Estudio de fase III, aleatorizado, multicéntrico y abierto para evaluar la eficacia y seguridad de trastuzumab emtansina versus trastuzumab como terapia adyuvante en pacientes con cáncer de mama primario HER2-positivo que presentan tumor residual patológicamente en la mama o los ganglios linfáticos axilares tras la terapia preoperatoria

CompletadoFase 3ClinicalTrials.gov

ID: NCT01772472Tipo: INTERVENTIONALInicio: 3 de abr de 2013Fin estimado: 23 de may de 2024

Resumen

Este estudio abierto, aleatorizado, de 2 brazos, evaluará la eficacia y seguridad de trastuzumab emtansina versus trastuzumab como terapia adyuvante en pacientes con cáncer de mama HER2-positivo que presentan tumor residual en la mama o los ganglios linfáticos axilares tras la terapia preoperatoria. Los pacientes elegibles serán aleatorizados para recibir trastuzumab emtansina 3,6 mg/kg o trastuzumab 6 mg/kg por vía intravenosa cada 3 semanas durante 14 ciclos. Se administrará radioterapia y/o terapia hormonal de forma adicional si está indicado.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Adult patient, \>/= 18 years of age
HER2-positive breast cancer
Histologically confirmed invasive breast carcinoma
Clinical stage T1-4/N0-3/M0 at presentation (patients with T1a/bN0 tumors will not be eligible)
Completion of preoperative systemic chemotherapy and HER2-directed treatment consisting of at least 6 cycles of chemotherapy with a total duration of at least 16 weeks, including at least 9 weeks of trastuzumab and at least 9 weeks of taxane-based therapy
Adequate excision: surgical removal of all clinically evident disease in the breast and lymph nodes as specified in protocol
Pathological evidence of residual invasive carcinoma in the breast or axillary lymph nodes following completion of preoperative therapy
An interval of no more than 12 weeks between the date of surgery and the date of randomization
Known hormone-receptor status
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Adequate hematologic, renal and liver function
Screening Left ventricular ejection fraction (LVEF) \>/= 50% on echocardiogram (ECHO) or multiple-gated acquisition (MUGA) after receiving neoadjuvant chemotherapy and no decrease in LVEF by more than 15% absolute points from the pre-chemotherapy LVEF. Or, if pre-chemotherapy LVEF was not assessed, the screening LVEF must be \>/= 55% after completion of neoadjuvant chemotherapy.
For women who are not postmenopausal or surgically sterile: agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of \< 1% per year during the treatment period and for at least 7 months after the last dose of study drug
Documentation of hepatitis B virus and hepatitis C virus serology is required

Criterios de exclusión

Stage IV (metastatic) breast cancer
History of any prior (ipsi- or contralateral breast cancer except lobular carcinoma in situ
Evidence of clinically evident gross residual or recurrent disease following preoperative therapy and surgery
Progressive disease during preoperative systemic therapy
Treatment with any anti-cancer investigational drug within 28 days prior to commencing study treatment
History of other malignancy within the last 5 years except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other non-breast malignancies with a similar outcome to those mentioned above
Patients for whom radiotherapy would be recommended for breast cancer treatment but for whom it is contraindicated because of medical reasons
Current NCI CTCAE (Version 4.0) Grade \>/= 2 peripheral neuropathy
History of exposure to the following cumulative doses of anthracyclines: Doxorubicin \> 240 mg/m2; Epirubicin or Liposomal Doxorubicin-Hydrochloride (Myocet®) \> 480 mg/m2; For other anthracyclines, exposure equivalent to doxorubicin \> 240 mg/m2
Cardiopulmonary dysfunction as defined by protocol
Prior treatment with trastuzumab emtansine
Current severe, uncontrolled systemic disease
Pregnant or lactating women
Any known active liver disease, e.g. due to HBV, HCV, autoimmune hepatic disorders, or sclerosing cholangitis
Concurrent serious uncontrolled infections requiring treatment or known infection with HIV
History of intolerance, including Grade 3 to 4 infusion reaction or hypersensitivity to trastuzumab or murine proteins or any components of the product

Intervenciones

drug

trastuzumab

6 mg/kg intravenously every 3 weeks, 14 cycles

drug

trastuzumab emtansine

3.6 mg/kg intravenously every 3 weeks, 14 cycles

Ubicaciones

Fundación CENIT para la Investigación en Neurociencias

Buenos Aires, Argentina

Centro Oncologico Riojano Integral (CORI)

La Rioja, Argentina

Instituto de Oncología de Rosario

Rosario, Argentina

Patrocinadores

PrincipalHoffmann-La Roche

ColaboradorNSABP Foundation Inc

ColaboradorGBG Forschungs GmbH

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

Estudio de fase III, aleatorizado, multicéntrico y abiert... | EligiMed