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

Phase 2

• Conditions: Breast Cancer
• Interventions: Drug: Fulvestrant 500 mg; Drug: Exemestane 25 mg

• Registration Number: NCT02646735
• Lead Sponsor: Chinese Academy of Medical Sciences

Brief 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

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-01-04
• Study First Submitted QC: 2016-01-04
• Study First Posted: 2016-01-06
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-30
• Last Update Posted: 2017-01-02
• Primary Completion: 2019-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 148

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fulvestrant	Fulvestrant 500 mg	Fulvestrant 500 mg
Exemestane	Exemestane 25 mg	Exemestane 25mg

Primary Outcome Measures

Name	Time	Method
PFS	3 years	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.

Secondary Outcome Measures

Name	Time	Method
ORR	3 years	To compare the objective response rate of patients treated with Fulvestrant 500 mg with Exemestane.

Trial Locations

Locations (1)

National Cancer Institute, Cancer Hospital Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China