NCT02025712

Exemestane Plus Everolimus for Hormone-receptor Positive Metastatic Breast Cancer

A Phase II Open-label Pilot Study Evaluating the Maintenance Therapy With Exemestane Plus Everolimus After Induction Chemotherapy in Patients With Hormone-receptor Positive Metastatic Breast Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Organisation for Oncology and Translational Research · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether exemestane plus everolimus are effective in the treatment of patients who have achieved disease stabilization after induction chemotherapy for hormone-receptor positive metastatic breast cancer.

Detailed description

Postmenopausal women with HR-positive, HER2-negative metastatic breast cancer achieving clinical benefit after the induction chemotherapy for visceral disease with sign(s) and/or symptom(s) will be recruited to receive study the maintenance treatment of everolimus plus exemestane.

Conditions

• Hormone Receptor Positive Malignant Neoplasm of Breast

Interventions

Type	Name	Description
DRUG	Exemestane	Commercially available exemestane was supplied to sites as 25-mg tablets according to local regulations.
DRUG	Everolimus	Everolimus was administered by continuous oral dosing of two 5-mg tablets or one 10-mg tablets.

Timeline

• Primary completion: 2016-08-01
• First posted: 2014-01-01
• Last updated: 2014-01-01

Locations

1 site across 1 country: China