centers of the Carolinas Easley, SC	Easley	South Carolina
United States	Michigan State University	East Lansing	Michigan
United States	Pocono Medical Center	East Stroudsburg	Pennsylvania
United States	Marshfield Clinic Regional CA Cntr - Sacred Heart Hospital	Eau Claire	Wisconsin
United States	Fairview Southdale Hospital	Edina	Minnesota
United States	Minnesota Oncology Hematology-Edina	Edina	Minnesota
United States	Puget Sound Cancer Center- Edmonds	Edmonds	Washington
United States	Shaw Regional Cancer Center	Edwards	Colorado
United States	El Paso Cancer Treatment Center - East	El Paso	Texas
United States	El Paso Cancer Treatment Center - West	El Paso	Texas
United States	Virginia Oncology Associates	Elizabeth City	North Carolina
United States	SCRI Florida Cancer Specialists - Englewood	Englewood	Florida
United States	Swedish Medical Center	Englewood	Colorado
United States	Ephrata Community Hopital	Ephrata	Pennsylvania
United States	Southwest Cancer Care (E. Grand)	Escondido	California
United States	Willamette Valley Cancer Institute and Research Center	Eugene	Oregon
United States	CCOP NorthShore University HealthSystem	Evanston	Illinois
United States	Fair Oaks Office	Fairfax	Virginia
United States	Fairfax Northern VA Hematology-Oncology PC	Fairfax	Virginia
United States	HemOnc Care, Inc.	Fairfield	Ohio
United States	Saint Anne's Hospital	Fall River	Massachusetts
United States	Innovis Health	Fargo	North Dakota
United States	University of Connecticut	Farmington	Connecticut
United States	Cape Fear Valley Medical Center Cancer Center	Fayetteville	North Carolina
United States	Central Indiana Cancer Centers	Fishers	Indiana
United States	Northern Arizona Hematology & Onclogy Associates	Flagstaff	Arizona
United States	CCOP - Genesys Regional Hospital	Flint	Michigan
United States	CCOP - Hurley Medical Center	Flint	Michigan
United States	McLaren Regional Medical Center	Flint	Michigan
United States	Front Range Cancer Specialists	Fort Collins	Colorado
United States	Poudre Valley Hospital	Fort Collins	Colorado
United States	Holy Cross Hospital	Fort Lauderdale	Florida
United States	SCRI Florida Cancer Specialists - Fort Myers (Hampshire)	Fort Myers	Florida
United States	SCRI Florida Cancer Specialists - Ft. Myers (Broadway)	Fort Myers	Florida
United States	SCRI Florida Cancer Specialists- Fort Myers (Veronica)	Fort Myers	Florida
United States	Southwest Fort Worth Cancer Center	Fort Worth	Texas
United States	Texas Oncology - 8th Avenue	Fort Worth	Texas
United States	Texas Oncology at Klabzuba	Fort Worth	Texas
United States	Texas Oncology PA - 12th Avenue	Fort Worth	Texas
United States	Atrium Medical Center - Middletown Regional Hosp	Franklin	Ohio
United States	SCRI Tennessee Oncology - PLLC Franklin	Franklin	Tennessee
United States	Frederick Memorial Hospital	Frederick	Maryland
United States	San Antonio Tumor and Blood Clinic	Fredericksburg	Texas
United States	Kaiser Permanente Fremont	Fremont	California
United States	Unity Hospital	Fridley	Minnesota
United States	St. Jude Heritage Healthcare	Fullerton	California
United States	Fairfax-Northern Virginia Hematology-Oncology PC	Gainesville	Virginia
United States	University of Florida Shands Cancer Center	Gainesville	Florida
United States	SCRI Tennessee Oncology- Gallatin	Gallatin	Tennessee
United States	Texas Oncology PA	Garland	Texas
United States	Interlakes Oncology Hematology PC	Geneva	New York
United States	Georgetown Hospital System	Georgetown	South Carolina
United States	Cancer Center at Glens Falls Hospital	Glens Falls	New York
United States	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina
United States	St. Mary's Hospital and Medical Center	Grand Junction	Colorado
United States	St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center	Grand Junction	Colorado
United States	Texas Oncology	Grapevine	Texas
United States	North Colorado Medical Center	Greeley	Colorado
United States	CCOP, St. Mary's Hospital Medical Center	Green Bay	Wisconsin
United States	CCOP, St. Vincent Hospital	Green Bay	Wisconsin
United States	Arizona Oncolocy (CASA-Green Valley)	Green Valley	Arizona
United States	Central Indiana Cancer Centers	Greenfield	Indiana
United States	CCOP, Moses Cone Health System-Regional CA Cntr	Greensboro	North Carolina
United States	Cancer Centers of the Carolinas (Butternut)	Greenville	South Carolina
United States	Cancer Centers of the Carolinas (International)	Greenville	South Carolina
United States	Cancer Centers of the Carolinas-W. Faris Road	Greenville	South Carolina
United States	East Carolina University	Greenville	North Carolina
United States	Wayne Hospital	Greenville	Ohio
United States	Cancer Institute of New Jersey at Hamilton	Hamilton	New Jersey
United States	SCRI Oncology Hematology Care, Inc. - Hamilton (HAM)	Hamilton	Ohio
United States	Virginia Oncology Associates	Hampton	Virginia
United States	Hartford Hospital	Hartford	Connecticut
United States	Ingalls Memorial Hospital	Harvey	Illinois
United States	Kaiser Permanente Medical Center - Hayward	Hayward	California
United States	Geisinger Hazleton Cancer Center	Hazleton	Pennsylvania
United States	Comprehensive Cancer Centers of Nevada (Siena)	Henderson	Nevada
United States	Comprehensive Cancer Centers of Nevada (Wigwam)	Henderson	Nevada
United States	US Oncology West Region Office (Horizon Ridge)	Henderson	Nevada
United States	Margaret R. Pardee Memorial Hospital	Hendersonville	North Carolina
United States	SCRI Tennessee Oncology, PLLC Hermitage	Hermitage	Tennessee
United States	High Point Regional Hospital	High Point	North Carolina
United States	Hinsdale Hematology Oncology Associates	Hinsdale	Illinois
United States	SCRI Chattanooga Oncol & Hematol Assoc, PC Hixson	Hixson	Tennessee
United States	Kaiser Permanente Hawaii - Moanalua Med Center	Honolulu	Hawaii
United States	University of Hawaii	Honolulu	Hawaii
United States	MD Anderson Cancer Center	Houston	Texas
United States	Texas Oncology PA - Frostwood	Houston	Texas
United States	Florida Cancer Institute - New Hope	Hudson	Florida
United States	New York Oncology Hematology, P.C. at Cavell Cancer Treatment Program	Hudson	New York
United States	Pacific Shores Medical Group	Huntington Beach	California
United States	Clearview Cancer Institute- Huntsville	Huntsville	Alabama
United States	Central Indiana Cancer Centers	Indianapolis	Indiana
United States	Central Indiana Cancer Centers (E. County)	Indianapolis	Indiana
United States	St. Vincent Hospital and Health Care Center	Indianapolis	Indiana
United States	University of Iowa	Iowa City	Iowa
United States	Southern California Permanente Medical Group	Irvine	California
United States	CCOP - Allegiance Health	Jackson	Michigan
United States	Baptist Cancer Institute - Jacksonville	Jacksonville	Florida
United States	Integrated Community Oncology Network (ICON)	Jacksonville	Florida
United States	TORI-ICON - Shircl	Jacksonville	Florida
United States	TORI-ICON St.Aug	Jacksonville	Florida
United States	CCOP, Jupiter Medical Cener	Jupiter	Florida
United States	Borgess Medical Center	Kalamazoo	Michigan
United States	Bronson Methodist Hospital	Kalamazoo	Michigan
United States	West Michigan Cancer Center	Kalamazoo	Michigan
United States	CCOP - Kansas City	Kansas City	Missouri
United States	Kansas City Cancer Center - Central	Kansas City	Missouri
United States	Kansas City Cancer Center - North	Kansas City	Missouri
United States	Kansas City Cancer Center - South	Kansas City	Missouri
United States	Kansas Cty Cancer Center - West	Kansas City	Kansas
United States	Research Medical Center	Kansas City	Missouri
United States	Research Medical Center	Kansas City	Missouri
United States	Saint Luke's Hospital	Kansas City	Missouri
United States	Columbia Basin Hematology and Oncology	Kennewick	Washington
United States	San Antonio Tumor and Blood Clinic	Kerrville	Texas
United States	Greater Dayton Cancer Center	Kettering	Ohio
United States	Kettering Medical Center	Kettering	Ohio
United States	CCOP Holston Valley Medical Center	Kingsport	Tennessee
United States	Medical Oncology Associates	Kingston	Pennsylvania
United States	Wilshire Oncology Medical Group (Business Office)	La Verne	California
United States	Ocala Oncology Center - Lady Lake	Lady Lake	Florida
United States	Clarian Arnett Cancer Care	Lafayette	Indiana
United States	Kaiser Permanente Rock Creek	Lafayette	Colorado
United States	Rocky Mountain Cancer Center	Lakewood	Colorado
United States	Antelope Valley Cancer Center	Lancaster	California
United States	CCOP, Sparrow Health System	Lansing	Michigan
United States	Ingham Regional Medical Center - Lansing	Lansing	Michigan
United States	Lapeer Regional Hospital	Lapeer	Michigan
United States	Texas Oncology PA Las Cruces	Las Cruces	New Mexico
United States	Comprehensive Cancer Centers of Nevada (Peak Dr.)	Las Vegas	Nevada
United States	Comprehensive Cancer Centers of Nevada (Southern Hills)	Las Vegas	Nevada
United States	Comprehensive Cancer Centers of Nevada (Twain)	Las Vegas	Nevada
United States	New York Oncology Hematology, PC	Latham	New York
United States	Suburban Hematology-Oncology Associates	Lawrenceville	Georgia
United States	SCRI Tennessee Oncology Lebanon	Lebanon	Tennessee
United States	Kansas City Cancer Centers - East	Lee's Summit	Missouri
United States	Fairfax-Northern Virginia Hematology-Oncology PC	Leesburg	Virginia
United States	Lake Vista Cancer Center	Lewisville	Texas
United States	University of Kentucky Medical Center	Lexington	Kentucky
United States	Nebraska Cancer Research Center	Lincoln	Nebraska
United States	St. Elizabeth Community Health Center	Lincoln	Nebraska
United States	Rocky Mountain Cancer Center - Dry Creek	Littleton	Colorado
United States	CCOP - St. Mary Mercy Hospital - Livonia	Livonia	Michigan
United States	Rocky Mountain Cancer Center- Sky Ridge	Lone Tree	Colorado
United States	Breastlink Medical Group, Incorporated at Long Beach Memorial Medical Center	Long Beach	California
United States	Pacific Shores Medical Group	Long Beach	California
United States	Todd Cancer Institute at Long Beach Memorial Med Cent	Long Beach	California
United States	Rocky Mountain Cancer Center - Longmont	Longmont	Colorado
United States	Longview Cancer Center	Longview	Texas
United States	Pacific Shores Medical Group	Los Alamitos	California
United States	Consultants in Blood Disorders and Cancer	Louisville	Kentucky
United States	NortonHealtcare Inc.	Louisville	Kentucky
United States	McKee Medical Center	Loveland	Colorado
United States	Joe Arrington Cancer Research & Treatment Center	Lubbock	Texas
United States	CCOP - North Shore University Hospital	Manhasset	New York
United States	Minnesota Oncology Hematology PA - Maplewood	Maplewood	Minnesota
United States	St. John's Hospital Northeast/HealthEast, Inc.	Maplewood	Minnesota
United States	Northwest Georgia Oncology Centers	Marietta	Georgia
United States	Marquette General Hospital	Marquette	Michigan
United States	CCOP - Marshfield Clinic Research Foundation	Marshfield	Wisconsin
United States	South Texas Cancer Center - McAllen	McAllen	Texas
United States	SCRI Virginia Cancer Institute (Flank)	Mechanicsville	Virginia
United States	Riddle Memorial Hospital	Media	Pennsylvania
United States	Melbourne International Medicine Associates	Melbourne	Florida
United States	Texas Cancer Center of Mesquite	Mesquite	Texas
United States	Advanced Medical Specialists- Sunset	Miami	Florida
United States	Advanced Medical Specialties - AMS	Miami	Florida
United States	Advanced Medical Specialties - N Kendall (STE 300E)	Miami	Florida
United States	Advanced Medical Specialties - N. Kendall (STE 905E)	Miami	Florida
United States	CCOP - Mount Sinai Medical Center	Miami Beach	Florida
United States	Allison Cancer Center	Midland	Texas
United States	SCRI Virginia Cancer Institute	Midlothian	Virginia
United States	Aurora Sinai Medical Center	Milwaukee	Wisconsin
United States	Froedtert Hospital	Milwaukee	Wisconsin
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Abbott-Northwestern Hospital	Minneapolis	Minnesota
United States	Hennepin County Medical Center - Minneapolis	Minneapolis	Minnesota
United States	Minnesota Oncology Hematology-Minneapolis	Minneapolis	Minnesota
United States	Marshfield Clinic Minocqua Center	Minocqua	Wisconsin
United States	TORI- N Valley Hematology Oncology Med Group	Mission Hills	California
United States	TORI - Oncology Care Medical Assoc.	Montebello	California
United States	West Virginia University Hospitals Inc.	Morgantown	West Virginia
United States	Hematology-Oncology Associates of NNJ, PA	Morristown	New Jersey
United States	Mount Clemens Regional Medical Center	Mount Clemens	Michigan
United States	Community Hospital	Munster	Indiana
United States	SCRI Tennessee Oncology Murfreesboro	Murfreesboro	Tennessee
United States	Southwest Cancer Care (Medical Center)	Murrieta	California
United States	Edward Hospital	Naperville	Illinois
United States	SCRI Florida Cancer Specialists - Naples (Goodlette)	Naples	Florida
United States	SCRI Florida Cancer Specialists - Naples (Pine)	Naples	Florida
United States	SCRI - Tennessee Oncology PLLC	Nashville	Tennessee
United States	SCRI - Tennessee Oncology PLLC	Nashville	Tennessee
United States	SCRI Tennessee Onclogy, PLLC (Dickerson)	Nashville	Tennessee
United States	SCRI Tennessee Oncology, PLLC (Harding)	Nashville	Tennessee
United States	SCRI Tennessee Oncology, PLLC (Wallace)	Nashville	Tennessee
United States	HOAST - New Braunfels	New Braunfels	Texas
United States	Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	CCOP, Long Island Jewish Medical Center	New Hyde Park	New York
United States	Tulane University Medical Center	New Orleans	Louisiana
United States	Florida Cancer Institute - New Hope	New Port Richey	Florida
United States	New York University School of Medicine	New York	New York
United States	Newark Beth Israel Medical Center	Newark	New Jersey
United States	Virginia Oncology Associates	Newport News	Virginia
United States	Cancer Care & Hematology Specialists of Chicagoland	Niles	Illinois
United States	Virginia Oncology Associates - Lake Wright	Norfolk	Virginia
United States	NValley Hematology/Oncology Medical Group	Northridge	California
United States	Kaiser Permanente-Oakland	Oakland	California
United States	Ocala Oncology Center	Ocala	Florida
United States	Cancer Centers of Florida, P.A.	Ocoee	Florida
United States	Texas Oncology - Odessa	Odessa	Texas
United States	McKay-Dee Hospital Center	Ogden	Utah
United States	Alegent Health Bergan Mercy Medical Center	Omaha	Nebraska
United States	Alegent Health Immanuel Medical Center	Omaha	Nebraska
United States	CCOP, Missouri Valley Cance Consortium	Omaha	Nebraska
United States	Creighton University Cancer Center	Omaha	Nebraska
United States	St. Joseph Hospital	Orange	California
United States	Tori-Icon	Orange Park	Florida
United States	Cancer Centers of Florida, P.A.	Orlando	Florida
United States	Florida Hospital	Orlando	Florida
United States	MD Anderson Cancer Center	Orlando	Florida
United States	Arizona Oncology (CASA- Oro Valley)	Oro Valley	Arizona
United States	Vince Lombardi Cancer Clinic - Oshkosh	Oshkosh	Wisconsin
United States	Kansas City Cancer Center (CBO)	Overland Park	Kansas
United States	Kansas CityCancer Centers - Southwest	Overland Park	Kansas
United States	Menorah Medical Center	Overland Park	Kansas
United States	Alliance Hematology Oncology PA	Owings Mills	Maryland
United States	Memorial Healthcare	Owosso	Michigan
United States	Ventura County Hematology-Oncology Specialists	Oxnard	California
United States	Stanford University Medical Center	Palo Alto	California
United States	Alegent Health Midlands Hospital	Papillion	Nebraska
United States	Paris Regional Cancer Center	Paris	Texas
United States	Advocate Lutheran General Cancer Care Center	Park Ridge	Illinois
United States	Rocky Mountain Cancer Center	Parker	Colorado
United States	Camden-Clark Memorial Hospital	Parkersburg	West Virginia
United States	Saint Clare's Center at Parsippany Commons	Parsippany	New Jersey
United States	Albert Einstein Healthcare Network	Philadelphia	Pennsylvania
United States	Rittenhouse Hematology/Oncology	Philadelphia	Pennsylvania
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	Hematology Oncology Associates	Phoenix	Arizona
United States	Allegheny General Hospital/Allegheny-Singer Research Institute	Pittsburgh	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Berkshire Hematology Oncology, P.C.	Pittsfield	Massachusetts
United States	North Texas Regional Cancer Center	Plano	Texas
United States	Texas Oncology Plano West Cancer Center	Plano	Texas
United States	CCOP - St. Joseph Mercy Hospital - Oakland	Pontiac	Michigan
United States	SCRI - Florida Cancer Specialists - Port Charlotte	Port Charlotte	Florida
United States	CCOP - St. Joseph Mercy Port Huron	Port Huron	Michigan
United States	Northwest Cancer Specialists- Rose Qtr	Portland	Oregon
United States	Northwest Cancer Specialists- St. Vincent	Portland	Oregon
United States	Northwest Cancer Specialists-Portland	Portland	Oregon
United States	Providence Medical Center	Portland	Oregon
United States	Providence St. Vincent Medical Center	Portland	Oregon
United States	Northern Arizona Hematology & Oncology Associates	Prescott Valley	Arizona
United States	Utah Valley Regional Medical Center - Provo	Provo	Utah
United States	Cancer Centers of North Carolina	Raleigh	North Carolina
United States	Cancer Centers of North Carolina- North Raleigh	Raleigh	North Carolina
United States	Kaiser Permanente Medical Center - Redwood City	Redwood City	California
United States	Renown Regional Medical Center	Reno	Nevada
United States	New York Oncology Hematology PC	Rexford	New York
United States	Marshfield Clinic at James Beck Cancer Center	Rhinelander	Wisconsin
United States	Marshfield Clinic Rice Lake Center	Rice Lake	Wisconsin
United States	Kaiser Permanente Medical Center - Richmond	Richmond	California
United States	MBCCOP, Virginia Commonwealth University	Richmond	Virginia
United States	SCRI Virginia Cancer Institute (1401)	Richmond	Virginia
United States	SCRI Virginia Cancer Institute (6605)	Richmond	Virginia
United States	SCRI Chattanooga Oncol & Hematol Assoc, PC - Ringgold	Ringgold	Georgia
United States	Oncology and Hematology Associates of SW VA, Inc	Roanoke	Virginia
United States	North Memorial Health Care	Robbinsdale	Minnesota
United States	Interlakes Oncology Hematology PC - White Spruce	Rochester	New York
United States	Interlakes Oncology Hematology PC- Long Pond	Rochester	New York
United States	Kaiser Permanente Roseville	Roseville	California
United States	Sutter Roseville Medical Center	Roseville	California
United States	Texas Oncology - Round Rock Cancer Center	Round Rock	Texas
United States	Texas Oncology Seton Williamson	Round Rock	Texas
United States	CCOP, William Beaumont Hospital	Royal Oak	Michigan
United States	Kaiser Permanente Medical Center - Sacramento	Sacramento	California
United States	Kaiser Permanente, South Sacramento	Sacramento	California
United States	Sutter Medical Center	Sacramento	California
United States	Arizona Oncology (CASA-Safford)	Safford	Arizona
United States	CCOP, St. Mary's Medical Center	Saginaw	Michigan
United States	Tori-Icon	Saint Augustine	Florida
United States	Dixie Regional Medical Center - East Campus	Saint George	Utah
United States	St. Louis University Health Sciences Center	Saint Louis	Missouri
United States	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota
United States	Park Nicollet Health Services	Saint Louis Park	Minnesota
United States	Minnesota Hematology Oncology-St. Paul	Saint Paul	Minnesota
United States	Regions Hospital Cancer Care Center	Saint Paul	Minnesota
United States	Oncology and Hematology Associates of SW VA, Inc	Salem	Virginia
United States	Penisula Regional Medical Center	Salisbury	Maryland
United States	Huntsman Cancer Inst. at the University of Utah- Salt Lake City	Salt Lake City	Utah
United States	LDS Hospital	Salt Lake City	Utah
United States	Cancer Care Centers of South Texas - Loop 410	San Antonio	Texas
United States	Cancer Care Centers of South Texas- Brooklyn	San Antonio	Texas
United States	HOAST - Medical Drive	San Antonio	Texas
United States	San Antonio Tumor and Blood Clinic - M.Oak	San Antonio	Texas
United States	University of Texas Health Science Center	San Antonio	Texas
United States	Kaiser Permanente-San Diego	San Diego	California
United States	Kaiser Permanente Medical Center - San Francisco Geary Campus	San Francisco	California
United States	TORI - Oncology Care Med Assoc	San Gabriel	California
United States	Kaiser Permanente Santa Teresa	San Jose	California
United States	Texas Oncology - San Marcos	San Marcos	Texas
United States	Kaiser Permanente San Rafael	San Rafael	California
United States	Santa Barbara Hematology Oncology Medical Group	Santa Barbara	California
United States	Santa Barbara II (Samsum Clinic) - TORI	Santa Barbara	California
United States	Kaiser Permanente Medical Center - Santa Clara Kiely Campus	Santa Clara	California
United States	New Mexico Cancer Care Associates	Santa Fe	New Mexico
United States	Central Coast Medical Oncology Corporation	Santa Maria	California
United States	Kaiser Permanente Medical Center - Santa Rosa	Santa Rosa	California
United States	SCRI Florida Cancer Specialists - Sarasota (Cattleman)	Sarasota	Florida
United States	SCRI- Florida Cancer Specialists - Sarasota	Sarasota	Florida
United States	Memorial Health University Medical Center	Savannah	Georgia
United States	Hematology Oncology Associates	Scottsdale	Arizona
United States	Hematology and Oncology Associates of NEPA	Scranton	Pennsylvania
United States	Scranton Hematology Oncology	Scranton	Pennsylvania
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington
United States	Puget Sound Cancer Center - Seattle	Seattle	Washington
United States	Northern Arizona Hematology & Oncology Associates	Sedona	Arizona
United States	Cancer Centers of the Carolinas - Seneca	Seneca	South Carolina
United States	Kansas City Cancer Center, Shawnee Mission	Shawnee Mission	Kansas
United States	Tennessee Oncology	Shelbyville	Tennessee
United States	Texas Cancer Center	Sherman	Texas
United States	Holy Cross Hospital	Silver Spring	Maryland
United States	Mercy Medical Center - Sioux City	Sioux City	Iowa
United States	Siouxland Hematology-Oncology Associates	Sioux City	Iowa
United States	St. Luke's Regional Medical Center	Sioux City	Iowa
United States	Avera Cancer Institute	Sioux Falls	South Dakota
United States	Avera McKenna Hospital	Sioux Falls	South Dakota
United States	CCOP, Sanford Cancer Center - Oncology Clinic	Sioux Falls	South Dakota
United States	SCRI Tennessee Oncology, PLLC Smyrna	Smyrna	Tennessee
United States	Santa Barbara Hematology/Oncology Medical Group, Inc	Solvang	California
United States	Somerset Medical Center	Somerville	New Jersey
United States	Kaiser Permanente-South San Francisco	South San Francisco	California
United States	Providence Hospital - Southfield	Southfield	Michigan
United States	Sparta Cancer Center	Sparta	New Jersey
United States	Cancer Centers of the Carolinas - Spartanburg	Spartanburg	South Carolina
United States	Spartanburg Regional Healthcare System	Spartanburg	South Carolina
United States	Cancer Care Northwest- Valley - Mission	Spokane	Washington
United States	Cancer Care Northwest-North - Holland	Spokane	Washington
United States	Cancer Care Northwest-Radiation Therapy (XRT)	Spokane	Washington
United States	Cancer Care Northwest-South	Spokane	Washington
United States	Evergreen Hematology & Oncology (Farwell)	Spokane	Washington
United States	Rockwood Clinic Cancer Treatment Center	Spokane	Washington
United States	Williamette Valley Cancer Institute and Research Center	Springfield	Oregon
United States	Geisinger Medical Group - Scenery Park	State College	Pennsylvania
United States	Marshfield Clinic Cancer Care at St. Michael's Hospital	Stevens Point	Wisconsin
United States	Kaiser Permanente Medical Facility - Stockton	Stockton	California
United States	University Hospital and Medical Center - SUNY Stony Brook	Stony Brook	New York
United States	Texas Oncology Cancer Center - Sugar Land	Sugar Land	Texas
United States	Olive View/UCLA Medical Center	Sylmar	California
United States	SCRI - Florida Cancer Specialists - Armenia	Tampa	Florida
United States	SCRI - Florida Cancer Specialists - Tampa	Tampa	Florida
United States	Celilo Center for Cancer Care	The Dalles	Oregon
United States	US Oncology	The Woodlands	Texas
United States	Rocky Mountain Cancer Centers	Thornton	Colorado
United States	Troy Cancer Treatment Program	Troy	New York
United States	Upper Valley Medical Center	Troy	Ohio
United States	Northwest Cancer Specialists-Tualatin	Tualatin	Oregon
United States	Arizona Oncology (CASA-Craycroft)	Tucson	Arizona
United States	Arizona Oncology (CASA-Office Only)	Tucson	Arizona
United States	Arizona Oncology - CASA St. Mary's	Tucson	Arizona
United States	Arizona Oncology Associates - Carondelet	Tucson	Arizona
United States	Arizona Oncology Associates - Rudasill	Tucson	Arizona
United States	Tyler Cancer Center	Tyler	Texas
United States	Associates in Hematology-Oncology, PC at Crozer Regional Cancer Center	Upland	Pennsylvania
United States	Carle Cancer Center, CCOP	Urbana	Illinois
United States	Carle Foundation Hospital	Urbana	Illinois
United States	Kaiser Permanente Medical Center Vacaville	Vacaville	California
United States	Kaiser Permanente Medical Center - Vallejo	Vallejo	California
United States	Northwest Cancer Specialists-134th St.	Vancouver	Washington
United States	Northwest Cancer Specialists-136th Ave	Vancouver	Washington
United States	SCRI Florida Cancer Specialists - Venice (Tamiami)	Venice	Florida
United States	SCRI Florida Cancer Specilaists - Venice	Venice	Florida
United States	Virginia Oncology Associates	Virginia Beach	Virginia
United States	Texas Oncology Cancer Care and Research Center	Waco	Texas
United States	Kaiser Permanente Medical Center - Walnut Creek	Walnut Creek	California
United States	CCOP, St. John Macomb Hospital	Warren	Michigan
United States	Sibley Memorial Hospital	Washington	District of Columbia
United States	Washington Regional Cancer Center	Washington	District of Columbia
United States	Covenant Cancer Treatment Center	Waterloo	Iowa
United States	Aspirus Regional Cancer Center	Wausau	Wisconsin
United States	Texas Oncology - Clear Lake	Webster	Texas
United States	South Texas Cancer Clinic	Weslaco	Texas
United States	Aurora Women's Pavilion of Aurora West Allis Medical Center	West Allis	Wisconsin
United States	Reading Hospital and Medical Center	West Reading	Pennsylvania
United States	Trivalley Oncology Hematology	Westlake Village	California
United States	Westlake Infusion Center	Westlake Village	California
United States	Alliance Hematology Oncology PA	Westminster	Maryland
United States	CCOP Marshfield Clinic - Weston Center	Weston	Wisconsin
United States	Exempla Lutheran Medical Center	Wheat Ridge	Colorado
United States	Wheeling Hospital	Wheeling	West Virginia
United States	TORI - Oncology Care Med Assoc	Whittier	California
United States	Texoma Cancer Center	Wichita Falls	Texas
United States	Geisinger Wyoming Valley Medical Center	Wilkes-Barre	Pennsylvania
United States	Virginia Oncology Associates	Williamsburg	Virginia
United States	Clinton Memorial Hospital	Wilmington	Ohio
United States	SCRI Oncology Hematology Care, Inc. - Wilmington (WLM)	Wilmington	Ohio
United States	Fairfax Northern Virginia Hematology-Oncology - Winchester	Winchester	Virginia
United States	Cancer Care and Hematology Specialists of Chicagoland	Winfield	Illinois
United States	CCOP Forsyth Memorial Hospital	Winston-Salem	North Carolina
United States	Cancer Centers of Florida, P.A.	Winter Park	Florida
United States	Marshfield Clinic Wisconsin Rapids Center	Wisconsin Rapids	Wisconsin
United States	Fairfax-Northern Virginia Hematology-Oncology PC	Woodbridge	Virginia
United States	Minnesota Oncology Hematology	Woodbury	Minnesota
United States	Oncology and Hematology Associates of SW VA, Inc	Wytheville	Virginia
United States	Yakima Valley Memorial Hospital - North Star Lodge	Yakima	Washington

Sponsors (3)

Lead Sponsor	Collaborator
NSABP Foundation Inc	Genentech, Inc., US Oncology Research

Countries where clinical trial is conducted

United States,  Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Invasive disease-free survival(IDFS)relative to the TAC chemotherapy regimen alone		Every 12 months until recurrence
Secondary	Invasive disease-free survival (IDFS) relative to the TAC chemotherapy regimen		Every 12 months until recurrence
Secondary	Disease-free survival (DFS-DCIS) relative to the TC alone regimen		Every 12 months until recurrence
Secondary	Overall survival (OS) relative to the TC alone regimen		Every 12 months from randomization until death from any cause
Secondary	OS relative to the TAC regimen		Every 12 months from randomization until death from any cause
Secondary	Recurrence-free interval (RFI) relative to the TC alone regimen		Every 12 months, from randomization to local, regional, or distant recurrence
Secondary	RFI relative to the TAC regimen		Every 12 months, from randomization to local, regional, or distant recurrence
Secondary	Develop molecular predictive markers for the degree of benefit from TCB over TC or TAC		6 years
Secondary	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		10 years
Secondary	Toxicity associated with each of the regimens		Every 6 months
Secondary	Determine the role of topoisomerase II alpha (TOP2A) in prognosis and prediction of degree of benefit from TAC over TC		6 years
Secondary	Develop predictive markers for benefit from doxorubicin		6 years