NCT02646735

Fulvestrant 500mg With Exemestane Endocrine Therapy for Postmenopausal Advanced Breast Cancer Patients

A Randomized, Open Label, Multi-Centre Study to Compare the Efficacy and Tolerability of Fulvestrant 500mg With Exemestane for Postmenopausal Advanced Breast Cancer Patients

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 148 (estimated)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

A Randomized, Open label, Parallel-group, Multi-center study. Eligible patients will be randomized in a 1:1 ratio to receive fulvestrant 500 mg or Exemestane 25mg.

Detailed description

To compare the efficacy and tolerability of Fulvestrant 500 mg with Exemestane 25 mg as first line endocrine therapy in postmenopausal women with oestrogen receptor positive HER2 negative advanced breast cancer who have relapsed on or after adjuvant non-aromatase inhibitor therapy

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Fulvestrant 500 mg	Fulvestrant 500mg will be given monthly.
DRUG	Exemestane 25 mg	Exemestane 25mg will be given once daily.

Timeline

• Start date: 2015-12-01
• Primary completion: 2019-12-01
• Completion: 2020-12-01
• First posted: 2016-01-06
• Last updated: 2017-01-02

Locations

1 site across 1 country: China