Fulvestrant 500mg With Exemestane Endocrine Therapy for Postmenopausal Advanced Breast Cancer Patients
|Treatments||fulvestrant 500 mg, exemestane 25 mg|
|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|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Fulvestrant 500 mg
time frame: 3 years
time frame: 3 years
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.
|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|
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