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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Fulvestrant 500 mg
* Drug: Exemestane 25 mg


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fulvestrant<br>Fulvestrant 500 mg | Drug: Fulvestrant 500 mg<br>* Fulvestrant 500mg will be given monthly.<br>|
| Active Comparator: Exemestane<br>Exemestane 25mg | Drug: Exemestane 25 mg<br>* Exemestane 25mg will be given once daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | 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. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | To compare the objective response rate of patients treated with Fulvestrant 500 mg with Exemestane. | 3 years |