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| Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) Eastern Cooperative Oncology Group Cancer and Leukemia Group B Southwest Oncology Group National Cancer Institute of Canada |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00005970 |
Purpose
RATIONALE: 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.
PURPOSE: This randomized phase III trial is studying combination chemotherapy and trastuzumab to see how well they work compared to combination chemotherapy alone in treating women with breast cancer.
| Condition | Intervention | Phase |
|
Breast Cancer |
Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: paclitaxel Drug: tamoxifen citrate Drug: trastuzumab Procedure: adjuvant therapy Procedure: aromatase inhibition therapy |
Phase III |
| Genetics Home Reference related topics: | breast cancer |
| MedlinePlus related topics: | Breast Cancer Cancer |
| ChemIDplus related topics: | Doxorubicin Doxorubicin hydrochloride Cyclophosphamide Paclitaxel Tamoxifen Tamoxifen citrate Citric acid Sodium Citrate Trastuzumab |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | Phase III Trial of Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Paclitaxel With or Without Trastuzumab as Adjuvant Treatment for Women With HER-2 Overexpressing Node Positive or High-Risk Node Negative Breast Cancer |
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed operable adenocarcinoma of the breast, meeting 1 of the following criteria:
Node-positive disease, meeting the following criteria:
High-risk node-negative disease, meeting the following criteria:
Node-negative as determined by 1 of the following:
HER-2 positive
No locally advanced (T4) tumors at diagnosis, including:
No bilateral invasive carcinoma or DCIS (metachronous or synchronous)
No more than 84 days since prior mastectomy or axillary or sentinel node dissection
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
No other prior malignancy within the past 5 years except:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations![]() |
Show 210 Study Locations |
| North Central Cancer Treatment Group |
| National Cancer Institute (NCI) |
| Eastern Cooperative Oncology Group |
| Cancer and Leukemia Group B |
| Southwest Oncology Group |
| National Cancer Institute of Canada |
| Study Chair: | Edith A. Perez, MD | Mayo Clinic |
| Study Chair: | Nancy E. Davidson, MD | Sidney Kimmel Comprehensive Cancer Center |
| Study Chair: | Peter A. Kaufman, MD | Norris Cotton Cancer Center |
| Study Chair: | Silvana Martino, DO | John Wayne Cancer Institute at Saint John's Health Center |
| Study Chair: | Karen A. Gelmon, MD | British Columbia Cancer Agency |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Perez EA, Suman VJ, Davidson NE, Sledge GW, Kaufman PA, Hudis CA, Martino S, Gralow JR, Dakhil SR, Ingle JN, Winer EP, Gelmon KA, Gersh BJ, Jaffe AS, Rodeheffer RJ. Cardiac Safety Analysis of Doxorubicin and Cyclophosphamide Followed by Paclitaxel With or Without Trastuzumab in the North Central Cancer Treatment Group N9831 Adjuvant Breast Cancer Trial. J Clin Oncol. 2008 Feb 4; [Epub ahead of print]
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| Kutteh LA, Hobday T, Jaffe A, et al.: A correlative study of cardiac biomarkers and left ventricular ejection fraction (LVEF) from N9831, a phase III randomized trial of chemotherapy and trastuzumab as adjuvant therapy for HER2-positive breast cancer. [Abstract] J Clin Oncol 25 (Suppl 18): A-579, 2007. |
| Halyard MY, Pisansky TM, Solin LJ, et al.: Adjuvant radiotherapy (RT) and trastuzumab in stage I-IIA breast cancer: toxicity data from North Central Cancer Treatment Group phase III trial N9831. [Abstract] J Clin Oncol 24 (Suppl 18): A-523, 2006. |
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Perez EA, Suman VJ, Davidson NE, Martino S, Kaufman PA, Lingle WL, Flynn PJ, Ingle JN, Visscher D, Jenkins RB. HER2 testing by local, central, and reference laboratories in specimens from the North Central Cancer Treatment Group N9831 intergroup adjuvant trial. J Clin Oncol. 2006 Jul 1;24(19):3032-8.
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| Miller DV, Jenkins RB, Lingle WL, et al.: Focal HER2/neu amplified clones partially account for discordance between immunohistochemistry and fluorescence in-situ hybridization results: data from NCCTG N9831 intergroup adjuvant trial. [Abstract] J Clin Oncol 22 (Suppl 14): A-568, 19s, 2004. |
| Perez EA, Suman VJ, Davidson NE, et al.: HER2 testing by local, central, and reference laboratories in the NCCTG N9831 intergroup adjuvant trial. [Abstract] J Clin Oncol 22 (Suppl 14): A-567, 19s, 2004. |
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Perez EA, Suman VJ, Davidson NE, Kaufman PA, Martino S, Dakhil SR, Ingle JN, Rodeheffer RJ, Gersh BJ, Jaffe AS. Effect of doxorubicin plus cyclophosphamide on left ventricular ejection fraction in patients with breast cancer in the North Central Cancer Treatment Group N9831 Intergroup Adjuvant Trial. J Clin Oncol. 2004 Sep 15;22(18):3700-4.
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| Perez EA, Suman VJ, Davidson NE, et al.: Effect of doxorubicin plus cyclophosphamide (AC) on left ventricular ejection fraction (LVEF) in the NCCTG N9831 intergroup adjuvant trial. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-75, 19, 2003. |
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Roche PC, Suman VJ, Jenkins RB, Davidson NE, Martino S, Kaufman PA, Addo FK, Murphy B, Ingle JN, Perez EA. Concordance between local and central laboratory HER2 testing in the breast intergroup trial N9831. J Natl Cancer Inst. 2002 Jun 5;94(11):855-7.
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| Study ID Numbers: | CDR0000067953, NCCTG-N9831, CALGB-49909, ECOG-N9831, SWOG-N9831, GUMC-00224, CAN-NCIC-MA28 |
| First Received: | July 5, 2000 |
| Last Updated: | June 21, 2008 |
| ClinicalTrials.gov Identifier: | NCT00005970 |
| Health Authority: | United States: Federal Government |
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