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

CompletadoFase 3ClinicalTrials.gov

ID: NCT01566721Tipo: INTERVENTIONALInicio: 17 de may de 2012Fin estimado: 19 de feb de 2020

Traducción no disponible, mostrando original

Resumen

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).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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%

Criterios de exclusión

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

Intervenciones

drug

Herceptin

Herceptin will be given as 600 mg SC (into thigh) on Day 1 of each 3-week cycle for up to 18 cycles.

Ubicaciones

Fundación CENIT para la Investigación en Neurociencias

Buenos Aires, Argentina

Hospital Britanico; Oncologia

Buenos Aires, Argentina

Instituto De Investigaciones Clinicas Zarate

Zárate, Argentina

Patrocinadores

PrincipalHoffmann-La Roche

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