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

Carcinoma Breast Stage IV Clinical Trial

Official title: 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Status Withdrawn

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Carcinoma Breast Stage IV

• NCT number: NCT02140437
• Study type: Interventional
• Source: Fudan University
• Status: Withdrawn
• Phase: Phase 2
• Start date: March 2014
• Completion date: June 2016