Comparison of Combination Chemotherapy Regimens in Treating Older Women Who Have Undergone Surgery for Breast Cancer

A Randomized Trial of Adjuvant Chemotherapy With Standard Regimens, Cyclophosphamide, Methotrexate and Fluorouracil - (CMF) or Doxorubicin and Cyclophosphamide - (AC), Versus Capecitabine in Women 65 Years and Older With Node Positive or Node-Negative Breast Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them in different ways after surgery may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective in treating older women with breast cancer.

PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens to see how well they work in treating older women who have undergone surgery for breast cancer.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Standard Treatment; Drug: capecitabine

Detailed Description

OBJECTIVES:

• Compare the effectiveness of adjuvant chemotherapy comprising standard cyclophosphamide, methotrexate, and fluorouracil (CMF) or doxorubicin and cyclophosphamide (AC) vs oral capecitabine, in terms of disease-free and overall survival, in elderly women with operable adenocarcinoma of the breast.
• Compare the quality of life and physical functioning of patients treated with these regimens.
• Compare the toxicity of these regimens in these patients.
• Evaluate the adherence of older patients to an oral chemotherapy regimen.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (65 to 69 vs 70 to 80 vs over 80), performance status (0-1 vs 2), and HER2 status (positive vs negative vs unknown). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients with insufficient left ventricular ejection fraction (LVEF) are assigned to group A. Patients with normal LVEF are assigned to group A or B based on physician/patient choice.

  • Group A (CMF): Patients receive oral cyclophosphamide (CTX) daily on days 1-14 and methotrexate IV and fluorouracil IV on days 1 and 8. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
  • Group B (AC): Patients receive doxorubicin IV and CTX IV on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
• Arm II: Patients receive oral capecitabine twice daily on days 1-14. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

Beginning within 12 weeks after treatment in arm I or II, patients with estrogen or progesterone receptor-positive disease receive oral tamoxifen or an aromatase inhibitor daily for 5 years.

Beginning 4-6 weeks after treatment in arm I or II, eligible patients who previously underwent breast conservation surgery undergo radiotherapy.

Quality of life is assessed at baseline; at 6 weeks (group B), 9 weeks (arm II), or 12 weeks (group A); and then at 1, 12, 18, and 24 months after study.

Drug adherence is assessed at 9 weeks during study (arm II).

Patients are followed at 1 month, every 6 months for 2 years, and then annually for 15 years.

PROJECTED ACCRUAL: A total of 600-1,800 patients (300-900 per treatment arm) will be accrued for this study within 2-6 years.

• Study Type: Interventional
• Enrollment (Actual): 633
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Tom Baker Cancer Centre - Calgary
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute at University of Alberta
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0V9
      • CancerCare Manitoba
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X5
      • Mount Sinai Hospital - Toronto
    • Windsor, Ontario, Canada, N8W 2X3
      • Windsor Regional Cancer Centre at Windsor Regional Hospital
  • Prince Edward Island
    • Charlottetown, Prince Edward Island, Canada, C1A 8T5
      • Prince Edward Island Cancer Centre at Queen Elizabeth Hospital
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4T 7T1
      • Allan Blair Cancer Centre at Pasqua Hospital
• Peru
  • Lima, Peru, Lima 34
    • Instituto Nacional de Enfermedades Neoplasicas
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham Comprehensive Cancer Center
    • Mobile, Alabama, United States, 36652-2144
      • Mobile Infirmary Medical Center
  • Arizona
    • Scottsdale, Arizona, United States, 85259-5499
      • Mayo Clinic Scottsdale
    • Tucson, Arizona, United States, 85724-5024
      • Arizona Cancer Center at University of Arizona Health Sciences Center
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • St. Joseph's Mercy Cancer Center
  • California
    • Glendale, California, United States, 91204
      • Glendale Memorial Hospital Comprehensive Cancer Center
    • Hayward, California, United States, 94545
      • Saint Rose Hospital
    • La Jolla, California, United States, 92093-0658
      • Moores UCSD Cancer Center
    • Los Angeles, California, United States, 90089-9181
      • USC/Norris Comprehensive Cancer Center and Hospital
    • Northridge, California, United States, 91328
      • Leavey Cancer Center at Northridge Hospital Medical Center
    • Oakland, California, United States, 94609
      • Alta Bates Summit Medical Center - Summit Campus
    • Oakland, California, United States, 94609
      • CCOP - Bay Area Tumor Institute
    • Oakland, California, United States, 94602
      • Highland General Hospital at St. George's University School of Medicine
    • Pleasanton, California, United States, 94588
      • Valley Care Medical Center
    • Salinas, California, United States, 93901
      • Salinas Valley Memorial Hospital
    • San Diego, California, United States, 92120
      • Kaiser Permanente Medical Office -Vandever Medical Office
    • San Pablo, California, United States, 94806
      • Doctors Medical Center - San Pablo Campus
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • Memorial Hospital
  • Connecticut
    • Norwich, Connecticut, United States, 06360
      • Eastern Connecticut Hematology and Oncology Associates
  • Delaware
    • Dover, Delaware, United States, 19901
      • Kent General Hospital at Bayhealth Medical Center
    • Newark, Delaware, United States, 19713
      • CCOP - Christiana Care Health Services
  • District of Columbia
    • Washington, District of Columbia, United States, 20016
      • Sibley Memorial Hospital
    • Washington, District of Columbia, United States, 20307-5001
      • Walter Reed Army Medical Center
  • Florida
    • Daytona Beach, Florida, United States, 32115
      • Halifax Medical Center - Daytona Beach
    • Fort Lauderdale, Florida, United States, 33308
      • Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic - Jacksonville
    • Jupiter, Florida, United States, 33458
      • Ella Milbank Foshay Cancer Center at Jupiter Medical Center
    • Lakeland, Florida, United States, 33805
      • Lakeland Regional Cancer Center at Lakeland Regional Medical Center
    • Miami, Florida, United States, 33136
      • University of Miami Sylvester Comprehensive Cancer Center
    • Miami Beach, Florida, United States, 33140
      • CCOP - Mount Sinai Medical Center
    • West Palm Beach, Florida, United States, 33401
      • Palm Beach Cancer Institute - West Palm Beach
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • CCOP - Atlanta Regional
    • Augusta, Georgia, United States, 30901
      • Augusta Oncology Associates - Walton Way
    • Lawrenceville, Georgia, United States, 30045
      • Gwinnett Medical Center
    • Savannah, Georgia, United States, 31405
      • Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
  • Hawaii
    • Aiea, Hawaii, United States, 96701
      • Kapiolani Medical Center at Pali Momi
    • Honolula, Hawaii, United States, 96813
      • Cancer Research Center of Hawaii
    • Honolulu, Hawaii, United States, 96826
      • Kapiolani Medical Center for Women and Children
    • Honolulu, Hawaii, United States, 96813
      • OnCare Hawaii, Incorporated - Lusitana
    • Honolulu, Hawaii, United States, 96813
      • Queen's Cancer Institute at Queen's Medical Center
    • Honolulu, Hawaii, United States, 96813
      • Straub Clinic and Hospital, Incorporated
    • Honolulu, Hawaii, United States, 96817
      • OnCare Hawaii, Incorporated - Kuakini
    • Honolulu, Hawaii, United States, 96817
      • St. Francis Medical Center
    • Wailuku, Maui, Hawaii, United States, 96793
      • Pacific Cancer Institute - Maui
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Hematology Oncology Associates of Eastern Idaho
  • Illinois
    • Aurora, Illinois, United States, 60507
      • Rush-Copley Cancer Care Center
    • Bloomington, Illinois, United States, 61701
      • St. Joseph Medical Center
    • Canton, Illinois, United States, 61520
      • Graham Hospital
    • Carthage, Illinois, United States, 62321
      • Memorial Hospital
    • Chicago, Illinois, United States, 60637-1470
      • University of Chicago Cancer Research Center
    • Chicago, Illinois, United States, 60611-3013
      • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
    • Chicago, Illinois, United States, 60612-7243
      • University of Illinois Cancer Center
    • Chicago, Illinois, United States, 60625
      • Swedish Covenant Hospital
    • Chicago, Illinois, United States, 60611
      • Hematology and Oncology Associates
    • Chicago, Illinois, United States, 60612
      • Veterans Affairs Medical Center - Chicago Westside Hospital
    • Chicago, Illinois, United States, 60616
      • Mercy Hospital and Medical Center
    • Decatur, Illinois, United States, 62526
      • Decatur Memorial Hospital Cancer Care Institute
    • Eureka, Illinois, United States, 61530
      • Eureka Community Hospital
    • Evanston, Illinois, United States, 60201-1781
      • Evanston Northwestern Healthcare - Evanston Hospital
    • Evanston, Illinois, United States, 60202
      • St. Francis Hospital
    • Galesburg, Illinois, United States, 61401
      • Galesburg Cottage Hospital
    • Galesburg, Illinois, United States, 61401
      • Galesburg Clinic
    • Havana, Illinois, United States, 62644
      • Mason District Hospital
    • Hopedale, Illinois, United States, 61747
      • Hopedale Medical Complex
    • Joliet, Illinois, United States, 60435
      • Joliet Oncology-Hematology Associates, Limited - West
    • Joliet, Illinois, United States, 60432
      • Midwest Center for Hematology/Oncology
    • Kankakee, Illinois, United States, 60901
      • Provena St. Mary's Wasser Regional Cancer Center - Kankakee
    • Libertyville, Illinois, United States, 60048
      • North Shore Oncology and Hematology Associates, Limited - Libertyville
    • Macomb, Illinois, United States, 61455
      • Mcdonough District Hospital
    • Niles, Illinois, United States, 60714
      • Cancer Care and Hematology Specialists of Chicagoland - Niles
    • Normal, Illinois, United States, 61761
      • Bromenn Regional Medical Center
    • Normal, Illinois, United States, 61761
      • Community Cancer Center
    • Olympia Fields, Illinois, United States, 60461
      • Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields
    • Ottawa, Illinois, United States, 61350
      • Community Hospital of Ottawa
    • Pekin, Illinois, United States, 61554
      • Cancer Treatment Center at Pekin Hospital
    • Peoria, Illinois, United States, 61636
      • Methodist Medical Center of Illinois
    • Peoria, Illinois, United States, 61614
      • Proctor Hospital
    • Peoria, Illinois, United States, 61637
      • OSF St. Francis Medical Center
    • Peoria, Illinois, United States, 61615
      • CCOP - Illinois Oncology Research Association
    • Peoria, Illinois, United States, 61615
      • Oncology Hematology Associates of Central Illinois, PC - Peoria
    • Peru, Illinois, United States, 61354
      • Illinois Valley Community Hospital
    • Princeton, Illinois, United States, 61356
      • Perry Memorial Hospital
    • Rockford, Illinois, United States, 61104-2315
      • Swedish-American Regional Cancer Center
    • Rockford, Illinois, United States, 61108
      • Center for Cancer Care at OSF Saint Anthony Medical Center
    • Skokie, Illinois, United States, 60076
      • Hematology Oncology Associates - Skokie
    • Skokie, Illinois, United States, 60076
      • Hematology/Oncology of the North Shore at Gross Point Medical Center
    • Spring Valley, Illinois, United States, 61362
      • St. Margaret's Hospital
    • Springfield, Illinois, United States, 62781-0001
      • Regional Cancer Center at Memorial Medical Center
    • Urbana, Illinois, United States, 61801
      • Carle Cancer Center at Carle Foundation Hospital
    • Urbana, Illinois, United States, 61801
      • CCOP - Carle Cancer Center
  • Indiana
    • Beech Grove, Indiana, United States, 46107
      • St. Francis Hospital and Health Centers - Beech Grove Campus
    • Bloomington, Indiana, United States, 47403
      • Regional Cancer Institute at Bloomington Hospital
    • Fort Wayne, Indiana, United States, 46815
      • Fort Wayne Medical Oncology and Hematology
    • Michigan City, Indiana, United States, 46360
      • Saint Anthony Memorial Health Centers
    • Munster, Indiana, United States, 46321
      • Community Hospital
    • South Bend, Indiana, United States, 46601
      • CCOP - Northern Indiana CR Consortium
  • Iowa
    • Ames, Iowa, United States, 50010
      • McFarland Clinic, PC
    • Bettendorf, Iowa, United States, 52722
      • Hematology Oncology Associates of the Quad Cities
    • Cedar Rapids, Iowa, United States, 52402
      • St. Luke's Hospital
    • Cedar Rapids, Iowa, United States, 52403
      • Cedar Rapids Oncology Associates
    • Cedar Rapids, Iowa, United States, 52403
      • Mercy Regional Cancer Center at Mercy Medical Center
    • Council Bluffs, Iowa, United States, 51503
      • Heartland Oncology & Hematology
    • Davenport, Iowa, United States, 52803
      • Genesis Regional Cancer Center at Genesis Medical Center
    • Ottumwa, Iowa, United States, 52501
      • McCreery Cancer Center at Ottumwa Regional
    • Waterloo, Iowa, United States, 50702
      • Cedar Valley Medical Specialists, PC - West Ridgeway Avenue
  • Kansas
    • Topeka, Kansas, United States, 66606
      • St. Francis Comprehensive Cancer Center
    • Topeka, Kansas, United States, 66604
      • Stormont-Vail Cancer Center
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • MBCCOP - LSU Health Sciences Center
    • Shreveport, Louisiana, United States, 71101
      • Christus Schumpert Cancer Treatment Center
  • Maine
    • Lewiston, Maine, United States, 04240
      • Central Maine Medical Center
    • Portland, Maine, United States, 04101
      • Mercy Hospital of Portland
    • Scarborough, Maine, United States, 04074
      • Maine Center for Cancer Medicine and Blood Disorders - Scarborough
    • Waterville, Maine, United States, 04901
      • MaineGeneral Medical Center - Waterville Campus
  • Maryland
    • Baltimore, Maryland, United States, 21231-2410
      • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    • Baltimore, Maryland, United States, 21201
      • Greenebaum Cancer Center at University of Maryland Medical Center
    • Frederick, Maryland, United States, 21701
      • Frederick Memorial Hospital Regional Cancer Therapy Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
    • Boston, Massachusetts, United States, 02118
      • Cancer Research Center at Boston Medical Center
    • Boston, Massachusetts, United States, 02111
      • Tufts-NEMC Cancer Center
    • Boston, Massachusetts, United States, 02130
      • Faulkner Hospital
    • Concord, Massachusetts, United States, 01742
      • Bethke Cancer Center at Emerson Hospital
    • Hyannis, Massachusetts, United States, 02601
      • Cape Cod Hospital
    • Lowell, Massachusetts, United States, 01852
      • Saints Memorial Cancer Center at Saints Memorial Medical Center
    • Medford, Massachusetts, United States, 02155
      • Lawrence Memorial Hospital of Medford
    • Norwood, Massachusetts, United States, 02062
      • Caritas Norwood Hospital
    • South Weymouth, Massachusetts, United States, 02190
      • South Shore Hospital
  • Michigan
    • Adrian, Michigan, United States, 49221
      • Hickman Cancer Center at Bixby Medical Center
    • Detroit, Michigan, United States, 48202
      • Josephine Ford Cancer Center at Henry Ford Hospital
    • Grand Rapids, Michigan, United States, 49503
      • CCOP - Grand Rapids
    • Kalamazoo, Michigan, United States, 49007-3731
      • West Michigan Cancer Center
    • Lambertville, Michigan, United States, 48144
      • Haematology-Oncology Associates of Ohio and Michigan, PC
    • Monroe, Michigan, United States, 48162
      • Community Cancer Center of Monroe
    • Monroe, Michigan, United States, 48162
      • Mercy Memorial Hospital System
    • Petoskey, Michigan, United States, 49770
      • Northern Michigan Hospital
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital - Royal Oak Campus
    • Southfield, Michigan, United States, 48075
      • Providence Cancer Institute at Providence Hospital - Southfield Campus
    • St. Joseph, Michigan, United States, 49085
      • Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
  • Minnesota
    • Albert Lea, Minnesota, United States, 56007
      • Albert Lea Cancer Center at Albert Lea Medical Center
    • Bemidji, Minnesota, United States, 56601
      • MeritCare Clinic - Bemidji
    • Burnsville, Minnesota, United States, 55337
      • Fairview Ridges Hospital
    • Coon Rapids, Minnesota, United States, 55433
      • Mercy and Unity Cancer Center at Mercy Hospital
    • Duluth, Minnesota, United States, 55805
      • CCOP - Duluth
    • Duluth, Minnesota, United States, 55805
      • Cancer Care Center at St. Luke's Hospital
    • Edina, Minnesota, United States, 55435
      • Fairview Southdale Hospital
    • Fridley, Minnesota, United States, 55432
      • Mercy and Unity Cancer Center at Unity Hospital
    • Hutchinson, Minnesota, United States, 55350
      • Hutchinson Area Health Care
    • Lichfield, Minnesota, United States, 55355
      • Meeker County Memorial Hospital
    • Mankato, Minnesota, United States, 56002
      • Immanuel St. Joseph's Clinic
    • Maplewood, Minnesota, United States, 55109
      • HealthEast Cancer Care at St. John's Hospital
    • Maplewood, Minnesota, United States, 55109
      • Minnesota Oncology Hematology, PA at Maplewood Cancer Center
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Medical Center & Children's Hospital - Fairview
    • Minneapolis, Minnesota, United States, 55415
      • Hennepin County Medical Center - Minneapolis
    • Minneapolis, Minnesota, United States, 55407
      • Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
    • Montevideo, Minnesota, United States, 56265
      • Chippewa County - Montevideo Hospital
    • Robbinsdale, Minnesota, United States, 55422-2900
      • Hubert H. Humphrey Cancer Center at North Memorial Medical Center
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Cancer Center
    • Saint Louis Park, Minnesota, United States, 55416
      • CCOP - Metro-Minnesota
    • Shakopee, Minnesota, United States, 55379
      • Saint Francis Cancer Center
    • St Paul, Minnesota, United States, 55102
      • St. Joseph's Hospital
    • St. Cloud, Minnesota, United States, 56303
      • CentraCare Clinic - River Campus
    • St. Louis Park, Minnesota, United States, 55416
      • Park Nicollet Health Services
    • St. Paul, Minnesota, United States, 55102
      • United Hospital
    • St. Paul, Minnesota, United States, 55101
      • Regions Hospital Cancer Care Center
    • Waconia, Minnesota, United States, 55387
      • Ridgeview Medical Center
    • Willmar, Minnesota, United States, 56201
      • Willmar Cancer Center at Rice Memorial Hospital
    • Woodbury, Minnesota, United States, 55125
      • Woodwinds Health Campus
    • Woodbury, Minnesota, United States, 55125
      • Minnesota Oncology Hematology, PA - Woodbury
  • Mississippi
    • Pascagoula, Mississippi, United States, 39581
      • Regional Cancer Center at Singing River Hospital
  • Missouri
    • Columbia, Missouri, United States, 65203
      • Ellis Fischel Cancer Center at University of Missouri - Columbia
    • Springfield, Missouri, United States, 65804
      • St. John's Regional Health Center
    • Springfield, Missouri, United States, 65807
      • Hulston Cancer Center at Cox Medical Center South
    • St Louis, Missouri, United States, 63110
      • Siteman Cancer Center at Barnes-Jewish Hospital
    • St. Louis, Missouri, United States, 63131
      • Missouri Baptist Cancer Center
  • Montana
    • Billings, Montana, United States, 59101
      • CCOP - Montana Cancer Consortium
    • Great Falls, Montana, United States, 59405
      • Great Falls Clinic
    • Great Falls, Montana, United States, 59405
      • Sletten Regional Cancer Institute at Benefis Healthcare
  • Nebraska
    • Grand Island, Nebraska, United States, 68803
      • Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center
    • Kearney, Nebraska, United States, 68848-1990
      • Good Samaritan Cancer Center at Good Samaritan Hospital
    • Omaha, Nebraska, United States, 68198-6805
      • UNMC Eppley Cancer Center at the University of Nebraska Medical Center
    • Omaha, Nebraska, United States, 68106
      • CCOP - Missouri Valley Cancer Consortium
    • Omaha, Nebraska, United States, 68122
      • Immanuel Medical Center
    • Omaha, Nebraska, United States, 68124
      • Alegant Health Cancer Center at Bergan Mercy Medical Center
    • Omaha, Nebraska, United States, 68131-2197
      • Creighton University Medical Center
  • Nevada
    • Carson City, Nevada, United States, 89703
      • Carson-Tahoe Cancer Services at Carson Tahoe Regional Healthcare
    • Las Vegas, Nevada, United States, 89102
      • University Medical Center of Southern Nevada
    • Las Vegas, Nevada, United States, 89106
      • CCOP - Nevada Cancer Research Foundation
  • New Hampshire
    • Derry, New Hampshire, United States, 03038
      • Parkland Oncology-Hematology Clinic at Parkland Medical Center
    • Hooksett, New Hampshire, United States, 03106
      • New Hampshire Oncology-Hematology, PA - Hooksett
    • Laconia, New Hampshire, United States, 03246
      • Lakes Region General Hospital
    • Manchester, New Hampshire, United States, 03103
      • Elliot Regional Cancer Center at Elliot Hospital
  • New Jersey
    • Brick, New Jersey, United States, 08724
      • Ocean Medical Center at Meridian Health
    • Marlton, New Jersey, United States, 08053
      • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
    • Morristown, New Jersey, United States, 07962
      • Carol G. Simon Cancer Center at Morristown Memorial Hospital
    • Red Bank, New Jersey, United States, 07701
      • Booker Cancer Center at Riverview Medical Center
    • Summit, New Jersey, United States, 07902
      • Overlook Hospital
    • Toms River, New Jersey, United States, 08755
      • J. Phillip Citta Regional Cancer Center at Community Medical Center
    • Voorhees, New Jersey, United States, 08043
      • Fox Chase Virtua Health Cancer Program at Virtua West Jersey
  • New York
    • Bronx, New York, United States, 10456
      • Bronx-Lebanon Hospital Center & BronxCare Adult Medical Practice
    • Buffalo, New York, United States, 14263-0001
      • Roswell Park Cancer Institute
    • Glens Falls, New York, United States, 12801
      • Adirondack Cancer Care - Glens Falls
    • Glens Falls, New York, United States, 12801
      • Charles R. Wood Cancer Center at Glens Falls Hospital
    • Mineola, New York, United States, 11501
      • Winthrop University Hospital
    • New York, New York, United States, 10021
      • Memorial Sloan-Kettering Cancer Center
    • Rochester, New York, United States, 14642
      • James P. Wilmot Cancer Center at University of Rochester Medical Center
    • Rochester, New York, United States, 14620
      • Highland Hospital of Rochester
    • Stony Brook, New York, United States, 11794-8174
      • Stony Brook University Cancer Center
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Medical University Hospital
    • Syracuse, New York, United States, 13057
      • CCOP - Hematology-Oncology Associates of Central New York
  • North Carolina
    • Asheboro, North Carolina, United States, 27203-5400
      • Randolph Hospital
    • Asheville, North Carolina, United States, 28801
      • Mission Hospitals - Memorial Campus
    • Durham, North Carolina, United States, 27710
      • Duke Comprehensive Cancer Center
    • Gastonia, North Carolina, United States, 28053
      • CaroMont Cancer Center at Gaston Memorial Hospital
    • Goldsboro, North Carolina, United States, 27534
      • Wayne Memorial Hospital, Incorporated
    • Greensboro, North Carolina, United States, 27403-1198
      • Moses Cone Regional Cancer Center at Wesley Long Community Hospital
    • Pinehurst, North Carolina, United States, 28374
      • FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
    • Reidsville, North Carolina, United States, 27320
      • Annie Penn Cancer Center
    • Rutherfordton, North Carolina, United States, 28139
      • Rutherford Hospital
    • Wilmington, North Carolina, United States, 28401
      • Zimmer Cancer Center at New Hanover Regional Medical Center
  • North Dakota
    • Bismarck, North Dakota, United States, 58501
      • Mid Dakota Clinic, PC
    • Bismarck, North Dakota, United States, 58501
      • Cancer Care Center at Medcenter One Hospital
    • Fargo, North Dakota, United States, 58122
      • CCOP - MeritCare Hospital
    • Fargo, North Dakota, United States, 58122
      • MeritCare Medical Group
    • Grand Forks, North Dakota, United States, 58201
      • Altru Cancer Center at Altru Hospital
    • Minot, North Dakota, United States, 58701
      • Trinity Cancer Care Center
  • Ohio
    • Akron, Ohio, United States, 44309-2090
      • Akron City Hospital
    • Bowling Green, Ohio, United States, 43402
      • Wood County Oncology Center
    • Canton, Ohio, United States, 44710-1799
      • Aultman Hospital Cancer Center at Aultman Health Foundation
    • Cincinnati, Ohio, United States, 45267
      • Charles M. Barrett Cancer Center at University Hospital
    • Cleveland, Ohio, United States, 44109
      • MetroHealth's Cancer Care Center at MetroHealth Medical Center
    • Cleveland, Ohio, United States, 44106
      • Case Comprehensive Cancer Center
    • Dayton, Ohio, United States, 45428
      • Veterans Affairs Medical Center - Dayton
    • Dayton, Ohio, United States, 45405
      • Grandview Hospital
    • Dayton, Ohio, United States, 45406
      • Good Samaritan Hospital
    • Dayton, Ohio, United States, 45409
      • David L. Rike Cancer Center at Miami Valley Hospital
    • Dayton, Ohio, United States, 45415
      • Samaritan North Cancer Care Center
    • Fremont, Ohio, United States, 43420
      • Fremont Memorial Hospital
    • Kettering, Ohio, United States, 45429
      • Charles F. Kettering Memorial Hospital
    • Lima, Ohio, United States, 45804
      • Lima Memorial Hospital
    • Lima, Ohio, United States, 45801
      • St. Rita's Medical Center
    • Maumee, Ohio, United States, 43537
      • Northwest Ohio Oncology Center
    • Maumee, Ohio, United States, 43537
      • St. Luke's Hospital
    • Middletown, Ohio, United States, 45044
      • Middletown Regional Hospital
    • Oregon, Ohio, United States, 43616
      • St. Charles Mercy Hospital
    • Oregon, Ohio, United States, 43616
      • Toledo Clinic - Oregon
    • Sandusky, Ohio, United States, 44870
      • Firelands Regional Medical Center
    • Sandusky, Ohio, United States, 44870
      • North Coast Cancer Care, Incorporated
    • Sylvania, Ohio, United States, 43560
      • Flower Hospital Cancer Center
    • Toledo, Ohio, United States, 43608
      • St. Vincent Mercy Medical Center
    • Toledo, Ohio, United States, 43606
      • Toledo Hospital
    • Toledo, Ohio, United States, 43614
      • Medical University of Ohio Cancer Center
    • Toledo, Ohio, United States, 43617
      • CCOP - Toledo Community Hospital
    • Toledo, Ohio, United States, 43623
      • Toledo Clinic, Incorporated - Main Clinic
    • Troy, Ohio, United States, 45373-1300
      • UVMC Cancer Care Center at Upper Valley Medical Center
    • Wauseon, Ohio, United States, 43567
      • Fulton County Health Center
    • Xenia, Ohio, United States, 45385
      • Ruth G. McMillan Cancer Center at Greene Memorial Hospital
  • Oklahoma
    • Lawton, Oklahoma, United States, 73505
      • Cleo Craig Cancer Research Clinic
    • Oklahoma City, Oklahoma, United States, 73104
      • Oklahoma University Medical center
    • Oklahoma City, Oklahoma, United States, 73120
      • Cancer Care Associates - Mercy Campus
    • Tulsa, Oklahoma, United States, 74104
      • LaFortune Cancer Center at St. John Medical Center
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • St. Luke's Hospital Cancer Center
    • Bryn Mawr, Pennsylvania, United States, 19010
      • Bryn Mawr Hospital
    • Danville, Pennsylvania, United States, 17822-0001
      • Geisinger Medical Center
    • East Stroudsburg, Pennsylvania, United States, 18301
      • Dale and Frances Hughes Cancer Center at Pocono Medical Center
    • Hershey, Pennsylvania, United States, 17033-0850
      • Penn State Cancer Institute at Milton S. Hershey Medical Center
    • Lewistown, Pennsylvania, United States, 17044
      • Lewistown Hospital
    • Meadville, Pennsylvania, United States, 16335
      • Meadville Medical Center
    • Paoli, Pennsylvania, United States, 19301-1792
      • Cancer Center of Paoli Memorial Hospital
    • Philadelphia, Pennsylvania, United States, 19107-5541
      • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
    • Pittsburgh, Pennsylvania, United States, 15224-1791
      • Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
    • Reading, Pennsylvania, United States, 19612-6052
      • Reading Hospital and Medical Center
    • Reading, Pennsylvania, United States, 19604
      • St. Joseph Medical Center
    • Scranton, Pennsylvania, United States, 18510
      • Hematology and Oncology Associates
    • State College, Pennsylvania, United States, 16803
      • Mount Nittany Medical Center
    • State College, Pennsylvania, United States, 16801
      • Geisinger Medical Group - Scenery Park
    • Upland, Pennsylvania, United States, 19013
      • Associates in Hematology-Oncology, PC at Crozer Regional Cancer Center
    • West Grove, Pennsylvania, United States, 19390-9499
      • Jennersville Regional Hospital
    • Wilkes-Barre, Pennsylvania, United States, 18711
      • Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
    • Wynnewood, Pennsylvania, United States, 19096
      • CCOP - MainLine Health
    • Wynnewood, Pennsylvania, United States, 19096
      • Lankenau Cancer Center at Lankenau Hospital
  • Rhode Island
    • Pawtucket, Rhode Island, United States, 02860
      • Memorial Hospital of Rhode Island
    • Warwick, Rhode Island, United States, 02886
      • Kent County Memorial Hospital
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • AnMed Health Cancer Center
    • Charleston, South Carolina, United States, 29425
      • Hollings Cancer Center at Medical University of South Carolina
    • Spartanburg, South Carolina, United States, 29303
      • CCOP - Upstate Carolina
    • Spartanburg, South Carolina, United States, 29303
      • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
  • South Dakota
    • Aberdeen, South Dakota, United States, 57401
      • Oncology Services of Aberdeen
    • Sioux Falls, South Dakota, United States, 57105
      • Avera Cancer Institute
    • Sioux Falls, South Dakota, United States, 57117-5039
      • Sioux Valley Hospital and University of South Dakota Medical Center
    • Sioux Falls, South Dakota, United States, 57105
      • Medical X-Ray Center, PC
  • Tennessee
    • Johnson City, Tennessee, United States, 37604
      • East Tennessee State University Cancer Center at Johnson City Medical Center
    • Knoxville, Tennessee, United States, 37916
      • Thompson Cancer Survival Center
    • Nashville, Tennessee, United States, 37208-3599
      • MBCCOP - Meharry Medical College - Nashville
    • Nashville, Tennessee, United States, 37203
      • Nashville Oncology Associates, P.C.
  • Texas
    • Fort Sam Houston, Texas, United States, 78234
      • Brooke Army Medical Center
    • Lackland AFB, Texas, United States, 78236
      • Wilford Hall Medical Center
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute at University of Utah
  • Vermont
    • Berlin, Vermont, United States, 05602
      • Mountainview Medical
    • Burlington, Vermont, United States, 05401
      • Fletcher Allen Health Care - University Health Center Campus
  • Virginia
    • Charlottesville, Virginia, United States, 22901
      • Martha Jefferson Hospital Cancer Care Center
  • Washington
    • Auburn, Washington, United States, 98002
      • Auburn Regional Center for Cancer Care
    • Bellingham, Washington, United States, 98225
      • St. Joseph Cancer Center
    • Federal Way, Washington, United States, 98003
      • St. Francis Hospital
    • Olympia, Washington, United States, 98507
      • Capital Medical Center
    • Olympia, Washington, United States, 98506-5166
      • Providence St. Peter Hospital Regional Cancer Center
    • Puyallup, Washington, United States, 98372
      • Good Samaritan Cancer Center
    • Seattle, Washington, United States, 98112
      • Group Health Central Hospital
    • Seattle, Washington, United States, 98122-4307
      • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
    • Seattle, Washington, United States, 98195-6043
      • University Cancer Center at University of Washington Medical Center
    • Spokane, Washington, United States, 99202
      • Cancer Care Northwest - Spokane South
    • Spokane, Washington, United States, 99204
      • Providence Cancer Center at Sacred Heart Medical Center
    • Spokane, Washington, United States, 99207
      • Providence Cancer Center at Holy Family Hospital
    • Tacoma, Washington, United States, 98405
      • CCOP - Northwest
    • Tacoma, Washington, United States, 98499
      • St. Clare Hospital
    • Tacoma, Washington, United States, 98431
      • Madigan Army Medical Center - Tacoma
    • Tacoma, Washington, United States, 98405-3004
      • St. Joseph Medical Center at Franciscan Health System
    • Yakima, Washington, United States, 98902
      • North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
  • West Virginia
    • Huntington, West Virginia, United States, 25701
      • Marshall University Medical Center
  • Wisconsin
    • Elkhorn, Wisconsin, United States, 53121
      • Vince Lombardi Cancer Center at Aurora Lakeland Medical Center - Elkhorn
    • Green Bay, Wisconsin, United States, 54311
      • Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
    • La Crosse, Wisconsin, United States, 54601
      • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
    • Madison, Wisconsin, United States, 53792-6164
      • University of Wisconsin Comprehensive Cancer Center
    • Madison, Wisconsin, United States, 53717
      • Dean Medical Center - Madison
    • Manitowoc, Wisconsin, United States, 54221-1450
      • Holy Family Memorial Medical Center Cancer Care Center
    • Milwaukee, Wisconsin, United States, 53201-0342
      • Aurora Sinai Medical Center
    • Milwaukee, Wisconsin, United States, 53215
      • Medical Consultants, Limited
    • Wausau, Wisconsin, United States, 54401
      • University of Wisconcin Cancer Center at Aspirus Wausau Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

1. Patients with operable, histologically confirmed adenocarcinoma of the female breast.

2. TNM Stage per AJCC Cancer Staging Manual 6th edition:

   • T1-4 (Tumor size > 1 cm), N0, M0 or T1-4, N1-3, M0
   • Patients with bilateral, synchronous breast cancer are eligible as long as one primary tumor meets the criteria above.

3. Patients with HER2/neu positive, negative or unknown disease are eligible for this trial.

   Patients whose tumors are HER2 positive by either immunohistochemistry 3+ staining or demonstrate gene amplification by FISH will be eligible to receive trastuzumab, as outlined in the protocol.

4. Age 65 years or older
5. Performance status 0-2 (Common Toxicity Criteria).

6. Prior treatment:

   • Surgical resection -

     • All tumor should be removed by either a modified radical mastectomy or a lumpectomy. Patients must be registered ≤ 84 days from mastectomy or within 84 days of axillary dissection if patient's most extensive breast surgery was a breast sparing procedure.
     • Node dissection: Axillary node dissection is not required. Management of the axilla is at the discretion of the treating physician. There is no restriction on eligibility based on the number of nodes removed.
     • Mastectomy: There should be no evidence of gross or microscopic invasive tumor at the surgical resection margins noted in the final surgery or pathology reports for patients who have had a modified radical mastectomy. Patients with close margins (tumor < 1 mm from margin) are eligible.
     • Segmental mastectomy (lumpectomy): Although clear margins are preferable, DCIS or LCIS at the surgical resection margin will not render a patient who has undergone a segmental mastectomy ineligible for this study. Invasive tumor at the final resection margin will render a patient ineligible.
   • No prior chemotherapy for this malignancy.
   • Patients with a history of hypersensitivity to 5-FU or known dihydropyrimidine dehydrogenase (DPD) deficiency are not eligible to participate.
   • Patients may receive up to four weeks of tamoxifen therapy for this malignancy and still be eligible for study entry. Patients who received tamoxifen or raloxifene for purposes of chemoprevention (e.g., Breast Cancer Prevention Trial) or for other indications (including previous breast cancer) are eligible. Tamoxifen or raloxifene therapy should be discontinued before the patient is enrolled on this study.

7. Required Initial Laboratory Data:

   • Granulocytes > 1,500/µl
   • Platelet count ≥100,000/µl
   • Calculated Creatinine Clearance > 30 mL/min
   • Total bilirubin ≤ ULN

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Chemotherapy; Patient/Physician choice of cyclophosphamide + MTX + 5-FU OR Cyclophosphamide + doxorubicin	Drug: Standard Treatment; Cyclophosphamide 100 mg/sq m PO d 1-14 + MTX 40 mg/sq m IV push d 1 & 8 and 5-FU 600 mg/sq m IV push d 1 & 8 q 28 days for 6 cycles OR doxorubicin 60 mg/sq m IV d 1 + cyclophosphamide 600 mg/sq m IV d 1 q 21 d for 4 cycles; Other Names: doxorubicin = adriamycin
Experimental: Capecitabine; Treatment with capecitabine	Drug: capecitabine; 2000 mg/sq m PO d 1-14, 7 day rest then repeat for a total of 6 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relapse-free Survival Rates at 2.4 Years	Percentage of participants who were alive and relapse-free at time of analysis were counted as "Alive without relapse" at 2.4 years. Participants who had a first local recurrence, first distant metastasis or death from any cause were counted as "relapse, first occurrence". These rates were estimated using the Kaplan Meier method	randomization until date of first event, or date last known to be event free if no event was reported (up to 5 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival Rate at 2.4 Years	Percentage of patients who were alive at 2.4 years. This rate was estimated using the Kaplan Meier method.	Time from registration to death (up to 15 years)
Number of Participants With Grade 3, 4 or 5 Adverse Event at Least Possibly Related to Treatment.	The National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Version 2.0 was used to evaluate toxicity. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death.	Reported during protocol treatment after each cycle

Collaborators and Investigators

• Sponsor: Alliance for Clinical Trials in Oncology
• Collaborators: National Cancer Institute (NCI); NCIC Clinical Trials Group
• Investigators: Study Chair: Hyman B. Muss, MD, University of North Carolina

Publications and helpful links

General Publications

• Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.
• Pal SK, Mortimer J. Adjuvant chemotherapy for older adults with breast cancer: making the standard a standard. Womens Health (Lond). 2009 Sep;5(5):481-4. doi: 10.2217/whe.09.43.
• Partridge AH, Archer L, Kornblith AB, Gralow J, Grenier D, Perez E, Wolff AC, Wang X, Kastrissios H, Berry D, Hudis C, Winer E, Muss H. Adherence and persistence with oral adjuvant chemotherapy in older women with early-stage breast cancer in CALGB 49907: adherence companion study 60104. J Clin Oncol. 2010 May 10;28(14):2418-22. doi: 10.1200/JCO.2009.26.4671. Epub 2010 Apr 5.
• Kornblith AB, Archer L, Lan L, et al.: Quality of life of early stage breast cancer patients 65 years old or older randomized to standard chemotherapy or capecitabine: A Cancer and Leukemia Group B Study (CALGB 49907). [Abstract] 32nd Annual San Antonio Breast Cancer Symposium, December 9-13, 2009, San Antonio, Texas. A-5035, 2009.
• Muss HB, Berry DA, Cirrincione CT, Theodoulou M, Mauer AM, Kornblith AB, Partridge AH, Dressler LG, Cohen HJ, Becker HP, Kartcheske PA, Wheeler JD, Perez EA, Wolff AC, Gralow JR, Burstein HJ, Mahmood AA, Magrinat G, Parker BA, Hart RD, Grenier D, Norton L, Hudis CA, Winer EP; CALGB Investigators. Adjuvant chemotherapy in older women with early-stage breast cancer. N Engl J Med. 2009 May 14;360(20):2055-65. doi: 10.1056/NEJMoa0810266. Erratum In: N Engl J Med. 2009 Oct 22;361(17):1714. Magrinat, Gutav [corrected to Magrinat, Gustav].
• Muss HB, Berry DL, Cirrincione C, et al.: Standard chemotherapy (CMF or AC) versus capecitabine in early-stage breast cancer (BC) patients aged 65 and older: results of CALGB/CTSU 49907. [Abstract] J Clin Oncol 26 (Suppl 15): A-507, 2008.
• Partridge AH, Archer LE, Kornblith AB, et al.: CALGB 60104: adherence with adjuvant capecitabine among women age 65 and older with early stage breast cancer treated on CALGB 49907. [Abstract] J Clin Oncol 26 (Suppl 15): A-6542, 2008.
• Muss HB, Polley MC, Berry DA, Liu H, Cirrincione CT, Theodoulou M, Mauer AM, Kornblith AB, Partridge AH, Dressler LG, Cohen HJ, Kartcheske PA, Perez EA, Wolff AC, Gralow JR, Burstein HJ, Mahmood AA, Sutton LM, Magrinat G, Parker BA, Hart RD, Grenier D, Hurria A, Jatoi A, Norton L, Hudis CA, Winer EP, Carey L. Randomized Trial of Standard Adjuvant Chemotherapy Regimens Versus Capecitabine in Older Women With Early Breast Cancer: 10-Year Update of the CALGB 49907 Trial. J Clin Oncol. 2019 Sep 10;37(26):2338-2348. doi: 10.1200/JCO.19.00647. Epub 2019 Jul 24.
• Magnuson A, Lei L, Gilmore N, Kleckner AS, Lin FV, Ferguson R, Hurria A, Wittink MN, Esparaz BT, Giguere JK, Misleh J, Bautista J, Mohile SG, Janelsins MC. Longitudinal Relationship Between Frailty and Cognition in Patients 50 Years and Older with Breast Cancer. J Am Geriatr Soc. 2019 May;67(5):928-936. doi: 10.1111/jgs.15934.
• Gajra A, McCall L, Muss HB, Cohen HJ, Jatoi A, Ballman KV, Partridge AH, Sutton L, Parker BA, Magrinat G, Klepin HD, Lafky JM, Hurria A. The preference to receive chemotherapy and cancer-related outcomes in older adults with breast cancer CALGB 49907 (Alliance). J Geriatr Oncol. 2018 May;9(3):221-227. doi: 10.1016/j.jgo.2018.02.003. Epub 2018 Mar 28.
• Morrison VA, McCall L, Muss HB, Jatoi A, Cohen HJ, Cirrincione CT, Ligibel JA, Lafky JM, Hurria A. The impact of actual body weight-based chemotherapy dosing and body size on adverse events and outcome in older patients with breast cancer: Results from Cancer and Leukemia Group B (CALGB) trial 49907 (Alliance A151436). J Geriatr Oncol. 2018 May;9(3):228-234. doi: 10.1016/j.jgo.2017.11.007. Epub 2017 Dec 8.

Study record dates

Study Major Dates

• Study Start: September 1, 2001
• Primary Completion (Actual): May 1, 2008
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: September 13, 2001
• First Submitted That Met QC Criteria: January 26, 2003
• First Posted (Estimate): January 27, 2003

Study Record Updates

• Last Update Posted (Estimate): August 12, 2016
• Last Update Submitted That Met QC Criteria: July 12, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: stage IIIA breast cancer; stage IIIB breast cancer; stage II breast cancer; stage IIIC breast cancer; stage I breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Capecitabine; Doxorubicin
• Other Study ID Numbers: CALGB-49907; U10CA031946 (U.S. NIH Grant/Contract); CAN-NCIC-MAC1; CDR0000068891 (Registry Identifier: NCI Physician Data Query)