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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00024102
• Other study ID #: CALGB-49907
• Secondary ID: U10CA031946CAN-N
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2001
• Last updated: June 23, 2015
• Start date: September 2001
• Est. completion date: November 2012

Study information

• Verified date: June 2015
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 633
• Est. completion date: November 2012
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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
• capecitabine
2000 mg/sq m PO d 1-14, 7 day rest then repeat for a total of 6 cycles

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Centre - Calgary	Calgary	Alberta
Canada	Prince Edward Island Cancer Centre at Queen Elizabeth Hospital	Charlottetown	Prince Edward Island
Canada	Cross Cancer Institute at University of Alberta	Edmonton	Alberta
Canada	Allan Blair Cancer Centre at Pasqua Hospital	Regina	Saskatchewan
Canada	Mount Sinai Hospital - Toronto	Toronto	Ontario
Canada	Windsor Regional Cancer Centre at Windsor Regional Hospital	Windsor	Ontario
Canada	CancerCare Manitoba	Winnipeg	Manitoba
Peru	Instituto Nacional de Enfermedades Neoplasicas	Lima
United States	Oncology Services of Aberdeen	Aberdeen	South Dakota
United States	Hickman Cancer Center at Bixby Medical Center	Adrian	Michigan
United States	Kapiolani Medical Center at Pali Momi	Aiea	Hawaii
United States	Akron City Hospital	Akron	Ohio
United States	Albert Lea Cancer Center at Albert Lea Medical Center	Albert Lea	Minnesota
United States	McFarland Clinic, PC	Ames	Iowa
United States	AnMed Health Cancer Center	Anderson	South Carolina
United States	Randolph Hospital	Asheboro	North Carolina
United States	Mission Hospitals - Memorial Campus	Asheville	North Carolina
United States	CCOP - Atlanta Regional	Atlanta	Georgia
United States	Auburn Regional Center for Cancer Care	Auburn	Washington
United States	Augusta Oncology Associates - Walton Way	Augusta	Georgia
United States	Rush-Copley Cancer Care Center	Aurora	Illinois
United States	Greenebaum Cancer Center at University of Maryland Medical Center	Baltimore	Maryland
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	St. Francis Hospital and Health Centers - Beech Grove Campus	Beech Grove	Indiana
United States	St. Joseph Cancer Center	Bellingham	Washington
United States	MeritCare Clinic - Bemidji	Bemidji	Minnesota
United States	Mountainview Medical	Berlin	Vermont
United States	St. Luke's Hospital Cancer Center	Bethlehem	Pennsylvania
United States	Hematology Oncology Associates of the Quad Cities	Bettendorf	Iowa
United States	CCOP - Montana Cancer Consortium	Billings	Montana
United States	University of Alabama at Birmingham Comprehensive Cancer Center	Birmingham	Alabama
United States	Cancer Care Center at Medcenter One Hospital	Bismarck	North Dakota
United States	Mid Dakota Clinic, PC	Bismarck	North Dakota
United States	Regional Cancer Institute at Bloomington Hospital	Bloomington	Indiana
United States	St. Joseph Medical Center	Bloomington	Illinois
United States	Cancer Research Center at Boston Medical Center	Boston	Massachusetts
United States	Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute	Boston	Massachusetts
United States	Faulkner Hospital	Boston	Massachusetts
United States	Tufts-NEMC Cancer Center	Boston	Massachusetts
United States	Wood County Oncology Center	Bowling Green	Ohio
United States	Ocean Medical Center at Meridian Health	Brick	New Jersey
United States	Bronx-Lebanon Hospital Center & BronxCare Adult Medical Practice	Bronx	New York
United States	Bryn Mawr Hospital	Bryn Mawr	Pennsylvania
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Fletcher Allen Health Care - University Health Center Campus	Burlington	Vermont
United States	Fairview Ridges Hospital	Burnsville	Minnesota
United States	Aultman Hospital Cancer Center at Aultman Health Foundation	Canton	Ohio
United States	Graham Hospital	Canton	Illinois
United States	Carson-Tahoe Cancer Services at Carson Tahoe Regional Healthcare	Carson City	Nevada
United States	Memorial Hospital	Carthage	Illinois
United States	Cedar Rapids Oncology Associates	Cedar Rapids	Iowa
United States	Mercy Regional Cancer Center at Mercy Medical Center	Cedar Rapids	Iowa
United States	St. Luke's Hospital	Cedar Rapids	Iowa
United States	Hollings Cancer Center at Medical University of South Carolina	Charleston	South Carolina
United States	Martha Jefferson Hospital Cancer Care Center	Charlottesville	Virginia
United States	Hematology and Oncology Associates	Chicago	Illinois
United States	Mercy Hospital and Medical Center	Chicago	Illinois
United States	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois
United States	Swedish Covenant Hospital	Chicago	Illinois
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	University of Illinois Cancer Center	Chicago	Illinois
United States	Veterans Affairs Medical Center - Chicago Westside Hospital	Chicago	Illinois
United States	Charles M. Barrett Cancer Center at University Hospital	Cincinnati	Ohio
United States	Case Comprehensive Cancer Center	Cleveland	Ohio
United States	MetroHealth's Cancer Care Center at MetroHealth Medical Center	Cleveland	Ohio
United States	Memorial Hospital	Colorado Springs	Colorado
United States	Ellis Fischel Cancer Center at University of Missouri - Columbia	Columbia	Missouri
United States	Bethke Cancer Center at Emerson Hospital	Concord	Massachusetts
United States	Mercy and Unity Cancer Center at Mercy Hospital	Coon Rapids	Minnesota
United States	Heartland Oncology & Hematology	Council Bluffs	Iowa
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Genesis Regional Cancer Center at Genesis Medical Center	Davenport	Iowa
United States	David L. Rike Cancer Center at Miami Valley Hospital	Dayton	Ohio
United States	Good Samaritan Hospital	Dayton	Ohio
United States	Grandview Hospital	Dayton	Ohio
United States	Samaritan North Cancer Care Center	Dayton	Ohio
United States	Veterans Affairs Medical Center - Dayton	Dayton	Ohio
United States	Halifax Medical Center - Daytona Beach	Daytona Beach	Florida
United States	Decatur Memorial Hospital Cancer Care Institute	Decatur	Illinois
United States	Parkland Oncology-Hematology Clinic at Parkland Medical Center	Derry	New Hampshire
United States	Josephine Ford Cancer Center at Henry Ford Hospital	Detroit	Michigan
United States	Kent General Hospital at Bayhealth Medical Center	Dover	Delaware
United States	Cancer Care Center at St. Luke's Hospital	Duluth	Minnesota
United States	CCOP - Duluth	Duluth	Minnesota
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	Dale and Frances Hughes Cancer Center at Pocono Medical Center	East Stroudsburg	Pennsylvania
United States	Fairview Southdale Hospital	Edina	Minnesota
United States	Vince Lombardi Cancer Center at Aurora Lakeland Medical Center - Elkhorn	Elkhorn	Wisconsin
United States	Eureka Community Hospital	Eureka	Illinois
United States	Evanston Northwestern Healthcare - Evanston Hospital	Evanston	Illinois
United States	St. Francis Hospital	Evanston	Illinois
United States	CCOP - MeritCare Hospital	Fargo	North Dakota
United States	MeritCare Medical Group	Fargo	North Dakota
United States	St. Francis Hospital	Federal Way	Washington
United States	Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital	Fort Lauderdale	Florida
United States	Brooke Army Medical Center	Fort Sam Houston	Texas
United States	Fort Wayne Medical Oncology and Hematology	Fort Wayne	Indiana
United States	Frederick Memorial Hospital Regional Cancer Therapy Center	Frederick	Maryland
United States	Fremont Memorial Hospital	Fremont	Ohio
United States	Mercy and Unity Cancer Center at Unity Hospital	Fridley	Minnesota
United States	Galesburg Clinic	Galesburg	Illinois
United States	Galesburg Cottage Hospital	Galesburg	Illinois
United States	CaroMont Cancer Center at Gaston Memorial Hospital	Gastonia	North Carolina
United States	Glendale Memorial Hospital Comprehensive Cancer Center	Glendale	California
United States	Adirondack Cancer Care - Glens Falls	Glens Falls	New York
United States	Charles R. Wood Cancer Center at Glens Falls Hospital	Glens Falls	New York
United States	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina
United States	Altru Cancer Center at Altru Hospital	Grand Forks	North Dakota
United States	Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center	Grand Island	Nebraska
United States	CCOP - Grand Rapids	Grand Rapids	Michigan
United States	Great Falls Clinic	Great Falls	Montana
United States	Sletten Regional Cancer Institute at Benefis Healthcare	Great Falls	Montana
United States	Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center	Green Bay	Wisconsin
United States	Moses Cone Regional Cancer Center at Wesley Long Community Hospital	Greensboro	North Carolina
United States	Mason District Hospital	Havana	Illinois
United States	Saint Rose Hospital	Hayward	California
United States	Penn State Cancer Institute at Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Cancer Research Center of Hawaii	Honolula	Hawaii
United States	Kapiolani Medical Center for Women and Children	Honolulu	Hawaii
United States	OnCare Hawaii, Incorporated - Kuakini	Honolulu	Hawaii
United States	OnCare Hawaii, Incorporated - Lusitana	Honolulu	Hawaii
United States	Queen's Cancer Institute at Queen's Medical Center	Honolulu	Hawaii
United States	St. Francis Medical Center	Honolulu	Hawaii
United States	Straub Clinic and Hospital, Incorporated	Honolulu	Hawaii
United States	New Hampshire Oncology-Hematology, PA - Hooksett	Hooksett	New Hampshire
United States	Hopedale Medical Complex	Hopedale	Illinois
United States	St. Joseph's Mercy Cancer Center	Hot Springs	Arkansas
United States	Marshall University Medical Center	Huntington	West Virginia
United States	Hutchinson Area Health Care	Hutchinson	Minnesota
United States	Cape Cod Hospital	Hyannis	Massachusetts
United States	Hematology Oncology Associates of Eastern Idaho	Idaho Falls	Idaho
United States	Mayo Clinic - Jacksonville	Jacksonville	Florida
United States	East Tennessee State University Cancer Center at Johnson City Medical Center	Johnson City	Tennessee
United States	Joliet Oncology-Hematology Associates, Limited - West	Joliet	Illinois
United States	Midwest Center for Hematology/Oncology	Joliet	Illinois
United States	Ella Milbank Foshay Cancer Center at Jupiter Medical Center	Jupiter	Florida
United States	West Michigan Cancer Center	Kalamazoo	Michigan
United States	Provena St. Mary's Wasser Regional Cancer Center - Kankakee	Kankakee	Illinois
United States	Good Samaritan Cancer Center at Good Samaritan Hospital	Kearney	Nebraska
United States	Charles F. Kettering Memorial Hospital	Kettering	Ohio
United States	Thompson Cancer Survival Center	Knoxville	Tennessee
United States	Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center	La Crosse	Wisconsin
United States	Moores UCSD Cancer Center	La Jolla	California
United States	Wilford Hall Medical Center	Lackland AFB	Texas
United States	Lakes Region General Hospital	Laconia	New Hampshire
United States	Lakeland Regional Cancer Center at Lakeland Regional Medical Center	Lakeland	Florida
United States	Haematology-Oncology Associates of Ohio and Michigan, PC	Lambertville	Michigan
United States	CCOP - Nevada Cancer Research Foundation	Las Vegas	Nevada
United States	University Medical Center of Southern Nevada	Las Vegas	Nevada
United States	Gwinnett Medical Center	Lawrenceville	Georgia
United States	Cleo Craig Cancer Research Clinic	Lawton	Oklahoma
United States	Central Maine Medical Center	Lewiston	Maine
United States	Lewistown Hospital	Lewistown	Pennsylvania
United States	North Shore Oncology and Hematology Associates, Limited - Libertyville	Libertyville	Illinois
United States	Meeker County Memorial Hospital	Lichfield	Minnesota
United States	Lima Memorial Hospital	Lima	Ohio
United States	St. Rita's Medical Center	Lima	Ohio
United States	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California
United States	Saints Memorial Cancer Center at Saints Memorial Medical Center	Lowell	Massachusetts
United States	McDonough District Hospital	Macomb	Illinois
United States	Dean Medical Center - Madison	Madison	Wisconsin
United States	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin
United States	Elliot Regional Cancer Center at Elliot Hospital	Manchester	New Hampshire
United States	Holy Family Memorial Medical Center Cancer Care Center	Manitowoc	Wisconsin
United States	Immanuel St. Joseph's Clinic	Mankato	Minnesota
United States	HealthEast Cancer Care at St. John's Hospital	Maplewood	Minnesota
United States	Minnesota Oncology Hematology, PA at Maplewood Cancer Center	Maplewood	Minnesota
United States	Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton	Marlton	New Jersey
United States	Northwest Ohio Oncology Center	Maumee	Ohio
United States	St. Luke's Hospital	Maumee	Ohio
United States	Meadville Medical Center	Meadville	Pennsylvania
United States	Lawrence Memorial Hospital of Medford	Medford	Massachusetts
United States	University of Miami Sylvester Comprehensive Cancer Center	Miami	Florida
United States	CCOP - Mount Sinai Medical Center	Miami Beach	Florida
United States	Saint Anthony Memorial Health Centers	Michigan City	Indiana
United States	Middletown Regional Hospital	Middletown	Ohio
United States	Aurora Sinai Medical Center	Milwaukee	Wisconsin
United States	Medical Consultants, Limited	Milwaukee	Wisconsin
United States	Winthrop University Hospital	Mineola	New York
United States	Hennepin County Medical Center - Minneapolis	Minneapolis	Minnesota
United States	University of Minnesota Medical Center & Children's Hospital - Fairview	Minneapolis	Minnesota
United States	Virginia Piper Cancer Institute at Abbott-Northwestern Hospital	Minneapolis	Minnesota
United States	Trinity Cancer Care Center	Minot	North Dakota
United States	Mobile Infirmary Medical Center	Mobile	Alabama
United States	Community Cancer Center of Monroe	Monroe	Michigan
United States	Mercy Memorial Hospital System	Monroe	Michigan
United States	Chippewa County - Montevideo Hospital	Montevideo	Minnesota
United States	Carol G. Simon Cancer Center at Morristown Memorial Hospital	Morristown	New Jersey
United States	Community Hospital	Munster	Indiana
United States	MBCCOP - Meharry Medical College - Nashville	Nashville	Tennessee
United States	Nashville Oncology Associates, P.C.	Nashville	Tennessee
United States	MBCCOP - LSU Health Sciences Center	New Orleans	Louisiana
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	CCOP - Christiana Care Health Services	Newark	Delaware
United States	Cancer Care and Hematology Specialists of Chicagoland - Niles	Niles	Illinois
United States	BroMenn Regional Medical Center	Normal	Illinois
United States	Community Cancer Center	Normal	Illinois
United States	Leavey Cancer Center at Northridge Hospital Medical Center	Northridge	California
United States	Eastern Connecticut Hematology and Oncology Associates	Norwich	Connecticut
United States	Caritas Norwood Hospital	Norwood	Massachusetts
United States	Alta Bates Summit Medical Center - Summit Campus	Oakland	California
United States	CCOP - Bay Area Tumor Institute	Oakland	California
United States	Highland General Hospital at St. George's University School of Medicine	Oakland	California
United States	Cancer Care Associates - Mercy Campus	Oklahoma City	Oklahoma
United States	Oklahoma University Medical Center	Oklahoma City	Oklahoma
United States	Capital Medical Center	Olympia	Washington
United States	Providence St. Peter Hospital Regional Cancer Center	Olympia	Washington
United States	Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields	Olympia Fields	Illinois
United States	Alegant Health Cancer Center at Bergan Mercy Medical Center	Omaha	Nebraska
United States	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska
United States	Creighton University Medical Center	Omaha	Nebraska
United States	Immanuel Medical Center	Omaha	Nebraska
United States	UNMC Eppley Cancer Center at the University of Nebraska Medical Center	Omaha	Nebraska
United States	St. Charles Mercy Hospital	Oregon	Ohio
United States	Toledo Clinic - Oregon	Oregon	Ohio
United States	Community Hospital of Ottawa	Ottawa	Illinois
United States	McCreery Cancer Center at Ottumwa Regional	Ottumwa	Iowa
United States	Cancer Center of Paoli Memorial Hospital	Paoli	Pennsylvania
United States	Regional Cancer Center at Singing River Hospital	Pascagoula	Mississippi
United States	Memorial Hospital of Rhode Island	Pawtucket	Rhode Island
United States	Cancer Treatment Center at Pekin Hospital	Pekin	Illinois
United States	CCOP - Illinois Oncology Research Association	Peoria	Illinois
United States	Methodist Medical Center of Illinois	Peoria	Illinois
United States	Oncology Hematology Associates of Central Illinois, PC - Peoria	Peoria	Illinois
United States	OSF St. Francis Medical Center	Peoria	Illinois
United States	Proctor Hospital	Peoria	Illinois
United States	Illinois Valley Community Hospital	Peru	Illinois
United States	Northern Michigan Hospital	Petoskey	Michigan
United States	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania
United States	FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center	Pinehurst	North Carolina
United States	Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital	Pittsburgh	Pennsylvania
United States	Valley Care Medical Center	Pleasanton	California
United States	Mercy Hospital of Portland	Portland	Maine
United States	Perry Memorial Hospital	Princeton	Illinois
United States	Good Samaritan Cancer Center	Puyallup	Washington
United States	Reading Hospital and Medical Center	Reading	Pennsylvania
United States	St. Joseph Medical Center	Reading	Pennsylvania
United States	Booker Cancer Center at Riverview Medical Center	Red Bank	New Jersey
United States	Annie Penn Cancer Center	Reidsville	North Carolina
United States	Hubert H. Humphrey Cancer Center at North Memorial Medical Center	Robbinsdale	Minnesota
United States	Highland Hospital of Rochester	Rochester	New York
United States	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	Center for Cancer Care at OSF Saint Anthony Medical Center	Rockford	Illinois
United States	Swedish-American Regional Cancer Center	Rockford	Illinois
United States	William Beaumont Hospital - Royal Oak Campus	Royal Oak	Michigan
United States	Rutherford Hospital	Rutherfordton	North Carolina
United States	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota
United States	Salinas Valley Memorial Hospital	Salinas	California
United States	Huntsman Cancer Institute at University of Utah	Salt Lake City	Utah
United States	Kaiser Permanente Medical Office -Vandever Medical Office	San Diego	California
United States	Doctors Medical Center - San Pablo Campus	San Pablo	California
United States	Firelands Regional Medical Center	Sandusky	Ohio
United States	North Coast Cancer Care, Incorporated	Sandusky	Ohio
United States	Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler	Savannah	Georgia
United States	Maine Center for Cancer Medicine and Blood Disorders - Scarborough	Scarborough	Maine
United States	Mayo Clinic Scottsdale	Scottsdale	Arizona
United States	Hematology and Oncology Associates	Scranton	Pennsylvania
United States	Group Health Central Hospital	Seattle	Washington
United States	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus	Seattle	Washington
United States	University Cancer Center at University of Washington Medical Center	Seattle	Washington
United States	Saint Francis Cancer Center	Shakopee	Minnesota
United States	Christus Schumpert Cancer Treatment Center	Shreveport	Louisiana
United States	Avera Cancer Institute	Sioux Falls	South Dakota
United States	Medical X-Ray Center, PC	Sioux Falls	South Dakota
United States	Sioux Valley Hospital and University of South Dakota Medical Center	Sioux Falls	South Dakota
United States	Hematology Oncology Associates - Skokie	Skokie	Illinois
United States	Hematology/Oncology of the North Shore at Gross Point Medical Center	Skokie	Illinois
United States	CCOP - Northern Indiana CR Consortium	South Bend	Indiana
United States	South Shore Hospital	South Weymouth	Massachusetts
United States	Providence Cancer Institute at Providence Hospital - Southfield Campus	Southfield	Michigan
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center	Spartanburg	South Carolina
United States	Cancer Care Northwest - Spokane South	Spokane	Washington
United States	Providence Cancer Center at Holy Family Hospital	Spokane	Washington
United States	Providence Cancer Center at Sacred Heart Medical Center	Spokane	Washington
United States	St. Margaret's Hospital	Spring Valley	Illinois
United States	Hulston Cancer Center at Cox Medical Center South	Springfield	Missouri
United States	Regional Cancer Center at Memorial Medical Center	Springfield	Illinois
United States	St. John's Regional Health Center	Springfield	Missouri
United States	Siteman Cancer Center at Barnes-Jewish Hospital	St Louis	Missouri
United States	St. Joseph's Hospital	St Paul	Minnesota
United States	CentraCare Clinic - River Campus	St. Cloud	Minnesota
United States	Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph	St. Joseph	Michigan
United States	Missouri Baptist Cancer Center	St. Louis	Missouri
United States	Park Nicollet Health Services	St. Louis Park	Minnesota
United States	Regions Hospital Cancer Care Center	St. Paul	Minnesota
United States	United Hospital	St. Paul	Minnesota
United States	Geisinger Medical Group - Scenery Park	State College	Pennsylvania
United States	Mount Nittany Medical Center	State College	Pennsylvania
United States	Stony Brook University Cancer Center	Stony Brook	New York
United States	Overlook Hospital	Summit	New Jersey
United States	Flower Hospital Cancer Center	Sylvania	Ohio
United States	CCOP - Hematology-Oncology Associates of Central New York	Syracuse	New York
United States	SUNY Upstate Medical University Hospital	Syracuse	New York
United States	CCOP - Northwest	Tacoma	Washington
United States	Madigan Army Medical Center - Tacoma	Tacoma	Washington
United States	St. Clare Hospital	Tacoma	Washington
United States	St. Joseph Medical Center at Franciscan Health System	Tacoma	Washington
United States	CCOP - Toledo Community Hospital	Toledo	Ohio
United States	Medical University of Ohio Cancer Center	Toledo	Ohio
United States	St. Vincent Mercy Medical Center	Toledo	Ohio
United States	Toledo Clinic, Incorporated - Main Clinic	Toledo	Ohio
United States	Toledo Hospital	Toledo	Ohio
United States	J. Phillip Citta Regional Cancer Center at Community Medical Center	Toms River	New Jersey
United States	St. Francis Comprehensive Cancer Center	Topeka	Kansas
United States	Stormont-Vail Cancer Center	Topeka	Kansas
United States	UVMC Cancer Care Center at Upper Valley Medical Center	Troy	Ohio
United States	Arizona Cancer Center at University of Arizona Health Sciences Center	Tucson	Arizona
United States	LaFortune Cancer Center at St. John Medical Center	Tulsa	Oklahoma
United States	Associates in Hematology-Oncology, PC at Crozer Regional Cancer Center	Upland	Pennsylvania
United States	Carle Cancer Center at Carle Foundation Hospital	Urbana	Illinois
United States	CCOP - Carle Cancer Center	Urbana	Illinois
United States	Fox Chase Virtua Health Cancer Program at Virtua West Jersey	Voorhees	New Jersey
United States	Ridgeview Medical Center	Waconia	Minnesota
United States	Pacific Cancer Institute - Maui	Wailuku, Maui	Hawaii
United States	Kent County Memorial Hospital	Warwick	Rhode Island
United States	Sibley Memorial Hospital	Washington	District of Columbia
United States	Walter Reed Army Medical Center	Washington	District of Columbia
United States	Cedar Valley Medical Specialists, PC - West Ridgeway Avenue	Waterloo	Iowa
United States	MaineGeneral Medical Center - Waterville Campus	Waterville	Maine
United States	University of Wisconcin Cancer Center at Aspirus Wausau Hospital	Wausau	Wisconsin
United States	Fulton County Health Center	Wauseon	Ohio
United States	Jennersville Regional Hospital	West Grove	Pennsylvania
United States	Palm Beach Cancer Institute - West Palm Beach	West Palm Beach	Florida
United States	Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center	Wilkes-Barre	Pennsylvania
United States	Willmar Cancer Center at Rice Memorial Hospital	Willmar	Minnesota
United States	Zimmer Cancer Center at New Hanover Regional Medical Center	Wilmington	North Carolina
United States	Minnesota Oncology Hematology, PA - Woodbury	Woodbury	Minnesota
United States	Woodwinds Health Campus	Woodbury	Minnesota
United States	CCOP - MainLine Health	Wynnewood	Pennsylvania
United States	Lankenau Cancer Center at Lankenau Hospital	Wynnewood	Pennsylvania
United States	Ruth G. McMillan Cancer Center at Greene Memorial Hospital	Xenia	Ohio
United States	North Star Lodge Cancer Center at Yakima Valley Memorial Hospital	Yakima	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	Canadian Cancer Trials Group, National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada,  Peru, 

References & Publications (6)

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 B

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 — View Citation

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.

Pal SK, Mortimer J. Adjuvant chemotherapy for older adults with breast cancer: making the standard a standard. Womens Health (Lond Engl). 2009 Sep;5(5):481-4. doi: 10.2217/whe.09.43. Review. — View Citation

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: — View Citation

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	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	Yes