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NCT00003519 Clinical Trial

Combination Chemotherapy in Treating Women With Breast Cancer

Breast Cancer Clinical Trial

Official title:
Phase III Study of Adriamycin/Taxotere Versus Adriamycin/Cytoxan for the Adjuvant Treatment of Node Positive or High Risk Node Negative Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00003519
Other study ID # CDR0000066563
Secondary ID E2197CLB-49802NC
Status Completed
Phase Phase 3
First received
Last updated
Start date August 20, 1998

Study information
Verified date June 2023
Source Eastern Cooperative Oncology Group
Contact n/a
Is FDA regulated No
Health authority
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 may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating women with breast cancer who have undergone surgery to remove the tumor.

Description:

OBJECTIVES: I. Determine whether doxorubicin/docetaxel (DD) will improve disease-free survival and overall survival when compared to doxorubicin/cyclophosphamide (DC) in women with lymph node positive (1-3 positive nodes) or high risk lymph node negative breast cancer. II. Compare the toxicity of DD to DC in this patient population. OUTLINE: This is a randomized study. Patients are stratified by node status (positive vs negative), menopause status (pre- vs post), estrogen receptor (ER) status/progesterone receptor (PR) status (ER/PR unknown vs ER+/PR+ vs ER+/PR- vs ER-/PR+ vs ER-/PR-). Patients in arm I receive doxorubicin IV plus docetaxel IV over 1 hour every 3 weeks for 4 treatment courses. Patients in arm II receive doxorubicin IV plus cyclophosphamide IV every 3 weeks for 4 treatment courses. All patients who are estrogen receptor or progesterone receptor positive receive oral tamoxifen daily for 5 years following chemotherapy. Some patients may also receive radiotherapy following chemotherapy. Patients are followed every 3 months if patient is less than 2 years from study entry; every 6 months if patient is 2-5 years from study entry; and every 12 months if patient is greater than 5 years from study entry. PROJECTED ACCRUAL: Approximately 2778 patients will be accrued for this study within 2.5 years.

Recruitment information / eligibility
Status Completed
Enrollment 2778
Est. completion date
Est. primary completion date January 2007
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 120 Years
Eligibility DISEASE CHARACTERISTICS: Histologically confirmed resectable adenocarcinoma of the breast Histologically positive lymph nodes (1 to 3) OR Lymph node negative and high risk disease Tumor greater than 1.0 cm diameter May have undergone an axillary dissection with at least 6 nodes removed and examined or a sentinel node biopsy Patients who are positive by sentinel node biopsy will receive an axillary dissection No locally advanced or inflammatory or metastatic breast cancer Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Adequate hepatic function Bilirubin no greater than upper limit of normal Renal: Adequate renal function Cardiovascular: Adequate cardiac function Normal MUGA or echocardiogram Other: Not pregnant or nursing Fertile patients must use effective barrier method contraception At least 5 years since prior invasive malignancies, except basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for this malignancy Endocrine therapy: No concurrent tamoxifen Up to 4 weeks of tamoxifen treatment for this malignancy allowed Radiotherapy: No prior radiotherapy for this malignancy Prior radiotherapy to the breast for ductal carcinoma in situ allowed Surgery: Tumor should be removed by either a modified radical mastectomy and/or a segmental mastectomy plus axillary lymph node dissection or sentinel node biopsy before beginning treatment on protocol No greater than 84 days since last surgical procedure that constitutes or completes definitive surgical therapy (mastectomy; axillary dissection/sentinel node biopsy; or resection of primary site to obtain a negative margin

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• cyclophosphamide

• docetaxel

• doxorubicin hydrochloride

Locations
Country Name City State
United States University of New Mexico Cancer Research & Treatment Center Albuquerque New Mexico
United States Veterans Affairs Medical Center - Albuquerque Albuquerque New Mexico
United States University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
United States Veterans Affairs Medical Center - Ann Arbor Ann Arbor Michigan
United States CCOP - Atlanta Regional Atlanta Georgia
United States Marlene & Stewart Greenebaum Cancer Center, University of Maryland Baltimore Maryland
United States CCOP - Montana Cancer Consortium Billings Montana
United States Veterans Affairs Medical Center - Biloxi Biloxi Mississippi
United States Veterans Affairs Medical Center - Birmingham Birmingham Alabama
United States Boston Medical Center Boston Massachusetts
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Veterans Affairs Medical Center - Brooklyn Brooklyn New York
United States Roswell Park Cancer Institute Buffalo New York
United States Veterans Affairs Medical Center - Buffalo Buffalo New York
United States Vermont Cancer Center Burlington Vermont
United States Lineberger Comprehensive Cancer Center, UNC Chapel Hill North Carolina
United States Medical University of South Carolina Charleston South Carolina
United States University of Chicago Cancer Research Center Chicago Illinois
United States University of Illinois at Chicago Health Sciences Center Chicago Illinois
United States Veterans Affairs Medical Center - Chicago (Westside Hospital) Chicago Illinois
United States Barrett Cancer Center, The University Hospital Cincinnati Ohio
United States Veterans Affairs Medical Center - Cincinnati Cincinnati Ohio
United States Cleveland Clinic Cancer Center Cleveland Ohio
United States Ellis Fischel Cancer Center - Columbia Columbia Missouri
United States Veterans Affairs Medical Center - Columbia (Truman Memorial) Columbia Missouri
United States Arthur G. James Cancer Hospital - Ohio State University Columbus Ohio
United States CCOP - Columbus Columbus Ohio
United States Veterans Affairs Medical Center - Dayton Dayton Ohio
United States University of Colorado Cancer Center Denver Colorado
United States Veterans Affairs Medical Center - Denver Denver Colorado
United States Barbara Ann Karmanos Cancer Institute Detroit Michigan
United States Henry Ford Hospital Detroit Michigan
United States Veterans Affairs Medical Center - Detroit Detroit Michigan
United States Beckman Research Institute, City of Hope Duarte California
United States Duke Comprehensive Cancer Center Durham North Carolina
United States Veterans Affairs Medical Center - Durham Durham North Carolina
United States Dwight David Eisenhower Army Medical Center Fort Gordon Georgia
United States Brooke Army Medical Center Fort Sam Houston Texas
United States University of Texas Medical Branch Galveston Texas
United States CCOP - Grand Rapids Clinical Oncology Program Grand Rapids Michigan
United States CCOP - Greenville Greenville South Carolina
United States Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) Hines Illinois
United States Cancer Research Center of Hawaii Honolulu Hawaii
United States University of Iowa Hospitals and Clinics Iowa City Iowa
United States University of Mississippi Medical Center Jackson Mississippi
United States Veterans Affairs Medical Center - Jackson Jackson Mississippi
United States Veterans Affairs Medical Center - Boston (Jamaica Plain) Jamaica Plain Massachusetts
United States CCOP - Kansas City Kansas City Missouri
United States University of Kansas Medical Center Kansas City Kansas
United States Veterans Affairs Medical Center - Kansas City Kansas City Missouri
United States Keesler Medical Center - Keesler AFB Keesler Air Force Base Mississippi
United States CCOP - Dayton Kettering Ohio
United States University of California San Diego Cancer Center La Jolla California
United States CCOP - Southern Nevada Cancer Research Foundation Las Vegas Nevada
United States Norris Cotton Cancer Center Lebanon New Hampshire
United States Albert B. Chandler Medical Center, University of Kentucky Lexington Kentucky
United States Veterans Affairs Medical Center - Lexington Lexington Kentucky
United States University of Arkansas for Medical Sciences Little Rock Arkansas
United States Veterans Affairs Medical Center - Little Rock (McClellan) Little Rock Arkansas
United States Veterans Affairs Medical Center - Long Beach Long Beach California
United States Jonsson Comprehensive Cancer Center, UCLA Los Angeles California
United States USC/Norris Comprehensive Cancer Center Los Angeles California
United States Texas Tech University Health Science Center Lubbock Texas
United States CCOP - North Shore University Hospital Manhasset New York
United States North Shore University Hospital Manhasset New York
United States Veterans Affairs Outpatient Clinic - Martinez Martinez California
United States Loyola University Medical Center Maywood Illinois
United States University of Tennessee, Memphis Cancer Center Memphis Tennessee
United States Veterans Affairs Medical Center - Memphis Memphis Tennessee
United States CCOP - Mount Sinai Medical Center Miami Beach Florida
United States University of Minnesota Cancer Center Minneapolis Minnesota
United States Veterans Affairs Medical Center - Minneapolis Minneapolis Minnesota
United States MBCCOP - University of South Alabama Mobile Alabama
United States MBCCOP - LSU Medical Center New Orleans Louisiana
United States Tulane University School of Medicine New Orleans Louisiana
United States Veterans Affairs Medical Center - New Orleans New Orleans Louisiana
United States Herbert Irving Comprehensive Cancer Center New York New York
United States Memorial Sloan-Kettering Cancer Center New York New York
United States Mount Sinai Medical Center, NY New York New York
United States New York Presbyterian Hospital - Cornell Campus New York New York
United States CCOP - Bay Area Tumor Institute Oakland California
United States Oklahoma Medical Research Foundation Oklahoma City Oklahoma
United States Veterans Affairs Medical Center - Oklahoma City Oklahoma City Oklahoma
United States University of Nebraska Medical Center Omaha Nebraska
United States Veterans Affairs Medical Center - Omaha Omaha Nebraska
United States Chao Family Comprehensive Cancer Center Orange California
United States CCOP - Greater Phoenix Phoenix Arizona
United States Veterans Affairs Medical Center - Phoenix (Hayden) Phoenix Arizona
United States CCOP - Columbia River Program Portland Oregon
United States Oregon Cancer Center at Oregon Health Sciences University Portland Oregon
United States Veterans Affairs Medical Center - Portland Portland Oregon
United States Rhode Island Hospital Providence Rhode Island
United States MBCCOP - Massey Cancer Center Richmond Virginia
United States Veterans Affairs Medical Center - Richmond Richmond Virginia
United States University of California Davis Medical Center Sacramento California
United States Barnes-Jewish Hospital Saint Louis Missouri
United States CCOP - St. Louis-Cape Girardeau Saint Louis Missouri
United States St. Louis University Health Sciences Center Saint Louis Missouri
United States Huntsman Cancer Institute Salt Lake City Utah
United States Veterans Affairs Medical Center - Salt Lake City Salt Lake City Utah
United States University of Texas Health Science Center at San Antonio San Antonio Texas
United States Veterans Affairs Medical Center - San Antonio (Murphy) San Antonio Texas
United States UCSF Cancer Center and Cancer Research Institute San Francisco California
United States Veterans Affairs Medical Center - San Francisco San Francisco California
United States CCOP - Santa Rosa Memorial Hospital Santa Rosa California
United States CCOP - Virginia Mason Research Center Seattle Washington
United States Swedish Hospital Tumor Institute Seattle Washington
United States Veterans Affairs Medical Center - Seattle Seattle Washington
United States Louisiana State University Hospital - Shreveport Shreveport Louisiana
United States Veterans Affairs Medical Center - Shreveport Shreveport Louisiana
United States Providence Hospital - Southfield Southfield Michigan
United States CCOP - Upstate Carolina Spartanburg South Carolina
United States CCOP - Central Illinois Springfield Illinois
United States CCOP - Ozarks Regional Springfield Missouri
United States CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. Syracuse New York
United States State University of New York - Upstate Medical University Syracuse New York
United States Veterans Affairs Medical Center - Syracuse Syracuse New York
United States CCOP - Northwest Tacoma Washington
United States CCOP - Scott and White Hospital Temple Texas
United States Veterans Affairs Medical Center - Temple Temple Texas
United States Veterans Affairs Medical Center - Togus Togus Maine
United States David Grant Medical Center Travis Air Force Base California
United States Arizona Cancer Center Tucson Arizona
United States Veterans Affairs Medical Center - Tucson Tucson Arizona
United States Van Nuys Breast Center Van Nuys California
United States Vincent T. Lombardi Cancer Research Center, Georgetown University Washington District of Columbia
United States Walter Reed Army Medical Center Washington District of Columbia
United States Veterans Affairs Medical Center - White River Junction White River Junction Vermont
United States CCOP - Wichita Wichita Kansas
United States Veterans Affairs Medical Center - Wichita Wichita Kansas
United States CCOP - Christiana Care Health Services Wilmington Delaware
United States CCOP - Southeast Cancer Control Consortium Winston-Salem North Carolina
United States Comprehensive Cancer Center of Wake Forest University Baptist Medical Center Winston-Salem North Carolina
United States University of Massachusetts Memorial Medical Center Worcester Massachusetts

Sponsors (5)
Lead Sponsor Collaborator
Eastern Cooperative Oncology Group Cancer and Leukemia Group B, National Cancer Institute (NCI), North Central Cancer Treatment Group, SWOG Cancer Research Network

Country where clinical trial is conducted

United States, 

References & Publications (6)

Badve SS, Baehner FL, Gray RP, Childs BH, Maddala T, Liu ML, Rowley SC, Shak S, Perez EA, Shulman LJ, Martino S, Davidson NE, Sledge GW, Goldstein LJ, Sparano JA. Estrogen- and progesterone-receptor status in ECOG 2197: comparison of immunohistochemistry — View Citation

Goldstein L, Ravdin P, Gray R, et al.: Prognostic utility of the 21-gene assay compared with adjuvant in hormone receptor (HR) positive operable breast cancer with 0-3 positive axillary nodes treated with adjuvant chemohormonal therapy (CHT): an analysis

Goldstein LJ, Gray R, Badve S, Childs BH, Yoshizawa C, Rowley S, Shak S, Baehner FL, Ravdin PM, Davidson NE, Sledge GW Jr, Perez EA, Shulman LN, Martino S, Sparano JA. Prognostic utility of the 21-gene assay in hormone receptor-positive operable breast ca — View Citation

Goldstein LJ, Gray R, Childs BH, et al.: Prognostic utility of 21-gene assay in hormone receptor (HR) positive operable breast cancer and 0-3 positive axillary nodes treated with adjuvant chemohormonal therapy (CHT): an analysis of Intergroup trial E2197.

Goldstein LJ, O'Neill A, Sparano J, et al.: E2197: Phase III AT (doxorubucin/docetaxel) vs. AC (doxorubicin/cyclophosphamide) in the adjuvant treatment of node positive and high risk node negative breast cancer. [Abstract] J Clin Oncol 23 (Suppl 16): A-51

Goldstein LJ, O'Neill A, Sparano JA, et al.: LVEF assessment of adjuvant doxorubicin/cyclophosphamide (AC) vs. doxorubicin/docetaxel (AT) in early stage breast cancer: cardiac safety results of ECOG 2197. [Abstract] Proceedings of the American Society of

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