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Last Modified: 5/14/2009     First Published: 9/23/2006  
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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 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

500

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
 Pramod Vadlamani
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
  Little Rock
 Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
 Clinical Trial Office - Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Ph: 501-686-8274
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
 Peter Yu, MD
Ph: 408-524-5814
  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
Colorado
  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
  Montrose
 Montrose Memorial Hospital Cancer Center
 Clinical Trials Office - Montrose Memorial Hospital Cancer Center
Ph: 670-240-7267
Hawaii
  Aiea
 Kapiolani Medical Center at Pali Momi
 Jonathan Cho
Ph: 808-486-6000
  Honolulu
 Cancer Research Center of Hawaii
 Clinical Trials Office - Cancer Research Center of Hawaii
Ph: 808-586-2979
 Hawaii Medical Center - East
 Jonathan Cho
Ph: 808-547-6011
 Kapiolani Medical Center for Women and Children
 Jonathan Cho
Ph: 808-973-8511
 OnCare Hawaii, Incorporated - Kuakini
 Jonathan Cho
Ph: 808-531-8521
 OnCare Hawaii, Incorporated - Lusitana
 Jonathan Cho
Ph: 808-524-6115
 Queen's Cancer Institute at Queen's Medical Center
 Jonathan Cho
Ph: 808-545-8778
800-547-4742
 Straub Clinic and Hospital, Incorporated
 Jonathan Cho
Ph: 808-522-4000
800-232-9491
  Wailuku
 Pacific Cancer Institute - Maui
 Jonathan Cho
Ph: 808-242-2600
Idaho
  Coeur d'Alene
 Kootenai Cancer Center - Coeur d'Alene
 Clinical Trials Office - North Idaho Cancer Center
Ph: 208-666-3764
Illinois
  Alton
 Saint Anthony's Hospital at Saint Anthony's Health Center
 Bethany Sleckman, MD
Ph: 314-251-7057
  Aurora
 Rush-Copley Cancer Care Center
 Kendrith Rowland, MD
Ph: 217-383-3019
  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
  Decatur
 Decatur Memorial Hospital Cancer Care Institute
 Clinical Trials Office - Decatur Memorial Hospital Cancer Care Institute
Ph: 217-876-6601
  Elmhurst
 Elmhurst Memorial Hospital
 Gerald Kozuh, MD
Ph: 630-614-4060
  Harvey
 Ingalls Cancer Care Center at Ingalls Memorial Hospital
 Clinical Trials Office - Ingalls Cancer Care Center at Ingalls Memorial Hospital
Ph: 708-915-6747
  Joliet
 Joliet Oncology-Hematology Associates, Limited - West
 Kendrith Rowland, MD
Ph: 217-383-3019
  Mt. Vernon
 Good Samaritan Regional Health Center
 Bethany Sleckman, MD
Ph: 314-251-7057
  Rockford
 Swedish-American Regional Cancer Center
 Clinical Trials Office - Swedish-American Regional Cancer Center
Ph: 815-489-4413
  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
  Elkhart
 Elkhart General Hospital
 Rafat Ansari, MD, FACP
Ph: 574-234-5123
  Fort Wayne
 Fort Wayne Medical Oncology and Hematology
 Sreenivasa Nattam, MD
Ph: 260-484-8830
  Indianapolis
 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
 Kendrith Rowland, MD
Ph: 217-383-3019
  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
 Roscoe Morton, MD, FACP
Ph: 515-282-2921
 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: 515-282-2921
 Medical Oncology and Hematology Associates at Mercy Cancer Center
 Roscoe Morton, MD, FACP
Ph: 515-282-2921
 Mercy Cancer Center at Mercy Medical Center - Des Moines
 Roscoe Morton, MD, FACP
Ph: 515-282-2921
 Mercy Capitol Hospital
 Roscoe Morton, MD, FACP
Ph: 515-282-2921
  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
 Cedar Valley Medical Specialists, PC - West Ridgeway Avenue
 Boriana Kamenova
Ph: 319-833-5907
 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
 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
  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
 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
 Marianne Lange, MD
Ph: 616-977-6243
  Bay City
 Bay Regional Medical Center
 Clinical Trials Office - Bay Regional Medical Center
Ph: 989-667-6257
  Big Rapids
 Mecosta County Medical Center
 Marianne Lange, MD
Ph: 616-977-6243
  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
  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
 Marianne Lange, MD
Ph: 616-977-6243
 CCOP - Grand Rapids
 Marianne Lange, MD
Ph: 616-977-6243
 Lacks Cancer Center at Saint Mary's Health Care
 Marianne Lange, MD
Ph: 616-977-6243
  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
  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
  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
 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
  Midland
 MidMichigan Medical Center - Midland
 Clinical Trials Office - MidMichigan Medical Center - Midland
Ph: 989-839-3377
  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
 Ted B. Wahby Cancer Center at Mount Clemens General Hospital
 Clinical Trials Office - Ted B. Wahby Cancer Center at Mount Clemens General Hospital
Ph: 586-493-3426
  Muskegon
 Hackley Hospital
 Marianne Lange, MD
Ph: 616-977-6243
 Mercy General Health Partners
 Marianne Lange, MD
Ph: 616-977-6243
  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
  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
 Marianne Lange, MD
Ph: 616-977-6243
  Warren
 St. John Macomb Hospital
 Philip Stella, MD
Ph: 734-712-1000
  Wyoming
 Metro Health Hospital
 Marianne Lange, MD
Ph: 616-977-6243
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
  Fergus Falls
 Donald Jurgens
  Fridley
 Mercy and Unity Cancer Center at Unity Hospital
 Patrick Flynn, MD
Ph: 612-863-8585
  Hutchinson
 Hutchinson Area Health Care
 Daniel Anderson
Ph: 320-234-5000
800-454-3903
  Lichfield
 Meeker County Memorial Hospital
 Clinical Trials Office - Meeker County Memorial Hospital
Ph: 320-693-4520
  Maplewood
 HealthEast Cancer Care at St. John's Hospital
 Daniel Anderson
Ph: 651-232-7970
 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
 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: 320-252-5131
 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
 Daniel Anderson
Ph: 952-403-2031
  St. Paul
 Regions Hospital Cancer Care Center
 Clinical Trials Office - Regions Hospital Cancer Care Center
Ph: 651-254-1517
  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
  Cape Girardeau
 Saint Francis Medical Center
 Bethany Sleckman, MD
Ph: 314-251-7057
 Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
 Bethany Sleckman, MD
Ph: 314-251-7057
  Saint Louis
 Arch Medical Services, Incorporated at Center for Cancer Care and Research
 Alan Lyss, MD
Ph: 314-996-5514
 CCOP - St. Louis-Cape Girardeau
 Bethany Sleckman, MD
Ph: 314-251-7057
 David C. Pratt Cancer Center at St. John's Mercy
 Clinical Trials Office - David C. Pratt Cancer Center at St. John's Mercy
Ph: 314-251-6770
 Midwest Hematology Oncology Group, Incorporated
 Bethany Sleckman, MD
Ph: 314-251-7057
 Missouri Baptist Cancer Center
 Alan Lyss, MD
Ph: 314-996-5514
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
 Michael Naughton, MD
Ph: 314-996-8872
  Springfield
 CCOP - Cancer Research for the Ozarks
 Robert Carolla
Ph: 417-269-4520
 Hulston Cancer Center at Cox Medical Center South
 Robert Carolla
Ph: 417-269-5257
 St. John's Regional Health Center
 Robert Carolla
Ph: 417-820-2000
Montana
  Billings
 Billings Clinic - Downtown
 Clinical Trials Office - Billings Clinic - Downtown
Ph: 800-996-2663
 Email: research@billingsclinic.org
 CCOP - Montana Cancer Consortium
 Benjamin Marchello, MD
Ph: 406-238-6290
 Hematology-Oncology Centers of the Northern Rockies - Billings
 Benjamin Marchello, MD
Ph: 406-238-6290
 Northern Rockies Radiation Oncology Center
 Benjamin Marchello, MD
Ph: 406-238-6290
 St. Vincent Healthcare Cancer Care Services
 Benjamin Marchello, MD
Ph: 406-238-6290
  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
  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
 Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
 Clinical Trials Office - Cancer Institute of New Jersey
Ph: 732-235-8675
 Saint Peter's University Hospital
 Kathleen Toomey
Ph: 732-745-8600
  Trenton
 Capital Health Regional Cancer Center
 David Schaebler, MD
Ph: 609-771-0800
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
 Adirondack Cancer Care - Glens Falls
 Mark Hoffman, MD
Ph: 518-761-0000
 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
  Asheville
 Mission Hospitals - Memorial Campus
 Clinical Trials Office - Mission Hospitals - Memorial Campus
Ph: 828-213-4150
  Durham
 Duke Comprehensive Cancer Center
 Clinical Trials Office - Duke Comprehensive Cancer Center
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
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
  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
 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
 MetroHealth Cancer Care Center at MetroHealth Medical Center
 Bruce Averbook, MD, FACS
Ph: 216-778-4795
  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
 St. Rita's Medical Center
 Clinical Trials Office - St. Rita's Medical Center
Ph: 419-226-9617
  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
Oklahoma
  Tulsa
 Natalie Warren Bryant Cancer Center at St. Francis Hospital
 David Barnes, MD, FACS
Ph: 423-778-8582
Oregon
  Grants Pass
 Three Rivers Community Hospital
 Charles Dibb, MD
Ph: 541-774-5853
  Gresham
 Legacy Mount Hood Medical Center
 Clinical Trials Office - Legacy Mount Hood Medical Center
Ph: 503-413-2150
  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
 Keith Lanier, MD
Ph: 503-299-6500
  Portland
 Adventist Medical Center
 Keith Lanier, MD
Ph: 503-299-6500
 CCOP - Columbia River Oncology Program
 Keith Lanier, MD
Ph: 503-299-6500
 Legacy Emanuel Hospital and Health Center and Children's Hospital
 Clinical Trials Office - Legacy Emanuel Hospital and Health Center and Children's Hospital
Ph: 503-413-8199
 Legacy Good Samaritan Hospital & Comprehensive Cancer Center
 Clinical Trials Office - Legacy Good Samaritan Hospital & Comprehensive Cancer Center
Ph: 503-413-1742
 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
  Tualatin
 Legacy Meridian Park Hospital
 Clinical Trials Office - Legacy Meridian Park Hospital
Ph: 503-413-1742
Pennsylvania
  Bryn Mawr
 Bryn Mawr Hospital
 Clinical Trials Office - Bryn Mawr Hospital
Ph: 610-645-2680
  Ephrata
 Ephrata Cancer Center at Ephrata Community Hospital
 Allison Zibelli, MD
Ph: 215-923-5676
  Paoli
 Cancer Center of Paoli Memorial Hospital
 Clinical Trials Office - Cancer Center of Paoli Memorial Hospital
Ph: 610-648-1637
  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
  Scranton
 Hematology and Oncology Associates of Northeastern Pennsylvania
 Allison Zibelli, MD
Ph: 215-923-5676
  Wynnewood
 CCOP - Main Line Health
 Paul Gilman, MD
Ph: 610-645-2000
 Lankenau Cancer Center at Lankenau Hospital
 Paul Gilman, MD
Ph: 610-645-2000
Rhode Island
  Providence
 Miriam Hospital
 Clinical Trials Office - Miriam Hospital
Ph: 401-793-2224
 Rhode Island Hospital Comprehensive Cancer Center
 Clinical Trials Office - Rhode Island Hospital Comprehensive Cancer Center
Ph: 401-444-1488
South Carolina
  Charleston
 Roper St. Francis Cancer Center at Roper Hospital
 James Orcutt, MD
Ph: 843-577-2276
  Greenville
 CCOP - Greenville
 Jeffrey Giguere, MD, FACP
Ph: 864-987-7000
South Dakota
  Aberdeen
 Oncology Services of Aberdeen
 Richard Conklin, MD
Ph: 605-622-5613
Tennessee
  Knoxville
 U.T. Medical Center Cancer Institute
 Clinical Trials Office - U.T. Medical Center Cancer Institute
Ph: 865-544-9773
  Nashville
 MBCCOP - Meharry Medical College - Nashville
 Steven Wolff, MD
Ph: 615-327-6277
 Nashville Oncology Associates, PC
 Steven Wolff, MD
Ph: 615-327-6277
Texas
  Dallas
 Medical City Dallas Hospital
 Barry Mirtsching, MD
Ph: 972-566-5588
  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
 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
 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
  Bellingham
 St. Joseph Cancer Center
 Saul Rivkin, MD
Ph: 206-386-2441
  Bremerton
 Olympic Hematology and Oncology
 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
 Lauren Colman, MD
Ph: 253-403-1677
  Kennewick
 Columbia Basin Hematology
 Saul Rivkin, MD
Ph: 206-386-2441
  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
  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
 Polyclinic First Hill
 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
 Clinical Trials Office - University Cancer Center at University of Washington Medical Center
Ph: 206-616-8289
  Spokane
 Cancer Care Northwest - Spokane South
 Clinical Trials Office - Cancer Care Northwest - Spokane South
Ph: 509-228-1083
  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
 Keith Lanier, MD
Ph: 503-299-6500
West Virginia
  Parkersburg
 Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital
 Clinical Trials Office - Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital
Ph: 304-424-2585
Wisconsin
  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

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 2009-05-14
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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