Tamoxifen Citrate or Letrozole With or Without Bevacizumab in Treating Women With Stage IIIB or Stage IV Breast Cancer
Invasive Breast Carcinoma, Recurrent Breast Carcinoma, Stage III Breast Cancer AJCC v6
About this trial
This is an interventional treatment trial for Invasive Breast Carcinoma
Eligibility Criteria
Inclusion Criteria:
Histologic confirmation of invasive cancer of the female breast in either the primary or metastatic setting
- Stage IV disease or stage IIIB disease (using American Joint Committee on Cancer [AJCC] criteria, 6th edition) not amenable to local therapy
- Patients may not have a "currently active" second malignancy other than non-melanoma skin cancers; patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse
- Tumors (from either primary or metastatic sites) must express estrogen receptor (ER) and/or progesterone receptor (PgR) in >= 1% of cells will be considered positive
Postmenopausal women are eligible for this trial; before study registration, menopausal status must be defined according to the criteria below:
- Age >= 55 years and one year or more of amenorrhea
- Age < 55 years and one year or more of amenorrhea, with an estradiol assay < 20 pg/ml
- For women age < 55 with prior hysterectomy but intact ovaries, with an estradiol assay < 20 pg/ml
- Surgical menopause with bilateral oophorectomy (at least 28 days must elapse from surgery to time of study registration)
- Ovarian suppression on a luteinizing hormone-releasing hormone (LH-RH) agonist
- Premenopausal women who do not meet the postmenopausal criteria above are also eligible, but are required to undergo ovarian suppression; this can be initiated any time prior to or on day 1 of protocol therapy, regardless of chosen endocrine therapy, and will continue for the duration of protocol therapy
Patients must have measurable or non-measurable disease by RECIST criteria, with radiologic scans within 28 days of study registration
- Measurable disease: lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 2.0 cm with conventional techniques or as >= 1.0 cm with spiral computed tomography (CT) scan
- Non-measurable disease: all other lesions, including small lesions (longest diameter < 2.0 cm with conventional techniques or < 1.0 cm with spiral CT scan) and truly non-measurable lesions
Lesions that are considered non-measurable include the following:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Inflammatory breast disease
- Abdominal masses that are not confirmed and followed by imaging techniques
- Cystic lesions
Prior endocrine therapy is not required
- Prior endocrine therapy in the metastatic setting is not permitted (unless tamoxifen or an aromatase inhibitor was initiated within 4 weeks prior to registration to facilitate enrollment of patients who recently started first-line endocrine therapy for metastatic breast cancer); if prior letrozole therapy was initiated within the past 4 weeks, the patients should remain on letrozole as the study therapy; patients who began therapy with tamoxifen, anastrozole or exemestane must switch to letrozole to be eligible to participate in this study
- Prior endocrine therapy in the adjuvant setting is permitted; there is no time restriction for how long the patient must be on the adjuvant endocrine therapy, nor is there a time restriction for how long the patient needs to be off prior adjuvant endocrine therapy before beginning protocol therapy on 40503
- Prior treatment with ovarian suppression is allowed in either the adjuvant or metastatic setting; if medical ovarian suppression is being administered it can be initiated any time prior to or at the start of protocol therapy, and continued throughout the duration of the trial; surgical castration with bilateral oophorectomy must be performed at least 28 days prior to study registration (due to concerns of poor wound healing on bevacizumab)
- Patients may not have received any prior anti-VEGF or VEGFR tyrosine kinase inhibitor therapy
- Prior radiotherapy must have been completed and all toxicities resolved at least two weeks prior to registration
- Chemotherapy in the adjuvant or neoadjuvant setting is permitted; at least twelve months prior to registration must have elapsed since the completion of adjuvant or neoadjuvant chemotherapy and all toxicities must have resolved; taxane-related neurotoxicity must have resolved to sensory grade < 2 and no motor neuropathy of any grade is allowed
- Patients may have received one prior chemotherapy regimen for metastatic disease; the final dose of prior chemotherapy must have been administered at least 3 weeks prior to study registration
- Treatment with bisphosphonates is allowed and recommended as per American Society of Clinical Oncology (ASCO) guidelines
- Patients must not have had a major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study registration, and must have fully recovered from any such procedure
- Patients must not have anticipation of need for major surgical procedure during the course of the study
- Patients must not have had a core biopsy or other minor surgical procedure, within 7 days prior to study registration; placement of a vascular access device is allowed within 7 days of registration
- Patients must not have a history of abdominal fistula, or intra-abdominal abscess within 6 months prior to study registration
- Patients with a history of gastrointestinal (GI) perforation within 12 months prior to registration are not eligible
- Patients with a history of significant bleeding episodes (e.g., hemoptysis, upper or lower GI bleeding) within 6 months prior to registration are not eligible
Patients must not have clinically significant cardiovascular disease that includes the following:
- Uncontrolled hypertension defined as systolic blood pressure > 150 and/or diastolic blood pressure > 90 mmHg on antihypertensive medications or any prior history of hypertensive crisis or hypertensive encephalopathy
- History of myocardial infarction or unstable angina within past 6 months
- New York Heart Association (NYHA) grade 2 or greater congestive heart failure
- Symptomatic peripheral vascular disease
- Significant vascular disease (e.g., aortic aneurysm, aortic dissection) or arterial thrombotic events
- Full dose anticoagulation therapy is allowed for the treatment of prior conditions such as venous thrombosis or atrial fibrillation, but not for the treatment of prior arterial thrombotic events; patients on full dose anticoagulants must be on a stable dose of warfarin and have an in-range international normalized ratio (INR) (usually between 2 and 3) or be on a stable dose of low-molecular weight (LMW) heparin; patients receiving antiplatelet agents are eligible, as are patients on daily prophylactic aspirin or anticoagulation for atrial fibrillation
- Patients may not have a history of stroke or transient ischemic attack within 6 months prior to study registration
- Patients with a history of seizures must be well controlled with standard medication
- Patients must not have known central nervous system (CNS) metastases or leptomeningeal disease (screening with brain imaging is not required for asymptomatic patients)
- In aromatase inhibitor (AI)-treated patients: no known allergies to imidazole drugs, (e.g. clotrimazole, ketoconazole, miconazole, econazole, sulconazole, tioconazole, or terconazole) or compounds structurally similar to bevacizumab
- In tamoxifen treated patients: no known allergies to selective estrogen receptor modulators (e.g. tamoxifen, raloxifene or toremifene) or compounds structurally similar to bevacizumab; for patients enrolled after Update #5, endocrine therapy will consist of letrozole only and this criterion will no longer apply
- Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status =< 1
- No serious, non-healing wound, ulcer, or bone fracture
- Life expectancy of >= 12 weeks
- All patients who are premenopausal (if not already receiving ovarian suppression therapy/surgical oophorectomy) must have a negative beta-human chorionic gonadotropin (beta-Hcg) prior to starting on study treatment; patients may not be pregnant or nursing at any time during the study; ovarian suppression is required in women of childbearing potential by the start of protocol therapy, and will continue for the duration of protocol therapy
- Granulocytes >= 1,000/ul
- Platelet count >= 100,000/ul
- Creatinine =< 2.0 mg/dL
- Bilirubin =< 1.5 times upper limit of normal (ULN) unless due to Gilbert's syndrome
- Transaminases (alanine aminotransferase [ALT], aspartate aminotransferase [AST]) =< 2.5 times ULN
- International normalized ratio (INR) =< 1.6, unless on full dose warfarin
- Beta-Hcg negative in premenopausal women
Urine protein =< 1+ or urine to plasma creatinine (UPC) < 1
- Patients discovered to have >= 2+ proteinuria at baseline must undergo a 24-hour urine collection that must demonstrate < 1 g of protein/24 hr, or UPC ratio < 1 to allow participation in the study
Sites / Locations
- Providence Hospital
- Sparks Regional Medical Center
- East Bay Medical Oncology Hematology Medical Associates-Antioch
- Alta Bates Summit Medical Center-Herrick Campus
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
- Mills-Peninsula Medical Center
- East Bay Radiation Oncology Center
- Eden Hospital Medical Center
- Valley Medical Oncology Consultants-Castro Valley
- Adventist Health Cancer Care Center Chico
- Community Cancer Institute
- Bay Area Breast Surgeons Inc
- Valley Medical Oncology Consultants-Fremont
- Marin General Hospital
- Los Angeles County-USC Medical Center
- USC / Norris Comprehensive Cancer Center
- Contra Costa Regional Medical Center
- Fremont - Rideout Cancer Center
- Memorial Medical Center
- El Camino Hospital
- Sutter Cancer Research Consortium
- Highland General Hospital
- Alta Bates Summit Medical Center - Summit Campus
- Bay Area Tumor Institute
- Hematology and Oncology Associates-Oakland
- Tom K Lee Inc
- UC Irvine Health/Chao Family Comprehensive Cancer Center
- East Bay Medical Oncology Hematology Medical Associates Inc-Pleasant Hill
- John Muir Health Cancer Medical Group
- Valley Care Health System - Pleasanton
- Valley Medical Oncology Consultants
- Pomona Valley Hospital Medical Center
- University of California Davis Comprehensive Cancer Center
- Saint Helena Hospital
- Zuckerberg San Francisco General Hospital
- California Pacific Medical Center-Pacific Campus
- UCSF Medical Center-Mount Zion
- East Bay Medical Oncology Hematology Associates Inc
- Doctors Medical Center- JC Robinson Regional Cancer Center
- Gene Upshaw Memorial Tahoe Forest Cancer Center
- Northbay Cancer Center
- Sutter Solano Medical Center/Cancer Center
- The Medical Center of Aurora
- Boulder Community Hospital
- Penrose-Saint Francis Healthcare
- Porter Adventist Hospital
- Presbyterian - Saint Lukes Medical Center - Health One
- SCL Health Saint Joseph Hospital
- Rose Medical Center
- Western States Cancer Research NCORP
- Swedish Medical Center
- Poudre Valley Hospital
- Saint Mary's Hospital and Regional Medical Center
- North Colorado Medical Center
- Saint Anthony Hospital
- Littleton Adventist Hospital
- Sky Ridge Medical Center
- Longmont United Hospital
- McKee Medical Center
- Saint Mary Corwin Medical Center
- North Suburban Medical Center
- SCL Health Lutheran Medical Center
- Hartford Hospital
- Smilow Cancer Hospital Care Center at Saint Francis
- Middlesex Hospital
- The Hospital of Central Connecticut
- Yale University
- Stamford Hospital/Bennett Cancer Center
- Beebe Medical Center
- Christiana Care Health System-Christiana Hospital
- Sibley Memorial Hospital
- Boca Raton Regional Hospital
- Holy Cross Hospital
- Florida Cancer Specialists-Gainesville Cancer Center
- Jupiter Medical Center
- Mount Sinai Medical Center
- University Cancer and Blood Center LLC
- Piedmont Hospital
- Atlanta Regional CCOP
- Emory Saint Joseph's Hospital
- Northside Hospital
- Augusta University Medical Center
- WellStar Cobb Hospital
- John B Amos Cancer Center
- Dekalb Medical Center
- Dublin Hematology Oncology Care PC
- Piedmont Fayette Hospital
- Eisenhower Army Medical Center
- Northeast Georgia Medical Center-Gainesville
- Northside Hospital - Gwinnett
- Medical Center of Central Georgia
- Wellstar Kennestone Hospital
- Southern Regional Medical Center
- Harbin Clinic Medical Oncology and Clinical Research
- Pali Momi Medical Center
- Hawaii Cancer Care Inc - Waterfront Plaza
- Queen's Medical Center
- Straub Clinic and Hospital
- University of Hawaii Cancer Center
- Queen's Cancer Center - Kuakini
- The Cancer Center of Hawaii-Liliha
- Kapiolani Medical Center for Women and Children
- Maui Memorial Medical Center
- Pacific Cancer Institute of Maui
- Saint Anthony's Health
- Rush - Copley Medical Center
- Saint Joseph Medical Center
- Illinois CancerCare-Bloomington
- Graham Hospital Association
- Illinois CancerCare-Canton
- Illinois CancerCare-Carthage
- Memorial Hospital
- Mount Sinai Hospital Medical Center
- John H Stroger Jr Hospital of Cook County
- Mercy Hospital and Medical Center
- Presence Resurrection Medical Center
- University of Chicago Comprehensive Cancer Center
- Advocate Illinois Masonic Medical Center
- Decatur Memorial Hospital
- Heartland Cancer Research NCORP
- Advocate Good Samaritan Hospital
- Ascension Alexian Brothers - Elk Grove Village
- Elmhurst Memorial Hospital
- Eureka Hospital
- Illinois CancerCare-Eureka
- Freeport Memorial Hospital/Leonard C Ferguson Cancer Center
- Illinois CancerCare-Galesburg
- Ingalls Memorial Hospital
- Illinois CancerCare-Havana
- Mason District Hospital
- Duly Health and Care Joliet
- Presence Saint Mary's Hospital
- Illinois CancerCare-Kewanee Clinic
- AMITA Health Adventist Medical Center
- Illinois CancerCare-Macomb
- Mcdonough District Hospital
- Garneau, Stewart C MD (UIA Investigator)
- Porubcin, Michael MD (UIA Investigator)
- Sharis, Christine M MD (UIA Investigator)
- Spector, David MD (UIA Investigator)
- Stoffel, Thomas J MD (UIA Investigator)
- Trinity Medical Center
- Holy Family Medical Center
- Illinois CancerCare-Monmouth
- Good Samaritan Regional Health Center
- Bromenn Regional Medical Center
- Carle Cancer Institute Normal
- Illinois CancerCare-Community Cancer Center
- Illinois CancerCare-Ottawa Clinic
- Ottawa Regional Hospital and Healthcare Center
- Illinois CancerCare-Pekin
- OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
- Proctor Hospital
- Illinois CancerCare-Peoria
- Methodist Medical Center of Illinois
- OSF Saint Francis Medical Center
- Illinois CancerCare-Peru
- Illinois Valley Hospital
- Illinois CancerCare-Princeton
- Perry Memorial Hospital
- Illinois CancerCare-Spring Valley
- Memorial Medical Center
- Carle Cancer Center
- Franciscan Saint Francis Health-Beech Grove
- Elkhart Clinic
- Michiana Hematology Oncology PC-Elkhart
- Elkhart General Hospital
- Fort Wayne Medical Oncology and Hematology Inc-Parkview
- Ascension Saint Vincent Indianapolis Hospital
- Community Howard Regional Health
- IU Health La Porte Hospital
- IU Health Arnett Cancer Care
- Franciscan Saint Anthony Health-Michigan City
- Michiana Hematology Oncology PC-Mishawaka
- Saint Joseph Regional Medical Center-Mishawaka
- Michiana Hematology Oncology PC-Plymouth
- Reid Health
- Memorial Hospital of South Bend
- Michiana Hematology Oncology PC-South Bend
- Northern Indiana Cancer Research Consortium
- Michiana Hematology Oncology PC-Westville
- McFarland Clinic - Ames
- Constantinou, Costas L MD (UIA Investigator)
- University of Iowa Healthcare Cancer Services Quad Cities
- Medical Oncology and Hematology Associates-West Des Moines
- Mercy Capitol
- Iowa Methodist Medical Center
- Iowa-Wide Oncology Research Coalition NCORP
- Medical Oncology and Hematology Associates-Des Moines
- Mercy Medical Center - Des Moines
- Mission Cancer and Blood - Laurel
- Iowa Lutheran Hospital
- University of Iowa/Holden Comprehensive Cancer Center
- Ottumwa Regional Health Center
- Siouxland Regional Cancer Center
- Mercy Medical Center-Sioux City
- Saint Luke's Regional Medical Center
- HaysMed University of Kansas Health System
- Hutchinson Regional Medical Center
- University of Kansas Cancer Center
- Olathe Cancer Center
- Ascension Via Christi - Pittsburg
- Salina Regional Health Center
- Cotton O'Neil Cancer Center / Stormont Vail Health
- University of Kansas Health System Saint Francis Campus
- Our Lady Bellefonte Hospital
- Doctors Carrol, Sheth, Raghavan
- Hematology/Oncology Clinic PLLC
- Mary Bird Perkins Cancer Center
- Ochsner Health Center-Summa
- Ochsner Health Center-Covington
- Louisiana State University Health Science Center
- Tulane University Health Sciences Center
- Ochsner Baptist Medical Center
- Ochsner Medical Center Jefferson
- Harold Alfond Center for Cancer Care
- Eastern Maine Medical Center
- Maine Center for Cancer Medicine-Scarborough
- University of Maryland/Greenebaum Cancer Center
- Veterans Administration Medical Center-Baltimore
- Greater Baltimore Medical Center
- Sinai Hospital of Baltimore
- Christiana Care - Union Hospital
- Frederick Memorial Hospital
- Meritus Medical Center
- Kaiser Permanente - Largo Medical Center
- Kaiser Permanente Lutherville - Timonium Medical Center
- Kaiser Permanente - Shady Grove Medical Center
- Holy Cross Hospital
- Brigham and Women's Hospital
- Beth Israel Deaconess Medical Center
- Dana-Farber Cancer Institute
- Addison Gilbert Hospital
- Cape Cod Hospital
- Lowell General Hospital
- Holy Family Hospital
- Dana-Farber/Brigham and Women's Cancer Center at Milford Regional
- Newton-Wellesley Hospital
- Michigan Cancer Research Consortium NCORP
- Saint Joseph Mercy Hospital
- Bronson Battle Creek
- McLaren Cancer Institute-Bay City
- Spectrum Health Big Rapids Hospital
- Beaumont Hospital - Dearborn
- Wayne State University/Karmanos Cancer Institute
- Ascension Saint John Hospital
- Michigan State University Clinical Center
- Green Bay Oncology - Escanaba
- Hurley Medical Center
- Genesys Regional Medical Center-West Flint Campus
- McLaren Cancer Institute-Flint
- Cancer Research Consortium of West Michigan NCORP
- Spectrum Health at Butterworth Campus
- Trinity Health Grand Rapids Hospital
- Green Bay Oncology - Iron Mountain
- Allegiance Health
- Bronson Methodist Hospital
- West Michigan Cancer Center
- Borgess Medical Center
- Karmanos Cancer Institute at McLaren Greater Lansing
- Sparrow Hospital
- Trinity Health Saint Mary Mercy Livonia Hospital
- UP Health System Marquette
- MyMichigan Medical Center Midland
- Mercy Health Partners-Hackley Campus
- Trinity Health Muskegon Hospital
- Lakeland Hospital Niles
- McLaren Cancer Institute-Northern Michigan
- Saint Joseph Mercy Oakland
- Lake Huron Medical Center
- Ascension Saint Mary's Hospital
- Lakeland Medical Center Saint Joseph
- Marie Yeager Cancer Center
- Ascension Providence Hospitals - Southfield
- Munson Medical Center
- Saint John Macomb-Oakland Hospital
- University of Michigan Health - West
- Medini, Eitan MD (UIA Investigator)
- Essentia Health Cancer Center
- Essentia Health Saint Mary's Medical Center
- Miller-Dwan Hospital
- Etzell, Paul S MD (UIA Investigator)
- Swenson, Wade II, MD (UIA Investigator)
- Mayo Clinic Health Systems-Mankato
- Coborn Cancer Center at Saint Cloud Hospital
- Saint Cloud Hospital
- Rice Memorial Hospital
- University of Mississippi Medical Center
- Singing River Hospital
- Central Care Cancer Center - Bolivar
- Cox Cancer Center Branson
- Southeast Missouri Hospital
- Saint Francis Medical Center
- Southeast Cancer Center
- MU Health - University Hospital/Ellis Fischel Cancer Center
- Capital Region Southwest Campus
- Freeman Health System
- Truman Medical Centers
- Delbert Day Cancer Institute at PCRMC
- Saint Louis Cancer and Breast Institute-South City
- Washington University School of Medicine
- Missouri Baptist Medical Center
- Comprehensive Cancer Care PC
- Mercy Hospital Saint Louis
- Saint Louis-Cape Girardeau CCOP
- Cancer Research for the Ozarks NCORP
- Mercy Hospital Springfield
- CoxHealth South Hospital
- Billings Clinic Cancer Center
- Northern Rockies Radiation Oncology Center
- Saint Vincent Healthcare
- Montana Cancer Consortium NCORP
- Saint Vincent Frontier Cancer Center
- Bozeman Deaconess Hospital
- Saint James Community Hospital and Cancer Treatment Center
- Benefis Healthcare- Sletten Cancer Institute
- Berdeaux, Donald MD (UIA Investigator)
- Great Falls Clinic
- Northern Montana Hospital
- Saint Peter's Community Hospital
- Glacier Oncology PLLC
- Kalispell Medical Oncology
- Kalispell Regional Medical Center
- Montana Cancer Specialists
- Saint Patrick Hospital - Community Hospital
- Community Medical Hospital
- Guardian Oncology and Center for Wellness
- CHI Health Saint Francis
- Nebraska Cancer Research Center
- Great Plains Health Callahan Cancer Center
- Missouri Valley Cancer Consortium
- Alegent Health Immanuel Medical Center
- Alegent Health Bergan Mercy Medical Center
- Creighton University Medical Center
- University of Nebraska Medical Center
- Renown Regional Medical Center
- New Hampshire Oncology Hematology PA-Concord
- Cheshire Medical Center-Dartmouth-Hitchcock Keene
- LRGHealthcare-Lakes Region General Hospital
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
- Solinsky Center for Cancer Care
- Saint Joseph Hospital
- Cooper Hospital University Medical Center
- CentraState Medical Center
- Hackensack University Medical Center
- Morristown Medical Center
- Newark Beth Israel Medical Center
- Overlook Hospital
- Inspira Medical Center Vineland
- Montefiore Medical Center-Weiler Hospital
- Montefiore Medical Center-Wakefield Campus
- Montefiore Medical Center - Moses Campus
- Hematology Oncology Associates of Central New York-East Syracuse
- Elmhurst Hospital Center
- Arnot Ogden Medical Center/Falck Cancer Center
- Adirondack Cancer Center
- Queens Hospital Center
- Mount Sinai Union Square
- Mount Sinai West
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
- Ralph Lauren Center for Cancer Care and Prevention
- Memorial Sloan Kettering Cancer Center
- NYP/Weill Cornell Medical Center
- Highland Hospital
- Interlakes Foundation Inc-Rochester
- University of Rochester
- Staten Island University Hospital
- Faxton-Saint Luke's Healthcare
- Randolph Hospital
- UNC Lineberger Comprehensive Cancer Center
- Carolinas Medical Center/Levine Cancer Institute
- Wayne Memorial Hospital
- Cone Health Cancer Center
- Vidant Oncology-Kinston
- Annie Penn Memorial Hospital
- Rutherford Hospital
- Southeast Clinical Oncology Research Consortium NCORP
- Wake Forest University Health Sciences
- Mid Dakota Clinic
- Saint Alexius Medical Center
- Sanford Bismarck Medical Center
- Altru Cancer Center
- Trinity Cancer Care Center
- Mary Rutan Hospital
- Aultman Health Foundation
- Adena Regional Medical Center
- MetroHealth Medical Center
- Ohio State University Comprehensive Cancer Center
- Riverside Methodist Hospital
- Columbus NCI Community Oncology Research Program
- Grant Medical Center
- Mount Carmel Health Center West
- Doctors Hospital
- Grandview Hospital
- Good Samaritan Hospital - Dayton
- Miami Valley Hospital
- Miami Valley Hospital North
- Dayton Veterans Affairs Medical Center
- Grady Memorial Hospital
- Blanchard Valley Hospital
- Atrium Medical Center-Middletown Regional Hospital
- Wayne Hospital
- Kettering Medical Center
- Fairfield Medical Center
- Saint Rita's Medical Center
- Marietta Memorial Hospital
- Knox Community Hospital
- Licking Memorial Hospital
- Southern Ohio Medical Center
- Springfield Regional Medical Center
- Upper Valley Medical Center
- Saint Ann's Hospital
- Clinton Memorial Hospital
- Greene Memorial Hospital
- Genesis Healthcare System Cancer Care Center
- Natalie Warren Bryant Cancer Center at Saint Francis
- Saint Charles Health System
- Clackamas Radiation Oncology Center
- Legacy Mount Hood Medical Center
- Providence Milwaukie Hospital
- Providence Newberg Medical Center
- Providence Willamette Falls Medical Center
- Legacy Good Samaritan Hospital and Medical Center
- Providence Portland Medical Center
- Adventist Medical Center
- Providence Saint Vincent Medical Center
- Kaiser Permanente Northwest
- Legacy Emanuel Hospital and Health Center
- Legacy Meridian Park Hospital
- Jefferson Abington Hospital
- Lehigh Valley Hospital-Cedar Crest
- Bryn Mawr Hospital
- Doylestown Hospital
- Paoli Memorial Hospital
- West Penn Hospital
- University of Pittsburgh Cancer Institute (UPCI)
- Guthrie Medical Group PC-Robert Packer Hospital
- Mercy Hospital
- Scranton Hematology Oncology
- Grand View Hospital
- Chester County Hospital
- Reading Hospital
- UPMC Susquehanna
- Lankenau Medical Center
- Hematology and Oncology Associates of Rhode Island Inc
- Memorial Hospital of Rhode Island
- Kent Hospital
- AnMed Health Cancer Center
- AnMed Health Hospital
- McLeod Regional Medical Center
- Saint Francis Hospital
- Spartanburg Medical Center
- Avera Cancer Institute-Aberdeen
- Rapid City Regional Hospital
- Sanford Cancer Center Oncology Clinic
- Avera Cancer Institute
- Medical X-Ray Center
- Avera McKennan Hospital and University Health Center
- Sanford USD Medical Center - Sioux Falls
- Erlanger Medical Center
- Doctor's Hospital of Laredo
- Sentara Martha Jefferson Hospital
- Danville Regional Medical Center
- Kaiser Permanente - Fair Oaks Medical Center
- Providence Regional Cancer System-Centralia
- Saint Francis Hospital
- Saint Clare Hospital
- Providence - Saint Peter Hospital
- MultiCare Good Samaritan Hospital
- Providence Sacred Heart Medical Center and Children's Hospital
- Providence Holy Family Hospital
- Rockwood Clinic
- MultiCare Allenmore Hospital
- Saint Joseph Medical Center
- PeaceHealth Southwest Medical Center
- West Virginia University Charleston Division
- Wheeling Hospital/Schiffler Cancer Center
- Langlade Hospital and Cancer Center
- Aurora Cancer Care-Southern Lakes VLCC
- Marshfield Clinic-Chippewa Center
- Marshfield Clinic Cancer Center at Sacred Heart
- Aurora Cancer Care-Franklin
- Aurora Health Care Germantown Health Center
- Aurora Cancer Care-Glendale
- Green Bay Oncology at Saint Vincent Hospital
- Bellin Memorial Hospital
- Saint Vincent Hospital Cancer Center Green Bay
- Green Bay Oncology Limited at Saint Mary's Hospital
- Saint Vincent Hospital Cancer Center at Saint Mary's
- Aurora BayCare Medical Center
- Mercyhealth Hospital and Cancer Center - Janesville
- Aurora Cancer Care-Kenosha South
- Gundersen Lutheran Medical Center
- Dean Hematology and Oncology Clinic
- Holy Family Memorial Hospital
- Aurora Bay Area Medical Group-Marinette
- Bay Area Medical Center
- Marshfield Medical Center-Marshfield
- Marshfield Medical Center
- Aurora Saint Luke's Medical Center
- Medical College of Wisconsin
- Aurora Sinai Medical Center
- Marshfield Clinic-Minocqua Center
- ProHealth Oconomowoc Memorial Hospital
- Saint Vincent Hospital Cancer Center at Oconto Falls
- Vince Lombardi Cancer Clinic - Oshkosh
- Aurora Cancer Care-Racine
- Ascension Saint Mary's Hospital
- Marshfield Medical Center-Rice Lake
- HSHS Saint Nicholas Hospital
- Vince Lombardi Cancer Clinic-Sheboygan
- Ascension Saint Michael's Hospital
- Green Bay Oncology - Sturgeon Bay
- Aurora Medical Center in Summit
- Vince Lombardi Cancer Clinic-Two Rivers
- Aurora Cancer Care-Waukesha
- ProHealth Waukesha Memorial Hospital
- Aspirus Regional Cancer Center
- Aurora Cancer Care-Milwaukee West
- Aurora West Allis Medical Center
- Marshfield Medical Center - Weston
- Aspirus Cancer Care - Wisconsin Rapids
- Marshfield Clinic - Wisconsin Rapids Center
- Rocky Mountain Oncology
- Welch Cancer Center
- San Juan City Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Arm I (endocrine therapy with monoclonal antibody)
Arm II (endocrine therapy)
Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.