The Efficacy of Fulvestrant in ESR1(Estrogen Receptor 1) Mutated Metastatic Breast Cancer

Breast Neoplasms Clinical Trial

Official title: An Open-Label, Single Arm, Phase II Trial to Evaluate the Efficacy of 500mg Fulvestrant (Faslodex) in ESR1 Mutated Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer After Previous Aromatase Inhibitor Treatment

Status Not yet recruiting

Clinical Trial Summary

This is an open-label, single arm, phase II trial to evaluate the efficacy and safety of 500mg Fulvestrant (Faslodex®) in ESR1 mutated postmenopausal women with hormone receptor positive, HER2 negative locally advanced or metastatic breast cancer after previous aromatase inhibitor therapy. Fifty patients will be enrolled and treated with 500 mg Fulvestrant until disease progression or study closed.

Treatment will continue until disease progression, unless any of the criteria for treatment discontinuation are met first. If a patient progresses during the treatment period, the patient must be withdrawn from the treatment and further treatment will be at the investigator's discretion.

Clinical Trial Description

All patients will be followed up for disease progression, regardless of whether they have discontinued treatment, unless they have withdrawn consent.

Efficacy will be determined based on tumor assessments performed by each investigator according to RECIST 1.1. Safety will be monitored based on the frequency and severity of adverse events (AEs), as assessed by Common Terminology Criteria (CTC) grade version 4.0.

Tumor assessments will be assessed by computed tomography (CT) or magnetic resonance imaging (MRI) or X ray if necessary every 12 weeks for all patients until documented evidence of objective disease progression.

Reporting of SAEs to regulatory authorities will be done by the investigator in accordance with CFDA regulations. ;

Related Conditions & MeSH terms

• Breast Neoplasms

• NCT number: NCT03202862
• Study type: Interventional
• Source: Fudan University
• Contact: Zhimin Shao
• Phone: +86-021-64175590
• Email: zhimingshao@fudan.edu.cn
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 1, 2017
• Completion date: August 1, 2019