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KATHERINE: Estudo randomizado, multicêntrico, aberto, de fase III para avaliar a eficácia e segurança de trastuzumabe-entansina versus trastuzumabe como terapia adjuvante em pacientes com câncer de mama primário HER2 positivo que apresentam tumor residual patologicamente presente nos linfonodos mamários ou axilares após terapia pré-operatória
- Câncer
- Câncer de Mama
- Câncer de Mama HER2 Positivo
- Câncer de mama positivo para HER-2
Observe que o status de recrutamento do estudo em seu centro pode ser diferente do status geral do estudo porque alguns centros de estudo podem recrutar mais cedo do que outros.
Status do estudo:
Concluído
Este estudo é realizado em
Cidades
- Paraná
- Rio de Janeiro
- Rio Grande do Sul
- São Paulo
Identificador de estudo:
NCT01772472 2012-002018-37 BO27938
Resumo do Estudo
Este é um estudo de Fase III, de 2 braços, aberto, multinacional, multicêntrico, randomizado em pacientes com câncer de mama primário HER2 positivo que receberam quimioterapia pré-operatória e terapia direcionada para HER2 incluindo trastuzumabe seguido por cirurgia, com um achado de doença invasiva residual nos linfonodos mamários ou axilares.
Hoffmann-La Roche
Patrocinador
Phase 3
Fase
NCT01772472, BO27938, 2012-002018-37
Identificador de estudo
trastuzumab, trastuzumab emtansine
Tratamento
Breast Cancer
Condição
Título
A Randomized, Multicenter, Open-Label Phase III Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy for Patients With HER2-Positive Primary Breast Cancer Who Have Residual Tumor Present Pathologically in the Breast or Axillary Lymph Nodes Following Preoperative Therapy
Critérios de elegibilidade
Todos
Gênero
≥18 Anos
Idade
Não
Voluntários Saudáveis
Critérios de Inclusão
- 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
Critérios de Exclusão
- 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
For the latest version of this information please go to www.forpatients.roche.com
