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Clinical Trials (PDQ®)

  • First Published: 9/23/2006
  • Last Modified: 2/10/2012

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Phase III Randomized Study of Treatment Decision Making Based on Levels of Circulating Tumor Cells in Women With Metastatic Breast Cancer Undergoing Chemotherapy

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

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIIDiagnostic, TreatmentActiveNot specifiedNCISWOG-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 metastatic 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

651

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

Outcomes

Primary Outcome(s)

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

Secondary Outcome(s)

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

Trial Sites

U.S.A.
Alabama
  Anniston
 Regional Medical Center
 Ellen Spremulli
Ph: 256-235-5877
Alaska
  Anchorage
 Alaska Regional Hospital Cancer Center
 Saul Rivkin, MD
Ph: 206-386-2441
 Providence Cancer Center
 Clinical Trials Office - Providence Cancer Center
Ph: 907-261-3109
Arkansas
  Jonesboro
 NEA Medical Center - Stadium Boulevard
 Carroll Scroggin, MD
Ph: 870-934-5343
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
  Mountain View
 Camino Medical Group - Treatment Center
 Peter Yu, MD
Ph: 408-524-5814
  Palo Alto
 Palo Alto Medical Foundation
 David Leibowitz
Ph: 650-321-4121
  Salinas
 Salinas Valley Memorial Hospital
 Shehzad Aziz, MD
Ph: 831-755-1701
  Stanford
 Stanford Cancer Center
 Clinical Trials Office - Stanford Cancer Center
Ph: 650-498-7061
  Email: cctoffice@stanford.edu
Colorado
  Alamosa
 San Luis Valley Regional Medical Center
 Anthony Elias, MD
Ph: 720-848-1622
  Aurora
 University of Colorado Cancer Center at UC Health Sciences Center
 Clinical Trials Office - University of Colorado Cancer Center
Ph: 720-848-0650
  Denver
 Veterans Affairs Medical Center - Denver
 Anthony Elias, MD
Ph: 720-848-1622
  Edwards
 Shaw Regional Cancer Center
 Anthony Elias, MD
Ph: 720-848-1622
  Glenwood Springs
 Valley View Hospital Cancer Center
 Anthony Elias, MD
Ph: 720-848-1622
  Grand Junction
 St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
 Anthony Elias, MD
Ph: 720-848-1622
  Montrose
 Montrose Memorial Hospital Cancer Center
 Clinical Trials Office - Montrose Memorial Hospital Cancer Center
Ph: 670-240-7267
Connecticut
  Hartford
 Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
 Philip Stella, MD
Ph: 734-712-1000
  New Haven
 Yale Cancer Center
 Clinical Trials Office - Yale Cancer Center
Ph: 203-785-5702
Florida
  Orlando
 Florida Hospital Cancer Institute at Florida Hospital Orlando
 Clinical Trials Office - Florida Hospital Cancer Institute
Ph: 407-303-5623
Georgia
  Valdosta
 Pearlman Comprehensive Cancer Center at South Georgia Medical Center
 Jeffrey Hoy, MD
Ph: 229-259-4628
Hawaii
  Aiea
 Kapiolani Medical Center at Pali Momi
 Jeffrey Berenberg, MD
Ph: 808-433-4089
  Honolulu
 Cancer Research Center of Hawaii
 Clinical Trials Office - Cancer Research Center of Hawaii
Ph: 808-586-2979
 Hawaii Medical Center - East
 Jeffrey Berenberg, MD
Ph: 808-433-4089
 Kapiolani Medical Center for Women and Children
 Jeffrey Berenberg, MD
Ph: 808-433-4089
 OnCare Hawaii, Incorporated - Kuakini
 Jeffrey Berenberg, MD
Ph: 808-433-4089
 OnCare Hawaii, Incorporated - Lusitana
 Jeffrey Berenberg, MD
Ph: 808-433-4089
 Queen's Cancer Institute at Queen's Medical Center
 Jeffrey Berenberg, MD
Ph: 808-433-4089
 Straub Clinic and Hospital, Incorporated
 Jeffrey Berenberg, MD
Ph: 808-433-4089
 Tripler Army Medical Center
 Jeffrey Berenberg, MD
Ph: 808-433-4089
  Wailuku
 Maui Memorial Medical Center
 Jeffrey Berenberg, MD
Ph: 808-433-4089
 Pacific Cancer Institute - Maui
 Jeffrey Berenberg, MD
Ph: 808-433-4089
Idaho
  Boise
 Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
 Clinical Trials Office - Saint Alphonsus Cancer Care Center
Ph: 208-367-7954
  Coeur d'Alene
 Kootenai Cancer Center - Coeur d'Alene
 Clinical Trials Office - North Idaho Cancer Center
Ph: 208-666-3764
Illinois
  Aurora
 Rush-Copley Cancer Care Center
 Patricia Johnson, MD, PhD
Ph: 217-383-3010
  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
 Louis A. Weiss Memorial Hospital
 Clinical Trials Office - Louis A. Weiss Memorial Hospital
Ph: 773- 564-5044
 Resurrection Medical Center
 Christopher Rose, MD
Ph: 847-965-3200
  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: 708-915-4673
  Rockford
 Swedish-American Regional Cancer Center
 Clinical Trials Office - Swedish-American Regional Cancer Center
Ph: 815-489-4413
  Urbana
 CCOP - Carle Cancer Center
 Clinical Trials Office - CCOP - Carle Cancer Center
Ph: 800-446-5532
Indiana
  Elkhart
 Elkhart Clinic, LLC
 Rafat Ansari, MD, FACP
Ph: 574-234-5123
 Elkhart General Hospital
 Rafat Ansari, MD, FACP
Ph: 574-234-5123
 Michiana Hematology-Oncology, PC - Elkhart
 Rafat Ansari, MD, FACP
Ph: 574-234-5123
  Indianapolis
 Community Regional Cancer Care at Community Hospital North
 Pablo Bedano
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
  Michigan City
 Saint Anthony Memorial Health Centers
 Patricia Johnson, MD, PhD
Ph: 217-383-3010
  Mishawaka
 Michiana Hematology-Oncology, PC - South Bend
 Rafat Ansari, MD, FACP
Ph: 574-234-5123
 Saint Joseph Regional Medical Center
 Rafat Ansari, MD, FACP
Ph: 574-234-5123
  Muncie
 Cancer Center at Ball Memorial Hospital
 Clinical Trials Office - Cancer Center at Ball Memorial Hospital
Ph: 765-281-2107
  Plymouth
 Michiana Hematology Oncology PC - Plymouth
 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
 Michiana Hematology-Oncology, PC - South Bend
 Rafat Ansari, MD, FACP
Ph: 574-234-5123
  Westville
 Michiana Hematology Oncology PC - La Porte
 Rafat Ansari, MD, FACP
Ph: 574-234-5123
Iowa
  Ames
 McFarland Clinic, PC
 Clinical Trials Office - McFarland Clinic, PC
Ph: 515-239-2621
  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
  Waterloo
 Covenant Cancer Treatment Center
 Clinical Trials Office - Covenant Cancer Treatment Center
Ph: 319-272-2070
Kansas
  Salina
 Tammy Walker Cancer Center at Salina Regional Health Center
 William Cathcart-Rake, MD
Ph: 785-452-4860
  Topeka
 Cotton-O'Neil Cancer Center
 Clinical Trials Office - Cotton-O'Neil Cancer Center
Ph: 785-270-4963
Maine
  Portland
 Mercy Hospital
 Roger Inhorn, MD, PhD
Ph: 207-879-3030
Maryland
  Baltimore
 Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
 Mayer Gorbaty
Ph: 410-601-4734
Massachusetts
  Worcester
 Saint Vincent Hospital at Worcester Medical Center
 Clinical Trials Office - Saint Vincent Hospital at Worcester Medical Center
Ph: 508-363-7018
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
 CCOP - Michigan Cancer Research Consortium
 Philip Stella, MD
Ph: 734-712-1000
 Saint Joseph Mercy Cancer Center
 Philip Stella, MD
Ph: 734-712-1000
 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
  Dearborn
 Oakwood Cancer Center at Oakwood Hospital and Medical Center
 Clinical Trials Office - Oakwood Cancer Center at Oakwood Hospital and Medical Center
Ph: 313-593-8090
  Detroit
 Barbara Ann Karmanos Cancer Institute
 Clinical Trials Office - Barbara Ann Karmanos Cancer Institute
Ph: 313-576-9363
 Josephine Ford Cancer Center at Henry Ford Hospital
 Robert Chapman, MD
Ph: 313-916-1332
  Escanaba
 Green Bay Oncology, Limited - Escanaba
 Thomas Saphner, MD, FACP
Ph: 920-884-3135
  Flint
 Genesys Hurley Cancer Institute
 Clinical Trials Office - Genesys Hurley Cancer Institute
Ph: 810-762-8057
 Hurley Medical Center
 Clinical Trials Office - Hurley Medical Center
Ph: 810-762-8057
  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
  Grosse Pointe Woods
 Van Elslander Cancer Center at St. John Hospital and Medical Center
 Clincial Trials Office - Van Elslander Cancer Center at St. John Hospital and Medical Center
Ph: 313-343-3166
  Iron Mountain
 Dickinson County Healthcare System
 Thomas Saphner, MD, FACP
Ph: 920-884-3135
  Jackson
 Foote Memorial Hospital
 Philip Stella, MD
Ph: 734-712-1000
  Kalamazoo
 Borgess Medical Center
 Raymond Lord, MD
Ph: 269-373-7458
 Bronson Methodist Hospital
 Raymond Lord, MD
Ph: 269-373-7458
 West Michigan Cancer Center
 Clinical Trials Office - West Michigan Cancer Center
Ph: 269-373-7458
  Lansing
 Breslin Cancer Center at Ingham Regional Medical Center
 Clinical Trials Office - Breslin Cancer Center at Ingham Regional Medical Center
Ph: 517-334-2765
 Sparrow Regional Cancer Center
 Clinical Trials Office - Sparrow Regional Cancer Center
Ph: 517-364-2890
  Livonia
 St. Mary Mercy Hospital
 Philip Stella, MD
Ph: 734-712-1000
  Monroe
 Community Cancer Center of Monroe
 Rex Mowat
Ph: 734-242-7902
 Mercy Memorial Hospital - Monroe
 Rex Mowat
Ph: 734-240-8400
  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
  Pontiac
 St. Joseph Mercy Oakland
 Philip Stella, MD
Ph: 734-712-1000
  Port Huron
 Mercy Regional Cancer Center at Mercy Hospital
 Philip Stella, MD
Ph: 734-712-1000
  Royal Oak
 William Beaumont Hospital - Royal Oak Campus
 Clinical Trials Office - William Beaumont Hospital - Royal Oak Campus
Ph: 248-551-7695
  Saginaw
 Seton Cancer Institute at Saint Mary's - Saginaw
 Clinical Trials Office - Seton Cancer Institute - Saginaw
Ph: 989-776-8411
  Saint Joseph
 Lakeside Cancer Specialists, PLLC
 Rafat Ansari, MD, FACP
Ph: 574-234-5123
  Southfield
 Providence Cancer Institute at Providence Hospital - Southfield Campus
 Anibal Drelichman, MD, MPH, FACP
Ph: 313-552-0620
  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
  Warren
 St. John Macomb Hospital
 Philip Stella, MD
Ph: 734-712-1000
Minnesota
  Alexandria
 Donald Jurgens
  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
  Fridley
 Mercy and Unity Cancer Center at Unity Hospital
 Patrick Flynn, MD
Ph: 612-863-8585
  Hutchinson
 Hutchinson Area Health Care
 Patrick Flynn, MD
Ph: 612-863-8585
  Maplewood
 HealthEast Cancer Care at St. John's Hospital
 Patrick Flynn, MD
Ph: 612-863-8585
 Minnesota Oncology Hematology, PA - Maplewood
 Patrick Flynn, MD
Ph: 612-863-8585
  Minneapolis
 Hennepin County Medical Center - Minneapolis
 Clinical Trials Office - Hennepin County Medical Center - Minneapolis
Ph: 612-873-5911
 Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
 Clinical Trials Office - Virginia Piper Cancer Institute
Ph: 612-863-5654
  Robbinsdale
 Humphrey Cancer Center at North Memorial Outpatient Center
 Clinical Trials Office - Humphrey Cancer Center at North Memorial Outpatient Center
Ph: 763-520-1893
  Saint Cloud
 CentraCare Clinic - River Campus
 Donald Jurgens
Ph: 320-252-5131
 Coborn Cancer Center
 Donald Jurgens
Ph: 320-229-4907
877-229-4907
  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
  St. Paul
 Regions Hospital Cancer Care Center
 Clinical Trials Office - Regions Hospital Cancer Care Center
Ph: 651-254-1517
  Stillwater
 Lakeview Hospital
 Patrick Flynn, MD
Ph: 612-863-8585
  Waconia
 Ridgeview Medical Center
 Patrick Flynn, MD
Ph: 612-863-8585
  Willmar
 Willmar Cancer Center at Rice Memorial Hospital
 Patrick Flynn, MD
Ph: 612-863-8585
  Woodbury
 Minnesota Oncology Hematology, PA - Woodbury
 Patrick Flynn, MD
Ph: 612-863-8585
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
 Southeast Cancer Center
 Alan Lyss, MD
Ph: 314-996-5514
  Jefferson City
 Goldschmidt Cancer Center
 Alan Lyss, MD
Ph: 314-996-5514
  Saint Louis
 Comprehensive Cancer Care, PC
 Alan Lyss, MD
Ph: 314-996-5514
 Missouri Baptist Cancer Center
 Alan Lyss, MD
Ph: 314-996-5514
  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: 406-238-6290
 Hematology-Oncology Centers of the Northern Rockies - Billings
 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
 Big Sky Oncology
 Clinical Trial 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
 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
Nebraska
  Kearney
 Good Samaritan Cancer Center at Good Samaritan Hospital
 Clinical Trials Office - Good Samaritan Cancer Center at Good Samaritan Hospital
Ph: 308-865-7963
New Hampshire
  Lebanon
 Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
 Clinical Trials Office - Norris Cotton Cancer Center
Ph: 603-650-7609
  Email: cancerhelp@dartmouth.edu
New Jersey
  Morristown
 Carol G. Simon Cancer Center at Morristown Memorial Hospital
 Bonni Guerin
Ph: 973-971-6100
800-247-9580
  New Brunswick
 Saint Peter's University Hospital
 Kathleen Toomey
Ph: 732-745-8600
  Newark
 Newark Beth Israel Medical Center
 Clinical Trials Office - Newark Beth Israel Medical Center
Ph: 973-926-3136
 UMDNJ University Hospital
 Robert Wieder
Ph: 973-972-4300
  Paterson
 St. Joseph's Hospital and Medical Center
 David Cornell, MD
Ph: 718-579-5000
  Summit
 Overlook Hospital
 Bonni Guerin
Ph: 908-522-2000
New Mexico
  Albuquerque
 Hematology Oncology Associates, PC
 Melanie Royce, MD, PhD
Ph: 505-272-6057
 Lovelace Medical Center - Downtown
 Melanie Royce, MD, PhD
Ph: 505-272-6057
 Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital
 Melanie Royce, MD, PhD
Ph: 505-272-6057
 University of New Mexico Cancer Center
 Clinical Trials Office - University of New Mexico Cancer Center
Ph: 505-272-6972
  Las Cruces
 University of New Mexico Cancer Center - South
 Melanie Royce, MD, PhD
Ph: 505-272-6057
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
  Utica
 Faxton Regional Cancer Center
 Atul Butala, MD, FACP
Ph: 315-798-9300
  White Plains
 Dickstein Cancer Treatment Center at White Plains Hospital Center
 Clinical Trials Office - Dickstein Cancer Treatment Center
Ph: 914-681-2290
North Carolina
  Asheville
 Mission Hospitals - Memorial Campus
 Clinical Trials Office - Mission Hospitals - Memorial Campus
Ph: 828-213-4150
  Durham
 Duke Cancer Institute
 Clinical Trials Office - Duke Cancer Institute
Ph: 888-275-3853
  Goldsboro
 Wayne Memorial Hospital, Incorporated
 James Atkins, MD
Ph: 919-580-0000
  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
  Minot
 Trinity CancerCare Center
 Stephen Makoni
Ph: 701-857-3535
800-862-0005
Ohio
  Beachwood
 Cleveland Clinic Beachwood Family Health and Surgery Center
 Anjali Advani
Ph: 216-839-3200
  Bowling Green
 Wood County Oncology Center
 Rex Mowat
Ph: 419-352-9498
  Cincinnati
 Charles M. Barrett Cancer Center at University Hospital
 Leslie Oleksowicz
Ph: 513-584-3200
888-640-CARE
  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
  Elyria
 Community Cancer Center
 Rex Mowat
Ph: 440-324-0400
 Hematology Oncology Center
 Rex Mowat
Ph: 440-324-0401
  Independence
 Cleveland Clinic Cancer Center
 Anjali Advani
Ph: 216-524-7979
  Lima
 Lima Memorial Hospital
 Rex Mowat
Ph: 419-228-3335
 St. Rita's Medical Center
 Clinical Trials Office - St. Rita's Medical Center
Ph: 419-226-9617
  Maumee
 Rex Mowat
Ph: 419-891-5600
 Northwest Ohio Oncology Center
 Rex Mowat
Ph: 419-891-5600
 St. Luke's Hospital
 Rex Mowat
Ph: 419-893-5911
  Mayfield Heights
 Hillcrest Cancer Center at Hillcrest Hospital
 Anjali Advani
Ph: 440-312-4500
  Mentor
 Lake/University Ireland Cancer Center
 Joseph Baar
Ph: 440-205-5755
  Norwalk
 Fisher-Titus Medical Center
 Rex Mowat
Ph: 419-668-8101
800-589-3862
  Orange Village
 UHHS Chagrin Highlands Medical Center
 Joseph Baar
Ph: 216-292-1783
  Oregon
 St. Charles Mercy Hospital
 Rex Mowat
Ph: 419-696-7200
 Toledo Clinic - Oregon
 Rex Mowat
Ph: 419-691-4235
  Parma
 Parma Community General Hospital
 Clinical Trials Office - Parma Community General Hospital
Ph: 440-743-4747
  Sandusky
 North Coast Cancer Care, Incorporated
 Rex Mowat
Ph: 419-626-9090
  Strongsville
 Cleveland Clinic Foundation - Strongsville
 Anjali Advani
Ph: 440-878-2500
800-239-1098
  Sylvania
 Flower Hospital Cancer Center
 Clinical Trials Office - Flower Hospital Cancer Center
Ph: 419-824-1842
  Tiffin
 Mercy Hospital of Tiffin
 Rex Mowat
Ph: 419-447-3130
  Toledo
 CCOP - Toledo Community Hospital
 Rex Mowat
Ph: 419-843-6147
 Medical University of Ohio Cancer Center
 Clinical Trials Office - Medical University of Ohio Cancer Center
Ph: 419-383-6583
 St. Anne Mercy Hospital
 Rex Mowat
Ph: 419-407-2663
 St. Vincent Mercy Medical Center
 Rex Mowat
Ph: 419-251-4515
 Toledo Clinic, Incorporated - Main Clinic
 Rex Mowat
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
  Westlake
 UHHS Westlake Medical Center
 Joseph Baar
Ph: 440-250-2001
  Wooster
 Cleveland Clinic - Wooster
 Clinical Trials Office - Cleveland Clinic - Wooster
Ph: 800-862-7798
Oklahoma
  Tulsa
 Natalie Warren Bryant Cancer Center at St. Francis Hospital
 Joseph Lynch, MD
Ph: 918-494-8275
Oregon
  Bend
 St. Charles Medical Center - Bend
 Robert Boone, MD
Ph: 541-317-4298
  Clackamas
 Clackamas Radiation Oncology Center
 Janet Ruzich
Ph: 503-513-3300
  Coos Bay
 Bay Area Hospital
 Bret Cook, MD
Ph: 541-267-5151
  Grants Pass
 Three Rivers Community Hospital
 Charles Dibb, MD
Ph: 541-774-5853
  Medford
 Dubs Cancer Center at Rogue Valley Medical Center
 Charles Dibb, MD
Ph: 541-774-5853
 Providence Cancer Center at PMCC
 Charles Dibb, MD
Ph: 541-774-5853
  Milwaukie
 Providence Milwaukie Hospital
 Janet Ruzich
Ph: 503-513-8300
  Newberg
 Providence Newberg Medical Center
 Janet Ruzich
Ph: 503-537-1555
  Oregon City
 Willamette Falls Hospital
 Janet Ruzich
Ph: 503-650-6758
  Portland
 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
  Butler
 Butler Memorial Hospital
 Rex Mowat
Ph: 412-283-6666
  Ephrata
 Ephrata Cancer Center at Ephrata Community Hospital
 Allison Zibelli, MD
Ph: 215-923-5676
  Philadelphia
 Fox Chase Cancer Center - Philadelphia
 Clinical Trials Office - Fox Chase Cancer Center - Philadelphia
Ph: 215-728-4790
  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
  Sayre
 Guthrie Cancer Center at Guthrie Clinic Sayre
 Clinical Trials Office - Guthrie Cancer Center at Guthrie Clinic Sayre
Ph: 800-836-0388
  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
  Easley
 Cancer Centers of the Carolinas - Easley
 Clinical Trials Office - Cancer Centers of the Carolinas
Ph: 864-241-6251
  Greenville
 Cancer Centers of the Carolinas - Faris Road
 Jeffrey Giguere, MD, FACP
Ph: 864-987-7000
 Cancer Centers of the Carolinas - Grove Commons
 Clinical Trials Office - Cancer Centers of the Carolinas
Ph: 864-241-6251
 CCOP - Greenville
 Jeffrey Giguere, MD, FACP
Ph: 864-987-7000
 Greenville Hospital Cancer Center
 Clinical Trials Office - Greenville Hospital Cancer Center
Ph: 864-241-6251
  Greenwood
 Self Regional Cancer Center at Self Regional Medical Center
 Jeffrey Giguere, MD, FACP
Ph: 864-987-7000
  Greer
 Cancer Centers of the Carolinas - Greer Medical Oncology
 Jeffrey Giguere, MD, FACP
Ph: 864-987-7000
  Seneca
 Cancer Centers of the Carolinas - Seneca
 Jeffrey Giguere, MD, FACP
Ph: 864-987-7000
  Spartanburg
 Cancer Centers of the Carolinas - Spartanburg
 Jeffrey Giguere, MD, FACP
Ph: 864-987-7000
Tennessee
  Jackson
 West Tennessee Cancer Center at Jackson-Madison County General Hospital
 Clinical Trials Office - West Tennessee Cancer Center
Ph: 731-425-6865
  Nashville
 MBCCOP - Meharry Medical College - Nashville
 Steven Wolff, MD
Ph: 615-327-6277
Texas
  Houston
 M. D. Anderson Cancer Center at University of Texas
 Clinical Trials Office - M. D. Anderson Cancer Center at the University of Texas
Ph: 713-792-3245
  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
  Temple
 CCOP - Scott and White Hospital
 Lucas Wong, MD
Ph: 254-724-1053
Utah
  American Fork
 American Fork Hospital
 W. Harker, MD
Ph: 801-269-0231
  Cedar City
 Sandra L. Maxwell Cancer Center
 W. Harker, MD
Ph: 801-269-0231
  Logan
 Logan Regional Hospital
 W. Harker, MD
Ph: 801-269-0231
  Murray
 Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
 W. Harker, MD
Ph: 801-269-0231
  Ogden
 Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
 Clinical Trials Office - McKay-Dee Hospital Center
Ph: 801 387-7426
  Provo
 Utah Valley Regional Medical Center - Provo
 Clinical Trials Office - Utah Valley Regional Medical Center - Provo
Ph: 801-357-7965
  Saint George
 Dixie Regional Medical Center - East Campus
 Clinical Trials Office - Dixie Regional Medical Center - East Campus
Ph: 435-688-4167
  Salt Lake City
 LDS Hospital
 W. Harker, MD
Ph: 801-269-0231
 Utah Cancer Specialists at UCS Cancer Center
 W. Harker, MD
Ph: 801-269-0231
Virginia
  Danville
 Danville Regional Medical Center
 Clinical Trials Office - Danville Regional Medical Center
Ph: 434-799-3753
  Fredericksburg
 Fredericksburg Oncology, Incorporated
 Rex Mowat
Ph: 540-368-0500
  Richmond
 Virginia Cancer Institute - West End
 James May, MD, FACP
Ph: 804-330-7990
Washington
  Anacortes
 Island Hospital Cancer Care Center at Island Hospital
 Saul Rivkin, MD
Ph: 206-386-2441
  Bellingham
 St. Joseph Cancer Center
 Saul Rivkin, MD
Ph: 206-386-2441
  Bremerton
 Olympic Hematology and Oncology
 Saul Rivkin, MD
Ph: 206-386-2441
  Burien
 Highline Medical Center Cancer Center
 Saul Rivkin, MD
Ph: 206-386-2441
  Centralia
 Providence Centralia Hospital
 Clinical Trials Office - Providence Centralia Hospital
Ph: 360-493-4300
  Federal Way
 St. Francis Hospital
 Yoshio Inoue
Ph: 253-944-7997
  Kennewick
 Columbia Basin Hematology
 Saul Rivkin, MD
Ph: 206-386-2441
  Mount Vernon
 Skagit Valley Hospital Cancer Care Center
 Saul Rivkin, MD
Ph: 206-386-2441
  Olympia
 Providence St. Peter Hospital Regional Cancer Center
 Yoshio Inoue
Ph: 360-493-7514
  Poulsbo
 Harrison Poulsbo Hematology and Onocology
 Saul Rivkin, MD
Ph: 206-386-2441
  Puyallup
 Good Samaritan Cancer Center
 Yoshio Inoue
Ph: 253-697-4000
  Seattle
 Fred Hutchinson Cancer Research Center
 Saul Rivkin, MD
Ph: 206-386-2441
 Group Health Central Hospital
 Clinical Trials Office - Group Health Central Hospital
Ph: 206-287-2900
 Harborview Medical Center
 Saul Rivkin, MD
Ph: 206-386-2441
 Minor and James Medical, PLLC
 Saul Rivkin, MD
Ph: 206-386-2441
 Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
 Saul Rivkin, MD
Ph: 206-386-2441
 University Cancer Center at University of Washington Medical Center
 Saul Rivkin, MD
Ph: 206-386-2441
  Sedro-Woolley
 North Puget Oncology at United General Hospital
 Saul Rivkin, MD
Ph: 206-386-2441
  Spokane
 Cancer Care Northwest - Spokane South
 Clinical Trials Office - Cancer Care Northwest - Spokane South
Ph: 509-228-1083
 Evergreen Hematology and Oncology, PS
 Saul Rivkin, MD
Ph: 206-386-2441
  Tacoma
 Allenmore Hospital
 Yoshio Inoue
Ph: 253-459-6446
 CCOP - Northwest
 Yoshio Inoue
Ph: 253-403-1461
 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
 Yoshio Inoue
Ph: 253-588-1711
  Vancouver
 Southwest Washington Medical Center Cancer Center
 Janet Ruzich
Ph: 360-514-2174
  Wenatchee
 Wenatchee Valley Medical Center
 Clinical Trials Office - Wenatchee Valley Medical Center
Ph: 509-665-5800
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: 920-884-3135
 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
  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
 Thomas Saphner, MD, FACP
Ph: 920-884-3135
  Oconto Falls
 Green Bay Oncology, Limited - Oconto Falls
 Thomas Saphner, MD, FACP
Ph: 920-884-3135
  Sheboygan
 St. Nicholas Hospital
 Thomas Saphner, MD, FACP
Ph: 920-884-3135
  Sturgeon Bay
 Green Bay Oncology, Limited - Sturgeon Bay
 Thomas Saphner, MD, FACP
Ph: 920-884-3135
  Wauwatosa
 Oncology Alliance, SC - Milwaukee - West
 Rubina Qamar
Ph: 414-476-8450
Wyoming
  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 2012-02-10
NCI Grant/Contract Number CA32102

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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