Condition breast cancer
Treatments fulvestrant 500 mg, exemestane 25 mg
Phase phase 2
Sponsor Chinese Academy of Medical Sciences
Collaborator Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Start date December 2015
End date December 2019
Trial size 148 participants
Trial identifier NCT02646735, 10982


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.

Recruiting in the following locations…

United States No locations recruiting
Other countries China

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Fulvestrant 500 mg
fulvestrant 500 mg
Fulvestrant 500mg will be given monthly.
(Active Comparator)
Exemestane 25mg
exemestane 25 mg
Exemestane 25mg will be given once daily.

Primary Outcomes

time frame: 3 years

Secondary Outcomes

time frame: 3 years

Eligibility Criteria

Male or female participants of any age.

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.

Additional Information

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
Principal investigator XU Binghe, MD
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 information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Chinese Academy of Medical Sciences.