NCT02511639

Maintenance Aromatase Inhibitors (AIs)+ Everolimus vs AIs in Hormone Receptor Positive Metastatic Breast Cancer Patients

MAINtenance Afinitor: A Randomized Trial Comparing Maintenance Aromatase Inhibitors (AIs) + Everolimus (Afinitor) vs AIs in Hormone Receptor Positive (HR+) Metastatic Breast Cancer Patients With Disease Control After First Line Chemotherapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Istituto Oncologico Veneto IRCCS · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare maintenance Aromatase Inhibitors (AIs) + everolimus with Aromatase Inhibitors alone after 1st line chemotherapy in patients with HR+ metastatic breast cancer.

Detailed description

The purpose of this study is: * to compare the progression free survival (PFS) of AIs/everolimus to AIs administered as maintenance therapy in HR+ advanced breast cancer patients with disease control (Complete Response (CR), Partial Response (PR) or Stable Disease (SD))after 1st line chemotherapy. * To evaluate the overall survival * To assess the safety profile * To evaluate the response rate

Conditions

• Breast Cancer Metastatic

Interventions

Type	Name	Description
DRUG	Everolimus	Everolimus is formulated as tablets of 10 mg strength for oral administration.
DRUG	Aromatase Inhibitors	Anastrozole is formulated as tablets of 1 mg strength for oral administration. Letrozole is formulated as tablets of 2.5 mg strength for oral administration. Exemestane is formulated as tablets of 25 mg strength for oral administration.

Timeline

• Start date: 2014-07-30
• Primary completion: 2020-02-28
• Completion: 2020-07-31
• First posted: 2015-07-30
• Last updated: 2020-12-03

Locations

16 sites across 1 country: Italy