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Clinical Trial: Comparison of Combination Chemotherapy Regimens in Treating Older Women Who Have Undergone Surgery for Breast Cancer
This study is currently recruiting patients.
Purpose
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: Randomized phase III trial to compare the effectiveness of different chemotherapy regimens in treating older women who have undergone surgery for breast cancer.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| stage I breast cancer stage II breast cancer stage IIIA breast cancer | Drug: capecitabine Drug: cyclophosphamide Drug: doxorubicin Drug: fluorouracil Drug: methotrexate Procedure: adjuvant therapy Procedure: chemotherapy | Phase III |
MedlinePlus related topics: Breast Cancer
Genetics Home Reference related topics: breast cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase III Randomized Study of Adjuvant Chemotherapy Comprising Standard Cyclophosphamide, Methotrexate, and Fluorouracil (CMF) or Doxorubicin and Cyclophosphamide (AC) Versus Oral Capecitabine in Elderly Women With Operable Adenocarcinoma of the Breast
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) and performance status (0-1 vs 2). Patients are randomized to 1 of 2 treatment arms.
- 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.
Eligibility
Ages Eligible for Study: 65 Years and above, Genders Eligible for Study: Both
Criteria
DISEASE CHARACTERISTICS:
- Histologically proven operable adenocarcinoma of the breast
- Stage I-IIIA disease
- T1-3 (tumor size ≥ 1 cm), any N, M0
- Must have undergone 1 of the following within the past 12 weeks:
- Modified radical mastectomy
- No evidence of gross or microscopic invasive tumor at the surgical resection margins
- Close margins (tumor less than 1 mm from margin) allowed
- Lumpectomy (clear margins preferred)
- Ductal carcinoma in situ or lobular carcinoma in situ at the surgical resection margin allowed
- No invasive tumor at the final resection margin
- Any number of previously excised nodes allowed
- Axillary node dissection not required
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS: Age:
- 65 and over
Sex:
- Female
Menopausal status:
- Postmenopausal
Performance status:
- 0-2
Life expectancy:
- More than 5 years
Hematopoietic:
- Granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than upper limit of normal
Renal:
- Creatinine clearance at least 30 mL/min
Cardiovascular:
- No uncontrolled cardiac disease that would preclude study entry
- Left ventricular ejection fraction at least lower limit of normal (arm I, group B only)
Other:
- HIV negative
- No other concurrent active malignancy except nonmelanoma skin cancer
- Disease considered not currently active if completely treated with less than a 30% risk of relapse
- No psychiatric illness that would preclude informed consent
- No other medical condition (e.g., uncontrolled infection) that would preclude study entry
- No hypersensitivity to fluorouracil
- No known dihydropyrimidine dehydrogenase deficiency
PRIOR CONCURRENT THERAPY: Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy for breast cancer
- No other concurrent chemotherapy
Endocrine therapy:
- Up to 4 weeks of prior tamoxifen for current breast cancer allowed
- Prior tamoxifen or raloxifene for chemoprevention (e.g., breast cancer prevention study) or other indications (including prior breast cancer) allowed but must be discontinued before study entry
- No concurrent hormonal therapy except steroids for adrenal failure, hormones for non-disease related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic
Radiotherapy:
- Not specified
Surgery:
- See Disease Characteristics
Other:
- No concurrent dexrazoxane
- No concurrent bisphosphonates except for treatment of osteoporosis
Location and Contact Information
Alabama
Northeast Alabama Regional Medical Center, Anniston, Alabama, 36207, United States; Recruiting
California
Naval Medical Center - San Diego, San Diego, California, 92134-3202, United States; Recruiting
Rebecca and John Moores UCSD Cancer Center, La Jolla, California, 92093-0658, United States; Recruiting
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center, Los Angeles, California, 90048, United States; Recruiting
Veterans Affairs Medical Center - San Diego, San Diego, California, 92161, United States; Recruiting
Veterans Affairs Medical Center - San Francisco, San Francisco, California, 94121, United States; Recruiting
Delaware
CCOP - Christiana Care Health Services, Newark, Delaware, 19713, United States; Recruiting
District of Columbia
Lombardi Cancer Center at Georgetown University Medical Center, Washington, District of Columbia, 20007, United States; Recruiting
Veterans Affairs Medical Center - Washington, DC, Washington, District of Columbia, 20422, United States; Recruiting
Walter Reed Army Medical Center, Washington, District of Columbia, 20307-5001, United States; Recruiting
Florida
Broward General Medical Center, Fort Lauderdale, Florida, 33316, United States; Recruiting
CCOP - Mount Sinai Medical Center, Miami Beach, Florida, 33140, United States; Recruiting
Memorial Cancer Institute at Memorial Regional Hospital, Hollywood, Florida, 33021, United States; Recruiting
Palm Beach Cancer Institute - West Palm Beach, West Palm Beach, Florida, 33401, United States; Recruiting
University of Florida Shands Cancer Center, Gainesville, Florida, 32610-0277, United States; Recruiting
Veterans Affairs Medical Center - Tampa (Haley), Tampa, Florida, 33612, United States; Recruiting
Hawaii
MBCCOP - Hawaii, Honolulu, Hawaii, 96813, United States; Recruiting
Illinois
CCOP - Illinois Oncology Research Association, Peoria, Illinois, 61615-7828, United States; Recruiting
Center for Cancer Care at OSF Saint Anthony Medical Center, Rockford, Illinois, 61108, United States; Recruiting
La Grange Oncology Associates, La Grange, Illinois, 60525, United States; Recruiting
Louis A. Weiss Memorial Hospital, Chicago, Illinois, 60640, United States; Recruiting
Swedish-American Regional Cancer Center, Rockford, Illinois, 61104-2315, United States; Recruiting
University of Chicago Cancer Research Center, Chicago, Illinois, 60637-1470, United States; Recruiting
Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago, Illinois, 60612, United States; Recruiting
West Suburban Center for Cancer Care, River Forest, Illinois, 60305, United States; Recruiting
Indiana
CCOP - Northern Indiana CR Consortium, South Bend, Indiana, 46601, United States; Recruiting
Fort Wayne Medical Oncology and Hematology, Incorporated, Fort Wayne, Indiana, 46885-5099, United States; Recruiting
Iowa
Hematology Oncology Associates of the Quad Cities, Bettendorf, Iowa, 52722, United States; Recruiting
Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa, 52242-1009, United States; Recruiting
John Stoddard Cancer Center at Iowa Lutheran Hospital, Des Moines, Iowa, 50316-2301, United States; Recruiting
John Stoddard Cancer Center at Iowa Methodist Medical Center, Des Moines, Iowa, 50309, United States; Recruiting
Mercy Cancer Center at Mercy Medical Center - Des Moines, Des Moines, Iowa, 50314, United States; Recruiting
Kentucky
Baptist Hospital East - Louisville, Louisville, Kentucky, 40207, United States; Recruiting
Maryland
Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore, Maryland, 21201, United States; Recruiting
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, 21231, United States; Recruiting
Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts, 02115, United States; Recruiting
UMASS Memorial Cancer Center - University Campus, Worcester, Massachusetts, 01655, United States; Recruiting
Michigan
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph, Saint Joseph, Michigan, 49085, United States; Recruiting
Minnesota
University of Minnesota Cancer Center, Minneapolis, Minnesota, 55455, United States; Recruiting
Veterans Affairs Medical Center - Minneapolis, Minneapolis, Minnesota, 55417, United States; Recruiting
Missouri
Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia, Missouri, 65203, United States; Recruiting
Missouri Baptist Cancer Center, Saint Louis, Missouri, 63131, United States; Recruiting
Siteman Cancer Center at Barnes-Jewish Hospital, Saint Louis, Missouri, 63110, United States; Recruiting
Veterans Affairs Medical Center - Columbia (Truman Memorial), Columbia, Missouri, 65201, United States; Recruiting
Nebraska
Midlands Cancer Center at Midlands Community Hospital, Papillion, Nebraska, 68128-4157, United States; Recruiting
UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha, Nebraska, 68198-7680, United States; Recruiting
Nevada
CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada, 89106, United States; Recruiting
Veterans Affairs Medical Center - Las Vegas, Las Vegas, Nevada, 89106, United States; Recruiting
New Hampshire
New Hampshire Oncology-Hematology, PA - Hooksett, Hooksett, New Hampshire, 03106, United States; Recruiting
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, 03756-0002, United States; Recruiting
New Jersey
Cancer Institute of New Jersey at the Cooper University Hospital, Camden, New Jersey, 08103, United States; Recruiting
New Mexico
MBCCOP - University of New Mexico HSC, Albuquerque, New Mexico, 87131, United States; Recruiting
New York
CCOP - North Shore University Hospital, Manhasset, New York, 11030, United States; Recruiting
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., East Syracuse, New York, 13057, United States; Recruiting
Elmhurst Hospital Center, Elmhurst, New York, 11373, United States; Recruiting
Herbert Irving Comprehensive Cancer Center at Columbia University, New York, New York, 10032, United States; Recruiting
James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York, 14642, United States; Recruiting
Memorial Sloan-Kettering Cancer Center, New York, New York, 10021, United States; Recruiting
Mount Sinai Medical Center, New York, New York, 10029, United States; Recruiting
New York Weill Cornell Cancer Center at Cornell University, New York, New York, 10021, United States; Recruiting
North Shore University Hospital, Manhasset, New York, 11030, United States; Recruiting
NYU Cancer Institute at New York University Medical Center, New York, New York, 10016, United States; Recruiting
Queens Cancer Center of Queens Hospital, Jamaica, New York, 11432, United States; Recruiting
Roswell Park Cancer Institute, Buffalo, New York, 14263-0001, United States; Recruiting
SUNY Upstate Medical University Hospital, Syracuse, New York, 13210, United States; Recruiting
Veterans Affairs Medical Center - Buffalo, Buffalo, New York, 14215, United States; Recruiting
Veterans Affairs Medical Center - Syracuse, Syracuse, New York, 13210, United States; Recruiting
North Carolina
Cape Fear Valley Medical Center, Fayetteville, North Carolina, 28302-2000, United States; Recruiting
CCOP - Southeast Cancer Control Consortium, Goldsboro, North Carolina, 27534-9479, United States; Recruiting
Comprehensive Cancer Center at Moore Regional Hospital, Pinehurst, North Carolina, 28374, United States; Recruiting
Comprehensive Cancer Center at Wake Forest University, Winston Salem, North Carolina, 27157-1082, United States; Recruiting
Duke Comprehensive Cancer Center, Durham, North Carolina, 27710, United States; Recruiting
Lenoir Memorial Cancer Center, Kinston, North Carolina, 28503-1678, United States; Recruiting
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina, 27599-7295, United States; Recruiting
NorthEast Oncology Associates - Concord, Concord, North Carolina, 28025, United States; Recruiting
Veterans Affairs Medical Center - Asheville, Asheville, North Carolina, 28805-9913, United States; Recruiting
Veterans Affairs Medical Center - Durham, Durham, North Carolina, 27705, United States; Recruiting
Zimmer Cancer Center at New Hanover Regional Medical Center, Wilmington, North Carolina, 28402-9025, United States; Recruiting
Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University, Columbus, Ohio, 43210-1240, United States; Recruiting
Oklahoma
Oklahoma University Medical Center, Oklahoma City, Oklahoma, 73104, United States; Recruiting
Pennsylvania
Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania, 17033-0850, United States; Recruiting
PinnacleHealth Regional Cancer Center at Polyclinic Hospital, Harrisburg, Pennsylvania, 17110, United States; Recruiting
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital, Pittsburgh, Pennsylvania, 15224, United States; Recruiting
Rhode Island
Miriam Hospital at Lifespan, Providence, Rhode Island, 02906, United States; Recruiting
South Carolina
Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina, 29425, United States; Recruiting
Veterans Affairs Medical Center - Charleston, Charleston, South Carolina, 29401-5799, United States; Recruiting
Tennessee
Danville Radiation Therapy Center, Memphis, Tennessee, 38104, United States; Recruiting
University of Tennessee Cancer Institute at Methodist Central Hospital, Memphis, Tennessee, 38104, United States; Recruiting
Texas
Harrington Cancer Center, Amarillo, Texas, 79106, United States; Recruiting
Veterans Affairs Medical Center - Amarillo, Amarillo, Texas, 79106, United States; Recruiting
Vermont
Fletcher Allen Health Care - University Health Center Campus, Burlington, Vermont, 05401, United States; Recruiting
Vermont Cancer Center at University of Vermont, Burlington, Vermont, 05401-3498, United States; Recruiting
Virginia
Martha Jefferson Hospital, Charlottesville, Virginia, 22902, United States; Recruiting
MBCCOP - Massey Cancer Center, Richmond, Virginia, 23298-0037, United States; Recruiting
Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke, Roanoke, Virginia, 24014, United States; Recruiting
Virginia Oncology Associates - Norfolk, Norfolk, Virginia, 23502, United States; Recruiting
Washington
University Cancer Center at University of Washington Medical Center, Seattle, Washington, 98109, United States; Recruiting
West Virginia
St. Mary's Medical Center, Huntington, West Virginia, 25701, United States; Recruiting
Australia, New South Wales
Westmead Hospital, Westmead, New South Wales, 2145, Australia; Recruiting
Canada, British Columbia
British Columbia Cancer Agency, Vancouver, British Columbia, V5Z 4E6, Canada; Recruiting
Canada, Manitoba
St. Boniface General Hospital, Winnipeg, Manitoba, R2H 2A6, Canada; Recruiting
Peru
Instituto de Enfermedades Neoplasicas, Lima, 34, Peru; Recruiting
Puerto Rico
San Juan City Hospital, San Juan, 00936-7344, Puerto Rico; Recruiting
Hyman Bernard Muss, MD, Study Chair, Fletcher Allen Health Care - University Health Center Campus
Antonio C. Wolff, MD, Study Chair, Sidney Kimmel Cancer Center
Julie R. Gralow, MD, Study Chair, University of Washington
Tamara N. Shenkier, MD, Study Chair, British Columbia Cancer Agency
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: March 2005
Last Updated: March 28, 2005
Record first received: September 13, 2001
ClinicalTrials.gov Identifier: NCT00024102
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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