NCT02140437

Fulvestrant Combined Anastrozole Versus Anastrozole in Luminal A-like Postmenopausal ABC

An Open-label, Multi-center, Randomized Phase II Study of Fulvestrant Anastrozole Combination Versus Anastrozole Alone in Patients With Luminal A-like Postmenopausal Advanced Breast Cancer

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This research is designed to investigate whether the addition of fulvestrant 500mg to anastrozole is better than anastrozole alone as first-line endocrine therapy for advanced breast cancer.

Detailed description

Anastrozole is the standard first-line endocrine treatment for patients with hormonal receptor positive advanced breast cancer. It has been proven that the addition of fulvestrant 250mg can enhance PFS of anastrozole monotherapy according to SWOG0226 study. However, the optimal recommended dose of fulvestrant for patients with advanced breast cancer is 500mg worldwide according to CONFIRM study. The investigator designed this research to investigate whether high dose fulvestrant can further improve efficacy of anastrozole monotherapy.

Conditions

• Carcinoma Breast Stage IV

Interventions

Type	Name	Description
DRUG	Fulvestrant	Adding fulvestrant to the standard endocrine therapy, anastrozole
DRUG	Anastrozole	standard endocrine therapy

Timeline

• Start date: 2014-03-01
• Primary completion: 2015-12-01
• Completion: 2016-06-01
• First posted: 2014-05-16
• Last updated: 2015-12-29