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Estudio de trastuzumab emtansina en pacientes con cáncer de mama positivo para el receptor 2 del factor de crecimiento epidérmico humano (HER2) localmente avanzando que han recibido tratamiento previo anti-HER2 y quimioterapia.
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Detalles básicos
Sponsor
Hoffmann-La Roche
Phase
Fase 3
Study Identifier
NCT01702571, MO28231, 2012-001628-37
Condition
Breast Cancer
Official Title
ESTUDIO MULTICÉNTRICO, ABIERTO, DE DOS COHORTES DE TRASTUZUMAB EMTANSINA (T-DM1) EN PACIENTES CON CÁNCER DE MAMA METASTÁSICO O LOCALMENTE AVANZADOHER2 POSITIVO QUE HAN RECIBIDO PREVIAMENTE TRATAMIENTO BASADO EN QUIMIOTERAPIA Y ANTI-HER2
Study Summary
This two-cohort, open-label, multicenter study will assess the safety, efficacy and tolerability of trastuzumab emtansine in participants with HER2-positive locally advanced breast cancer (LABC) or metastatic breast cancer (mBC) who have received prior anti-HER2 and chemotherapy-based treatment. Participants in Cohort 1 will be drawn from the general participant population; Cohort 2 will include only Asian participants.
Criterios de elegibilidad
All
≥18 Years
No
Inclusion Criteria
- HER2-positive disease determined locally
- Histologically or cytologically confirmed invasive breast cancer
- Prior treatment for breast cancer in the adjuvant, unresectable, locally advanced or metastatic setting must include both chemotherapy, alone or in combination with another agent, and an anti-HER2 agent, alone or in combination with another agent
- Documented progression of incurable, unresectable, LABC, or mBC, defined by the investigator: progression must occur during or after most recent treatment for LABC/mBC or within 6 months of completing adjuvant therapy
- Measurable and/or non-measurable disease
- Left ventricular ejection fraction (LVEF) >/=50% by either echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2
- Adequate organ function
- Use of highly effective contraception as defined by the protocol
Exclusion Criteria
- History of treatment with trastuzumab emtansine
- Prior enrollment into a clinical study containing trastuzumab emtansine regardless of having received trastuzumab emtansine or not
- Peripheral neuropathy of Grade >/= 3 per National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) v 4.0
- History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer, synchronous or previously diagnosed HER2-positive breast cancer
- History of receiving any anti-cancer drug/biologic or investigational treatment within 21 days prior to first study treatment except hormone therapy, which can be given up to 7 days prior to first study treatment; recovery of treatment-related toxicity consistent with other eligibility criteria
- History of exposure to cumulative doses of anthracyclines
- History of radiation therapy within 14 days of first study treatment. The participant must have recovered from any resulting acute toxicity (to Grade </=1) prior to first study treatment.
- Metastatic central nervous system (CNS) disease only
- Brain metastases which are symptomatic
- History of a decrease in LVEF to less than (<) 40% or symptomatic congestive heart failure (CHF) with previous trastuzumab treatment
- History of symptomatic CHF (New York Heart Association [NYHA] Classes II-IV) or serious cardiac arrhythmia requiring treatment
- History of myocardial infarction or unstable angina within 6 months of first study treatment
- Current dyspnea at rest due to complications of advanced malignancy or requirement for continuous oxygen therapy
- Current severe, uncontrolled systemic disease (clinically significant cardiovascular, pulmonary, or metabolic disease)
- Pregnancy or lactation
- Currently known active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus
- History of intolerance (such as Grade 3-4 infusion reaction) or hypersensitivity to trastuzumab or murine proteins or any component of the product
En esta página, se resume la información de los sitios web de registros públicos, como ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. Para obtener más información sobre este estudio, consulte la pestaña Para profesionales médicos o visite uno de esos sitios web.
La información se obtuvo directamente de sitios web de registros públicos, como ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., y no se ha editado.
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