Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact 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, CALGB-40503, NCT00601900

Special Category: CTSU 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 To compare the time to treatment failure, defined as the interval from randomization until progression, toxicity, withdrawn consent, or going onto nonprotocol therapy, in patients receiving letrozole with and without bevacizumab.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
		Paul Schwarzenberger, MD	Ph:  251-435-5892
California
	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
	Fremont
	Valley Medical Oncology
		James Feusner, MD	Ph:  510-428-3689
	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 Pablo
	Doctors Medical Center - San Pablo Campus
		James Feusner, MD	Ph:  510-428-3689
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
Georgia
	Columbus
	John B. Amos Cancer Center
		Clinical Trials Office - John B. Amos Cancer Center	Ph:  706-660-6404
Illinois
	Alton
	Saint Anthony's Hospital at Saint Anthony's Health Center
		Bethany Sleckman, MD	Ph:  314-251-6573
	Aurora
	Rush-Copley Cancer Care Center
		Kendrith Rowland, MD	Ph:  217-383-3010
	Decatur
	Decatur Memorial Hospital Cancer Care Institute
		Clinical Trials Office - Decatur Memorial Hospital Cancer Care Institute	Ph:  217-876-6601
	La Grange
	La Grange Memorial Hospital
		Clinical Trials Office - La Grange Memorial Hospital	Ph:  630-856-7526
	Moline
		Costas Constantinou, MD
		Costas Constantinou, MD	Ph:  916-734-2781
		Costas Constantinou, MD	Ph:  309-779-4265
		Costas Constantinou, MD	Ph:  309-779-5090
	Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
		Costas Constantinou, MD	Ph:  309-779-5092
	Mt. Vernon
	Good Samaritan Regional Health Center
		Bethany Sleckman, MD	Ph:  314-251-6573
	Springfield
	Regional Cancer Center at Memorial Medical Center
		Clinical Trials Office - Regional Cancer Center at Memorial Medical Center	Ph:  217-788-4233
	Urbana
	Carle Cancer Center at Carle Foundation Hospital
		Clinical Trials Office - Carle Cancer Center	Ph:  800-446-5532
	CCOP - Carle Cancer Center
		Clinical Trials Office - CCOP - Carle Cancer Center	Ph:  800-446-5532
Indiana
	Beech Grove
	St. Francis Hospital and Health Centers - Beech Grove Campus
		Howard Gross, MD	Ph:  317-787-3311
	Fort Wayne
	Fort Wayne Medical Oncology and Hematology
		Sreenivasa Nattam, MD	Ph:  260-484-8830 800-852-2333
	Michigan City
	Saint Anthony Memorial Health Centers
		Kendrith Rowland, MD	Ph:  217-383-3010
	Richmond
	Reid Hospital & Health Care Services
		Howard Gross, MD	Ph:  765-983-3000
Iowa
	Ames
	McFarland Clinic, PC
		Clinical Trials Office - McFarland Clinic, PC	Ph:  515-239-2621
	Bettendorf
		Costas Constantinou, MD	Ph:  563-421-1960
	Des Moines
	CCOP - Iowa Oncology Research Association
		Roscoe Morton, MD, FACP	Ph:  515-244-7586
	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
		Roscoe Morton, MD, FACP	Ph:  515-244-7586
	Medical Oncology and Hematology Associates at Mercy Cancer Center
		Roscoe Morton, MD, FACP	Ph:  515-244-7586
	Mercy Cancer Center at Mercy Medical Center - Des Moines
		Roscoe Morton, MD, FACP	Ph:  515-244-7586
	Ottumwa
	McCreery Cancer Center at Ottumwa Regional
		Roscoe Morton, MD, FACP	Ph:  515-244-7586
	Sioux City
	Mercy Medical Center - Sioux City
		Donald Wender, MD, PhD	Ph:  712-252-9326
	Siouxland Hematology-Oncology Associates, LLP
		Donald Wender, MD, PhD	Ph:  712-252-9326
	St. Luke's Regional Medical Center
		Donald Wender, MD, PhD	Ph:  712-252-9326
Maryland
	Elkton MD
	Union Hospital Cancer Program at Union Hospital
		Stephen Grubbs, MD	Ph:  410-398-4000
	Frederick
	Frederick Memorial Hospital Regional Cancer Therapy Center
		Brian O'Connor, MD	Ph:  301-662-8477
Michigan
	Big Rapids
	Mecosta County Medical Center
		Marianne Lange, MD	Ph:  231-796-8691
	Escanaba
	Green Bay Oncology, Limited - Escanaba
		Thomas Saphner, MD, FACP	Ph:  800-432-6049
	Grand Rapids
	Butterworth Hospital at Spectrum Health
		Marianne Lange, MD	Ph:  616-391-2799
	CCOP - Grand Rapids
		Marianne Lange, MD	Ph:  616-391-1230
	Lacks Cancer Center at Saint Mary's Health Care
		Marianne Lange, MD	Ph:  616-752-5222
	Iron Mountain
	Dickinson County Healthcare System
		Thomas Saphner, MD, FACP	Ph:  906-774-1313
	Kalamazoo
	Borgess Medical Center
		Raymond Lord, MD	Ph:  269-373-7488
	Bronson Methodist Hospital
		Raymond Lord, MD	Ph:  269-373-7488
	West Michigan Cancer Center
		Clinical Trials Office - West Michigan Cancer Center	Ph:  269-373-7458
	Muskegon
	Hackley Hospital
		Marianne Lange, MD	Ph:  231-726-3511
	Traverse City
	Munson Medical Center
		Marianne Lange, MD	Ph:  231-935-6202
	Wyoming
	Metro Health Hospital
		Marianne Lange, MD	Ph:  616-252-7200
Minnesota
	Mankato
	Immanuel St. Joseph's
		Glenn Harman, MD	Ph:  507-625-4031 800-327-3721
Missouri
	Cape Girardeau
	Saint Francis Medical Center
		Bethany Sleckman, MD	Ph:  314-251-6573
	Columbia
	Ellis Fischel Cancer Center at University of Missouri - Columbia
		Clinical Trial Office - Ellis Fischel Cancer Center	Ph:  573-882-4894
	Gape Girardeau
	Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
		Bethany Sleckman, MD	Ph:  314-251-6573
	Saint Louis
	CCOP - St. Louis-Cape Girardeau
		Bethany Sleckman, MD	Ph:  314-251-6573
	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:  314-251-6573
	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
		Michael Naughton, MD	Ph:  314-747-7222 800-600-3606
	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
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:  406-259-2245 800-361-3239
	Hematology-Oncology Centers of the Northern Rockies - Billings
		Benjamin Marchello, MD	Ph:  406-238-6290 800-648-6274
	Northern Rockies Radiation Oncology Center
		Benjamin Marchello, MD	Ph:  406-248-2212 800-358-8818
	St. Vincent Healthcare Cancer Care Services
		Benjamin Marchello, MD	Ph:  406-657-7000
	Bozeman
	Bozeman Deaconess Cancer Center
		Benjamin Marchello, MD	Ph:  406-585-5070
	Butte
	St. James Healthcare Cancer Care
		Benjamin Marchello, MD	Ph:  406-723-2500
	Great Falls
		Benjamin Marchello, MD
	Big Sky Oncology
		Clinical Trail Office - Big Sky Oncology	Ph:  406-731-8217
	Great Falls Clinic - Main Facility
		Benjamin Marchello, MD	Ph:  406-454-2171 800-421-1649
	Sletten Cancer Institute at Benefis Healthcare
		Contact Person	Ph:  406-731-8200 866-466-6822
	Havre
	Northern Montana Hospital
		Benjamin Marchello, MD	Ph:  406-265-2211 800-352-5097
	Helena
	St. Peter's Hospital
		Benjamin Marchello, MD	Ph:  406-442-2480
	Kalispell
	Glacier Oncology, PLLC
		Benjamin Marchello, MD	Ph:  406-752-7600
	Kalispell Medical Oncology at KRMC
		Benjamin Marchello, MD	Ph:  406-752-8900
	Kalispell Regional Medical Center
		Benjamin Marchello, MD	Ph:  406-752-5111
	Missoula
	Community Medical Center
		Benjamin Marchello, MD	Ph:  406-728-4100
	Guardian Oncology and Center for Wellness
		Benjamin Marchello, MD	Ph:  406-721-1118
	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
	Lincoln
	Cancer Resource Center - Lincoln
		Alan Berg, MD	Ph:  402-420-7000
	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
Nevada
	Reno
	Renown Institute for Cancer at Renown Regional Medical Center
		Steven Schiff, MD	Ph:  775-329-0873
New Jersey
	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
	East Syracuse
	CCOP - Hematology-Oncology Associates of Central New York
		Jeffrey Kirshner, MD	Ph:  315-472-7504
	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:  212-639-2000 800-525-2225
	Ralph Lauren Center for Cancer Care and Prevention
		Maura Dickler, MD	Ph:  212-987-1777
North Carolina
	Goldsboro
	Wayne Memorial Hospital, Incorporated
		James Atkins, MD	Ph:  919-580-0000
	Kinston
	Kinston Medical Specialists
		Peter Watson, MD	Ph:  252-559-2200 ext. 201
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
	Columbus
	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
		Clinical Trials Office - OSU Comprehensive Cancer Center	Ph:  614-293-4976
			Email: osu@emergingmed.com
	Dayton
	CCOP - Dayton
		Howard Gross, MD	Ph:  937-395-8678
	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:  937-278-2612
	Grandview Hospital
		Howard Gross, MD	Ph:  937-226-3200
	Samaritan North Cancer Care Center
		Howard Gross, MD	Ph:  937-279-5800 800-616-6784
	Veterans Affairs Medical Center - Dayton
		Howard Gross, MD	Ph:  937-268-6511
	Findlay
	Blanchard Valley Medical Associates
		Howard Gross, MD	Ph:  419-424-0380
	Franklin
	Middletown Regional Hospital
		Howard Gross, MD	Ph:  513-424-2111
	Kettering
	Charles F. Kettering Memorial Hospital
		Clinical Trials Office - Charles F. Kettering Memorial Hospital	Ph:  937-298-3399 ext. 57556
	Lima
	St. Rita's Medical Center
		Clinical Trials Office - St. Rita's Medical Center	Ph:  419-226-9617
	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
	Wilmington
	Clinton Memorial Hospital
		Howard Gross, MD	Ph:  937-382-6611
	Xenia
	Ruth G. McMillan Cancer Center at Greene Memorial Hospital
		Howard Gross, MD	Ph:  937-352-2140
Pennsylvania
	Pittsburgh
	Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
		John Lister	Ph:  412-578-5000
	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
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
Virginia
	Danville
	Danville Regional Medical Center
		Clinical Trials Office - Danville Regional Medical Center	Ph:  434-799-3753
West Virginia
	Wheeling
	Schiffler Cancer Center at Wheeling Hospital
		Thomas Przybysz, MD	Ph:  304-243-3490
Wisconsin
	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:  920-432-6049
	St. Mary's Hospital Medical Center - Green Bay
		Thomas Saphner, MD, FACP	Ph:  920-498-4200
	St. Vincent Hospital Regional Cancer Center
		Clinical Trials Office - St. Vincent Hospital Regional Cancer Center	Ph:  920-433-8889
	La Crosse
	Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
		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:  715-735-6523 888-788-2070
	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:  920-846-3444 800-432-6049
	Sturgeon Bay
	Green Bay Oncology, Limited - Sturgeon Bay
		Thomas Saphner, MD, FACP	Ph:  800-432-6049
	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
Wyoming
	Sheridan
	Welch Cancer Center at Sheridan Memorial Hospital
		Benjamin Marchello, MD	Ph:  307-674-6022

Registry Information
Official Title		Endocrine Therapy in Combination with Anti-VEGF Therapy: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Endocrine Therapy Alone or Endocrine Therapy Plus Bevacizumab (NSC 704865; IND 7921) for Women with Hormone Receptor-Positive Advanced Breast Cancer
Trial Start Date		2008-05-15
Trial Completion Date		2009-02-01 (estimated)
Registered in ClinicalTrials.gov		NCT00601900
Date Submitted to PDQ		2008-01-04
Information Last Verified		2008-10-05
NCI Grant/Contract Number		CA31946