Clinical Trials /

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

NCT02646735

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Fulvestrant 500mg With Exemestane Endocrine Therapy for Postmenopausal Advanced Breast Cancer Patients
  • Official Title: A Randomized, Open Label, Multi-Centre Study to Compare the Efficacy and Tolerability of Fulvestrant 500mg With Exemestane for Postmenopausal Advanced Breast Cancer Patients

Clinical Trial IDs

  • ORG STUDY ID: 10982
  • NCT ID: NCT02646735

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
Fulvestrant 500 mgFulvestrant
Exemestane 25 mgExemestane

Purpose

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
    

Trial Arms

NameTypeDescriptionInterventions
FulvestrantExperimentalFulvestrant 500 mg
  • Fulvestrant 500 mg
ExemestaneActive ComparatorExemestane 25mg
  • Exemestane 25 mg

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:N/A
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:PFS
Time Frame:3 years
Safety Issue:
Description: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

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

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Chinese Academy of Medical Sciences

Last Updated

December 30, 2016