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

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

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Fulvestrant 500 mg; Drug: Exemestane 25 mg

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

• Study Type: Interventional
• Enrollment (Anticipated): 148
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: XU Binghe, MD; Phone Number: 0000 86-10-87788495; Email: wangjiayu8778@sina.com
• Study Contact Backup: Name: WANG Jiayu, MD; Phone Number: 0000 86-10-87788495; Email: wangjiayu8778@sina.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Recruiting
      • National Cancer Institute, Cancer Hospital Chinese Academy of Medical Sciences
      • Contact: Binghe Xu, M.D.; Phone Number: 86-10-88788826; Email: xubinghe@medmail.com.cn
      • Sub-Investigator: Jiayu Wang, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Signed informed consent document on file;
• Age over 60 years;
• Age < 60 years and amenorrheic for 12 or more months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression and FSH and oestradiol level in the postmenopausal range;
• Patients with metastatic or locally advanced disease not amenable to therapy with Curative intent
• ER + and/or PgR +;
• Duration of adjuvant non-aromatase inhibitors treatment should be at least 2 years or more;
• WHO performance status 0, 1 or 2;
• Patients with life expectancy of more than 3 months.

Exclusion Criteria:

• Presence of life-threatening metastatic visceral disease;
• Previous systemic chemotherapy for advanced breast cancer;
• Received systemic endocrine therapy for advanced disease;
• Extensive radiation therapy within the last 4 weeks ;
• Platelets < 100*109 / L,Total bilirubin no less than 1.5ULRR, ALT or AST no less than 2.5ULRR if no demonstrable liver metastases or no less than 5ULRR in presence of liver metastases;
• Severe renal impairment, bleeding diathesis, long-term anticoagulant therapy;
• History of hypersensitivity to active or inactive excipients of fulvestrant, Exemestane and/or castor oil.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fulvestrant; Fulvestrant 500 mg	Drug: Fulvestrant 500 mg; Fulvestrant 500mg will be given monthly.
Active Comparator: Exemestane; Exemestane 25mg	Drug: Exemestane 25 mg; Exemestane 25mg will be given once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	To compare the efficacy of Fulvestrant 500 mg with the patients treated with Exemestane 25mg as first line setting in terms of progression-free survival.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	To compare the objective response rate of patients treated with Fulvestrant 500 mg with Exemestane.	3 years

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Investigators: Principal Investigator: XU Binghe, MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: January 4, 2016
• First Submitted That Met QC Criteria: January 4, 2016
• First Posted (Estimate): January 6, 2016

Study Record Updates

• Last Update Posted (Estimate): January 2, 2017
• Last Update Submitted That Met QC Criteria: December 30, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Estrogen Receptor Antagonists; Fulvestrant; Exemestane
• Other Study ID Numbers: 10982 (DAIDS ES Registry Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO