Clareo Health | Daily Everolimus in Combination With Trastuzumab and Vinorelbine in HER2/Neu Positive Women With Locally Advanced or Metastatic Breast Cancer
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
