A Two-Cohort, Open-Label, Multicenter Study of Trastuzumab Emtansine (T-DM1) in HER2-Positive Locally Advanced or Metastatic Breast Cancer Patients Who Have Received Prior Anti-HER2 and Chemotherapy-Based Treatment

CompletadoFase 3ClinicalTrials.gov

ID: NCT01702571Tipo: INTERVENTIONALInicio: 27 de nov de 2012Fin estimado: 31 de jul de 2020

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

drug

Trastuzumab Emtansine

Participants will receive trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) intravenously on Day 1 of a 3-week cycle every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.

Ubicaciones

CEMIC

Buenos Aires, Argentina

Centro Oncologico Riojano Integral (CORI)

La Rioja, Argentina

Hospital Privado De Comunidad; General Practice

Mar del Plata, Argentina

Patrocinadores

PrincipalHoffmann-La Roche

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