Chemotherapy Plus Monoclonal Antibody Therapy in Treating Women With Stage II or Stage IIIA Breast Cancer That Overexpresses HER2
NCT ID: NCT00003992
Last Updated: 2013-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
200 participants
INTERVENTIONAL
1999-08-31
2009-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Trastuzumab Plus Paclitaxel in Treating Women With Metastatic Breast Cancer That Overexpresses HER2
NCT00005635
Paclitaxel With or Without Trastuzumab in Treating Patients With or Without HER-2/Neu Breast Cancer That is Inoperable, Recurrent, or Metastatic
NCT00003440
Trastuzumab and Irinotecan in Treating Patients With HER2/Neu Positive Metastatic Breast Cancer
NCT00303992
Trastuzumab, Docetaxel, and Carboplatin in Treating Women With Stage II, Stage III, or Inflammatory Breast Cancer
NCT00118053
Trastuzumab and Chemotherapy Followed by Surgery and Combination Chemotherapy in Treating Women With Locally Advanced Breast Cancer
NCT00009997
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
I. Evaluate the safety of paclitaxel plus trastuzumab (Herceptin) followed by adjuvant chemotherapy in women with node positive stage II or IIIa breast cancer with HER2 overexpression.
II. Evaluate the safety of long term trastuzumab (Herceptin) in this patient population.
OUTLINE: This is a randomized study. Patients are stratified according to radiotherapy (none planned vs planned to breast or chest wall). Patients are randomized to one of two treatment arms.
ARM I: Patients receive paclitaxel IV over 3 hours immediately followed by trastuzumab (Herceptin) IV over 30-90 minutes on day 1. Paclitaxel repeats every 3 weeks for 4 courses and trastuzumab (Herceptin) repeats weekly for 10 courses. At 3 weeks following paclitaxel and trastuzumab (Herceptin), patients receive doxorubicin IV and cyclophosphamide IV over 1 hour every 3 weeks for 4 courses. Following chemotherapy, estrogen receptor (ER) positive and/or progesterone receptor (PR) positive patients receive oral tamoxifen twice daily for 5 years.
ARM II: Patients receive same therapy as in Arm I, except for additional trastuzumab (Herceptin) IV weekly beginning within 3 weeks following completion of chemotherapy and local therapy and continuing for 1 year. ER and/or PR positive patients receive tamoxifen as in Arm I but may be concurrent with trastuzumab (Herceptin). Following completion of doxorubicin and cyclophosphamide, post lumpectomy and post mastectomy patients may receive local radiotherapy daily for 5-6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 200 patients (100 per treatment arm) will be accrued for this study within 1 year.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm I
Patients receive paclitaxel IV over 3 hours immediately followed by trastuzumab (Herceptin) IV over 30-90 minutes on day 1. Paclitaxel repeats every 3 weeks for 4 courses and trastuzumab (Herceptin) repeats weekly for 10 courses. At 3 weeks following paclitaxel and trastuzumab (Herceptin), patients receive doxorubicin IV and cyclophosphamide IV over 1 hour every 3 weeks for 4 courses. Following chemotherapy, estrogen receptor (ER) positive and/or progesterone receptor (PR) positive patients receive oral tamoxifen twice daily for 5 years.
trastuzumab
cyclophosphamide
doxorubicin hydrochloride
paclitaxel
tamoxifen citrate
Arm II
Patients receive same therapy as in Arm I, except for additional trastuzumab (Herceptin) IV weekly beginning within 3 weeks following completion of chemotherapy and local therapy and continuing for 1 year. ER and/or PR positive patients receive tamoxifen as in Arm I but may be concurrent with trastuzumab (Herceptin). Following completion of doxorubicin and cyclophosphamide, post lumpectomy and post mastectomy patients may receive local radiotherapy daily for 5-6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
trastuzumab
cyclophosphamide
doxorubicin hydrochloride
paclitaxel
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
trastuzumab
cyclophosphamide
doxorubicin hydrochloride
paclitaxel
tamoxifen citrate
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Histologically confirmed stage II or IIIa (T1-T3, N1-N2, M0) adenocarcinoma of the breast HER2 overexpression (2-3+ by immunochemistry)
* Bilateral breast cancer allowed
* Must have had local breast cancer surgery within past 12 weeks
* Mastectomy or lumpectomy with clear surgical margins AND axillary lymph node dissection with at least 6 nodes removed
* Hormone receptor status: Not specified
PATIENT CHARACTERISTICS:
* Age: 18 and over
* Sex: Female
* WBC at least 3,000/mm3
* Platelet count at least 100,000/mm3
* Hemoglobin at least 9 g/dL
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* Creatinine no greater than 1.5 times ULN
* LVEF at least 50%
* No history of congestive cardiomyopathy
* No congestive heart failure or myocardial infarction within the past 6 months
* No uncontrolled hypertension
* No uncontrolled arrhythmia within the past 6 months
* No other prior malignancy within the past 5 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
* No other serious medical illness that would limit survival to less than 2 years
* No psychiatric condition precluding study
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
* No prior chemotherapy for breast cancer
* No prior hormonal therapy for breast cancer
* At least one year since prior tamoxifen for chemoprevention (e.g., Breast Cancer Prevention Trial)
* No prior radiotherapy to the breast, chest wall, or regional lymph nodes
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
George W. Sledge, MD
Role: STUDY_CHAIR
Indiana University Melvin and Bren Simon Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Veterans Affairs Medical Center - Palo Alto
Palo Alto, California, United States
Stanford University Medical Center
Stanford, California, United States
CCOP - Colorado Cancer Research Program, Inc.
Denver, Colorado, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Emory University Hospital - Atlanta
Atlanta, Georgia, United States
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States
Veterans Affairs Medical Center - Chicago (Lakeside)
Chicago, Illinois, United States
CCOP - Central Illinois
Decatur, Illinois, United States
CCOP - Evanston
Evanston, Illinois, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States
CCOP - Wichita
Wichita, Kansas, United States
CCOP - Ochsner
New Orleans, Louisiana, United States
Johns Hopkins Oncology Center
Baltimore, Maryland, United States
New England Medical Center Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States
Trinitas Hospital - Jersey Street Campus
Elizabeth, New Jersey, United States
Hunterdon Regional Cancer Program
Flemington, New Jersey, United States
CCOP - Northern New Jersey
Hackensack, New Jersey, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Morristown Memorial Hospital
Morristown, New Jersey, United States
Veterans Affairs Medical Center - Albany
Albany, New York, United States
Veterans Affairs Medical Center - New York
New York, New York, United States
Kaplan Cancer Center
New York, New York, United States
University of Rochester Cancer Center
Rochester, New York, United States
Albert Einstein Comprehensive Cancer Center
The Bronx, New York, United States
CCOP - Merit Care Hospital
Fargo, North Dakota, United States
Ireland Cancer Center
Cleveland, Ohio, United States
CCOP - Sooner State
Tulsa, Oklahoma, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States
Vanderbilt Cancer Center
Nashville, Tennessee, United States
Veterans Affairs Medical Center - Madison
Madison, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, United States
Pretoria Academic Hospital
Pretoria, , South Africa
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Sledge GW, O'Neill A, Thor A, et al.: Adjuvant trastuzumab: long-term results of E2198. [Abstract] Breast Cancer Res Treat 100 (Suppl 1): A-2075, S106, 2006.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
E-2198
Identifier Type: -
Identifier Source: secondary_id
CDR0000067197
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCI-2012-02305
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.