Maintenance Aromatase Inhibitors (AIs)+ Everolimus vs AIs in Hormone Receptor Positive Metastatic Breast Cancer Patients
NCT02511639 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 110
Last updated 2020-12-03
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.
Conditions
- Breast Cancer Metastatic
Interventions
- DRUG
-
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.
Sponsors & Collaborators
-
University of Padova
collaborator OTHER -
Istituto Oncologico Veneto IRCCS
lead OTHER
Principal Investigators
-
Pierfranco Conte, MD, PhD · Medical Oncology 2, Istituto Oncologico Veneto
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-07-30
- Primary Completion
- 2020-02-28
- Completion
- 2020-07-31
Countries
- Italy
Study Locations
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