Daily Everolimus in Combination With Trastuzumab and Vinorelbine in HER2/Neu Positive Women With Locally Advanced or Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Everolimus; Sirolimus; Trastuzumab; Vinblastine; Vinorelbine

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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