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

• Status: Unknown status
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Medical Sciences
• Collaborator: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Treatments: Estradiol; Exemestane; Fulvestrant

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.