Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

Tamoxifen or Letrozole With or Without Bevacizumab in Treating Women With Stage III or Stage IV Breast Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Active	18 and over	NCI	CALGB-40503 CALGB 40503, NCT00601900

Special Category: CTSU trial, NCI Web site featured trial

Objectives

Primary

1. To compare the progression-free survival of letrozole therapy plus placebo with the combination of letrozole therapy plus bevacizumab as first-line treatment in women with estrogen- and/or progesterone-receptor-positive stage IIIB-IV breast cancer.

Secondary

1. To compare the proportion of patients receiving letrozole plus placebo and receiving letrozole plus bevacizumab who remain progression-free at 6 and 12 months.
2. To compare the incidence of objective response (complete response [CR] + partial response [PR]), in patients receiving letrozole with and without bevacizumab, as determined by RECIST criteria, excluding patients with non-measurable disease.
3. To compare the incidence of clinical benefit (CR + PR + stable disease ≥ 6 months) in patients receiving letrozole with and without bevacizumab.
4. To compare the duration of objective response in patients receiving letrozole with and without bevacizumab.
5. To compare the time to treatment failure, defined as the interval from randomization until progression, toxicity, withdrawn consent, or going onto nonprotocol therapy, in patients receiving letrozole with and without bevacizumab.
6. To compare the overall survival of patients receiving letrozole with and without bevacizumab, including the probability of survival until 36 months.
7. To compare toxicity levels between placebo and bevacizumab in both the letrozole treated patients and in the tamoxifen-treated patients.
8. To compare progression-free survival and overall survival of all patients receiving endocrine therapy with and without bevacizumab (by combining both letrozole and tamoxifen patient subgroups).

Entry Criteria

Disease Characteristics:

• Histologic confirmation of invasive cancer of the female breast in either the primary or metastatic setting
  • Stage IIIB disease not amenable to local therapy or stage IV disease
• Must have measurable or nonmeasurable disease by RECIST criteria, with radiologic scans (CT scan of the chest/abdomen)
  • Measurable disease is defined as 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 CT scan
  • Nonmeasurable disease is defined as all other lesions, including small lesions (longest diameter < 2.0 cm with conventional techniques or < 1.0 cm with spiral CT scan) and truly nonmeasurable lesions, including any of 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
• Baseline bone scans required for all patients for determination of metastatic bone disease
  • CT scan with bone windows required only for patients with bone metastases as the only site of disease
• No known CNS metastases or leptomeningeal disease (screening with brain imaging is not required for asymptomatic patients)
• Hormone receptor status: tumors (from either primary or metastatic sites) must express estrogen receptor (ER) and/or progesterone receptor (PgR) in ≥ 1% of cells

Prior/Concurrent Therapy:

• No prior endocrine therapy in the metastatic setting unless tamoxifen or an aromatase inhibitor was initiated within 4 weeks prior to registration
  • If prior endocrine therapy was initiated within the past 4 weeks, the patients should remain on that chosen hormonal therapy (tamoxifen or aromatase inhibitor) as the study therapy
  • Patients who began therapy with anastrozole or exemestane must switch to letrozole
• Prior endocrine therapy in the adjuvant setting allowed
• 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
• At least 28 days since surgical castration with bilateral oophorectomy
• At least two weeks prior radiotherapy and all toxicities resolved
• At least 12 months since the completion of prior adjuvant or neoadjuvant chemotherapy and all toxicities must have resolved
• No prior anti-VEGF or VEGFR tyrosine kinase inhibitor therapy
• No prior chemotherapy for metastatic disease
• More than 28 days since prior major surgical procedure or open biopsy and fully recovered from any such procedure
• No core biopsy or other minor surgical procedure (except placement of a vascular access device) within 7 days prior to study registration
• Prior palliative irradiation of a symptomatic lesion, or one that may produce disability (e.g., unstable femur) prior to study initiation, provided other measurable or non-measurable disease is present, is allowed
• Palliative radiotherapy may not be administered during protocol therapy
• Must not have anticipation of need for major surgical procedure during the course of the study
• Concurrent full dose anticoagulation therapy is allowed for the treatment of prior conditions such as venous thromboses 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 INR (usually between 2 and 3) or be on a stable dose of low molecular weight heparin
• Concurrent antiplatelet agents, daily prophylactic aspirin, or anticoagulation for atrial fibrillation allowed
• Concurrent treatment with bisphosphonates is allowed and recommended
• No concurrent hormones or other chemotherapeutic agents except for steroids given for adrenal failure or chronic non-cancer related diseases, hormones administered for non-disease-related conditions (e.g., insulin for diabetes), and intermittent use of dexamethasone as an antiemetic in solid tumor protocols

Patient Characteristics:

• Menopausal status: pre- or postmenopausal, meeting 1 of the following criteria:
  • 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
  • Age < 55 with prior hysterectomy but intact ovaries, with an estradiol assay < 20 pg/ml
  • Surgical menopause with bilateral oophorectomy
  • Ovarian suppression on a luteinizing hormone-releasing hormone agonist (goserelin acetate or leuprolide acetate)
    • Premenopausal women must undergo ovarian suppression prior to beginning protocol therapy
      • Ovarian radiation is not permitted for induction of ovarian suppression
• ECOG (Zubrod) performance status 0-1
• Life expectancy ≥ 12 weeks
• Granulocytes ≥ 1,000/μl
• Platelet count ≥ 100,000/μl
• Creatinine ≤ 2.0 mg/dL
• Bilirubin ≤ 1.5 times upper limit of normal (ULN) unless due to Gilbert’s syndrome
• Transaminases (ALT, AST) ≤ 2.5 times ULN
• INR ≤ 1.6 unless on full dose warfarin
• Urinalysis ≤ 1+ protein
  • Proteinuria ≥ 2 + at baseline must demonstrate < 1 g of protein/24 hr or protein:creatinine ratio < 1 on 24-hour urine collection
• No “currently active” second malignancy other than nonmelanoma 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
• Taxane-related neurotoxicity must have resolved to sensory grade < 2
• No motor neuropathy of any grade
• No significant traumatic injury within 28 days prior to study registration
• No history of abdominal fistula, or intra-abdominal abscess within the past 6 months
• No history of GI perforation within the past 12 months
• No history of significant bleeding episodes (e.g., hemoptysis, upper or lower GI bleeding) within the past 6 months
• No clinically significant cardiovascular disease, including any of the following:
  • Uncontrolled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg and/or diastolic BP > 90 mm Hg on antihypertensive medications
  • Prior history of hypertensive crisis or hypertensive encephalopathy
  • Myocardial infarction or unstable angina within past 6 months
  • New York Heart Association class II-IV congestive heart failure
  • Symptomatic peripheral vascular disease
  • Significant vascular disease (e.g., aortic aneurysm, aortic dissection)
  • Significant arterial thrombotic events
• No history of stroke or transient ischemic attack within the past 6 months
• History of seizures must be well controlled with standard medication
• No known allergies to imidazole drugs, (e.g., clotrimazole, ketoconazole, miconazole, econazole, sulconazole, ticonazole, or terconazole) or compounds structurally similar to bevacizumab (for patients treated with aromatase inhibitors)
• No known allergies to selective estrogen receptor modulators (e.g., tamoxifen, raloxifene, or toremifene) or compounds structurally similar to bevacizumab (for patients treated with tamoxifen)
• No serious, non-healing wound, ulcer, or bone fracture
• Not pregnant or nursing
• Negative pregnancy test

Expected Enrollment

Outcomes

Progression-free survival defined as the interval from randomization until disease progression or death, whichever occurs first in patients treated with letrozole
Estimation of adverse events rate, especially for stroke, proteinuria, thrombosis, hypertension in patients treated with tamoxifen citrate
Toxicity

Objective tumor response as defined by RECIST criteria for those patients with measurable disease
Probability of being progression-free at 6- and 12-months
Site of progression
Treatment-related toxicity
Time to treatment failure
Duration of tumor response
Overall survival
Probability of surviving until 36 months

Outline

This is a multicenter study. Patients are stratified according to planned endocrine therapy (letrozole vs tamoxifen), disease measurability (no vs yes), and disease-free interval from initial diagnosis to first progression (≤ 24 months vs > 24 months). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive oral endocrine therapy (tamoxifen citrate or letrozole) once daily and bevacizumab IV every 21 days. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
• Arm II: Patients receive oral endocrine therapy (tamoxifen citrate or letrozole) once daily and a placebo IV every 21 days. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 6 months for the first 2 years, then annually for up to 3 years.

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

Maura Dickler, MD, Protocol chair		Ph: 646-888-4560; 800-525-2225

U.S.A.
Alabama
	Mobile
	Providence Cancer Center at Providence Hospital
		Thaddeus Beeker	Ph:  251-633-1890
California
	Berkeley
	Alta Bates Summit Comprehensive Cancer Center
		Clinical Trials Office - Alta Bates Summit Comprehensive Cancer Center	Ph:  510-204-3428
	Burbank
	Providence Saint Joseph Medical Center - Burbank
		Clinical Trials Office - Providence Saint Joseph Medical Center - Burbank	Ph:  818-847-3220
	Burlingame
	Peninsula Medical Center
		David Irwin, MD	Ph:  510-204-1591
	Castro Valley
	East Bay Radiation Oncology Center
		James Feusner, MD	Ph:  510-428-3689
	Eden Medical Center
		James Feusner, MD	Ph:  510-428-3689
	Valley Medical Oncology Consultants - Castro Valley
		James Feusner, MD	Ph:  510-428-3689
	Fairfield
	North Bay Cancer Center
		Clinical Trials Office - North Bay Cancer Center	Ph:  707-429-6976
	Fremont
	Valley Medical Oncology
		James Feusner, MD	Ph:  510-428-3689
	Greenbrae
	Marin Cancer Institute at Marin General Hospital
		David Irwin, MD	Ph:  510-204-1591
	Sutter Health - Western Division Cancer Research Group
		David Irwin, MD	Ph:  510-204-1591
	Martinez
	Contra Costa Regional Medical Center
		James Feusner, MD	Ph:  510-428-3689
	Modesto
	Memorial Medical Center
		Clinical Trials Office - Memorial Medical Center	Ph:  209-572-7116
	Mountain View
	El Camino Hospital Cancer Center
		Clinical Trials Office - El Camino Hospital Cancer Center	Ph:  650-988-7623
	Oakland
	Alta Bates Summit Medical Center - Summit Campus
		Clinical Trials Office - Alta Bates Summit Medical Center - Summit Campus	Ph:  510-204-1414
	Bay Area Breast Surgeons, Incorporated
		James Feusner, MD	Ph:  510-428-3689
	CCOP - Bay Area Tumor Institute
		James Feusner, MD	Ph:  510-428-3689
	Highland General Hospital
		James Feusner, MD	Ph:  510-428-3689
	Larry G Strieff MD Medical Corporation
		James Feusner, MD	Ph:  510-428-3689
	Tom K Lee, Incorporated
		James Feusner, MD	Ph:  510-428-3689
	Pleasanton
	Valley Care Medical Center
		James Feusner, MD	Ph:  510-428-3689
	Valley Medical Oncology Consultants - Pleasanton
		James Feusner, MD	Ph:  510-428-3689
	San Francisco
	California Pacific Medical Center - California Campus
		David Irwin, MD	Ph:  510-204-1591
	San Francisco General Hospital Medical Center
		Hope Rugo, MD	Ph:  415-353-7428
	UCSF Helen Diller Family Comprehensive Cancer Center
		Clinical Trials Office - UCSF Helen Diller Family Comprehensive Cancer Center	Ph:  877-827-3222
	San Pablo
	Doctors Medical Center - San Pablo Campus
		James Feusner, MD	Ph:  510-428-3689
	Vallejo
	Sutter Solano Medical Center
		David Irwin, MD	Ph:  510-204-1591
Connecticut
	New Haven
	Yale Cancer Center
		Clinical Trials Office - Yale Cancer Center	Ph:  203-785-5702
Delaware
	Lewes
	Tunnell Cancer Center at Beebe Medical Center
		Clinical Trials Office - Tunnell Cancer Center	Ph:  302-645-3171
	Newark
	CCOP - Christiana Care Health Services
		Clinical Trial Office - CCOP - Christiana Care Health Services	Ph:  302-733-6227
District of Columbia
	Washington
	Sibley Memorial Hospital
		Frederick Smith, MD	Ph:  301-657-4588
	Walter Reed Army Medical Center
		Clinical Trials Office - Walter Reed Army Medical Center	Ph:  202-782-7840
Georgia
	Atlanta
	CCOP - Atlanta Regional
		Thomas Seay, MD, PhD	Ph:  404-851-2340
	Northside Hospital Cancer Center
		Clinical Trials Office - Northside Hospital Cancer Center	Ph:  404-303-3355
	Piedmont Hospital
		Thomas Seay, MD, PhD	Ph:  404-851-2340
	Saint Joseph's Hospital of Atlanta
		Clinical Trials Office - Saint Joseph's Hospital of Atlanta	Ph:  404-851-7115
	Austell
	WellStar Cobb Hospital
		Clinical Trials Office - WellStar Cobb Hospital	Ph:  770-793-5980
	Columbus
	John B. Amos Cancer Center
		Clinical Trials Office - John B. Amos Cancer Center	Ph:  706-660-6404
	Decatur
	Charles B. Eberhart Cancer Center at DeKalb Medical Center
		Thomas Seay, MD, PhD	Ph:  404-851-2340
	Gainesville
	Northeast Georgia Medical Center
		Richard LoCicero, MD	Ph:  770-297-5700
	Lawrenceville
	Gwinnett Medical Center
		Thomas Seay, MD, PhD	Ph:  404-851-2340
	Macon
	Medical Center of Central Georgia
		Frederick Schnell, MD, FACP	Ph:  478-743-7068
	Marietta
	Kennestone Cancer Center at Wellstar Kennestone Hospital
		Clinical Trials Office - Kennestone Cancer Center	Ph:  770-793-5980
	Riverdale
	Southern Regional Medical Center
		Clinical Trials Office - Southern Regional Medical Center	Ph:  770-991-8611
	Rome
	Harbin Clinic Cancer Center - Medical Oncology
		Thomas Seay, MD, PhD	Ph:  404-851-2340
Illinois
	Alton
	Saint Anthony's Hospital at Saint Anthony's Health Center
		Bethany Sleckman, MD	Ph:  314-251-7057
	Chicago
	Resurrection Medical Center
		Christopher Rose, MD	Ph:  847-965-3200
	Decatur
	Decatur Memorial Hospital Cancer Care Institute
		Clinical Trials Office - Decatur Memorial Hospital Cancer Care Institute	Ph:  217-876-6601
	Harvey
	Ingalls Cancer Care Center at Ingalls Memorial Hospital
		Clinical Trials Office - Ingalls Cancer Care Center at Ingalls Memorial Hospital	Ph:  708-915-6747
	Kankakee
	Provena St. Mary's Regional Cancer Center - Kankakee
		Riaz Elahi, MD	Ph:  708-873-4500
	La Grange
	La Grange Memorial Hospital
		Clinical Trials Office - La Grange Memorial Hospital	Ph:  630-856-7526
	Moline
		Costas Constantinou, MD	Ph:  563-359-9876
	Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
		Costas Constantinou, MD	Ph:  563-359-9876
	Mt. Vernon
	Good Samaritan Regional Health Center
		Bethany Sleckman, MD	Ph:  314-251-7057
	Naperville
	Hematology Oncology Consultants - Naperville
		Fariborze Barhamand, MD	Ph:  630-369-1501
	Springfield
	Regional Cancer Center at Memorial Medical Center
		Clinical Trials Office - Regional Cancer Center at Memorial Medical Center	Ph:  217-788-4233
Indiana
	Beech Grove
	St. Francis Hospital and Health Centers - Beech Grove Campus
		Howard Gross, MD	Ph:  937-832-1093
	Fort Wayne
	Fort Wayne Medical Oncology and Hematology
		Sreenivasa Nattam, MD	Ph:  260-484-8830
	Lafayette
	Clarian Arnett Cancer Care
		Thomas Jones, MD	Ph:  765-448-7500
	Richmond
	Reid Hospital & Health Care Services
		Howard Gross, MD	Ph:  937-832-1093
Iowa
	Ames
	McFarland Clinic, PC
		Clinical Trials Office - McFarland Clinic, PC	Ph:  515-239-2621
	Bettendorf
		Costas Constantinou, MD	Ph:  563-359-9876
	Hematology Oncology Associates of the Quad Cities
		Shobha Chitneni, MD, MBBS	Ph:  563-355-7733
	Clive
	Medical Oncology and Hematology Associates - West Des Moines
		Robert Behrens	Ph:  515-875-9713
	Des Moines
	CCOP - Iowa Oncology Research Association
		Robert Behrens	Ph:  515-244-7586 888-244-6061
	John Stoddard Cancer Center at Iowa Lutheran Hospital
		Clinical Trials Office - John Stoddard Cancer Center at Iowa Lutheran Hospital	Ph:  515-241-8704
	John Stoddard Cancer Center at Iowa Methodist Medical Center
		Clinical Trials Office - John Stoddard Cancer Center at Iowa Methodist Medical Center	Ph:  515-241-6727
	Medical Oncology and Hematology Associates at John Stoddard Cancer Center
		Robert Behrens	Ph:  515-282-2921
	Medical Oncology and Hematology Associates at Mercy Cancer Center
		Robert Behrens	Ph:  515-643-8740
	Mercy Cancer Center at Mercy Medical Center - Des Moines
		Robert Behrens	Ph:  515-643-8206 888-221-4849
	Iowa City
	Holden Comprehensive Cancer Center at University of Iowa
		Cancer Information Service	Ph:  800-237-1225
	Ottumwa
	McCreery Cancer Center at Ottumwa Regional
		Robert Behrens	Ph:  641-684-2946
	Sioux City
	Mercy Medical Center - Sioux City
		Donald Wender, MD, PhD	Ph:  712-252-0088
	Siouxland Hematology-Oncology Associates, LLP
		Donald Wender, MD, PhD	Ph:  712-252-0088
	St. Luke's Regional Medical Center
		Donald Wender, MD, PhD	Ph:  712-252-0088
Kansas
	Kansas City
	Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
		Clinical Trials Office - Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center	Ph:  913-588-4709
	Topeka
	Cotton-O'Neil Cancer Center
		Clinical Trials Office - Cotton-O'Neil Cancer Center	Ph:  785-270-4963
Kentucky
	Ashland
	Cancer Care at Our Lady of Bellefonte Hospital
		Clinical Trials Office - Cancer Care at Our Lady of Bellefonte Hospital	Ph:  606-833-3253
Maine
	Bangor
	CancerCare of Maine at Eastern Maine Medical Center
		Clinical Trials Office - CancerCare of Maine	Ph:  207-973-4274
Maryland
	Elkton MD
	Union Hospital Cancer Program at Union Hospital
		Stephen Grubbs, MD	Ph:  302-366-1200
	Frederick
	Frederick Memorial Hospital Regional Cancer Therapy Center
		Brian O'Connor, MD	Ph:  301-662-8477
	Hagerstown
	John R. Marsh Cancer Center at Washington County Hospital
		Michael McCormack	Ph:  301-665-4650
	Largo
	Kaiser Permanente Mid-Atlantic Medical Group-Largo Medical Facility
		Leon Hwang, MD	Ph:  301-548-5768
	Lutherville
	Kaiser Permanente - Towson
		Leon Hwang, MD	Ph:  301-548-5768
	Rockville
	Kaiser Permanente Capital Area Medical Group - Shady Grove Facility
		Leon Hwang, MD	Ph:  301-548-5768
Massachusetts
	Boston
	Beth Israel Deaconess Medical Center
		Clinical Trials Office - Beth Israel Deaconess Medical Center	Ph:  617-667-9925
	Dana-Farber/Brigham and Women's Cancer Center
		Clinical Trials Office	Ph:  617-724-5200
	Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
		Harold J. Burstein, MD, PhD	Ph:  617-632-3800
	Hyannis
	Cape Cod Hospital
		Harold J. Burstein, MD, PhD	Ph:  617-632-3800
Michigan
	Battle Creek
	Battle Creek Health System Cancer Care Center
		Martin Bury	Ph:  616-966-8000
	Big Rapids
	Mecosta County Medical Center
		Martin Bury	Ph:  231-796-8691
	Escanaba
	Green Bay Oncology, Limited - Escanaba
		Thomas Saphner, MD, FACP	Ph:  920-884-3135
	Flint
	Great Lakes Cancer Institute at McLaren Regional Medical Center
		Clinical Trials Office - Great Lakes Cancer Institute at McLaren Regional Medical Center	Ph:  810-342-4071
	Grand Rapids
	Butterworth Hospital at Spectrum Health
		Martin Bury	Ph:  616-391-2799
	CCOP - Grand Rapids
		Martin Bury	Ph:  616-391-1230
	Lacks Cancer Center at Saint Mary's Health Care
		Martin Bury	Ph:  616-752-5222
	Iron Mountain
	Dickinson County Healthcare System
		Thomas Saphner, MD, FACP	Ph:  920-884-3135
	Lansing
	Breslin Cancer Center at Ingham Regional Medical Center
		Clinical Trials Office - Breslin Cancer Center at Ingham Regional Medical Center	Ph:  517-334-2765
	Muskegon
	Mercy General Health Partners
		Martin Bury	Ph:  231-672-2000
	Traverse City
	Munson Medical Center
		Martin Bury	Ph:  231-935-6202
	Wyoming
	Metro Health Hospital
		Martin Bury	Ph:  616-252-7200
Minnesota
	Alexandria
		Donald Jurgens	Ph:  320-229-4907
	Duluth
	CCOP - Duluth
		Daniel Nikcevich, MD, PhD	Ph:  218-786-3625
	Duluth Clinic Cancer Center - Duluth
		Clinical Trials Office - Duluth Clinic Cancer Center - Duluth	Ph:  218-786-3308
	Miller - Dwan Medical Center
		Daniel Nikcevich, MD, PhD	Ph:  218-786-3625
	Mankato
	Immanuel St. Joseph's
		Glenn Harman, MD	Ph:  815-777-1536
	Saint Cloud
	CentraCare Clinic - River Campus
		Donald Jurgens	Ph:  320-229-4907
	Coborn Cancer Center
		Donald Jurgens	Ph:  320-229-4907
	Willmar
	Willmar Cancer Center at Rice Memorial Hospital
		Joseph Ryan, MD	Ph:  320-231-6359
Mississippi
	Jackson
	University of Mississippi Cancer Clinic
		Barbara Craft	Ph:  601-984-5590
	Pascagoula
	Regional Cancer Center at Singing River Hospital
		James Clarkson, MD	Ph:  228-374-6296
Missouri
	Cape Girardeau
	Saint Francis Medical Center
		Bethany Sleckman, MD	Ph:  314-251-7057
	Columbia
	Ellis Fischel Cancer Center at University of Missouri - Columbia
		Clinical Trial Office - Ellis Fischel Cancer Center	Ph:  573-882-7440
	Joplin
	Freeman Cancer Institute at Freeman Health System
		Anisa Hassan	Ph:  417-347-3066
	Saint Louis
	CCOP - St. Louis-Cape Girardeau
		Bethany Sleckman, MD	Ph:  314-251-7057
	David C. Pratt Cancer Center at St. John's Mercy
		Clinical Trials Office - David C. Pratt Cancer Center at St. John's Mercy	Ph:  314-251-6770
	Midwest Hematology Oncology Group, Incorporated
		Bethany Sleckman, MD	Ph:  314-251-7057
	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
		Michael Naughton, MD	Ph:  314-996-8872
	Springfield
	CCOP - Cancer Research for the Ozarks
		Robert Carolla	Ph:  417-269-4520
	Hulston Cancer Center at Cox Medical Center South
		Robert Carolla	Ph:  417-269-5257
	St. John's Regional Health Center
		Robert Carolla	Ph:  417-820-2000
Montana
	Billings
	Billings Clinic - Downtown
		Clinical Trials Office - Billings Clinic - Downtown	Ph:  800-996-2663
			Email: research@billingsclinic.org
	CCOP - Montana Cancer Consortium
		Benjamin Marchello, MD	Ph:  406-238-6290
	Hematology-Oncology Centers of the Northern Rockies - Billings
		Benjamin Marchello, MD	Ph:  406-238-6290
	Northern Rockies Radiation Oncology Center
		Benjamin Marchello, MD	Ph:  406-238-6290
	St. Vincent Healthcare Cancer Care Services
		Benjamin Marchello, MD	Ph:  406-238-6290
	Bozeman
	Bozeman Deaconess Cancer Center
		Benjamin Marchello, MD	Ph:  406-238-6290
	Butte
	St. James Healthcare Cancer Care
		Benjamin Marchello, MD	Ph:  406-238-6290
	Great Falls
		Benjamin Marchello, MD	Ph:  406-238-6290
	Big Sky Oncology
		Clinical Trail Office - Big Sky Oncology	Ph:  406-731-8217
	Great Falls Clinic - Main Facility
		Benjamin Marchello, MD	Ph:  406-238-6290
	Sletten Cancer Institute at Benefis Healthcare
		Contact Person	Ph:  406-731-8200 866-466-6822
	Havre
	Northern Montana Hospital
		Benjamin Marchello, MD	Ph:  406-238-6290
	Helena
	St. Peter's Hospital
		Benjamin Marchello, MD	Ph:  406-238-6290
	Kalispell
	Glacier Oncology, PLLC
		Benjamin Marchello, MD	Ph:  406-238-6290
	Kalispell Medical Oncology at KRMC
		Benjamin Marchello, MD	Ph:  406-238-6290
	Kalispell Regional Medical Center
		Benjamin Marchello, MD	Ph:  406-238-6290
	Missoula
	Community Medical Center
		Benjamin Marchello, MD	Ph:  406-238-6290
	Guardian Oncology and Center for Wellness
		Benjamin Marchello, MD	Ph:  406-238-6290
	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
		Clinical Trials Office - Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Ph:  406-329-7029
	Montana Cancer Specialists at Montana Cancer Center
		Clinical Trials Office - Montana Cancer Specialists at Montana Cancer Center	Ph:  406-238-6962
Nebraska
	Grand Island
	Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center
		Elizabeth Reed, MD	Ph:  402-559-5388
	Lincoln
	Cancer Resource Center - Lincoln
		Alan Berg, MD	Ph:  402-420-7000
	North Platte
	Callahan Cancer Center at Great Plains Regional Medical Center
		Clinical Trials Office - Callahan Cancer Center at Great Plains Regional Medical Center	Ph:  308-696-7864
	Omaha
	Alegant Health Cancer Center at Bergan Mercy Medical Center
		Clinical Trials Office - Alegant Health Cancer Center at Bergen Mercy Medical Center	Ph:  402-398-6060
	CCOP - Missouri Valley Cancer Consortium
		Gamini Soori, MD, FACP, FRCP, MBA	Ph:  402-393-3110
	Creighton University Medical Center
		Clinical Trials Office - Creighton University Medical Center	Ph:  402-280-4100
	Immanuel Medical Center
		Gamini Soori, MD, FACP, FRCP, MBA	Ph:  402-393-3110
	UNMC Eppley Cancer Center at the University of Nebraska Medical Center
		Clinical Trials Office - UNMC Eppley Cancer Center at the University of Nebraska Medical Center	Ph:  800-999-5465
Nevada
	Reno
	Renown Institute for Cancer at Renown Regional Medical Center
		Steven Schiff, MD	Ph:  775-329-0873
New Jersey
	Hackensack
	CCOP - Northern New Jersey
		David Siegel	Ph:  201-996-5834
	Voorhees
	Cancer Institute of New Jersey at Cooper - Voorhees
		Clinical Trials Office - Cancer Institute of New Jersey at Cooper University Hospital - Voorhees	Ph:  856-325-6757
New York
	Bronx
	Our Lady of Mercy Medical Center Comprehensive Cancer Center
		Janice Dutcher	Ph:  718-304-7200
	Glens Falls
	Adirondack Cancer Care - Glens Falls
		Mark Hoffman, MD	Ph:  518-761-0000
	New York
	Memorial Sloan-Kettering Cancer Center
		Maura Dickler, MD	Ph:  646-888-4560
	New York Weill Cornell Cancer Center at Cornell University
		Clinical Trials Office - New York Weill Cornell Cancer Center at Cornell University	Ph:  212-746-1848
	St. Vincent's Comprehensive Cancer Center - Manhattan
		Clinical Trials Office - St. Vincent's Comprehensive Cancer Center - Manhattan	Ph:  212-367-1729
	Rochester
	Highland Hospital of Rochester
		Richard Fisher, MD	Ph:  585-275-0842
	Interlakes Oncology/Hematology PC
		Richard Fisher, MD	Ph:  585-275-0842
	James P. Wilmot Cancer Center at University of Rochester Medical Center
		Richard Fisher, MD	Ph:  585-275-0842
	Staten Island
	Nalitt Cancer Institute at Staten Island University Hospital
		Marcel Odaimi	Ph:  718-226-6400
North Carolina
	Asheboro
	Randolph Hospital
		Clinical Trails Office - Randolph Hospital	Ph:  336-832-0821
	Charlotte
	Blumenthal Cancer Center at Carolinas Medical Center
		Clinical Trials Office - Blumenthal Cancer Center at Carolinas Medical Center	Ph:  704-355-2884
	Goldsboro
	Wayne Memorial Hospital, Incorporated
		James Atkins, MD	Ph:  919-580-0000
	Greensboro
	Moses Cone Regional Cancer Center at Wesley Long Community Hospital
		Clinical Trials Office - Moses Cone Regional Cancer Center at Wesley Long Community Hospital	Ph:  336-621-8374
	Kinston
	Kinston Medical Specialists
		Peter Watson, MD	Ph:  252-559-2200ext.201
	Reidsville
	Annie Penn Cancer Center
		Clinical Trials Office - Annie Penn Cancer Center	Ph:  336-621-8374
North Dakota
	Bismarck
	Bismarck Cancer Center
		Edward Wos, DO	Ph:  701-323-5741
	Medcenter One Hospital Cancer Care Center
		Edward Wos, DO	Ph:  701-323-5741
	Mid Dakota Clinic, PC
		Clinical Trials Office - Mid Dakota Clinic, PC	Ph:  701-530-6950
	St. Alexius Medical Center Cancer Center
		Clinical Trials Office - St. Alexius Medical Center Cancer Center	Ph:  701-530-6950
Ohio
	Bellefontaine
	Mary Rutan Hospital
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Canton
	Aultman Cancer Center at Aultman Hospital
		Clinical Trials Office - Aultman Cancer Center at Aultman Hospital	Ph:  330-363-6891
	Chillicothe
	Adena Regional Medical Center
		Clinical Trials Office - Adena Regional Medical Center	Ph:  877-779-7585
	Cleveland
	MetroHealth Cancer Care Center at MetroHealth Medical Center
		Bruce Averbook, MD, FACS	Ph:  216-778-4795
	Columbus
	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
		Ohio State University Cancer Clinical Trial Matching Service	Ph:  866-627-7616
			Email: osu@emergingmed.com
	CCOP - Columbus
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Doctors Hospital at Ohio Health
		Clinical Trials Office - Doctors Hospital at Ohio Health	Ph:  614-566-3275
	Grant Medical Center Cancer Care
		Clinical Trials Office - Grant Medical Center Cancer Care	Ph:  614-566-4475
	Mount Carmel Health - West Hospital
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Riverside Methodist Hospital Cancer Care
		Clinical Trials Office - Riverside Methodist Hospital Cancer Care	Ph:  614-566-4475
	Dayton
	CCOP - Dayton
		Howard Gross, MD	Ph:  937-832-1093
	David L. Rike Cancer Center at Miami Valley Hospital
		Clinical Trials Office - David L. Rike Cancer Center at Miami Valley Hospital	Ph:  937-208-2079
	Good Samaritan Hospital
		Howard Gross, MD	Ph:  937-832-1093
	Grandview Hospital
		Howard Gross, MD	Ph:  937-832-1093
	Samaritan North Cancer Care Center
		Howard Gross, MD	Ph:  937-832-1093
	Delaware
	Grady Memorial Hospital
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Findlay
	Blanchard Valley Medical Associates
		Howard Gross, MD	Ph:  937-832-1093
	Franklin
	Middletown Regional Hospital
		Howard Gross, MD	Ph:  937-832-1093
	Greenville
	Wayne Hospital
		Howard Gross, MD	Ph:  937-832-1093
	Kettering
	Charles F. Kettering Memorial Hospital
		Clinical Trials Office - Charles F. Kettering Memorial Hospital	Ph:  937-298-3399 ext. 57556
	Lancaster
	Fairfield Medical Center
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Lima
	St. Rita's Medical Center
		Clinical Trials Office - St. Rita's Medical Center	Ph:  419-226-9617
	Marietta
	Strecker Cancer Center at Marietta Memorial Hospital
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Newark
	Licking Memorial Cancer Care Program at Licking Memorial Hospital
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Springfield
	Community Hospital of Springfield and Clark County
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Mercy Medical Center
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Troy
	UVMC Cancer Care Center at Upper Valley Medical Center
		Clinical Trials Office - UVMC Cancer Care Center at Upper Valley Medical Center	Ph:  937-440-4842
	Westerville
	Mount Carmel St. Ann's Cancer Center
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Wilmington
	Clinton Memorial Hospital
		Howard Gross, MD	Ph:  937-832-1093
	Xenia
	Ruth G. McMillan Cancer Center at Greene Memorial Hospital
		Howard Gross, MD	Ph:  937-832-1093
	Zanesville
	Genesis - Good Samaritan Hospital
		Clinical Trials Office - Genesis - Good Samaritan Hospital	Ph:  740-454-5232
Oregon
	Bend
	St. Charles Medical Center - Bend
		Robert Boone, MD	Ph:  541-317-4298
	Milwaukie
	Providence Milwaukie Hospital
		Janet Ruzich	Ph:  503-513-8300
	Portland
	Adventist Medical Center
		Janet Ruzich	Ph:  503-257-2500
	CCOP - Columbia River Oncology Program
		Janet Ruzich	Ph:  503-216-6260
	Kaiser Permanente Health Care - Portland
		Nagendra Tirumali, MD	Ph:  503-331-6500
	Providence Cancer Center at Providence Portland Medical Center
		Clinical Trials Office - Providence Cancer Center at Providence Portland Medical Center	Ph:  503-215-6412
	Providence St. Vincent Medical Center
		Clinical Trials Office - Providence St. Vincent Medical Center	Ph:  503-215-6412
Pennsylvania
	Abington
	Rosenfeld Cancer Center at Abington Memorial Hospital
		Clinical Trials Office - Rosenfeld Cancer Center at Abington Memorial Hospital	Ph:  215-481-2402
	Bryn Mawr
	Bryn Mawr Hospital
		Clinical Trials Office - Bryn Mawr Hospital	Ph:  610-645-2680
	Doylestown
	Doylestown Hospital Cancer Center
		Mitchell Alden, DO	Ph:  215-345-8444
	Paoli
	Cancer Center of Paoli Memorial Hospital
		Clinical Trials Office - Cancer Center of Paoli Memorial Hospital	Ph:  610-648-1637
	Pittsburgh
	Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
		John Lister	Ph:  412-578-5000
	Reading
	McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
		Clinical Trials Office - McGlinn Family Regional Cancer Center	Ph:  610-988-9323
	Scranton
	Hematology and Oncology Associates of Northeastern Pennsylvania
		Martin Hyzinski, MD	Ph:  570-558-3020
	Mercy Hospital Cancer Center - Scranton
		Martin Hyzinski, MD	Ph:  570-558-3020
	West Chester
	Chester County Hospital
		Clinical Trials Office - Chester County Hospital	Ph:  610-431-5297
	Wynnewood
	CCOP - Main Line Health
		Paul Gilman, MD	Ph:  610-645-2000
	Lankenau Cancer Center at Lankenau Hospital
		Paul Gilman, MD	Ph:  610-645-2000
Rhode Island
	Cranston
	Hematology and Oncology Associates of Rhode Island
		Adam Olszewski	Ph:  401-943-4660
	Pawtucket
	Memorial Hospital of Rhode Island
		Humera Khurshid	Ph:  401-729-2000
	Warwick
	Kent County Memorial Hospital
		Clinical Trials Office - Kent County Memorial Hospital	Ph:  401-737-7010 ext. 1864
South Carolina
	Florence
	McLeod Regional Medical Center
		Clinical Trials Office - McLeod Regional Medical Center	Ph:  843-679-7256
South Dakota
	Rapid City
	Rapid City Regional Hospital
		Richard Tenglin	Ph:  605-719-2360
	Sioux Falls
	Avera Cancer Institute
		Loren Tschetter, MD	Ph:  605-328-8000
	Medical X-Ray Center, PC
		Loren Tschetter, MD	Ph:  605-328-8000
	Sanford Cancer Center at Sanford USD Medical Center
		Clinical Trials Office - Sanford Cancer Center	Ph:  605-328-1367
Tennessee
	Chattanooga
	Erlanger Cancer Center at Erlanger Hospital - Baroness
		Clinical Trials Office - Erlanger Cancer Center	Ph:  423-778-6947
Virginia
	Danville
	Danville Regional Medical Center
		Clinical Trials Office - Danville Regional Medical Center	Ph:  434-799-3753
	Fairfax
	Kaiser Permanente Medical Center - Fair Oaks
		Leon Hwang, MD	Ph:  301-548-5768
Washington
	Spokane
	Rockwood Clinic Cancer Treatment Center
		Clinical Trials Office - Rockwood Clinic Cancer Treatment Center	Ph:  509-838-2531 ext. 6880
	Vancouver
	Southwest Washington Medical Center Cancer Center
		Janet Ruzich	Ph:  360-514-2174
West Virginia
	Charleston
	West Virginia University Health Sciences Center - Charleston
		Steven Jubelirer, MD	Ph:  304-388-8380
Wisconsin
	Chippewa Falls
	Marshfield Clinic - Chippewa Center
		Matthias Weiss, MD	Ph:  715-358-1266
	Eau Claire
	Marshfield Clinic Cancer Care at Regional Cancer Center
		Matthias Weiss, MD	Ph:  715-358-1266
	Elkhorn
	Vince Lombardi Cancer Center at Aurora Lakeland Medical Center - Elkhorn
		Rossana Madamba	Ph:  262-741-2671 800-252-2990
	Green Bay
	Green Bay Oncology, Limited at St. Mary's Hospital
		Thomas Saphner, MD, FACP	Ph:  920-884-3135
	Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
		Thomas Saphner, MD, FACP	Ph:  920-884-3135
	St. Mary's Hospital Medical Center - Green Bay
		Thomas Saphner, MD, FACP	Ph:  920-884-3135
	St. Vincent Hospital Regional Cancer Center
		Clinical Trials Office - St. Vincent Hospital Regional Cancer Center	Ph:  920-433-8889
	Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
		Clinical Trials Office - Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center	Ph:  414-649-5717
	Janesville
	Mercy Regional Cancer Center
		Robert Delaune, MD	Ph:  952-993-1517
	La Crosse
	Gundersen Lutheran Center for Cancer and Blood
		Clinical Trials Office - Gundersen Lutheran Cancer Center	Ph:  608-775-2385
			Email: cancerctr@gundluth.org
	Marinette
	Bay Area Cancer Care Center at Bay Area Medical Center
		Thomas Saphner, MD, FACP	Ph:  920-884-3135
	Vince Lombardi Cancer Clinic - Marinette
		Dhimant Patel, MD	Ph:  920-288-4180
	Marshfield
	Marshfield Clinic - Marshfield Center
		Clinical Trials Office - Marshfield Clinic - Marshfield Center	Ph:  800-782-1581 ext. 94457
	Saint Joseph's Hospital
		Matthias Weiss, MD	Ph:  715-358-1266
	Milwaukee
	Aurora Sinai Medical Center
		Clinical Trials Office - Aurora Sinai Medical Center	Ph:  414-649-5717
	Minocqua
	Marshfield Clinic - Lakeland Center
		Matthias Weiss, MD	Ph:  715-358-1266
	Oconomowoc
	Regional Cancer Center at Oconomowoc Memorial Hospital
		Clinical Trials Office - Regional Cancer Center at Oconomowoc Memorial Hospital	Ph:  262-928-7878
	Oconto Falls
	Green Bay Oncology, Limited - Oconto Falls
		Thomas Saphner, MD, FACP	Ph:  920-884-3135
	Oshkosh
	Vince Lombardi Cancer Clinic - Oshkosh
		Zahid Dar	Ph:  920-303-8700
	Rhinelander
	Ministry Medical Group at Saint Mary's Hospital
		Matthias Weiss, MD	Ph:  715-358-1266
	Rice Lake
	Marshfield Clinic - Indianhead Center
		Matthias Weiss, MD	Ph:  715-358-1266
	Sheboygan
	Vince Lombardi Cancer Clinic - Sheboygan
		Clinical Trials Office - Vince Lombardi Cancer Clinic - Sheboygan	Ph:  414-649-7200
	Sturgeon Bay
	Green Bay Oncology, Limited - Sturgeon Bay
		Thomas Saphner, MD, FACP	Ph:  920-884-3135
	Waukesha
	Waukesha Memorial Hospital Regional Cancer Center
		Clinical Trials Office - Waukesha Memorial Hospital Regional Cancer Center	Ph:  262-928-7632
	Wausau
	University of Wisconcin Cancer Center at Aspirus Wausau Hospital
		Clinical Trials Office - University of Wisconsin Cancer Center	Ph:  608-262-5223
	West Allis
	Aurora Women's Pavilion of West Allis Memorial Hospital
		Magdalena Flejsierowicz	Ph:  414-978-3000
	Weston
	Marshfield Clinic - Weston Center
		Matthias Weiss, MD	Ph:  715-358-1266
	Wisconsin Rapids
	Marshfield Clinic - Wisconsin Rapids Center
		Matthias Weiss, MD	Ph:  715-358-1266
	Riverview UW Cancer Center at Riverview Hospital
		Ron Kirschling, MD, FACP	Ph:  715-421-7442
Wyoming
	Casper
	Rocky Mountain Oncology
		Benjamin Marchello, MD	Ph:  406-238-6290
	Sheridan
	Welch Cancer Center at Sheridan Memorial Hospital
		Benjamin Marchello, MD	Ph:  406-238-6290