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

NCT00024102 | Completed Phase 3 Results DMC

• 4 other identifiers: CALGB-49907U10CA031946CAN-NCIC-MAC1CDR0000068891
• Study Type: interventional
• Target: 633
• Locations: 3 countries
• Sites: 334

Brief 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.

Conditions

Breast Cancer

Keywords

stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Overall Survival Rate at 2.4 Years

  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.

  Reported during protocol treatment after each cycle

Study Arms (2)

Standard Chemotherapy

ACTIVE COMPARATOR

Patient/Physician choice of cyclophosphamide + MTX + 5-FU OR Cyclophosphamide + doxorubicin

Drug: Standard Treatment

Capecitabine

EXPERIMENTAL

Treatment with capecitabine

Drug: capecitabine

Interventions

Standard Treatment DRUG

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

Also known as: doxorubicin = adriamycin

Standard Chemotherapy

capecitabine DRUG

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

Capecitabine

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator
• NCIC Clinical Trials Group: collaborator

Study Sites (334)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35294, United States

Location

Mobile Infirmary Medical Center

Mobile, Alabama, 36652-2144, United States

Location

Mayo Clinic Scottsdale

Scottsdale, Arizona, 85259-5499, United States

Location

Arizona Cancer Center at University of Arizona Health Sciences Center

Tucson, Arizona, 85724-5024, United States

Location

St. Joseph's Mercy Cancer Center

Hot Springs, Arkansas, 71913, United States

Location

Glendale Memorial Hospital Comprehensive Cancer Center

Glendale, California, 91204, United States

Location

Saint Rose Hospital

Hayward, California, 94545, United States

Location

Moores UCSD Cancer Center

La Jolla, California, 92093-0658, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90089-9181, United States

Location

Leavey Cancer Center at Northridge Hospital Medical Center

Northridge, California, 91328, United States

Location

Highland General Hospital at St. George's University School of Medicine

Oakland, California, 94602, United States

Location

Alta Bates Summit Medical Center - Summit Campus

Oakland, California, 94609, United States

Location

CCOP - Bay Area Tumor Institute

Oakland, California, 94609, United States

Location

Valley Care Medical Center

Pleasanton, California, 94588, United States

Location

Salinas Valley Memorial Hospital

Salinas, California, 93901, United States

Location

Kaiser Permanente Medical Office -Vandever Medical Office

San Diego, California, 92120, United States

Location

Doctors Medical Center - San Pablo Campus

San Pablo, California, 94806, United States

Location

Memorial Hospital

Colorado Springs, Colorado, 80909, United States

Location

Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut, 06360, United States

Location

Kent General Hospital at Bayhealth Medical Center

Dover, Delaware, 19901, United States

Location

CCOP - Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016, United States

Location

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307-5001, United States

Location

Halifax Medical Center - Daytona Beach

Daytona Beach, Florida, 32115, United States

Location

Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital

Fort Lauderdale, Florida, 33308, United States

Location

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224, United States

Location

Ella Milbank Foshay Cancer Center at Jupiter Medical Center

Jupiter, Florida, 33458, United States

Location

Lakeland Regional Cancer Center at Lakeland Regional Medical Center

Lakeland, Florida, 33805, United States

Location

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

CCOP - Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

Palm Beach Cancer Institute - West Palm Beach

West Palm Beach, Florida, 33401, United States

Location

CCOP - Atlanta Regional

Atlanta, Georgia, 30342, United States

Location

Augusta Oncology Associates - Walton Way

Augusta, Georgia, 30901, United States

Location

Gwinnett Medical Center

Lawrenceville, Georgia, 30045, United States

Location

Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler

Savannah, Georgia, 31405, United States

Location

Cancer Research Center of Hawaii

Honolula, Hawaii, 96813, United States

Location

OnCare Hawaii, Incorporated - Lusitana

Honolulu, Hawaii, 96813, United States

Location

Queen's Cancer Institute at Queen's Medical Center

Honolulu, Hawaii, 96813, United States

Location

Straub Clinic and Hospital, Incorporated

Honolulu, Hawaii, 96813, United States

Location

OnCare Hawaii, Incorporated - Kuakini

Honolulu, Hawaii, 96817, United States

Location

St. Francis Medical Center

Honolulu, Hawaii, 96817, United States

Location

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826, United States

Location

Pacific Cancer Institute - Maui

Wailuku, Maui, Hawaii, 96793, United States

Location

Kapiolani Medical Center at Pali Momi

‘Aiea, Hawaii, 96701, United States

Location

Hematology Oncology Associates of Eastern Idaho

Idaho Falls, Idaho, 83404, United States

Location

Rush-Copley Cancer Care Center

Aurora, Illinois, 60507, United States

Location

St. Joseph Medical Center

Bloomington, Illinois, 61701, United States

Location

Graham Hospital

Canton, Illinois, 61520, United States

Location

Memorial Hospital

Carthage, Illinois, 62321, United States

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

Hematology and Oncology Associates

Chicago, Illinois, 60611, United States

Location

University of Illinois Cancer Center

Chicago, Illinois, 60612-7243, United States

Location

Veterans Affairs Medical Center - Chicago Westside Hospital

Chicago, Illinois, 60612, United States

Location

Mercy Hospital and Medical Center

Chicago, Illinois, 60616, United States

Location

Swedish Covenant Hospital

Chicago, Illinois, 60625, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Decatur Memorial Hospital Cancer Care Institute

Decatur, Illinois, 62526, United States

Location

Eureka Community Hospital

Eureka, Illinois, 61530, United States

Location

Evanston Northwestern Healthcare - Evanston Hospital

Evanston, Illinois, 60201-1781, United States

Location

St. Francis Hospital

Evanston, Illinois, 60202, United States

Location

Galesburg Clinic

Galesburg, Illinois, 61401, United States

Location

Galesburg Cottage Hospital

Galesburg, Illinois, 61401, United States

Location

Mason District Hospital

Havana, Illinois, 62644, United States

Location

Hopedale Medical Complex

Hopedale, Illinois, 61747, United States

Location

Midwest Center for Hematology/Oncology

Joliet, Illinois, 60432, United States

Location

Joliet Oncology-Hematology Associates, Limited - West

Joliet, Illinois, 60435, United States

Location

Provena St. Mary's Wasser Regional Cancer Center - Kankakee

Kankakee, Illinois, 60901, United States

Location

North Shore Oncology and Hematology Associates, Limited - Libertyville

Libertyville, Illinois, 60048, United States

Location

McDonough District Hospital

Macomb, Illinois, 61455, United States

Location

Cancer Care and Hematology Specialists of Chicagoland - Niles

Niles, Illinois, 60714, United States

Location

BroMenn Regional Medical Center

Normal, Illinois, 61761, United States

Location

Community Cancer Center

Normal, Illinois, 61761, United States

Location

Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields

Olympia Fields, Illinois, 60461, United States

Location

Community Hospital of Ottawa

Ottawa, Illinois, 61350, United States

Location

Cancer Treatment Center at Pekin Hospital

Pekin, Illinois, 61554, United States

Location

Proctor Hospital

Peoria, Illinois, 61614, United States

Location

CCOP - Illinois Oncology Research Association

Peoria, Illinois, 61615, United States

Location

Oncology Hematology Associates of Central Illinois, PC - Peoria

Peoria, Illinois, 61615, United States

Location

Methodist Medical Center of Illinois

Peoria, Illinois, 61636, United States

Location

OSF St. Francis Medical Center

Peoria, Illinois, 61637, United States

Location

Illinois Valley Community Hospital

Peru, Illinois, 61354, United States

Location

Perry Memorial Hospital

Princeton, Illinois, 61356, United States

Location

Swedish-American Regional Cancer Center

Rockford, Illinois, 61104-2315, United States

Location

Center for Cancer Care at OSF Saint Anthony Medical Center

Rockford, Illinois, 61108, United States

Location

Hematology Oncology Associates - Skokie

Skokie, Illinois, 60076, United States

Location

Hematology/Oncology of the North Shore at Gross Point Medical Center

Skokie, Illinois, 60076, United States

Location

St. Margaret's Hospital

Spring Valley, Illinois, 61362, United States

Location

Regional Cancer Center at Memorial Medical Center

Springfield, Illinois, 62781-0001, United States

Location

Carle Cancer Center at Carle Foundation Hospital

Urbana, Illinois, 61801, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

St. Francis Hospital and Health Centers - Beech Grove Campus

Beech Grove, Indiana, 46107, United States

Location

Regional Cancer Institute at Bloomington Hospital

Bloomington, Indiana, 47403, United States

Location

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, 46815, United States

Location

Saint Anthony Memorial Health Centers

Michigan City, Indiana, 46360, United States

Location

Community Hospital

Munster, Indiana, 46321, United States

Location

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, 46601, United States

Location

McFarland Clinic, PC

Ames, Iowa, 50010, United States

Location

Hematology Oncology Associates of the Quad Cities

Bettendorf, Iowa, 52722, United States

Location

St. Luke's Hospital

Cedar Rapids, Iowa, 52402, United States

Location

Cedar Rapids Oncology Associates

Cedar Rapids, Iowa, 52403, United States

Location

Mercy Regional Cancer Center at Mercy Medical Center

Cedar Rapids, Iowa, 52403, United States

Location

Heartland Oncology & Hematology

Council Bluffs, Iowa, 51503, United States

Location

Genesis Regional Cancer Center at Genesis Medical Center

Davenport, Iowa, 52803, United States

Location

McCreery Cancer Center at Ottumwa Regional

Ottumwa, Iowa, 52501, United States

Location

Cedar Valley Medical Specialists, PC - West Ridgeway Avenue

Waterloo, Iowa, 50702, United States

Location

Stormont-Vail Cancer Center

Topeka, Kansas, 66604, United States

Location

St. Francis Comprehensive Cancer Center

Topeka, Kansas, 66606, United States

Location

MBCCOP - LSU Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Christus Schumpert Cancer Treatment Center

Shreveport, Louisiana, 71101, United States

Location

Central Maine Medical Center

Lewiston, Maine, 04240, United States

Location

Mercy Hospital of Portland

Portland, Maine, 04101, United States

Location

Maine Center for Cancer Medicine and Blood Disorders - Scarborough

Scarborough, Maine, 04074, United States

Location

MaineGeneral Medical Center - Waterville Campus

Waterville, Maine, 04901, United States

Location

Greenebaum Cancer Center at University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Frederick Memorial Hospital Regional Cancer Therapy Center

Frederick, Maryland, 21701, United States

Location

Tufts-NEMC Cancer Center

Boston, Massachusetts, 02111, United States

Location

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Cancer Research Center at Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Faulkner Hospital

Boston, Massachusetts, 02130, United States

Location

Bethke Cancer Center at Emerson Hospital

Concord, Massachusetts, 01742, United States

Location

Cape Cod Hospital

Hyannis, Massachusetts, 02601, United States

Location

Saints Memorial Cancer Center at Saints Memorial Medical Center

Lowell, Massachusetts, 01852, United States

Location

Lawrence Memorial Hospital of Medford

Medford, Massachusetts, 02155, United States

Location

Caritas Norwood Hospital

Norwood, Massachusetts, 02062, United States

Location

South Shore Hospital

South Weymouth, Massachusetts, 02190, United States

Location

Hickman Cancer Center at Bixby Medical Center

Adrian, Michigan, 49221, United States

Location

Josephine Ford Cancer Center at Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

CCOP - Grand Rapids

Grand Rapids, Michigan, 49503, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007-3731, United States

Location

Haematology-Oncology Associates of Ohio and Michigan, PC

Lambertville, Michigan, 48144, United States

Location

Community Cancer Center of Monroe

Monroe, Michigan, 48162, United States

Location

Mercy Memorial Hospital System

Monroe, Michigan, 48162, United States

Location

Northern Michigan Hospital

Petoskey, Michigan, 49770, United States

Location

William Beaumont Hospital - Royal Oak Campus

Royal Oak, Michigan, 48073, United States

Location

Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph

Saint Joseph, Michigan, 49085, United States

Location

Providence Cancer Institute at Providence Hospital - Southfield Campus

Southfield, Michigan, 48075, United States

Location

Albert Lea Cancer Center at Albert Lea Medical Center

Albert Lea, Minnesota, 56007, United States

Location

MeritCare Clinic - Bemidji

Bemidji, Minnesota, 56601, United States

Location

Fairview Ridges Hospital

Burnsville, Minnesota, 55337, United States

Location

Mercy and Unity Cancer Center at Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

Location

Cancer Care Center at St. Luke's Hospital

Duluth, Minnesota, 55805, United States

Location

CCOP - Duluth

Duluth, Minnesota, 55805, United States

Location

Fairview Southdale Hospital

Edina, Minnesota, 55435, United States

Location

Mercy and Unity Cancer Center at Unity Hospital

Fridley, Minnesota, 55432, United States

Location

Hutchinson Area Health Care

Hutchinson, Minnesota, 55350, United States

Location

Meeker County Memorial Hospital

Lichfield, Minnesota, 55355, United States

Location

Immanuel St. Joseph's Clinic

Mankato, Minnesota, 56002, United States

Location

HealthEast Cancer Care at St. John's Hospital

Maplewood, Minnesota, 55109, United States

Location

Minnesota Oncology Hematology, PA at Maplewood Cancer Center

Maplewood, Minnesota, 55109, United States

Location

Virginia Piper Cancer Institute at Abbott-Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Hennepin County Medical Center - Minneapolis

Minneapolis, Minnesota, 55415, United States

Location

University of Minnesota Medical Center & Children's Hospital - Fairview

Minneapolis, Minnesota, 55455, United States

Location

Chippewa County - Montevideo Hospital

Montevideo, Minnesota, 56265, United States

Location

Hubert H. Humphrey Cancer Center at North Memorial Medical Center

Robbinsdale, Minnesota, 55422-2900, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

CentraCare Clinic - River Campus

Saint Cloud, Minnesota, 56303, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

Park Nicollet Health Services

Saint Louis Park, Minnesota, 55416, United States

Location

Regions Hospital Cancer Care Center

Saint Paul, Minnesota, 55101, United States

Location

St. Joseph's Hospital

Saint Paul, Minnesota, 55102, United States

Location

United Hospital

Saint Paul, Minnesota, 55102, United States

Location

Saint Francis Cancer Center

Shakopee, Minnesota, 55379, United States

Location

Ridgeview Medical Center

Waconia, Minnesota, 55387, United States

Location

Willmar Cancer Center at Rice Memorial Hospital

Willmar, Minnesota, 56201, United States

Location

Minnesota Oncology Hematology, PA - Woodbury

Woodbury, Minnesota, 55125, United States

Location

Woodwinds Health Campus

Woodbury, Minnesota, 55125, United States

Location

Regional Cancer Center at Singing River Hospital

Pascagoula, Mississippi, 39581, United States

Location

Ellis Fischel Cancer Center at University of Missouri - Columbia

Columbia, Missouri, 65203, United States

Location

St. John's Regional Health Center

Springfield, Missouri, 65804, United States

Location

Hulston Cancer Center at Cox Medical Center South

Springfield, Missouri, 65807, United States

Location

Siteman Cancer Center at Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Missouri Baptist Cancer Center

St Louis, Missouri, 63131, United States

Location

CCOP - Montana Cancer Consortium

Billings, Montana, 59101, United States

Location

Great Falls Clinic

Great Falls, Montana, 59405, United States

Location

Sletten Regional Cancer Institute at Benefis Healthcare

Great Falls, Montana, 59405, United States

Location

Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center

Grand Island, Nebraska, 68803, United States

Location

Good Samaritan Cancer Center at Good Samaritan Hospital

Kearney, Nebraska, 68848-1990, United States

Location

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, 68106, United States

Location

Immanuel Medical Center

Omaha, Nebraska, 68122, United States

Location

Alegant Health Cancer Center at Bergan Mercy Medical Center

Omaha, Nebraska, 68124, United States

Location

Creighton University Medical Center

Omaha, Nebraska, 68131-2197, United States

Location

UNMC Eppley Cancer Center at the University of Nebraska Medical Center

Omaha, Nebraska, 68198-6805, United States

Location

Carson-Tahoe Cancer Services at Carson Tahoe Regional Healthcare

Carson City, Nevada, 89703, United States

Location

University Medical Center of Southern Nevada

Las Vegas, Nevada, 89102, United States

Location

CCOP - Nevada Cancer Research Foundation

Las Vegas, Nevada, 89106, United States

Location

Parkland Oncology-Hematology Clinic at Parkland Medical Center

Derry, New Hampshire, 03038, United States

Location

New Hampshire Oncology-Hematology, PA - Hooksett

Hooksett, New Hampshire, 03106, United States

Location

Lakes Region General Hospital

Laconia, New Hampshire, 03246, United States

Location

Elliot Regional Cancer Center at Elliot Hospital

Manchester, New Hampshire, 03103, United States

Location

Ocean Medical Center at Meridian Health

Brick, New Jersey, 08724, United States

Location

Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton

Marlton, New Jersey, 08053, United States

Location

Carol G. Simon Cancer Center at Morristown Memorial Hospital

Morristown, New Jersey, 07962, United States

Location

Booker Cancer Center at Riverview Medical Center

Red Bank, New Jersey, 07701, United States

Location

Overlook Hospital

Summit, New Jersey, 07902, United States

Location

J. Phillip Citta Regional Cancer Center at Community Medical Center

Toms River, New Jersey, 08755, United States

Location

Fox Chase Virtua Health Cancer Program at Virtua West Jersey

Voorhees Township, New Jersey, 08043, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

Adirondack Cancer Care - Glens Falls

Glens Falls, New York, 12801, United States

Location

Charles R. Wood Cancer Center at Glens Falls Hospital

Glens Falls, New York, 12801, United States

Location

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Highland Hospital of Rochester

Rochester, New York, 14620, United States

Location

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Stony Brook University Cancer Center

Stony Brook, New York, 11794-8174, United States

Location

CCOP - Hematology-Oncology Associates of Central New York

Syracuse, New York, 13057, United States

Location

SUNY Upstate Medical University Hospital

Syracuse, New York, 13210, United States

Location

Bronx-Lebanon Hospital Center & BronxCare Adult Medical Practice

The Bronx, New York, 10456, United States

Location

Randolph Hospital

Asheboro, North Carolina, 27203-5400, United States

Location

Mission Hospitals - Memorial Campus

Asheville, North Carolina, 28801, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

CaroMont Cancer Center at Gaston Memorial Hospital

Gastonia, North Carolina, 28053, United States

Location

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, 27534, United States

Location

Moses Cone Regional Cancer Center at Wesley Long Community Hospital

Greensboro, North Carolina, 27403-1198, United States

Location

FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center

Pinehurst, North Carolina, 28374, United States

Location

Annie Penn Cancer Center

Reidsville, North Carolina, 27320, United States

Location

Rutherford Hospital

Rutherfordton, North Carolina, 28139, United States

Location

Zimmer Cancer Center at New Hanover Regional Medical Center

Wilmington, North Carolina, 28401, United States

Location

Cancer Care Center at Medcenter One Hospital

Bismarck, North Dakota, 58501, United States

Location

Mid Dakota Clinic, PC

Bismarck, North Dakota, 58501, United States

Location

CCOP - MeritCare Hospital

Fargo, North Dakota, 58122, United States

Location

MeritCare Medical Group

Fargo, North Dakota, 58122, United States

Location

Altru Cancer Center at Altru Hospital

Grand Forks, North Dakota, 58201, United States

Location

Trinity Cancer Care Center

Minot, North Dakota, 58701, United States

Location

Akron City Hospital

Akron, Ohio, 44309-2090, United States

Location

Wood County Oncology Center

Bowling Green, Ohio, 43402, United States

Location

Aultman Hospital Cancer Center at Aultman Health Foundation

Canton, Ohio, 44710-1799, United States

Location

Charles M. Barrett Cancer Center at University Hospital

Cincinnati, Ohio, 45267, United States

Location

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

MetroHealth's Cancer Care Center at MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Grandview Hospital

Dayton, Ohio, 45405, United States

Location

Good Samaritan Hospital

Dayton, Ohio, 45406, United States

Location

David L. Rike Cancer Center at Miami Valley Hospital

Dayton, Ohio, 45409, United States

Location

Samaritan North Cancer Care Center

Dayton, Ohio, 45415, United States

Location

Veterans Affairs Medical Center - Dayton

Dayton, Ohio, 45428, United States

Location

Fremont Memorial Hospital

Fremont, Ohio, 43420, United States

Location

Charles F. Kettering Memorial Hospital

Kettering, Ohio, 45429, United States

Location

St. Rita's Medical Center

Lima, Ohio, 45801, United States

Location

Lima Memorial Hospital

Lima, Ohio, 45804, United States

Location

Northwest Ohio Oncology Center

Maumee, Ohio, 43537, United States

Location

St. Luke's Hospital

Maumee, Ohio, 43537, United States

Location

Middletown Regional Hospital

Middletown, Ohio, 45044, United States

Location

St. Charles Mercy Hospital

Oregon, Ohio, 43616, United States

Location

Toledo Clinic - Oregon

Oregon, Ohio, 43616, United States

Location

Firelands Regional Medical Center

Sandusky, Ohio, 44870, United States

Location

North Coast Cancer Care, Incorporated

Sandusky, Ohio, 44870, United States

Location

Flower Hospital Cancer Center

Sylvania, Ohio, 43560, United States

Location

Toledo Hospital

Toledo, Ohio, 43606, United States

Location

St. Vincent Mercy Medical Center

Toledo, Ohio, 43608, United States

Location

Medical University of Ohio Cancer Center

Toledo, Ohio, 43614, United States

Location

CCOP - Toledo Community Hospital

Toledo, Ohio, 43617, United States

Location

Toledo Clinic, Incorporated - Main Clinic

Toledo, Ohio, 43623, United States

Location

UVMC Cancer Care Center at Upper Valley Medical Center

Troy, Ohio, 45373-1300, United States

Location

Fulton County Health Center

Wauseon, Ohio, 43567, United States

Location

Ruth G. McMillan Cancer Center at Greene Memorial Hospital

Xenia, Ohio, 45385, United States

Location

Cleo Craig Cancer Research Clinic

Lawton, Oklahoma, 73505, United States

Location

Oklahoma University Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

Cancer Care Associates - Mercy Campus

Oklahoma City, Oklahoma, 73120, United States

Location

LaFortune Cancer Center at St. John Medical Center

Tulsa, Oklahoma, 74104, United States

Location

St. Luke's Hospital Cancer Center

Bethlehem, Pennsylvania, 18015, United States

Location

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, 19010, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822-0001, United States

Location

Dale and Frances Hughes Cancer Center at Pocono Medical Center

East Stroudsburg, Pennsylvania, 18301, United States

Location

Penn State Cancer Institute at Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

Lewistown Hospital

Lewistown, Pennsylvania, 17044, United States

Location

Meadville Medical Center

Meadville, Pennsylvania, 16335, United States

Location

Cancer Center of Paoli Memorial Hospital

Paoli, Pennsylvania, 19301-1792, United States

Location

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107-5541, United States

Location

Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, 15224-1791, United States

Location

St. Joseph Medical Center

Reading, Pennsylvania, 19604, United States

Location

Reading Hospital and Medical Center

Reading, Pennsylvania, 19612-6052, United States

Location

Hematology and Oncology Associates

Scranton, Pennsylvania, 18510, United States

Location

Geisinger Medical Group - Scenery Park

State College, Pennsylvania, 16801, United States

Location

Mount Nittany Medical Center

State College, Pennsylvania, 16803, United States

Location

Associates in Hematology-Oncology, PC at Crozer Regional Cancer Center

Upland, Pennsylvania, 19013, United States

Location

Jennersville Regional Hospital

West Grove, Pennsylvania, 19390-9499, United States

Location

Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center

Wilkes-Barre, Pennsylvania, 18711, United States

Location

CCOP - MainLine Health

Wynnewood, Pennsylvania, 19096, United States

Location

Lankenau Cancer Center at Lankenau Hospital

Wynnewood, Pennsylvania, 19096, United States

Location

Memorial Hospital of Rhode Island

Pawtucket, Rhode Island, 02860, United States

Location

Kent County Memorial Hospital

Warwick, Rhode Island, 02886, United States

Location

AnMed Health Cancer Center

Anderson, South Carolina, 29621, United States

Location

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Oncology Services of Aberdeen

Aberdeen, South Dakota, 57401, United States

Location

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

Location

Medical X-Ray Center, PC

Sioux Falls, South Dakota, 57105, United States

Location

Sioux Valley Hospital and University of South Dakota Medical Center

Sioux Falls, South Dakota, 57117-5039, United States

Location

East Tennessee State University Cancer Center at Johnson City Medical Center

Johnson City, Tennessee, 37604, United States

Location

Thompson Cancer Survival Center

Knoxville, Tennessee, 37916, United States

Location

Nashville Oncology Associates, P.C.

Nashville, Tennessee, 37203, United States

Location

MBCCOP - Meharry Medical College - Nashville

Nashville, Tennessee, 37208-3599, United States

Location

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

Wilford Hall Medical Center

Lackland Air Force Base, Texas, 78236, United States

Location

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, 84112, United States

Location

Mountainview Medical

Berlin Corners, Vermont, 05602, United States

Location

Fletcher Allen Health Care - University Health Center Campus

Burlington, Vermont, 05401, United States

Location

Martha Jefferson Hospital Cancer Care Center

Charlottesville, Virginia, 22901, United States

Location

Auburn Regional Center for Cancer Care

Auburn, Washington, 98002, United States

Location

St. Joseph Cancer Center

Bellingham, Washington, 98225, United States

Location

St. Francis Hospital

Federal Way, Washington, 98003, United States

Location

Providence St. Peter Hospital Regional Cancer Center

Olympia, Washington, 98506-5166, United States

Location

Capital Medical Center

Olympia, Washington, 98507, United States

Location

Good Samaritan Cancer Center

Puyallup, Washington, 98372, United States

Location

Group Health Central Hospital

Seattle, Washington, 98112, United States

Location

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

Seattle, Washington, 98122-4307, United States

Location

University Cancer Center at University of Washington Medical Center

Seattle, Washington, 98195-6043, United States

Location

Cancer Care Northwest - Spokane South

Spokane, Washington, 99202, United States

Location

Providence Cancer Center at Sacred Heart Medical Center

Spokane, Washington, 99204, United States

Location

Providence Cancer Center at Holy Family Hospital

Spokane, Washington, 99207, United States

Location

St. Joseph Medical Center at Franciscan Health System

Tacoma, Washington, 98405-3004, United States

Location

CCOP - Northwest

Tacoma, Washington, 98405, United States

Location

Madigan Army Medical Center - Tacoma

Tacoma, Washington, 98431, United States

Location

St. Clare Hospital

Tacoma, Washington, 98499, United States

Location

North Star Lodge Cancer Center at Yakima Valley Memorial Hospital

Yakima, Washington, 98902, United States

Location

Marshall University Medical Center

Huntington, West Virginia, 25701, United States

Location

Vince Lombardi Cancer Center at Aurora Lakeland Medical Center - Elkhorn

Elkhorn, Wisconsin, 53121, United States

Location

Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center

Green Bay, Wisconsin, 54311, United States

Location

Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601, United States

Location

Dean Medical Center - Madison

Madison, Wisconsin, 53717, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792-6164, United States

Location

Holy Family Memorial Medical Center Cancer Care Center

Manitowoc, Wisconsin, 54221-1450, United States

Location

Aurora Sinai Medical Center

Milwaukee, Wisconsin, 53201-0342, United States

Location

Medical Consultants, Limited

Milwaukee, Wisconsin, 53215, United States

Location

University of Wisconcin Cancer Center at Aspirus Wausau Hospital

Wausau, Wisconsin, 54401, United States

Location

Tom Baker Cancer Centre - Calgary

Calgary, Alberta, T2N 4N2, Canada

Location

Cross Cancer Institute at University of Alberta

Edmonton, Alberta, T6G 1Z2, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Mount Sinai Hospital - Toronto

Toronto, Ontario, M5G 1X5, Canada

Location

Windsor Regional Cancer Centre at Windsor Regional Hospital

Windsor, Ontario, N8W 2X3, Canada

Location

Prince Edward Island Cancer Centre at Queen Elizabeth Hospital

Charlottetown, Prince Edward Island, C1A 8T5, Canada

Location

Allan Blair Cancer Centre at Pasqua Hospital

Regina, Saskatchewan, S4T 7T1, Canada

Location

Instituto Nacional de Enfermedades Neoplasicas

Lima, Lima 34, Peru

Location

Related Publications (11)

• 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.

  PMID: 19702447 BACKGROUND

• 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.

  PMID: 20368559 RESULT

• 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.

  RESULT

• 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.

  PMID: 19439741 RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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.

  PMID: 34037241 DERIVED

• 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.

  PMID: 31339827 DERIVED

• 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.

  PMID: 31034595 DERIVED

• 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.

  PMID: 29602735 DERIVED

• 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.

  PMID: 29233548 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Hyman Muss, MD
• Organization: University of North Carolina

hyman.muss@gmail.com

Study Officials

• Hyman B. Muss, MD

  University of North Carolina

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2001
• First Posted: January 27, 2003
• Study Start: September 1, 2001
• Primary Completion: May 1, 2008
• Study Completion: November 1, 2012
• Last Updated: August 12, 2016
• Results First Posted: January 31, 2013

Record last verified: 2016-07

Locations

PE (1); US (326); CA (7)