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

Alternate Title

Treatment Decision Making Based on Blood Levels of Tumor Cells in Women With Metastatic Breast Cancer Receiving Chemotherapy

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Diagnostic, Treatment	Active	Not specified	NCI	SWOG-S0500 S0500, CALGB-SWOG-S0500, NCT00382018

Special Category: CTSU trial, NCI Web site featured trial

Objectives

Primary

1. Determine whether women with metastatic breast cancer and elevated circulating tumor cells (CTCs) (≥ 5 per 7.5 mL of whole blood) after 3 weeks of first-line chemotherapy derive increased overall survival from changing to an alternative chemotherapy regimen at the next course rather than waiting for clinical evidence of progressive disease before changing to an alternative chemotherapy regimen.
2. Determine whether these patients derive increased progression-free survival (PFS) from changing to an alternative chemotherapy regimen at the next course rather than waiting for clinical evidence of progressive disease before changing to an alternative chemotherapy regimen.
3. Confirm previous findings that patients with < 5 CTCs per 7.5 mL of whole blood on initial screening have longer median OS and PFS than patients with ≥ 5 CTCs per 7.5 mL of whole blood.
4. Determine the prognostic value of sequentially collected CTC values in these patients.
5. Compare toxicity between patients with and without elevated CTCs after 3 weeks of first-line chemotherapy AND between the two randomized treatment arms.

Secondary

1. Compare the prognostic and predictive value of CTC number vs breast cancer tumor markers, including CA 15-3 and carcinoembryonic antigen.
2. Create a serum specimen bank for future biologic investigation.

Entry Criteria

Disease Characteristics:

• Histologically confirmed breast cancer
  • Clinical evidence of metastatic disease (stage IV disease)
  • Newly metastatic disease OR progressive metastatic disease while on hormonal therapy
• Meets 1 of the following criteria:
  • Measurable disease
  • Bone-only disease*

   [Note: *Patients with nonmeasurable disease that does not include bone are not eligible]

• HER-2 status determined by immunohistochemistry (IHC) or fluorescent in situ hybridization (FISH) assay
  • HER-2 positivity is defined as IHC 3+ or FISH+
  • If IHC is indeterminate (2+), FISH must be performed to classify disease
• Planning to undergo first-line chemotherapy for metastatic disease
• Patients with brain metastases must have stable disease for > 90 days after completion of prior radiotherapy to the brain
• No leptomeningeal disease
• Hormone receptor status not specified

Prior/Concurrent Therapy:

• See Disease Characteristics
• Prior hormonal therapy, bisphosphonate therapy, trastuzumab (Herceptin®), and/or bevacizumab for metastatic disease allowed
  • Any number of exogenous hormonal therapies for metatstatic disease and/or as adjuvant therapy allowed
• At least 1 year since prior adjuvant chemotherapy
• At least 2 weeks since prior minor surgery and recovered
• At least 4 weeks since prior major surgery and recovered
• No prior chemotherapy for metastatic disease
• Concurrent hormonal therapy and/or bisphosphonate therapy allowed
• Concurrent trastuzumab and/or bevacizumab allowed

Patient Characteristics:

• Female
• Menopausal status not specified
• Zubrod performance status 0-2
• Not pregnant or nursing
• Negative pregnancy test
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or stage I or II cancer currently in complete remission

Expected Enrollment

A total of 500 patients will be accrued for this study.

Outcomes

Overall survival
Progression-free survival
Prognostic value of sequentially collected circulating tumor cell (CTC) values
Toxicity

Correlation of CTC levels with breast cancer tumor markers

Outline

This is a partially blinded, partially randomized, multicenter study. Patients are assigned to 1 of 3 groups based on circulating tumor cells (CTCs) after 1 course of chemotherapy.

All patients undergo blood collection before their first dose of first-line chemotherapy* to determine baseline CTC count. Patients with < 5 CTCs at baseline are assigned to group I. Patients with ≥ 5 CTCs at baseline undergo a second blood draw on day 22 (after completion of 1 course of chemotherapy). Patients with < 5 CTCs after completing 1 course of chemotherapy are assigned to group 2. Patients with ≥ 5 CTCs after completion of 1 course of chemotherapy are assigned to group 3.

 [Note: *Chemotherapy may be initiated while waiting for the baseline CTC result.]

• Group 1 (low risk of early progression): Patients continue to receive regular treatment without change at the discretion of the physician. Patients are eligible for other first-line chemotherapy trials. No further blood is collected.
• Group 2 (moderate risk of early progression): Patients continue to receive their current chemotherapy regimen without change.
• Group 3 (high risk of early progression): Patients are stratified according to HER-2 status (positive vs negative) and disease type (bone-only vs measurable disease). Patients are randomized to 1 of 2 treatment arms.
  • Arm I: Patients continue with their current chemotherapy regimen without change.
  • Arm II: Patients switch to a different chemotherapy regimen. Selection of a new chemotherapy regimen is made by the patient's doctor.

    Patients receiving hormonal therapy or biologic therapy and chemotherapy continue to receive the hormonal or biologic therapy unchanged regardless of CTC level.

In groups 2 and 3, blood is collected periodically during chemotherapy and then at the completion of chemotherapy. Samples are examined for CTCs via the CellSearch™ blood test. Blood is also tested for CA 15-3 and carcinoembryonic antigen (CEA).

After completion of study therapy, patients are followed for up to 5 years.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Jeffrey Smerage, MD, PhD, Study coordinator		Ph: 734-936-0453; 800-865-1125 Email: smerage@umich.edu
Daniel Hayes, MD, Study coordinator		Ph: 734-615-6725; 800-865-1125 Email: hayesdf@umich.edu

Cancer and Leukemia Group B

Eric Winer, MD, Study coordinator		Ph: 617-632-3800; 866-790-4500

U.S.A.
Alabama
	Anniston
	Regional Medical Center
		Pramod Vadlamani	Ph:  256-235-5877
Alaska
	Anchorage
	Providence Cancer Center
		Clinical Trials Office - Providence Cancer Center	Ph:  907-261-3109
California
	Glendale
	Glendale Memorial Hospital Comprehensive Cancer Center
		Clinical Trials Office - Glendale Memorial Hospital Comprehensive Cancer Center	Ph:  818-409-7653
	Greenbrae
	California Cancer Care, Incorporated - Greenbrae
		Peter Eisenberg, MD	Ph:  415-925-5000
	Loma Linda
	Loma Linda University Cancer Institute at Loma Linda University Medical Center
		Clinical Trials Office - Loma Linda University Cancer Institute	Ph:  909-558-3375
	Los Angeles
	USC/Norris Comprehensive Cancer Center and Hospital
		Clinical Trials Office - USC/Norris Comprehensive Cancer Center and Hospital	Ph:  323-865-0451
	Marysville
	Tibotec Therapeutics - Division of Ortho Biotech Products, LP
		Helen Chew, MD	Ph:  916-734-3771
	Mountain View
	Camino Medical Group - Treatment Center
		Peter Yu, MD	Ph:  408-524-5814
	Palm Springs
	Desert Regional Medical Center Comprehensive Cancer Center
		Clinical Trials Office - Desert Regional Medical Center Comprehensive Cancer Center	Ph:  760-416-4730
	Palo Alto
	Palo Alto Medical Foundation
		David Leibowitz	Ph:  650-321-4121
	Rancho Mirage
	Lucy Curci Cancer Center at Eisenhower Memorial Hospital and Medical Center
		Luke Dreisbach	Ph:  760-674-3600
	Sacramento
	University of California Davis Cancer Center
		Clinical Trials Office - University of California Davis Cancer Center	Ph:  916-734-3089
	Salinas
	Salinas Valley Memorial Hospital
		Shehzad Aziz, MD	Ph:  831-755-1701
	San Francisco
	San Francisco General Hospital Medical Center
		Judith Luce, MD	Ph:  415-476-4082ext.414
Hawaii
	Honolulu
	Tripler Army Medical Center
		Jeffrey Berenberg, MD	Ph:  808-433-4089
Idaho
	Coeur d'Alene
	Kootenai Cancer Center - Coeur d'Alene
		Clinical Trials Office - North Idaho Cancer Center	Ph:  208-666-3764
Illinois
	Chicago
	Creticos Cancer Center at Advocate Illinois Masonic Medical Center
		Clinical Trials Office - Creticos Cancer Center at Advocate Illinois Masonic Medical Center	Ph:  773-296-5360
	University of Chicago Cancer Research Center
		Clinical Trials Office - University of Chicago Cancer Research Center	Ph:  773-834-7424
	Elmhurst
	Elmhurst Memorial Hospital
		Robert Eisner	Ph:  630-833-1400
	Harvey
	Ingalls Cancer Care Center at Ingalls Memorial Hospital
		Clinical Trials Office - Ingalls Cancer Care Center at Ingalls Memorial Hospital	Ph:  708-915-6747
	Normal
	Mid-Illinois Hematology-Oncology Associates at Community Cancer Center
		John Migas, MD	Ph:  309-451-2207
	Rockford
	Swedish-American Regional Cancer Center
		Clinical Trials Office - Swedish-American Regional Cancer Center	Ph:  815-489-4413
Indiana
	Elkhart
	Elkhart General Hospital
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	Indianapolis
	Community Regional Cancer Care at Community Hospital East
		Shivaji Gunale	Ph:  317-355-5347
	Community Regional Cancer Care at Community Hospital North
		Shivaji Gunale	Ph:  317-621-4300
	St. Vincent Indianapolis Hospital
		Clinical Trials Office - St. Vincent Indianapolis Hospital	Ph:  317-338-2194
	Kokomo
	Howard Community Hospital
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	La Porte
	Center for Cancer Therapy at LaPorte Hospital and Health Services
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	South Bend
	CCOP - Northern Indiana CR Consortium
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	Memorial Hospital of South Bend
		Clinical Trials Office - Memorial Hospital of South Bend	Ph:  800-284-7370
	Saint Joseph Regional Medical Center
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	South Bend Clinic
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
Iowa
	Ames
	McFarland Clinic, PC
		Clinical Trials Office - McFarland Clinic, PC	Ph:  515-239-2621
	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
	Waterloo
	Covenant Cancer Treatment Center
		Clinical Trials Office - Covenant Cancer Treatment Center	Ph:  319-272-2070
Kansas
	Chanute
	Cancer Center of Kansas, PA - Chanute
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Dodge City
	Cancer Center of Kansas, PA - Dodge City
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	El Dorado
	Cancer Center of Kansas, PA - El Dorado
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Independence
	Cancer Center of Kansas-Independence
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Kingman
	Cancer Center of Kansas, PA - Kingman
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Lawrence
	Lawrence Memorial Hospital
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Liberal
	Southwest Medical Center
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Newton
	Cancer Center of Kansas, PA - Newton
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Parsons
	Cancer Center of Kansas, PA - Parsons
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Pratt
	Cancer Center of Kansas, PA - Pratt
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Salina
	Cancer Center of Kansas, PA - Salina
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Topeka
	Cotton-O'Neil Cancer Center
		Clinical Trials Office - Cotton-O'Neil Cancer Center	Ph:  785-270-4963
	Wellington
	Cancer Center of Kansas, PA - Wellington
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Wichita
	Associates in Womens Health, PA - North Review
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Cancer Center of Kansas, PA - Wichita
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Cancer Center of Kansas, PA - Medical Arts Tower
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	CCOP - Wichita
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Via Christi Cancer Center at Via Christi Regional Medical Center
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Winfield
	Cancer Center of Kansas, PA - Winfield
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
Maine
	Portland
	Mercy Hospital
		Roger Inhorn, MD, PhD	Ph:  207-879-3030
Michigan
	Adrian
	Hickman Cancer Center at Bixby Medical Center
		Clinical Trials Office - Hickman Cancer Center at Bixby Medical Center	Ph:  517-265-0116
	Ann Arbor
	University of Michigan Comprehensive Cancer Center
		Clinical Trials Office - University of Michigan Comprehensive Cancer Center	Ph:  800-865-1125
	Battle Creek
	Battle Creek Health System Cancer Care Center
		Martin Bury	Ph:  616-966-8000
	Bay City
	Bay Regional Medical Center
		Clinical Trials Office - Bay Regional Medical Center	Ph:  989-667-6257
	Big Rapids
	Mecosta County Medical Center
		Martin Bury	Ph:  231-796-8691
	Escanaba
	Green Bay Oncology, Limited - Escanaba
		Contact Person	Ph:  800-432-6049
	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
		Contact Person	Ph:  906-774-1313
	Lambertville
	Haematology-Oncology Associates of Ohio and Michigan, PC
		Paul Schaefer, MD	Ph:  419-479-5605
	Lansing
	Breslin Cancer Center at Ingham Regional Medical Center
		Clinical Trials Office - Breslin Cancer Center at Ingham Regional Medical Center	Ph:  517-334-2765
	Monroe
	Community Cancer Center of Monroe
		Paul Schaefer, MD	Ph:  419-479-5605
	Mercy Memorial Hospital - Monroe
		Paul Schaefer, MD	Ph:  419-479-5605
	Mount Clemens
	Clemens Regional Medical Center
		Clinical Trials Office - Ted B. Wahby Cancer Center at Mount Clemens General Hospital	Ph:  586-493-3426
	Muskegon
	Mercy General Health Partners
		Martin Bury	Ph:  231-672-2000
	St. Joseph
	Lakeland Regional Cancer Care Center - St. Joseph
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	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
	Burnsville
	Fairview Ridges Hospital
		Patrick Flynn, MD	Ph:  612-863-8585
	Coon Rapids
	Mercy and Unity Cancer Center at Mercy Hospital
		Patrick Flynn, MD	Ph:  612-863-8585
	Edina
	Fairview Southdale Hospital
		Clinical Trials Office - Fairview Southdale Hospital	Ph:  612-625-3650
	Fergus Falls
		Donald Jurgens	Ph:  320-229-4907
	Fridley
	Mercy and Unity Cancer Center at Unity Hospital
		Patrick Flynn, MD	Ph:  612-863-8585
	Maplewood
	Minnesota Oncology Hematology, PA - Maplewood
		Patrick Flynn, MD	Ph:  612-863-8585
	Minneapolis
	Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
		Clinical Trials Office - Virginia Piper Cancer Institute	Ph:  612-863-5654
	Robbinsdale
	Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
		Clinical Trials Office - Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center	Ph:  763-520-1893
	Saint Cloud
	CentraCare Clinic - River Campus
		Donald Jurgens	Ph:  320-229-4907
	Coborn Cancer Center
		Donald Jurgens	Ph:  320-229-4907
	Saint Louis Park
	CCOP - Metro-Minnesota
		Patrick Flynn, MD	Ph:  612-863-8585
	Park Nicollet Cancer Center
		Patrick Flynn, MD	Ph:  612-863-8585
	Saint Paul
	United Hospital
		Patrick Flynn, MD	Ph:  612-863-8585
	Shakopee
	St. Francis Cancer Center at St. Francis Medical Center
		Patrick Flynn, MD	Ph:  612-863-8585
	Waconia
	Ridgeview Medical Center
		Patrick Flynn, MD	Ph:  612-863-8585
	Woodbury
	Minnesota Oncology Hematology, PA - Woodbury
		Patrick Flynn, MD	Ph:  612-863-8585
Mississippi
	Pascagoula
	Regional Cancer Center at Singing River Hospital
		James Clarkson, MD	Ph:  228-374-6296
Missouri
	Saint Louis
	Arch Medical Services, Incorporated at Center for Cancer Care and Research
		Alan Lyss, MD	Ph:  314-996-5514
	Missouri Baptist Cancer Center
		Alan Lyss, MD	Ph:  314-996-5514
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
		Grant Harrer, MD, FACP, CCTI	Ph:  406-731-8100
	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
Nevada
	Carson City
	Carson Tahoe Cancer Center at Carson Tahoe Regional Medical Center
		John Kelly	Ph:  775-445-7508 877-284-2627
New Jersey
	New Brunswick
	Saint Peter's University Hospital
		Kathleen Toomey	Ph:  732-745-8600
New York
	Bronx
	Albert Einstein Cancer Center at Albert Einstein College of Medicine
		Clinical Trials Office - Albert Einstein Cancer Center at Albert Einstein College of Medicine	Ph:  718-904-2730
			Email: aecc@aecom.yu.edu
	Buffalo
	Roswell Park Cancer Institute
		Clinical Trials Office - Roswell Park Cancer Institute	Ph:  877-275-7724
	East Syracuse
	CCOP - Hematology-Oncology Associates of Central New York
		Jeffrey Kirshner, MD	Ph:  315-472-7504
	Glens Falls
	Charles R. Wood Cancer Center at Glens Falls Hospital
		Clinical Trials Office - Charles R. Wood Cancer Center at Glens Falls Hospital	Ph:  518-926-6700
	Utica
	Faxton Regional Cancer Center
		Atul Butala, MD, FACP	Ph:  315-798-9300
North Carolina
	Durham
	Duke Comprehensive Cancer Center
		Clinical Trials Office - Duke Comprehensive Cancer Center	Ph:  888-275-3853
	Goldsboro
	Southeastern Medical Oncology Center - Goldsboro
		James Atkins, MD	Ph:  919-580-0000
	Wayne Memorial Hospital, Incorporated
		James Atkins, MD	Ph:  919-580-0000
	Henderson
	Maria Parham Medical Center
		Jeffrey Crawford, MD	Ph:  919-681-9509
	Hendersonville
	Pardee Memorial Hospital
		James Radford, MD	Ph:  828-692-8045
	Kinston
	Kinston Medical Specialists
		Peter Watson, MD	Ph:  252-559-2200ext.201
	Lumberton
	Southeastern Regional Medical Center
		Jeffrey Crawford, MD	Ph:  919-681-9509
	Oxford
	Granville Medical Center
		Jeffrey Crawford, MD	Ph:  919-681-9509
	Raleigh
	Duke Health Raleigh Hospital
		Jeffrey Crawford, MD	Ph:  919-681-9509
	Roxboro
	Person Memorial Hospital
		Jeffrey Crawford, MD	Ph:  919-681-9509
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
	Grand Forks
	Altru Cancer Center at Altru Hospital
		Clinical Trails Office - Altru Cancer Center at Altru Hospital	Ph:  701-780-6520
Ohio
	Beachwood
	Cleveland Clinic Beachwood Family Health and Surgery Center
		George Budd, MD	Ph:  216-444-6480
	Bowling Green
	Wood County Oncology Center
		Paul Schaefer, MD	Ph:  419-479-5605
	Cleveland
	Case Comprehensive Cancer Center
		Clinical Trials Office - Case Comprehensive Cancer Center	Ph:  800-641-2422
	Cleveland Clinic Cancer Center at Fairview Hospital
		Clinical Trials Office - Cleveland Clinic Cancer Center at Fairview Hospital	Ph:  216-476-9362
	Cleveland Clinic Taussig Cancer Center
		Clinical Trials Office - Cleveland Clinic Taussig Cancer Center	Ph:  866-223-8100
	Clyde
	North Coast Cancer Care - Clyde
		Paul Schaefer, MD	Ph:  419-479-5605
	Elyria
	Hematology Oncology Center
		Paul Schaefer, MD	Ph:  419-479-5605
	Independence
	Cleveland Clinic Cancer Center
		George Budd, MD	Ph:  216-444-6480
	Lima
	Lima Memorial Hospital
		Paul Schaefer, MD	Ph:  419-479-5605
	Maumee
	Northwest Ohio Oncology Center
		Paul Schaefer, MD	Ph:  419-479-5605
		Paul Schaefer, MD	Ph:  419-479-5605
	St. Luke's Hospital
		Paul Schaefer, MD	Ph:  419-479-5605
	Mayfield Heights
	Hillcrest Cancer Center at Hillcrest Hospital
		George Budd, MD	Ph:  216-444-6480
	Oregon
	St. Charles Mercy Hospital
		Paul Schaefer, MD	Ph:  419-479-5605
	Toledo Clinic - Oregon
		Paul Schaefer, MD	Ph:  419-479-5605
	Sandusky
	North Coast Cancer Care, Incorporated
		Paul Schaefer, MD	Ph:  419-479-5605
	Sylvania
	Flower Hospital Cancer Center
		Clinical Trials Office - Flower Hospital Cancer Center	Ph:  419-824-1842
	Tiffin
	Mercy Hospital of Tiffin
		Paul Schaefer, MD	Ph:  419-479-5605
	Toledo
	CCOP - Toledo Community Hospital
		Paul Schaefer, MD	Ph:  419-479-5605
	Medical University of Ohio Cancer Center
		Clinical Trials Office - Medical University of Ohio Cancer Center	Ph:  419-383-6583
	St. Anne Mercy Hospital
		Paul Schaefer, MD	Ph:  419-479-5605
	St. Vincent Mercy Medical Center
		Paul Schaefer, MD	Ph:  419-479-5605
	Toledo Clinic, Incorporated - Main Clinic
		Paul Schaefer, MD	Ph:  419-479-5605
	Toledo Hospital
		Clinical Trials Office - Toledo Hospital	Ph:  419-824-1842
	Wauseon
	Fulton County Health Center
		Clinical Trials Office - Fulton County Health Center	Ph:  419-330-2708
	Wooster
	Cleveland Clinic - Wooster
		Clinical Trials Office - Cleveland Clinic - Wooster	Ph:  800-862-7798
Oregon
	Coos Bay
	Bay Area Hospital
		Bret Cook, MD	Ph:  541-267-5151
	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
	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
	Ephrata
	Ephrata Cancer Center at Ephrata Community Hospital
		Allison Zibelli, MD	Ph:  215-923-5676
	Philadelphia
	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
		Clinical Trials Office - Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Ph:  215-955-6084
	Phoenixville
	Cancer Center at Phoenixville Hospital
		Carl Sharer, DO	Ph:  610-983-1800
	Pittsburgh
	UPMC Cancer Centers
		Clinical Trials Office - UPMC Cancer Centers	Ph:  412-647-8073
	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
		Allison Zibelli, MD	Ph:  215-923-5676
South Carolina
	Charleston
	Roper St. Francis Cancer Center at Roper Hospital
		James Orcutt, MD	Ph:  843-577-2276
Tennessee
	Knoxville
	U.T. Medical Center Cancer Institute
		Clinical Trials Office - U.T. Medical Center Cancer Institute	Ph:  865-544-9773
Texas
	San Antonio
	Cancer Therapy and Research Center
		Clinical Trials Office - Cancer Therapy and Research Center	Ph:  210- 616-5798
	University Hospital - San Antonio
		Anand Karnad, MD	Ph:  210-567-4777
	University of Texas Health Science Center at San Antonio
		Anand Karnad, MD	Ph:  210-567-4777
	Veterans Affairs Medical Center - San Antonio (Murphy)
		Anand Karnad, MD	Ph:  210-567-4777
Virginia
	Danville
	Danville Regional Medical Center
		Clinical Trials Office - Danville Regional Medical Center	Ph:  434-799-3753
	Fredericksburg
	Fredericksburg Oncology, Incorporated
		Paul Schaefer, MD	Ph:  419-479-5605
	Richmond
	Virginia Cancer Institute - West End
		James May, MD, FACP	Ph:  804-330-7990
Washington
	Auburn
	Auburn Regional Center for Cancer Care
		Lauren Colman, MD	Ph:  253-403-1677
	Centralia
	Providence Centralia Hospital
		Clinical Trials Office - Providence Centralia Hospital	Ph:  360-493-4300
	Federal Way
	St. Francis Hospital
		Lauren Colman, MD	Ph:  253-403-1677
	Olympia
	Providence St. Peter Hospital Regional Cancer Center
		Lauren Colman, MD	Ph:  253-403-1677
	Puyallup
	Good Samaritan Cancer Center
		Lauren Colman, MD	Ph:  253-403-1677
	Tacoma
	Allenmore Hospital
		Lauren Colman, MD	Ph:  253-403-1677
	CCOP - Northwest
		Lauren Colman, MD	Ph:  253-403-1677
	Franciscan Cancer Center at St. Joseph Medical Center
		Clinical Trials Office - Franciscan Cancer Center	Ph:  253-426-6914
	MultiCare Regional Cancer Center at Tacoma General Hospital
		Clinical Trials Office - MultiCare Regional Cancer Center	Ph:  253-403-3229
	St. Clare Hospital
		Lauren Colman, MD	Ph:  253-403-1677
	Vancouver
	Southwest Washington Medical Center Cancer Center
		Janet Ruzich	Ph:  360-514-2174
Wisconsin
	Glendale
	Oncology Alliance, SC - Milwaukee - East
		Clinical Trials Office - Oncology Alliance, SC - Milwaukee - East	Ph:  414-906-4480
	Green Bay
	Green Bay Oncology, Limited at St. Mary's Hospital
		Contact Person	Ph:  920-884-3135
	Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
		Contact Person	Ph:  920-432-6049
	St. Mary's Hospital Medical Center - Green Bay
		Contact Person	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 Center for Cancer and Blood
		Clinical Trials Office - Gundersen Lutheran Cancer Center	Ph:  608-775-2385
			Email: cancerctr@gundluth.org
	Manitowoc
	Holy Family Memorial Medical Center Cancer Care Center
		Clinical Trials Office - Holy Family Memorial Medical Center Cancer Care Center	Ph:  920-320-2749
	Marinette
	Bay Area Cancer Care Center at Bay Area Medical Center
		Contact Person	Ph:  715-735-6523 888-788-2070
	Oconto Falls
	Green Bay Oncology, Limited - Oconto Falls
		Contact Person	Ph:  920-846-3444 800-432-6049
	Sturgeon Bay
	Green Bay Oncology, Limited - Sturgeon Bay
		Contact Person	Ph:  800-432-6049
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

Related Information

Featured trial article

Registry Information
Official Title		A Randomized Phase III Trial to Test the Strategy of Changing Therapy Versus Maintaining Therapy for Metastatic Breast Cancer Patients Who Have Elevated Circulating Tumor Cell Levels at First Follow-Up Assessment
Trial Start Date		2006-10-01
Trial Completion Date		2011-09-15 (estimated)
Registered in ClinicalTrials.gov		NCT00382018
Date Submitted to PDQ		2006-08-15
Information Last Verified		2009-11-04
NCI Grant/Contract Number		CA32102

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