Resumen

This phase III, double-blind, placebo-controlled multinational study will assess the combination everolimus, vinorelbine, and trastuzumab compared to the combination vinorelbine and trastuzumab with respect to progressive-free survival and over survival in HER2/neu positive women with locally advanced or metastatic breast cancer who are resistant to trastuzumab and have been pre-treated with a taxane.

Elegibilidad

Edad mínima: 18 YearsSexo: FEMALE

Criterios de inclusión

Histologically or cytologically confirmed invasive breast carcinoma with locally recurrent or radiological evidence of metastatic disease. Locally recurrent disease must not be amenable to resection with curative intent.
HER2+ status defined as IHC 3+ staining or in situ hybridization positive
Patients with resistance to trastuzumab
Prior taxane therapy
Patients with an ECOG performance status of 0 - 2
Patients with measurable disease as per RECIST criteria
Documentation of negative pregnancy test for patients of child bearing potential prior to enrollment within 7 days prior to randomization. Sexually active pre-menopausal women must use adequate contraceptive measures, excluding estrogen containing contraceptives, while on study;
Patients must meet laboratory criteria defined in the study within 21 days prior to randomization

Criterios de exclusión

Prior mTOR inhibitors or vinca alkaloid agents for the treatment of cancer
More than three prior chemotherapy lines for advanced disease.
Symptomatic CNS metastases or evidence of leptomeningeal disease. Previously treated asymptomatic CNS metastases are allowed provided that the last treatment for CNS metastases was completed \>8 weeks prior to randomization
Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral everolimus
Peripheral neuropathy ≥ grade 2 at randomization
Active cardiac disease
History of cardiac dysfunction
Any malignancy within 5 years prior to randomization, with the exception of adequately treated in-situ carcinoma of the cervix uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer
Known hypersensitivity to any study medication
Breastfeeding or pregnant

Intervenciones

drug

everolimus

Oral everolimus was taken once 5 mg/day (2 × 2.5 mg tablets) and were packaged into blister packs.

drug

Placebo

Oral everolimus placebo was taken once 5 mg/day (2 × 2.5 mg tablets) and were packaged into blister packs.

drug

vinorelbine

intravenous vinorelbine (25 mg/m2 weekly)

drug

trastuzumab

intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)

Ubicaciones

Novartis Investigative Site

C A B A, Buenos Aires, Argentina

Novartis Investigative Site

Caba, Buenos Aires, Argentina

Novartis Investigative Site

Mar del Plata, Buenos Aires, Argentina

Novartis Investigative Site

Quilmes, Buenos Aires, Argentina

Novartis Investigative Site

Córdoba, Córdoba Province, Argentina

Novartis Investigative Site

Posadas, Misiones Province, Argentina

Novartis Investigative Site

Rosario, Sante Fe, Argentina

Novartis Investigative Site

San Miguel de Tucumán, Tucumán Province, Argentina

Novartis Investigative Site

Rio Negro, Viedma, Argentina

A Randomized Phase III, Double-blind, Placebo-controlled Multicenter Trial of Daily Everolimus in Combination With Trastuzumab and Vinorelbine, in Pretreated Women With HER2/Neu Over-expressing Locally Advanced or Metastatic Breast Cancer.

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

everolimus

Placebo

vinorelbine

trastuzumab

Ubicaciones

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Patrocinadores