AzTrials
AzTrials

Breast CancerPhase 3NCT00382018

S0500 Treatment Decision Making Based on Blood Levels of Tumor Cells for Metastatic Breast Cancer Treated With Chemo

A Phase 3 study testing chemotherapy in people with Breast Cancer, run by SWOG Cancer Research Network at 296 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Measuring blood levels of tumor cells may help in learning how well chemotherapy works to kill metastatic breast cancer cells and allow doctors to plan better… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
624 participants
Where
296 sitesUnited States
Study dates
Oct 2006to 11 Jul 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

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

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

Trial locations and contacts

296 sites in 1 country.

296 sites in 1 country

United States296 sites

  • Kapiolani Medical Center at Pali Momi

    ‘Aiea, Hawaii, 96701

  • Hickman Cancer Center at Bixby Medical Center

    Adrian, Michigan, 49221

  • San Luis Valley Regional Medical Center

    Alamosa, Colorado, 81101

  • Lovelace Medical Center - Downtown

    Albuquerque, New Mexico, 87102

  • Hematology Oncology Associates, PC

    Albuquerque, New Mexico, 87106

  • Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital

    Albuquerque, New Mexico, 87110

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87131-5636

  • Study site

    Alexandria, Minnesota, 56308

  • American Fork Hospital

    American Fork, Utah, 84003

  • McFarland Clinic, PC

    Ames, Iowa, 50010

  • Island Hospital Cancer Care Center at Island Hospital

    Anacortes, Washington, 98221

  • Alaska Regional Hospital Cancer Center

    Anchorage, Alaska, 99508

  • Providence Cancer Center

    Anchorage, Alaska, 99508

  • Saint Joseph Mercy Cancer Center

    Ann Arbor, Michigan, 48106-0995

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0942

  • Regional Medical Center

    Anniston, Alabama, 36207

  • University of Colorado Cancer Center at UC Health Sciences Center

    Aurora, Colorado, 80045

  • Rush-Copley Cancer Care Center

    Aurora, Illinois, 60504

  • Alvin and Lois Lapidus Cancer Institute at Sinai Hospital

    Baltimore, Maryland, 21215

  • Battle Creek Health System Cancer Care Center

    Battle Creek, Michigan, 49017

  • Bay Regional Medical Center

    Bay City, Michigan, 48708

  • Cleveland Clinic Beachwood Family Health and Surgery Center

    Beachwood, Ohio, 44122

  • St. Joseph Cancer Center

    Bellingham, Washington, 98225

  • St. Charles Medical Center - Bend

    Bend, Oregon, 97701

  • Mecosta County Medical Center

    Big Rapids, Michigan, 49307

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • St. Vincent Healthcare Cancer Care Services

    Billings, Montana, 59101

  • Hematology-Oncology Centers of the Northern Rockies - Billings

    Billings, Montana, 59102

  • Billings Clinic - Downtown

    Billings, Montana, 59107-7000

  • Bismarck Cancer Center

    Bismarck, North Dakota, 58501

  • Medcenter One Hospital Cancer Care Center

    Bismarck, North Dakota, 58501

  • Mid Dakota Clinic, PC

    Bismarck, North Dakota, 58501

  • St. Alexius Medical Center Cancer Center

    Bismarck, North Dakota, 58502

  • Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center

    Boise, Idaho, 83706

  • Central Care Cancer Center at Carrie J. Babb Cancer Center

    Bolivar, Missouri, 65613

  • Wood County Oncology Center

    Bowling Green, Ohio, 43402

  • Bozeman Deaconess Cancer Center

    Bozeman, Montana, 59715

  • Olympic Hematology and Oncology

    Bremerton, Washington, 98310

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Highline Medical Center Cancer Center

    Burien, Washington, 98166

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • St. James Healthcare Cancer Care

    Butte, Montana, 59701

  • Southeast Cancer Center

    Cape Girardeau, Missouri, 63703

  • Sandra L. Maxwell Cancer Center

    Cedar City, Utah, 84720

  • Providence Centralia Hospital

    Centralia, Washington, 98531-9027

  • Roper St. Francis Cancer Center at Roper Hospital

    Charleston, South Carolina, 29401

  • Resurrection Medical Center

    Chicago, Illinois, 60631

  • Louis A. Weiss Memorial Hospital

    Chicago, Illinois, 60640

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

  • Cleveland Clinic Cancer Center at Fairview Hospital

    Cleveland, Ohio, 44111

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Mercy and Unity Cancer Center at Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Bay Area Hospital

    Coos Bay, Oregon, 97420

  • Danville Regional Medical Center

    Danville, Virginia, 24541

  • Oakwood Cancer Center at Oakwood Hospital and Medical Center

    Dearborn, Michigan, 48123-2500

  • Veterans Affairs Medical Center - Denver

    Denver, Colorado, 80220

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

  • Josephine Ford Cancer Center at Henry Ford Hospital

    Detroit, Michigan, 48202

  • Duke Cancer Institute

    Durham, North Carolina, 27710

  • Cancer Centers of the Carolinas - Easley

    Easley, South Carolina, 29640

  • CCOP - Hematology-Oncology Associates of Central New York

    East Syracuse, New York, 13057

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Shaw Regional Cancer Center

    Edwards, Colorado, 81632

  • Elkhart Clinic, LLC

    Elkhart, Indiana, 46514-2098

  • Michiana Hematology-Oncology, PC - Elkhart

    Elkhart, Indiana, 46514

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Elmhurst Memorial Hospital

    Elmhurst, Illinois, 60126

  • Community Cancer Center

    Elyria, Ohio, 44035

  • Hematology Oncology Center

    Elyria, Ohio, 44035

  • Ephrata Cancer Center at Ephrata Community Hospital

    Ephrata, Pennsylvania, 17522

  • Green Bay Oncology, Limited - Escanaba

    Escanaba, Michigan, 49431

  • St. Francis Hospital

    Federal Way, Washington, 98003

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Fredericksburg Oncology, Incorporated

    Fredericksburg, Virginia, 22401

  • Mercy and Unity Cancer Center at Unity Hospital

    Fridley, Minnesota, 55432

  • Glendale Memorial Hospital Comprehensive Cancer Center

    Glendale, California, 91204

  • Valley View Hospital Cancer Center

    Glenwood Springs, Colorado, 81601

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • Altru Cancer Center at Altru Hospital

    Grand Forks, North Dakota, 58201

  • St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center

    Grand Junction, Colorado, 81502

  • Butterworth Hospital at Spectrum Health

    Grand Rapids, Michigan, 49503

  • CCOP - Grand Rapids

    Grand Rapids, Michigan, 49503

  • Lacks Cancer Center at Saint Mary's Health Care

    Grand Rapids, Michigan, 49503

  • Three Rivers Community Hospital

    Grants Pass, Oregon, 97527

  • Big Sky Oncology

    Great Falls, Montana, 59405-5309

  • Great Falls Clinic - Main Facility

    Great Falls, Montana, 59405

  • Sletten Cancer Institute at Benefis Healthcare

    Great Falls, Montana, 59405

  • Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54301-3526

  • Green Bay Oncology, Limited at St. Mary's Hospital

    Green Bay, Wisconsin, 54303

  • St. Mary's Hospital Medical Center - Green Bay

    Green Bay, Wisconsin, 54303

  • St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54307-3508

  • California Cancer Care, Incorporated - Greenbrae

    Greenbrae, California, 94904

  • Cancer Centers of the Carolinas - Faris Road

    Greenville, South Carolina, 29605

  • Cancer Centers of the Carolinas - Grove Commons

    Greenville, South Carolina, 29605

  • Greenville Hospital Cancer Center

    Greenville, South Carolina, 29605

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • Cancer Centers of the Carolinas - Greer Medical Oncology

    Greer, South Carolina, 29650

  • Van Elslander Cancer Center at St. John Hospital and Medical Center

    Grosse Pointe Woods, Michigan, 48236

  • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

    Hartford, Connecticut, 06105

  • Ingalls Cancer Care Center at Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Northern Montana Hospital

    Havre, Montana, 59501

  • St. Peter's Hospital

    Helena, Montana, 59601

  • Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

  • Cancer Research Center of Hawaii

    Honolulu, Hawaii, 96813

  • OnCare Hawaii, Incorporated - Lusitana

    Honolulu, Hawaii, 96813

  • Queen's Cancer Institute at Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Straub Clinic and Hospital, Incorporated

    Honolulu, Hawaii, 96813

  • Hawaii Medical Center - East

    Honolulu, Hawaii, 96817

  • OnCare Hawaii, Incorporated - Kuakini

    Honolulu, Hawaii, 96817

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

  • Tripler Army Medical Center

    Honolulu, Hawaii, 96859

  • M. D. Anderson Cancer Center at University of Texas

    Houston, Texas, 77030-4009

  • Hutchinson Area Health Care

    Hutchinson, Minnesota, 55350

  • Cleveland Clinic Cancer Center

    Independence, Ohio, 44131

  • Community Regional Cancer Care at Community Hospital North

    Indianapolis, Indiana, 46256

  • St. Vincent Indianapolis Hospital

    Indianapolis, Indiana, 46260

  • Dickinson County Healthcare System

    Iron Mountain, Michigan, 49801

  • Foote Memorial Hospital

    Jackson, Michigan, 49201

  • University of Mississippi Cancer Clinic

    Jackson, Mississippi, 39216

  • West Tennessee Cancer Center at Jackson-Madison County General Hospital

    Jackson, Tennessee, 38301

  • Goldschmidt Cancer Center

    Jefferson City, Missouri, 65109

  • NEA Medical Center - Stadium Boulevard

    Jonesboro, Arkansas, 72401

  • Borgess Medical Center

    Kalamazoo, Michigan, 49001

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007-3731

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • Glacier Oncology, PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology at KRMC

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Good Samaritan Cancer Center at Good Samaritan Hospital

    Kearney, Nebraska, 68848-1990

  • Columbia Basin Hematology

    Kennewick, Washington, 99336

  • Kinston Medical Specialists

    Kinston, North Carolina, 28501

  • Howard Community Hospital

    Kokomo, Indiana, 46904

  • Gundersen Lutheran Center for Cancer and Blood

    La Crosse, Wisconsin, 54601

  • Center for Cancer Therapy at LaPorte Hospital and Health Services

    La Porte, Indiana, 46350

  • Breslin Cancer Center at Ingham Regional Medical Center

    Lansing, Michigan, 48910

  • Sparrow Regional Cancer Center

    Lansing, Michigan, 48912-1811

  • University of New Mexico Cancer Center - South

    Las Cruces, New Mexico, 88011

  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756-0002

  • St. Rita's Medical Center

    Lima, Ohio, 45801

  • Lima Memorial Hospital

    Lima, Ohio, 45804

  • St. Mary Mercy Hospital

    Livonia, Michigan, 48154

  • Logan Regional Hospital

    Logan, Utah, 84321

  • Loma Linda University Cancer Institute at Loma Linda University Medical Center

    Loma Linda, California, 92354

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90089-9181

  • Southeastern Regional Medical Center

    Lumberton, North Carolina, 28359

  • Holy Family Memorial Medical Center Cancer Care Center

    Manitowoc, Wisconsin, 54221-1450

  • HealthEast Cancer Care at St. John's Hospital

    Maplewood, Minnesota, 55109

  • Minnesota Oncology Hematology, PA - Maplewood

    Maplewood, Minnesota, 55109

  • Bay Area Cancer Care Center at Bay Area Medical Center

    Marinette, Wisconsin, 54143

  • Northwest Ohio Oncology Center

    Maumee, Ohio, 43537-1839

  • Hillcrest Cancer Center at Hillcrest Hospital

    Mayfield Heights, Ohio, 44124

  • Dubs Cancer Center at Rogue Valley Medical Center

    Medford, Oregon, 97504

  • Providence Cancer Center at PMCC

    Medford, Oregon, 97504

  • Saint Anthony Memorial Health Centers

    Michigan City, Indiana, 46360

  • Providence Milwaukie Hospital

    Milwaukie, Oregon, 97222

  • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center - Minneapolis

    Minneapolis, Minnesota, 55415

  • Michiana Hematology-Oncology, PC - South Bend

    Mishawaka, Indiana, 46545-1470

  • Saint Joseph Regional Medical Center

    Mishawaka, Indiana, 46545-1470

  • Montana Cancer Specialists at Montana Cancer Center

    Missoula, Montana, 59807-7877

  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

    Missoula, Montana, 59807

  • Community Cancer Center of Monroe

    Monroe, Michigan, 48162

  • Mercy Memorial Hospital - Monroe

    Monroe, Michigan, 48162

  • Montrose Memorial Hospital Cancer Center

    Montrose, Colorado, 81401

  • Clemens Regional Medical Center

    Mount Clemens, Michigan, 48043

  • Skagit Valley Hospital Cancer Care Center

    Mount Vernon, Washington, 98274

  • Camino Medical Group - Treatment Center

    Mountain View, California, 94040

  • Cancer Center at Ball Memorial Hospital

    Muncie, Indiana, 47303-3499

  • Jon and Karen Huntsman Cancer Center at Intermountain Medical Center

    Murray, Utah, 84157

  • Mercy General Health Partners

    Muskegon, Michigan, 49443

  • Saint Peter's University Hospital

    New Brunswick, New Jersey, 08901

  • Yale Cancer Center

    New Haven, Connecticut, 06520-8028

  • UMDNJ University Hospital

    Newark, New Jersey, 07103

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

  • Providence Newberg Medical Center

    Newberg, Oregon, 97132

  • Fisher-Titus Medical Center

    Norwalk, Ohio, 44857

  • Green Bay Oncology, Limited - Oconto Falls

    Oconto Falls, Wisconsin, 54154

  • Val and Ann Browning Cancer Center at McKay-Dee Hospital Center

    Ogden, Utah, 84403

  • Providence St. Peter Hospital Regional Cancer Center

    Olympia, Washington, 98506-5166

  • St. Charles Mercy Hospital

    Oregon, Ohio, 43616

  • Toledo Clinic - Oregon

    Oregon, Ohio, 43616

  • Willamette Falls Hospital

    Oregon City, Oregon, 97045

  • Florida Hospital Cancer Institute at Florida Hospital Orlando

    Orlando, Florida, 32803-1273

  • Granville Medical Center

    Oxford, North Carolina, 27565

  • Palo Alto Medical Foundation

    Palo Alto, California, 94301

  • Parma Community General Hospital

    Parma, Ohio, 44129

  • Regional Cancer Center at Singing River Hospital

    Pascagoula, Mississippi, 39581

  • St. Joseph's Hospital and Medical Center

    Paterson, New Jersey, 07503

  • Fox Chase Cancer Center - Philadelphia

    Philadelphia, Pennsylvania, 19111-2497

  • Cancer Center at Phoenixville Hospital

    Phoenixville, Pennsylvania, 19460

  • UPMC Cancer Centers

    Pittsburgh, Pennsylvania, 15232

  • Michiana Hematology Oncology PC - Plymouth

    Plymouth, Indiana, 46563

  • St. Joseph Mercy Oakland

    Pontiac, Michigan, 48341-2985

  • Mercy Regional Cancer Center at Mercy Hospital

    Port Huron, Michigan, 48060

  • Mercy Hospital

    Portland, Maine, 04101

  • Providence Cancer Center at Providence Portland Medical Center

    Portland, Oregon, 97213-2967

  • CCOP - Columbia River Oncology Program

    Portland, Oregon, 97225

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

  • Harrison Poulsbo Hematology and Onocology

    Poulsbo, Washington, 98370

  • Utah Valley Regional Medical Center - Provo

    Provo, Utah, 84604

  • Good Samaritan Cancer Center

    Puyallup, Washington, 98372

  • Duke Health Raleigh Hospital

    Raleigh, North Carolina, 27609

  • McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center

    Reading, Pennsylvania, 19612-6052

  • Spectrum Health Reed City Hospital

    Reed City, Michigan, 49677

  • Virginia Cancer Institute - West End

    Richmond, Virginia, 23230

  • Humphrey Cancer Center at North Memorial Outpatient Center

    Robbinsdale, Minnesota, 55422-2900

  • Swedish-American Regional Cancer Center

    Rockford, Illinois, 61104-2315

  • Person Memorial Hospital

    Roxboro, North Carolina, 27573

  • William Beaumont Hospital - Royal Oak Campus

    Royal Oak, Michigan, 48073

  • Seton Cancer Institute at Saint Mary's - Saginaw

    Saginaw, Michigan, 48601

  • CentraCare Clinic - River Campus

    Saint Cloud, Minnesota, 56303

  • Coborn Cancer Center

    Saint Cloud, Minnesota, 56303

  • Lakeland Regional Cancer Care Center - St. Joseph

    Saint Joseph, Michigan, 49085

  • Lakeside Cancer Specialists, PLLC

    Saint Joseph, Michigan, 49085

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • Park Nicollet Cancer Center

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital Cancer Care Center

    Saint Paul, Minnesota, 55101

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Tammy Walker Cancer Center at Salina Regional Health Center

    Salina, Kansas, 67401

  • Utah Cancer Specialists at UCS Cancer Center

    Salt Lake City, Utah, 84106

  • LDS Hospital

    Salt Lake City, Utah, 84143

  • Veterans Affairs Medical Center - San Antonio (Murphy)

    San Antonio, Texas, 78209

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229-3900

  • Cancer Therapy and Research Center

    San Antonio, Texas, 78229

  • University Hospital - San Antonio

    San Antonio, Texas, 78229

  • North Coast Cancer Care, Incorporated

    Sandusky, Ohio, 44870

  • Guthrie Cancer Center at Guthrie Clinic Sayre

    Sayre, Pennsylvania, 18840

  • Hematology and Oncology Associates of Northeastern Pennsylvania

    Scranton, Pennsylvania, 18508

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Minor and James Medical, PLLC

    Seattle, Washington, 98104

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

  • Group Health Central Hospital

    Seattle, Washington, 98112

  • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

    Seattle, Washington, 98122-4307

  • University Cancer Center at University of Washington Medical Center

    Seattle, Washington, 98195

  • North Puget Oncology at United General Hospital

    Sedro-Woolley, Washington, 98284

  • Cancer Centers of the Carolinas - Seneca

    Seneca, South Carolina, 29672

  • St. Francis Cancer Center at St. Francis Medical Center

    Shakopee, Minnesota, 55379

  • St. Nicholas Hospital

    Sheboygan, Wisconsin, 53081

  • Welch Cancer Center at Sheridan Memorial Hospital

    Sheridan, Wyoming, 82801

  • Siouxland Hematology-Oncology Associates, LLP

    Sioux City, Iowa, 51101

  • Mercy Medical Center - Sioux City

    Sioux City, Iowa, 51102

  • St. Luke's Regional Medical Center

    Sioux City, Iowa, 51104

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana, 46601

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Providence Cancer Institute at Providence Hospital - Southfield Campus

    Southfield, Michigan, 48075

  • Cancer Centers of the Carolinas - Spartanburg

    Spartanburg, South Carolina, 29307

  • Cancer Care Northwest - Spokane South

    Spokane, Washington, 99202

  • Evergreen Hematology and Oncology, PS

    Spokane, Washington, 99218

  • CCOP - Cancer Research for the Ozarks

    Springfield, Missouri, 65802

  • St. John's Regional Health Center

    Springfield, Missouri, 65804

  • Hulston Cancer Center at Cox Medical Center South

    Springfield, Missouri, 65807

  • Missouri Baptist Cancer Center

    St Louis, Missouri, 63131

  • Comprehensive Cancer Care, PC

    St Louis, Missouri, 63141

  • Dixie Regional Medical Center - East Campus

    St. George, Utah, 84770

  • Stanford Cancer Center

    Stanford, California, 94305-5824

  • Lakeview Hospital

    Stillwater, Minnesota, 55082

  • Cleveland Clinic Foundation - Strongsville

    Strongsville, Ohio, 44136

  • Green Bay Oncology, Limited - Sturgeon Bay

    Sturgeon Bay, Wisconsin, 54235

  • Flower Hospital Cancer Center

    Sylvania, Ohio, 43560

  • Franciscan Cancer Center at St. Joseph Medical Center

    Tacoma, Washington, 98405-3004

  • Allenmore Hospital

    Tacoma, Washington, 98405

  • CCOP - Northwest

    Tacoma, Washington, 98405

  • MultiCare Regional Cancer Center at Tacoma General Hospital

    Tacoma, Washington, 98405

  • St. Clare Hospital

    Tacoma, Washington, 98499

  • CCOP - Scott and White Hospital

    Temple, Texas, 76508

  • Albert Einstein Cancer Center at Albert Einstein College of Medicine

    The Bronx, New York, 10461

  • Mercy Hospital of Tiffin

    Tiffin, Ohio, 44883

  • Toledo Hospital

    Toledo, Ohio, 43606

  • St. Vincent Mercy Medical Center

    Toledo, Ohio, 43608

  • Medical University of Ohio Cancer Center

    Toledo, Ohio, 43614

  • CCOP - Toledo Community Hospital

    Toledo, Ohio, 43617

  • St. Anne Mercy Hospital

    Toledo, Ohio, 43623

  • Toledo Clinic, Incorporated - Main Clinic

    Toledo, Ohio, 43623

  • Cotton-O'Neil Cancer Center

    Topeka, Kansas, 66606

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • Natalie Warren Bryant Cancer Center at St. Francis Hospital

    Tulsa, Oklahoma, 74136

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • Faxton Regional Cancer Center

    Utica, New York, 13502

  • Pearlman Comprehensive Cancer Center at South Georgia Medical Center

    Valdosta, Georgia, 31602

  • Southwest Washington Medical Center Cancer Center

    Vancouver, Washington, 98664

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • Maui Memorial Medical Center

    Wailuku, Hawaii, 96793

  • Pacific Cancer Institute - Maui

    Wailuku, Hawaii, 96793

  • St. John Macomb Hospital

    Warren, Michigan, 48093

  • Covenant Cancer Treatment Center

    Waterloo, Iowa, 50702

  • Fulton County Health Center

    Wauseon, Ohio, 43567

  • Oncology Alliance, SC - Milwaukee - West

    Wauwatosa, Wisconsin, 53226

  • Wenatchee Valley Medical Center

    Wenatchee, Washington, 98801-2028

  • Michiana Hematology Oncology PC - La Porte

    Westville, Indiana, 46391

  • Dickstein Cancer Treatment Center at White Plains Hospital Center

    White Plains, New York, 10601

  • Willmar Cancer Center at Rice Memorial Hospital

    Willmar, Minnesota, 56201

  • Minnesota Oncology Hematology, PA - Woodbury

    Woodbury, Minnesota, 55125

  • Cleveland Clinic - Wooster

    Wooster, Ohio, 44691

  • Saint Vincent Hospital at Worcester Medical Center

    Worcester, Massachusetts, 01608

Other trials in United States

About this study

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

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Measuring blood levels of tumor cells may help in learning how well chemotherapy works to kill metastatic breast cancer cells and allow doctors to plan better treatment. When blood levels of tumor cells are high while receiving chemotherapy, it is not yet known whether it is more effective to change chemotherapy regimens at that time or wait until disease progression.

PURPOSE: This randomized phase III trial is studying treatment decision making based on blood levels of tumor cells in women with metastatic breast cancer receiving chemotherapy.

Read the detailed description

OBJECTIVES:

Primary

  • 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.
  • 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.
  • 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.
  • Determine the prognostic value of sequentially collected CTC values in these patients.
  • Compare toxicity between patients with and without elevated CTCs after 3 weeks of first-line chemotherapy AND between the two randomized treatment arms.

Secondary

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

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.

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

Conditions
Breast Cancer
Being tested
chemotherapy
Keywords
recurrent breast cancer, stage IV breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • chemotherapyDrug

    No administration details available

Study groups in NCT00382018
Study groupRoleWhat they receive
Group 1Active comparatorPatients 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.
Receives: Drug: chemotherapy
Group 2ExperimentalPatients continue to receive their current chemotherapy regimen without change.
Receives: Drug: chemotherapy
Group 3, Arm IActive comparatorPatients continue with their current chemotherapy regimen without change.
Receives: Drug: chemotherapy
Group 3, Arm IIExperimentalPatients switch to a different chemotherapy regimen. Selection of a new chemotherapy regimen is made by the patient's doctor.
Receives: Drug: chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.

    Measured: Every 3 months until progression then every 6 months for 5 years or until death

  2. Progression-free Survival

    Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

    Measured: every 3 months until progression. From date of registration to date of first documentation of progressive disease, death due to any cause or symptomatic deterioration, whichever occurs first, assessed up to five years.

  3. Progression Free Survival

    From date of registration to date of first documentation of progressive disease, death due to any cause or symptomatic deterioration, whichever occurs first. Patients last known to be alive and progression-free are censored at date of last contact.

    Measured: every 3 months until progression

Secondary outcomes (1)

  1. Number of Patients With Adverse Events That Are Related to Study Drugs

    Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.

    Measured: Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2006 (estimated)
  2. Study startOct 2006
  3. Primary completionDec 2015
  4. Study completion11 Jul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
624 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00382018
Sponsor's protocol ID
CDR0000504319
Other IDs
S0500, U10CA032102
Status last verified
Oct 2017
First submitted
26 Sep 2006
Last updated
6 Nov 2017
Data monitoring committee
Yes

Publications

  • Smerage JB, Barlow WE, Hortobagyi GN, Winer EP, Leyland-Jones B, Srkalovic G, Tejwani S, Schott AF, O'Rourke MA, Lew DL, Doyle GV, Gralow JR, Livingston RB, Hayes DF. Circulating tumor cells and response to chemotherapy in metastatic breast cancer: SWOG S0500. J Clin Oncol. 2014 Nov 1;32(31):3483-9. doi: 10.1200/JCO.2014.56.2561. Epub 2014 Jun 2.

    PubMed 24888818

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing chemotherapy in people with Breast Cancer, run by SWOG Cancer Research Network at 296 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 296 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: Every 3 months until progression then every 6 months for 5 years or until death). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00382018, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.

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