A Safety and Tolerability Study of Assisted and Self-Administered Subcutaneous (SC) Herceptin (Trastuzumab) as Adjuvant Therapy in Early Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer

  • Câncer
  • Câncer de Mama
  • Câncer de Mama HER2 Positivo
  • Breast Neoplasms
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Status do estudo:

Concluído

Este estudo é realizado em
Cidades
  • Bahia
  • Rio Grande do Sul
  • São Paulo
Identificador de estudo:

NCT01566721 2011-005328-17 MO28048

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      A seguinte informação vem do site ClinicalTrials.gov publicamente disponível e foi editada para leigos.

      As informações abaixo se origina a partir do site ClinicalTrials.gov publicamente disponível e não foi modificado.

      Results Disclaimer

      Resumo do Estudo

      This multicenter, two-cohort, non-randomized, open-label study will evaluate the safety and tolerability of assisted and self-administered SC Herceptin as adjuvant therapy in participants with early HER2-positive breast cancer following tumor excision. Participants will receive Herceptin 600 milligrams (mg) SC every 3 weeks for 18 cycles, either by an assisted administration using a conventional syringe and needle/vial formulation (Cohort A) or with assisted and self-administration using a single-use injection device (SID) in selected participants (Cohort B).

      Hoffmann-La Roche Patrocinador
      Phase 3 Fase
      NCT01566721, MO28048, 2011-005328-17 Identificador de estudo
      Herceptin Tratamento
      Breast Neoplasms Condição
      Título

      A Phase III Prospective, Two-Cohort Non-Randomized, Multi-Centre, Multinational, Open-Label Study to Assess the Safety of Assisted- and Self-Administered Subcutaneous Trastuzumab as Therapy in Patients With Operable HER2-Positive Early Breast Cancer

      Critérios de elegibilidade

      Todos Gênero
      ≥18 Anos Idade
      Não Voluntários Saudáveis
      Critérios de Inclusão
      • Histologically confirmed early invasive HER2-positive carcinoma of the breast with no evidence of residual, locally recurrent, or metastatic disease and defined as clinical Stage I to IIIC that is eligible for treatment with Herceptin
      • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
      • Screening left ventricular ejection fraction (LVEF) greater than or equal to (≥) 55%
      Critérios de Exclusão
      • Previous neoadjuvant or adjuvant breast cancer treatment with an approved or investigational anti-HER2 agent
      • History of other malignancy except for curatively treated carcinoma in situ of the cervix, basal cell carcinoma, or curatively treated malignancies (other than breast cancer) where the participant has been disease-free for at least 5 years
      • Past history of ductal carcinoma in situ treated with any systemic therapy or with radiation therapy to the ipsilateral breast where invasive cancer subsequently developed
      • Metastatic disease
      • Inadequate bone marrow, hepatic, or renal function
      • Serious cardiac or cardiovascular disease including uncontrolled hypertension or history of hypertensive crisis or hypertensive encephalopathy
      • History of severe allergic or immunological reactions, such as difficult-to-control asthma
      • Pregnant or lactating women

      For the latest version of this information please go to www.forpatients.roche.com

       

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