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Last Modified: 11/27/2008     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

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

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.
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
 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
  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
Florida
  Lakeland
 Lakeland Regional Cancer Center at Lakeland Regional Medical Center
 James Jakub
Ph: 863-904-1900
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
  Bloomington
 St. Joseph Medical Center
 John Kugler, MD
Ph: 309-243-3605
  Canton
 Graham Hospital
 John Kugler, MD
Ph: 309-243-3605
  Carthage
 Memorial Hospital
 John Kugler, MD
Ph: 309-243-3605
  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
  Eureka
 Eureka Community Hospital
 John Kugler, MD
Ph: 309-243-3605
  Galesburg
 Galesburg Clinic, PC
 John Kugler, MD
Ph: 309-243-3605
 Galesburg Cottage Hospital
 John Kugler, MD
Ph: 309-243-3605
  Harvey
 Ingalls Cancer Care Center at Ingalls Memorial Hospital
 Clinical Trials Office - Ingalls Cancer Care Center at Ingalls Memorial Hospital
Ph: 708-915-6747
  Havana
 Mason District Hospital
 John Kugler, MD
Ph: 309-243-3605
  Hopedale
 Hopedale Medical Complex
 John Kugler, MD
Ph: 309-243-3605
  Macomb
 McDonough District Hospital
 John Kugler, MD
Ph: 309-243-3605
  Mt. Vernon
 Good Samaritan Regional Health Center
 Bethany Sleckman, MD
Ph: 314-251-7057
  Normal
 BroMenn Regional Medical Center
 John Kugler, MD
Ph: 309-243-3605
 Community Cancer Center
 John Kugler, MD
Ph: 309-243-3605
 Mid-Illinois Hematology-Oncology Associates at Community Cancer Center
 John Migas, MD
Ph: 309-451-2207
  Ottawa
 Community Hospital of Ottawa
 John Kugler, MD
Ph: 309-243-3605
 Oncology Hematology Associates of Central Illinois, PC - Ottawa
 John Kugler, MD
Ph: 309-243-3605
  Pekin
 Cancer Treatment Center at Pekin Hospital
 John Kugler, MD
Ph: 309-243-3605
  Peoria
 CCOP - Illinois Oncology Research Association
 John Kugler, MD
Ph: 309-243-3605
 Methodist Medical Center of Illinois
 Clinical Trials Office - Methodist Medical Center of Illinois
Ph: 309-243-3000
 Oncology Hematology Associates of Central Illinois, PC - Peoria
 John Kugler, MD
Ph: 309-243-3605
 OSF St. Francis Medical Center
 John Kugler, MD
Ph: 309-243-3605
 Proctor Hospital
 John Kugler, MD
Ph: 309-243-3605
  Peru
 Illinois Valley Community Hospital
 John Kugler, MD
Ph: 309-243-3605
  Princeton
 Perry Memorial Hospital
 John Kugler, MD
Ph: 309-243-3605
  Spring Valley
 St. Margaret's Hospital
 John Kugler, MD
Ph: 309-243-3605
  Springfield
 Regional Cancer Center at Memorial Medical Center
 Clinical Trials Office - Regional Cancer Center at Memorial Medical Center
Ph: 217-788-4233
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
  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
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