Breast Cancer Clinical Trial

Doxorubicin Hydrochloride, Cyclophosphamide, and Pacltaxel With or Without Trastuzumab in Treating Women With HER2-Positive Node-Positive or High-Risk Node-Negative Breast Cancer

Summary

This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and trastuzumab to see how well they work compared to combination chemotherapy alone in treating women with breast cancer that is human epidermal growth factor receptor 2 (HER2)-positive and has spread to the lymph nodes or high-risk and has not spread to the lymph nodes. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without trastuzumab in treating breast cancer.

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Full Description

PRIMARY OBJECTIVES:

I. To compare the combination of doxorubicin hydrochloride and cyclophosphamide (AC) followed by weekly paclitaxel with the combination of AC followed by the combination of weekly paclitaxel and trastuzumab in terms of disease free survival (DFS). (Stage I) II. To compare the combination of AC followed by weekly paclitaxel with the combination of AC followed by the combination of weekly paclitaxel and trastuzumab in terms of the rate of cardiac events. (Stage I) III. To compare the combination AC followed by weekly paclitaxel with the sequential schedule of the combination of AC, weekly paclitaxel, and trastuzumab in terms of DFS. (Stage II) IV. To compare the sequential schedule of the combination of AC, weekly paclitaxel, and trastuzumab with the combination of AC followed by the combination of weekly paclitaxel and trastuzumab in terms of DFS. (Stage II) V. To compare the combination AC followed by weekly paclitaxel with the sequential schedule of the combination of AC, weekly paclitaxel, and trastuzumab in terms of the rate of cardiac events. (Stage II)

SECONDARY OBJECTIVES:

I. To compare the combination of AC followed by weekly paclitaxel with the sequential schedule of the combination of AC, weekly paclitaxel, and trastuzumab in terms of overall survival (OS).

II. To compare the combination AC followed by weekly paclitaxel with the combination of AC followed by the combination of weekly paclitaxel and trastuzumab in terms of OS.

III. To compare the sequential schedule of the combination AC, weekly paclitaxel, and trastuzumab with the combination of AC followed by the combination of weekly paclitaxel and trastuzumab in terms of OS.

TERTIARY OBJECTIVES:

I. To determine whether higher levels of shed ECD (extracellular domain) or autoantibodies to human epidermal growth factor receptor (HER)-2 and HER-1 measured in the serum prior to treatment are prognostic for DFS and survival.

II. To determine the concordance of central review of HER-2 overexpression as measured by the HercepTest (DAKO) and Vysis fluorescence in situ hybridization (FISH).

III. For each treatment arm, levels of brain natriuretic peptide (BNP), troponin-T (TnT), troponin-I (cTnI), tumor necrosis factor alpha (TNF-alpha), interleukin-1 beta (IL-1beta) and interleukin-6 (IL-6), CD40 ligand, and troponin levels will be compared and contrasted.

IV. To determine whether genetic markers are prognostic for cardiac adverse events associated with treatment.

OUTLINE: Patients are randomized to 1 of 3 treatment arms.

ARM I*: Patients receive doxorubicin hydrochloride intravenously (IV) and cyclophosphamide IV over 20-30 minutes on day 1. Treatment repeats every 3 weeks for 4 courses. Patients then receive paclitaxel IV over 1 hour beginning on day 1 of week 13 and continuing weekly for 12 courses in the absence of disease progression or unacceptable toxicity. NOTE: *Patients who completed paclitaxel on or after October 25, 2004 may receive trastuzumab for a maximum of 52 weeks either concurrently with paclitaxel or following completion of paclitaxel treatment.

ARM II*: Patients receive doxorubicin hydrochloride, cyclophosphamide, and paclitaxel as in arm I. Patients then receive trastuzumab IV over 30-90 minutes beginning on day 1 of week 25 and continuing weekly for 52 courses in the absence of disease progression or unacceptable toxicity. NOTE: *Patients who completed paclitaxel on or after October 25, 2004 may receive trastuzumab for a maximum of 52 weeks either concurrently with paclitaxel or following completion of paclitaxel treatment.

ARM III: Patients receive doxorubicin hydrochloride and cyclophosphamide as in arm I. Patients then receive paclitaxel IV over 1 hour and trastuzumab IV over 30-90 minutes beginning on day 1 of week 13 and continuing weekly for 12 courses. Patients then receive trastuzumab IV over 30 minutes beginning on day 1 of week 25 and continuing weekly for 40 courses in the absence of disease progression or unacceptable toxicity.

Within 5 weeks after completion of paclitaxel, patients may undergo radiotherapy. All postmenopausal estrogen receptor (ER)- or progesterone receptor (PR)-positive patients receive oral tamoxifen or an aromatase inhibitor once daily for 5 years beginning no later than 5 weeks after the last dose of paclitaxel. Patients may also receive an aromatase inhibitor once daily for 5 years after 5 years of daily tamoxifen. Patients who receive tamoxifen once daily for less than 4.5 years may receive an aromatase inhibitor daily until they have received a total of 5 years of adjuvant hormonal therapy.

After completion of study treatment, patients are followed up every 3 months for 1 year, every 6 months for 4 years, and then annually for 15 years or until disease progression.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Required tumor parameters for node positive disease: NOTE: This study will continue to use the American Joint Committee on Cancer (AJCC) 5th edition for TNM classification and staging

Operable, histologically confirmed adenocarcinoma of the female breast and positive lymph nodes

Node positivity may be determined by either an axillary node dissection or a positive sentinel node finding by hematoxylin and eosin (H&E)

NOTE: Positive nodes refers to H&E visible nodal metastases; immunohistochemistry (IHC) positive only cells in lymph nodes will not be considered positive nodes
One or more positive lymph nodes whose tumors are T1-3, pN1-2, M0 are eligible
cN2 disease is not eligible
pN2 disease is eligible
One positive lymph node by sentinel node biopsy or at least 6 axillary nodes must be examined on axillary node dissection with at least one positive lymph node
Metaplastic carcinoma is eligible
ER/PgR determination

HER-2 positive (pre-entry requirement for registration)

FISH must show gene amplification OR

IHC assay must show a strong positive (3+) staining score

NOTE: ductal carcinoma in situ (DCIS) components should not be counted in the determination of degree of IHC staining or FISH amplification

Required tumor parameters for high-risk node-negative disease; NOTE: This study will continue to use the AJCC 5th edition for TNM classification and staging

Operable, histologically confirmed adenocarcinoma of the female breast and negative lymph nodes

Node status may be determined by either axillary node dissection or sentinel node biopsy with H&E staining; to be considered node negative, either of the following must be true: 1) negative sentinel node biopsy or 2) no positive lymph nodes found among at least 6 axillary nodes examined on axillary node dissection
NOTE: IHC positive only cells in lymph nodes will not be considered positive nodes
Tumors > 2.0 cm (irrespective of hormonal receptor status) or > 1.0 cm if ER-negative and PR-negative disease
ER/PgR determination

HER-2 positive (pre-entry requirement for registration)

FISH must show gene amplification OR

IHC assay must show a strong positive (3+) staining score

NOTE: DCIS components should not be counted in the determination of degree of IHC staining or FISH amplification
=< 84 days from mastectomy or =< 84 days from axillary dissection or sentinel node detection if the patient's most extensive breast surgery was a breast sparing procedure; (This timing is per a decision by the Breast Intergroup)

Surgical resection margins. All tumor should be removed by either a modified radical mastectomy or a segmental mastectomy with axillary node dissection

Mastectomy: There will be no evidence of gross or microscopic tumor (invasive or DCIS) at the surgical resection margins noted in the final surgery or pathology reports; patients with close margins are eligible
Segmental mastectomy (lumpectomy): Margins must be clear of invasive cancer and DCIS
Axillary dissection or sentinel node dissection: There will be no gross residual adenopathy

TAM therapy

May have received up to four weeks of TAM therapy, or any other hormonal agent, for this malignancy
May have received TAM or raloxifene for purposes of chemoprevention (e.g., Breast Cancer Prevention Trial) or for other indications (including previous breast cancer if lobular carcinoma in situ [LCIS]) but must be discontinued before registration on this study
May never have received TAM, raloxifene, or any other hormonal agent
Absolute neutrophil count (ANC) >= 1500/mm^3
Platelets (PLT) >= 100,000/mm^3
Total bilirubin =< 1.5 x upper normal limit (UNL)
Aspartate aminotransferase (AST) =< 2.0 x UNL
Left ventricular ejection fraction (LVEF) within institutional normal range; if LVEF is > 75%, the investigator should consider performing a second review of the multigated acquisition (MUGA)/echocardiogram or performing a repeat MUGA/echocardiogram prior to registration; such re-reviews or repeat MUGA/echocardiogram are not permitted after registration
Willingness to discontinue sex hormonal therapy, e.g., birth control pills, ovarian hormonal replacement therapy, etc., prior to registration and while on study
Willingness to discontinue any hormonal agent such as raloxifene (Evista) prior to registration and while on study
Non-breast malignancies that have not recurred within the last 5 years and are deemed to be at low risk for recurrence

EXCEPTIONS: These non-breast malignancies are eligible even if diagnosed =< 5 years prior to registration:

Squamous or basal cell carcinoma of the skin that has been effectively treated
Carcinoma in situ of the cervix that has been treated by surgery only

Lobular carcinoma in situ (LCIS) of the ipsilateral or contralateral breast treated by surgery and/or tamoxifen only

Patients undergoing breast conservation therapy (i.e., lumpectomy and axillary dissection) must have plans to receive radiation therapy to the breast +/- regional lymphatics following completion of the chemotherapy; for patients treated with mastectomy, the use of radiation therapy is required for 4 or more positive lymph nodes and must be started after completion of chemotherapy; the use of radiation therapy is at the discretion of the investigator for 0-3 positive lymph nodes but, if used, must be started after the completion of chemotherapy
Prior to registration, the physician must designate if it is planned for the patient to receive radiation therapy (for adjuvant radiation therapy post-mastectomy or, less commonly, post-conservative therapy but not primary breast radiation as part of breast conserving treatment)
Willing and able to sign an informed consent
Gene amplified by FISH or strong positivity (3+) by HercepTest on central review; Note: The patient registers based on community HER-2 testing using FISH or IHC, AC chemotherapy is initiated; the tumor block or slides must be received =< 2 weeks from time of registration to the North Central Cancer Treatment Group (NCCTG) Operations Office for central HER-2 testing

Exclusion Criteria:

Any of the following:

Pregnant women
Nursing women
Women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, intrauterine device [IUD], surgical sterilization, or abstinence, etc.); hormonal birth control methods are not permitted
Locally advanced tumors (classification T4) at diagnosis including tumors fixed to chest wall, peau d'orange, skin ulcerations/nodules, or clinical inflammatory changes (diffuse brawny cutaneous induration with an erysipeloid edge)
Prior history of breast cancer, except LCIS
Bilateral invasive carcinoma, either metachronous or synchronous (EXCEPTION: Patients diagnosed with unilateral invasive carcinoma and metachronous or synchronous DCIS of the contralateral breast treated with mastectomy are eligible)
Prior chemotherapy, radiation therapy, immunotherapy, or biotherapy for breast cancer
Active, unresolved infection

Active cardiac disease

Any prior myocardial infarction
History of documented congestive heart failure (CHF)
Current use of digitalis or beta-blockers for CHF
Any prior history of arrhythmia or cardiac valvular disease requiring medications or clinically significant
Current use of medications for treatment of arrhythmias or angina pectoris
Current uncontrolled hypertension (diastolic > 100 mmHg or systolic > 200 mmHg)
Clinically significant pericardial effusion
Prior anthracycline or taxane therapy for any malignancy
Sensitivity to benzyl alcohol
Neurology/Neuropathy-Sensory >= grade 2 per the National Cancer Institute's (NCI's) Common Toxicity Criteria Version 2.0; EXCEPTION: Any chronic neurologic disorder will be looked at on a case-by-case basis by the study chair

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

3436

Study ID:

NCT00005970

Recruitment Status:

Completed

Sponsor:

National Cancer Institute (NCI)

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There are 152 Locations for this study

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University of Alabama at Birmingham Cancer Center
Birmingham Alabama, 35233, United States
Western Regional CCOP
Phoenix Arizona, 85006, United States
Mayo Clinic in Arizona
Scottsdale Arizona, 85259, United States
Banner University Medical Center - Tucson
Tucson Arizona, 85719, United States
University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States
Community Cancer Institute
Clovis California, 93611, United States
City of Hope Comprehensive Cancer Center
Duarte California, 91010, United States
Washington Hospital
Fremont California, 94538, United States
Glendale Memorial Hospital and Health Center
Glendale California, 91204, United States
USC / Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States
Memorial Medical Center
Modesto California, 95355, United States
Community Hospital of Monterey Peninsula
Monterey California, 93940, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange California, 92868, United States
Stanford Cancer Institute Palo Alto
Palo Alto California, 94304, United States
University of California Davis Comprehensive Cancer Center
Sacramento California, 95817, United States
Salinas Valley Memorial
Salinas California, 93901, United States
University of California San Diego
San Diego California, 92103, United States
Naval Medical Center -San Diego
San Diego California, 92134, United States
UCSF Medical Center-Mount Zion
San Francisco California, 94115, United States
The Angeles Clinic and Research Institute - Santa Monica Office
Santa Monica California, 90404, United States
Santa Rosa Memorial Hospital
Santa Rosa California, 95405, United States
University of Colorado Hospital
Aurora Colorado, 80045, United States
MedStar Georgetown University Hospital
Washington District of Columbia, 20007, United States
Mayo Clinic in Florida
Jacksonville Florida, 32224, United States
AdventHealth Orlando
Orlando Florida, 32803, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States
Emory University Hospital/Winship Cancer Institute
Atlanta Georgia, 30322, United States
Atlanta Regional CCOP
Atlanta Georgia, 30342, United States
Northeast Georgia Medical Center-Gainesville
Gainesville Georgia, 30501, United States
Memorial Health University Medical Center
Savannah Georgia, 31404, United States
University of Hawaii Cancer Center
Honolulu Hawaii, 96813, United States
Northwestern University
Chicago Illinois, 60611, United States
Rush University Medical Center
Chicago Illinois, 60612, United States
University of Illinois
Chicago Illinois, 60612, United States
University of Chicago Comprehensive Cancer Center
Chicago Illinois, 60637, United States
Heartland Cancer Research NCORP
Decatur Illinois, 62526, United States
Loyola University Medical Center
Maywood Illinois, 60153, United States
Carle Cancer Center
Urbana Illinois, 61801, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis Indiana, 46202, United States
Northern Indiana Cancer Research Consortium
South Bend Indiana, 46628, United States
Iowa-Wide Oncology Research Coalition NCORP
Des Moines Iowa, 50309, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City Iowa, 52242, United States
Siouxland Regional Cancer Center
Sioux City Iowa, 51101, United States
Via Christi Hospital-Pittsburg
Pittsburg Kansas, 66762, United States
Kansas City NCI Community Oncology Research Program
Prairie Village Kansas, 66208, United States
Salina Regional Health Center
Salina Kansas, 67401, United States
Cotton O'Neil Cancer Center / Stormont Vail Health
Topeka Kansas, 66606, United States
Saint Francis Hospital and Medical Center - Topeka
Topeka Kansas, 66606, United States
Wichita NCI Community Oncology Research Program
Wichita Kansas, 67214, United States
Tulane University Health Sciences Center
New Orleans Louisiana, 70112, United States
Ochsner Medical Center Jefferson
New Orleans Louisiana, 70121, United States
Louisiana State University Health Sciences Center Shreveport
Shreveport Louisiana, 71103, United States
University of Maryland/Greenebaum Cancer Center
Baltimore Maryland, 21201, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore Maryland, 21287, United States
Walter Reed National Military Medical Center
Bethesda Maryland, 20889, United States
Tufts Medical Center
Boston Massachusetts, 02111, United States
Massachusetts General Hospital Cancer Center
Boston Massachusetts, 02114, United States
Boston Medical Center
Boston Massachusetts, 02118, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
Milford Regional Medical Center
Milford Massachusetts, 01757, United States
Saint Vincent Hospital/Reliant Medical Group
Worcester Massachusetts, 01608, United States
University of Massachusetts Medical School
Worcester Massachusetts, 01655, United States
Michigan Cancer Research Consortium NCORP
Ann Arbor Michigan, 48106, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States
Wayne State University/Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
Cancer Research Consortium of West Michigan NCORP
Grand Rapids Michigan, 49503, United States
Kalamazoo Center for Medical Studies
Kalamazoo Michigan, 49008, United States
Ascension Providence Hospitals - Southfield
Southfield Michigan, 48075, United States
Essentia Health Cancer Center
Duluth Minnesota, 55805, United States
University of Minnesota/Masonic Cancer Center
Minneapolis Minnesota, 55455, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud Minnesota, 56303, United States
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park Minnesota, 55416, United States
University of Mississippi Medical Center
Jackson Mississippi, 39216, United States
University of Missouri - Ellis Fischel
Columbia Missouri, 65212, United States
Washington University - Jewish
Saint Louis Missouri, 63110, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Missouri Baptist Medical Center
Saint Louis Missouri, 63131, United States
Saint Louis-Cape Girardeau CCOP
Saint Louis Missouri, 63141, United States
Cancer Research for the Ozarks NCORP
Springfield Missouri, 65804, United States
Montana Cancer Consortium NCORP
Billings Montana, 59102, United States
CHI Health Good Samaritan
Kearney Nebraska, 68847, United States
Missouri Valley Cancer Consortium
Omaha Nebraska, 68106, United States
University of Nebraska Medical Center
Omaha Nebraska, 68198, United States
University Medical Center of Southern Nevada
Las Vegas Nevada, 89102, United States
New Hampshire Oncology Hematology PA-Hooksett
Hooksett New Hampshire, 03106, United States
Dartmouth Hitchcock Medical Center
Lebanon New Hampshire, 03756, United States
Englewood Hospital and Medical Center
Englewood New Jersey, 07631, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Rutgers Cancer Institute of New Jersey
New Brunswick New Jersey, 08903, United States
Montefiore Medical Center-Weiler Hospital
Bronx New York, 10461, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
North Shore University Hospital
Manhasset New York, 11030, United States
Long Island Jewish Medical Center
New Hyde Park New York, 11040, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York New York, 10016, United States
Mount Sinai Hospital
New York New York, 10029, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York New York, 10032, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
NYP/Weill Cornell Medical Center
New York New York, 10065, United States
University of Rochester
Rochester New York, 14642, United States
State University of New York Upstate Medical University
Syracuse New York, 13210, United States
SUNY Upstate Medical Center-Community Campus
Syracuse New York, 13215, United States
Mission Hospital Inc-Memorial Campus
Asheville North Carolina, 28801, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill North Carolina, 27599, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
Cone Health Cancer Center
Greensboro North Carolina, 27403, United States
Wilson Medical Center
Wilson North Carolina, 27893, United States
Novant Health Forsyth Medical Center
Winston-Salem North Carolina, 27103, United States
Southeast Clinical Oncology Research (SCOR) Consortium NCORP
Winston-Salem North Carolina, 27104, United States
Wake Forest University Health Sciences
Winston-Salem North Carolina, 27157, United States
Sanford Bismarck Medical Center
Bismarck North Dakota, 58501, United States
Sanford Broadway Medical Center
Fargo North Dakota, 58122, United States
Altru Cancer Center
Grand Forks North Dakota, 58201, United States
University of Cincinnati/Barrett Cancer Center
Cincinnati Ohio, 45219, United States
Case Western Reserve University
Cleveland Ohio, 44106, United States
Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States
Ohio State University Comprehensive Cancer Center
Columbus Ohio, 43210, United States
Toledo Community Hospital Oncology Program CCOP
Toledo Ohio, 43617, United States
University of Oklahoma Health Sciences Center
Oklahoma City Oklahoma, 73104, United States
University of Oregon
Eugene Oregon, 97403, United States
Providence Portland Medical Center
Portland Oregon, 97213, United States
Geisinger Medical Center
Danville Pennsylvania, 17822, United States
Penn State Milton S Hershey Medical Center
Hershey Pennsylvania, 17033, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia Pennsylvania, 19104, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
West Penn Hospital
Pittsburgh Pennsylvania, 15224, United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh Pennsylvania, 15232, United States
Lankenau Medical Center
Wynnewood Pennsylvania, 19096, United States
Memorial Hospital of Rhode Island
Pawtucket Rhode Island, 02860, United States
Rhode Island Hospital
Providence Rhode Island, 02903, United States
Roper Hospital
Charleston South Carolina, 29401, United States
Medical University of South Carolina
Charleston South Carolina, 29425, United States
Rapid City Regional Hospital
Rapid City South Dakota, 57701, United States
Sanford NCI Community Oncology Research Program of the North Central Plains
Sioux Falls South Dakota, 57104, United States
Wellmont Holston Valley Hospital and Medical Center
Kingsport Tennessee, 37660, United States
Thompson Cancer Survival Center
Knoxville Tennessee, 37916, United States
University of Tennessee - Knoxville
Knoxville Tennessee, 37920, United States
University of Tennessee Health Science Center
Memphis Tennessee, 38163, United States
Vanderbilt University/Ingram Cancer Center
Nashville Tennessee, 37232, United States
The Don and Sybil Harrington Cancer Center
Amarillo Texas, 79106, United States
Brooke Army Medical Center
Fort Sam Houston Texas, 78234, United States
University of Texas Medical Branch
Galveston Texas, 77555, United States
University of Texas Health Science Center at San Antonio
San Antonio Texas, 78229, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City Utah, 84112, United States
Southwestern Vermont Medical Center
Bennington Vermont, 05201, United States
University of Vermont and State Agricultural College
Burlington Vermont, 05405, United States
Sentara Martha Jefferson Hospital
Charlottesville Virginia, 22901, United States
Virginia Mason Medical Center
Seattle Washington, 98101, United States
Kaiser Permanente Washington
Seattle Washington, 98112, United States
Northwest NCI Community Oncology Research Program
Tacoma Washington, 98405, United States
University of Wisconsin Hospital and Clinics
Madison Wisconsin, 53792, United States
Froedtert and the Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States
Saskatoon Cancer Centre
Saskatoon Saskatchewan, S7N 4, Canada
Instituto Nacional de Enfermedades Neoplasicas
Lima , Lima , Peru
University Of Pretoria
Pretoria , 0002, South Africa

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

3436

Study ID:

NCT00005970

Recruitment Status:

Completed

Sponsor:


National Cancer Institute (NCI)

How clear is this clinincal trial information?

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