Breast Cancer Clinical Trial

Combination Chemotherapy in Treating Women With Stage II or Stage IIIA Breast Cancer That Has Spread to the Lymph Nodes

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of chemotherapy is more effective for breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of combination chemotherapy in treating women who have stage II or stage IIIA breast cancer that has spread to the lymph nodes.

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Full Description

OBJECTIVES:

Compare the disease-free survival and overall survival in patients with node-positive or high-risk node-negative operable stage II or IIIA breast cancer treated with docetaxel or paclitaxel after doxorubicin and cyclophosphamide.
Determine whether the weekly administration of paclitaxel or docetaxel for 12 weeks improves disease-free survival and overall survival when compared with the conventional schedule of every 3 weeks for 4 courses after doxorubicin and cyclophosphamide in this patient population.
Compare the toxic effects of docetaxel and paclitaxel when administered weekly for 12 weeks versus every 3 weeks for 4 courses in these patients.
Compare the toxicity of paclitaxel administered every 3 weeks for 4 courses or weekly for 12 weeks to that of docetaxel administered on the same schedules in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to estrogen receptor status (positive vs negative vs unknown), nodal status (0 positive nodes vs 1-3 positive nodes vs 4-9 positive nodes vs at least 10 positive nodes), tumor size (no more than 5 cm vs more than 5 cm vs unknown), and type of prior surgery (mastectomy vs breast conservation surgery). Patients are randomized to one of four treatment arms.

Arm I: Patients receive doxorubicin IV and cyclophosphamide IV every 3 weeks for 4 courses (weeks 1-12). Beginning at week 13, patients receive paclitaxel IV over 3 hours every 3 weeks for 4 courses.
Arm II: Patients receive doxorubicin and cyclophosphamide as in arm I. Beginning at week 13, patients receive paclitaxel IV over 1 hour weekly for 12 weeks.
Arm III: Patients receive doxorubicin and cyclophosphamide as in arm I. Beginning at week 13, patients receive docetaxel IV over 1 hour every 3 weeks for 4 courses.
Arm IV: Patients receive doxorubicin and cyclophosphamide as in arm I. Beginning at week 13, patients receive docetaxel IV over 1 hour weekly for 12 weeks.

Within 4 weeks after completion of chemotherapy, patients with estrogen and/or progesterone receptor positive tumors receive oral tamoxifen daily for 5 years.

After completion of all chemotherapy, patients with prior segmental mastectomy receive radiotherapy once daily 5 days per week for 5-6 weeks. Patients with prior modified radical mastectomy may receive radiotherapy after chemotherapy completion at the investigator's discretion.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 5,000 patients will be accrued for this study within 1.27 years.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed operable stage IIA, IIB, or IIIA adenocarcinoma of the breast with histologically involved lymph nodes (T1, 2, or 3; N1 or 2; M0) OR high-risk node-negative disease (T2 or 3; N0)

Primary tumor at least 2.1 cm in diameter for node-negative disease
Bilateral breast disease allowed if at least 1 primary tumor meets the criteria above
Must have had at least 6 axillary lymph nodes removed at dissection and at least one node positive for metastasis OR

Sentinel node biopsy negative for metastasis (sentinel node biopsy positive allowed if enrolled on American College of Surgery Trial Z0011 and have beenrandomized to receive no axillary dissection)

Additional axillary nodes may be obtained provided they are also negative for metastasis

Complete tumor removal by either a modified radical mastectomy or local excision plus axillary lymph node dissection (i.e., breast conservation therapy) or sentinel node biopsy

Tumor-free margins at least 1 mm for both invasive and noninvasive carcinoma except for lobular carcinoma in situ (less than 1 mm allowed)
Concurrent enrollment on American College of Surgery Trial Z0010, Z0011, or NSABP B-32 allowed

Hormone receptor status:

Estrogen receptor status positive, negative, or unknown

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/mm^3
Platelet count at least 100,000/mm^3

Hepatic:

Bilirubin no greater than 1.5 mg/dL
SGOT no greater than 2 times upper limit of normal

Renal:

Creatinine no greater than 1.5 mg/dL

Cardiovascular:

No history of myocardial infarction
No congestive heart failure
No significant ischemic or valvular heart disease

Other:

No other prior invasive malignancies within the past 5 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
No hypersensitivity to paclitaxel or docetaxel or other similarly formulated drugs (with Cremophor or polysorbate)
Not pregnant or nursing
Fertile patients must use effective barrier contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

No prior chemotherapy for breast cancer

Endocrine therapy:

Prior tamoxifen of no more than 4 weeks duration for breast cancer allowed
Prior tamoxifen or other selective estrogen receptor modulator (SERM) for chemoprevention (e.g., Breast Cancer Prevention Trial) or for other indications (e.g., osteoporosis) allowed
No concurrent tamoxifen or other SERMs

Radiotherapy:

No prior radiotherapy for this malignancy
At least 2 weeks since prior radiotherapy to the breast for ductal carcinoma in situ

Surgery:

See Disease Characteristics
Less than 84 days since prior surgical procedure to adequately treat primary tumor

Study is for people with:

Breast Cancer

Phase:

Phase 3

Study ID:

NCT00004125

Recruitment Status:

Completed

Sponsor:

Eastern Cooperative Oncology Group

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There are 45 Locations for this study

See Locations Near You

Veterans Affairs Medical Center - Birmingham
Birmingham Alabama, 35233, United States
University of California San Diego Cancer Center
La Jolla California, 92093, United States
Veterans Affairs Medical Center - San Francisco
San Francisco California, 94121, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco California, 94143, United States
CCOP - Christiana Care Health Services
Wilmington Delaware, 19899, United States
Lombardi Cancer Center
Washington District of Columbia, 20007, United States
Walter Reed Army Medical Center
Washington District of Columbia, 20307, United States
CCOP - Mount Sinai Medical Center
Miami Beach Florida, 33140, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago Illinois, 60612, United States
University of Chicago Cancer Research Center
Chicago Illinois, 60637, United States
Hematology Oncology Associates of the Quad Cities
Bettendorf Iowa, 52722, United States
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City Iowa, 52242, United States
Veterans Affairs Medical Center - Togus
Togus Maine, 04330, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore Maryland, 21201, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02115, United States
University of Massachusetts Memorial Medical Center
Worcester Massachusetts, 01655, United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis Minnesota, 55417, United States
University of Minnesota Cancer Center
Minneapolis Minnesota, 55455, United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia Missouri, 65201, United States
Ellis Fischel Cancer Center - Columbia
Columbia Missouri, 65203, United States
Barnes-Jewish Hospital
Saint Louis Missouri, 63110, United States
University of Nebraska Medical Center
Omaha Nebraska, 68198, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas Nevada, 89106, United States
Norris Cotton Cancer Center
Lebanon New Hampshire, 03756, United States
Veterans Affairs Medical Center - Buffalo
Buffalo New York, 14215, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
CCOP - North Shore University Hospital
Manhasset New York, 11030, United States
Schneider Children's Hospital at North Shore
Manhasset New York, 11030, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10021, United States
New York Presbyterian Hospital - Cornell Campus
New York New York, 10021, United States
Mount Sinai Medical Center, NY
New York New York, 10029, United States
State University of New York - Upstate Medical University
Syracuse New York, 13210, United States
Veterans Affairs Medical Center - Syracuse
Syracuse New York, 13210, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse New York, 13217, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill North Carolina, 27599, United States
Veterans Affairs Medical Center - Durham
Durham North Carolina, 27705, United States
Duke Comprehensive Cancer Center
Durham North Carolina, 27710, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem North Carolina, 27104, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem North Carolina, 27157, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus Ohio, 43210, United States
Rhode Island Hospital
Providence Rhode Island, 02903, United States
University of Tennessee, Memphis Cancer Center
Memphis Tennessee, 38103, United States
Veterans Affairs Medical Center - Memphis
Memphis Tennessee, 38104, United States
Green Mountain Oncology Group
Bennington Vermont, 05201, United States
Vermont Cancer Center
Burlington Vermont, 05401, United States
Veterans Affairs Medical Center - White River Junction
White River Junction Vermont, 05009, United States
Veterans Affairs Medical Center - Richmond
Richmond Virginia, 23249, United States
MBCCOP - Massey Cancer Center
Richmond Virginia, 23298, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Study ID:

NCT00004125

Recruitment Status:

Completed

Sponsor:


Eastern Cooperative Oncology Group

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