Phase II Study of Everolimus Beyond Progression
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 70
Summary
- Conditions
- Estrogen Receptor Positive Breast Cancer
- HER2 Negative Breast Cancer
- Progesterone Receptor-positive Breast Cancer
- Recurrent Breast Cancer
- Stage IIIA Breast Cancer
- Stage IIIB Breast Cancer
- Stage IIIC Breast Cancer
- Stage IV Breast Cancer
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 19 years and 125 years
- Gender
- Only males
Description
PRIMARY OBJECTIVE: Progression free survival in patients with advanced or metastatic breast cancer receiving everolimus plus hormonal therapy beyond first progression. SECONDARY OBJECTIVES: Clinical benefit rate (sum of stable disease, partial response, complete response). Response rate (partial res...
PRIMARY OBJECTIVE: Progression free survival in patients with advanced or metastatic breast cancer receiving everolimus plus hormonal therapy beyond first progression. SECONDARY OBJECTIVES: Clinical benefit rate (sum of stable disease, partial response, complete response). Response rate (partial response and complete response). Overall survival. Safety, side effects and tolerability profile of everolimus. OUTLINE: Patients receive everolimus orally (PO) daily and a hormone therapy regimen chosen at the discretion of the investigator (anastrozole PO daily; letrozole PO daily; tamoxifen citrate PO daily; fulvestrant intramuscularly [IM] or PO on days 1, 15, and 29, and then monthly; megestrol acetate PO 4 times daily [QID]; or other regimen). Treatment continues in the absence of disease progression or unacceptable toxicity.
Tracking Information
- NCT #
- NCT02269670
- Collaborators
- Novartis
- Investigators
- Principal Investigator: Suchita Pakkala, MD Emory University/Winship Cancer Institute
Get Well Soon