A Randomised, Double-blind, Parallel-group, Multicentre, Phase III Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX) 500 mg With Anastrozole (ARIMIDEX) 1 mg as Hormonal Treatment for Postmenopausal Women With Hormone Receptor-Positive Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Been Treated With Any Hormonal Therapy.
概览
- 阶段
- 3 期
- 干预措施
- faslodex 500mg
- 疾病 / 适应症
- Hormone Receptor Positive Breast Cancer
- 发起方
- AstraZeneca
- 入组人数
- 462
- 试验地点
- 118
- 主要终点
- Comparison of Progression-Free Survival (PFS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole
- 状态
- 进行中（未招募）
- 最后更新
- 3个月前
概览
简要总结
The purpose of the study is to compare how treatment with Fulvestrant (FASLODEX) or Anastrozole (ARIMIDEX) effects disease progression for women with locally advanced or metastatic breast cancer who have not had prior hormonal treatment.
详细描述
A Randomised, Double-blind, Parallel-group, Multicentre, Phase III Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX) 500 mg with Anastrozole (ARIMIDEX) 1 mg as Hormonal Treatment for Postmenopausal Women with Hormone Receptor-Positive Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Been Treated With Any Hormonal Therapy.
研究者
入排标准
入选标准
- •Histological confirmation of breast cancer in post menopausal women (age \>=60). Positive hormone receptor status (ER +ve and/or PgR +ve) of primary or metastatic tumour tissue based on local laboratory assessment.
- •EITHER locally advanced disease (1 line of chemotherapy allowed only if remain unsuitable for therapy of curative intent) OR Metastatic disease. (1 line of chemotherapy for breast cancer allowed only if subsequent evidence of further progressive disease)
- •At least 1 lesion (measurable and/or non-measurable) that can be accurately assessed at baseline and is suitable for repeated assessment.
- •Postmenopausal women, fulfilling 1 of:
- •Prior bilateral oophorectomy
- •Age \>60 years
- •Age \< 60 years and amenorrheic for 12+months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression and FSH and oestradiol in the postmenopausal range
排除标准
- •Presence of life-threatening metastatic disease
- •Extensive hepatic involvement
- •involving brain or meninges
- •symptomatic pulmonary lymph spread
- •Discrete lung metastases are acceptable if respiratory function is not significantly compromised
- •Prior systemic therapy for breast cancer other than one line of cytotoxic chemotherapy (the last dose of chemotherapy must have been received more than 28 days prior to randomisation)
- •Radiation therapy if not completed within 28 days prior to randomisation (with the exception of radiotherapy given for control of bone pain, started prior to randomisation). Prior hormonal treatment for breast cancer.
- •Current or prior malignancy within previous 3 years (other than breast cancer or adequately treated basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix).
研究组 & 干预措施
faslodex+placebo
Blinded: Fulvestrant 500mg intramuscular injection (2x250mg) plus dummy Anastrozole tablets
干预措施: faslodex 500mg
faslodex+placebo
Blinded: Fulvestrant 500mg intramuscular injection (2x250mg) plus dummy Anastrozole tablets
干预措施: arimidex dummy
arimidex +placebo
Blinded: Anastrozole 1mg tablets plus dummy Fulvestrant intramuscular injection (2x0mg)
干预措施: arimidex 1mg
arimidex +placebo
Blinded: Anastrozole 1mg tablets plus dummy Fulvestrant intramuscular injection (2x0mg)
干预措施: faslodex dummy
结局指标
主要结局
Comparison of Progression-Free Survival (PFS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole
时间窗: Baseline RECIST 1.1 assessments (Day 0) and then every 12 weeks until the earliest of disease progression evident, patient dies or has surgery/radiotherapy for their disease (up to approximately 38 months)
PFS was defined as the time from randomisation until objective disease progression according to Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1), surgery or radiotherapy to manage worsening of disease or death by any cause (in the absence of progression). Outcome measure is reported as median time from randomisation to PFS, calculated using the Kaplan-Meier technique.
次要结局
- Duration of Response (DoR) for Fulvestrant Treatment Versus Anastrozole Treatment(Baseline RECIST 1.1 assessments (Day 0) and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months))
- Expected Duration of Response (EDoR) for Fulvestrant Treatment Versus Anastrozole Treatment(Baseline RECIST 1.1 assessments and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months))
- Expected Duration of Clinical Benefit (EDoCB) for Fulvestrant Treatment Versus Anastrozole Treatment(Baseline RECIST 1.1 assessments (Day 0) and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months))
- Comparison of Overall Survival (OS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole; Percentage of Patients With Events(Baseline (Day 0) up to data cut-off for final analysis (up to approximately 116 months). Following disease progression, patients were to be contacted at 12 weekly intervals to determine survival status)
- Objective Response Rate (ORR) for Fulvestrant Treatment Versus Anastrozole Treatment(Baseline RECIST 1.1 assessments (Day 0) and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months))
- Clinical Benefit Rate (CBR) for Fulvestrant Treatment Versus Anastrozole Treatment(Baseline RECIST 1.1 assessments (Day 0) and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months))
- Duration of Clinical Benefit (DoCB) for Fulvestrant Treatment Versus Anastrozole Treatment(Baseline RECIST 1.1 assessments (Day 0) and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months))
- Comparison of the Effect of Fulvestrant Treatment Versus Anastrozole Treatment on Time to Deterioration of Health-Related Quality of Life (HRQoL)(Quality of life questionnaires administered at 3 months post objective disease progression, then at 6-monthly intervals (approximately 75 months))