NCT02269670

Phase II Study of Everolimus Beyond Progression

Phase II Study of Everolimus Beyond Progression in Postmenopausal Women With Advanced, Hormone Receptor Positive Breast Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: Female
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well everolimus and hormone therapy work in treating patients with hormone receptor positive breast cancer that has continued to spread (progressed) or returned after a period of improvement (recurred) on everolimus and exemestane hormone therapy. Everolimus is a chemotherapy drug that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen and progesterone are hormones that can cause the growth of breast cancer cells. Hormone therapy may fight breast cancer by lowering the amount of estrogen and progesterone the body makes. Giving everolimus with a different type of hormone therapy may be an effective treatment for breast cancer in patients who progressed on everolimus with exemestane.

Detailed description

PRIMARY OBJECTIVE: Progression free survival in patients with advanced or metastatic breast cancer receiving everolimus plus hormonal therapy beyond first progression. SECONDARY OBJECTIVES: 1. Clinical benefit rate (sum of stable disease, partial response, complete response). 2. Response rate (partial response and complete response). 3. Overall survival. 4. 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.

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

Interventions

Type	Name	Description
DRUG	everolimus	Given PO
DRUG	anastrozole	Given PO
DRUG	letrozole	Given PO
DRUG	tamoxifen citrate	Given PO
DRUG	fulvestrant	Given IM or PO
DRUG	megestrol acetate	Given PO

Timeline

• Start date: 2014-11-25
• Primary completion: 2021-01-25
• Completion: 2021-01-25
• First posted: 2014-10-21
• Last updated: 2022-04-05
• Results posted: 2022-04-05

Locations

3 sites across 1 country: United States