A Randomized Phase III, Double-Blind, Placebo-Controlled Multicenter Trial of Everolimus in Combination With Trastuzumab and Paclitaxel, as First Line Therapy in Women With HER2 Positive Locally Advanced or Metastatic Breast Cancer

CompletadoFase 3ClinicalTrials.gov

ID: NCT00876395Tipo: INTERVENTIONALInicio: 10 de sept de 2009Fin estimado: 23 de oct de 2017

Traducción no disponible, mostrando original

Resumen

The purpose of this Phase III study was to confirm the value of adding everolimus to weekly paclitaxel and trastuzumab as treatment of HER2-overexpressing metastatic breast cancer.

Elegibilidad

Edad mínima: 18 YearsSexo: FEMALE

Criterios de inclusión

Must have at least one lesion that can be accurately measured or bone lesions in the absence of measurable disease.
Adult Women (≥ 18 years old).
Histologically or cytologically confirmed invasive breast carcinoma with local recurrence or radiological evidence of metastatic disease.
HER2+ patients by local laboratory testing (IHC 3+ staining or in situ hybridization positive).
Prior trastuzumab and/or chemotherapy (taxanes included) as neo-adjuvant or adjuvant treatment is allowed but should be discontinued \> 12 months prior to randomization.
Prior treatment for breast cancer with endocrine therapy (adjuvant or metastatic settings) is allowed but should be discontinued at randomization. Patients treated with bisphosphonates at entry or who start bisphosphonates during study may continue this therapy during protocol treatment.
Documentation of negative pregnancy test.
Organ functions at time of inclusion.

Criterios de exclusión

Prior mTOR inhibitors for the treatment of cancer.
Other anticancer therapy for locally advanced or metastatic breast cancer except for prior hormonal therapy.
Patients with only non-measurable lesions other than bone metastasis (e.g. pleural effusion, ascites, etc).
Radiotherapy to ≥ 25% of the bone marrow within 4 weeks prior to randomization
History of central nervous system metastasis.
Impairment of gastrointestinal (GI) function or GI disease or active ulceration of the upper gastrointestinal tract.
Serious peripheral neuropathy.
Cardiac disease or dysfunction.
Uncontrolled hypertension.
HIV.
Pregnant,

Intervenciones

drug

Everolimus

Everolimus was administered in a continuous oral daily dosing of 10 mg (two 5-mg tablets).

drug

Placebo

Everolimus placebo was administered in a continuous oral daily dosing of 10 mg (two 5-mg tablets).

drug

Trastuzumab

Trastuzumab, 2 mg/kg weekly was used intravenously.

drug

Paclitaxel

Paclitaxel, 80 mg/m2 weekly was used intravenously.

Ubicaciones

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Novartis Investigative Site

Mar del Plata, Buenos Aires, Argentina

Novartis Investigative Site

Posadas, Misiones Province, Argentina

Novartis Investigative Site

Rosario, Sante Fe, Argentina

Novartis Investigative Site

Rio Negro, Viedma, Argentina

Novartis Investigative Site

Capital Federal, Argentina

Novartis Investigative Site

Córdoba, Argentina

Patrocinadores

PrincipalNovartis Pharmaceuticals

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.

A Randomized Phase III, Double-Blind, Placebo-Controlled ... | EligiMed