NCT02291913

Everolimus Combined With Anti-estrogen Therapy in Hormone-Receptor-Positive HER-2 Negative Advanced Breast Cancer

Phase II Open Label Study of Everolimus in Combination With Anti-estrogen Therapy in Hormone Receptor-Positive HER2-Negative Advanced Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Many patients with ER-positive or PR-positive breast cancer are treated with endocrine therapy. Although most ER/PR-positive tumors initially respond to hormonal therapy, patients often experience disease progression. Everolimus, in combination with exemestane, has shown activity in endocrine-resistant disease. This study will evaluate the efficacy of Everolimus+ anti-estrogen therapy in patients with ER-positive metastatic breast cancer who have progressed after receiving anti-estrogen therapy.

Detailed description

This is a multi-centered, open-labeled, Phase II study on metastastic breast cancer (MBC). The patient population includes locally recurrent or MBC patients with cytologically or histologically confirmed hormone receptor-positive breast cancer who have demonstrated disease progression on prior anti-estrogen therapy or therapies. Investigators propose to evaluate the efficacy of Everolimus in patients with ER-positive (estrogen receptor-positive) metastatic breast cancer who have progressed on anti-estrogen therapy. Forty-six (46) patients are planned for enrollment in the trial.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Everolimus
DRUG	Exemestane	Anti-estrogen therapy
DRUG	Tamoxifen	Anti-estrogen therapy
DRUG	Fulvestrant	Anti-estrogen therapy
DRUG	Anastrozole	Anti-estrogen therapy
DRUG	Letrozole	Anti-estrogen therapy
DRUG	Toremifine	Anti-estrogen therapy

Timeline

• Start date: 2014-12-18
• Primary completion: 2019-01-31
• Completion: 2019-01-31
• First posted: 2014-11-17
• Last updated: 2020-02-17
• Results posted: 2020-02-17

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study