Evaluation of trastuzumab without chemotherapy as a post-operative adjuvant therapy in HER2-positive elderly breast cancer patients: randomized controlled trial [RESPECT (N-SAS BC07)].
Jpn J Clin Oncol
; 41(5): 709-12, 2011 May.
Article
em En
| MEDLINE
| ID: mdl-21355003
ABSTRACT
OBJECTIVE:
This trial is conducted to investigate the benefit of trastuzumab monotherapy compared with a combination therapy of trastuzumab and chemotherapy in women over 70 years with human epidermal growth factor receptor type-2-positive primary breast cancer.METHODS:
Inclusion criteria are the following histologically diagnosed as invasive breast cancer and received curative operation for primary breast cancer; Stage I, IIA, IIB or IIIA/M0; and baseline left ventricular ejection fraction is ≥55%. Patients are randomized to receive either trastuzumab (8 mg/kg loading dose, 6 mg/kg every 3 weeks for 1 year) plus chemotherapy selected from regimens specified on the protocol or trastuzumab monotherapy. The primary endpoint is disease-free survival. Secondary endpoints are overall survival, relapse-free survival, safety, health-related quality of life, comprehensive geriatric assessment and cost effectiveness.RESULTS:
Patients recruitment has been commenced in October 2009. Enrollment of 300 patients is planned during the 4-year recruitment period.CONCLUSIONS:
We hereby report the study concept.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Neoplasias da Mama
/
Protocolos de Quimioterapia Combinada Antineoplásica
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Biomarcadores Tumorais
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Carcinoma Ductal de Mama
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Receptor ErbB-2
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Anticorpos Monoclonais
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Antineoplásicos
Tipo de estudo:
Clinical_trials
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Guideline
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Observational_studies
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Risk_factors_studies
Limite:
Aged
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Aged80
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Female
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Humans
Idioma:
En
Revista:
Jpn J Clin Oncol
Ano de publicação:
2011
Tipo de documento:
Article
País de afiliação:
Japão