NCT00229697已完成2 期
A Phase II Randomised, Double-Blind, Stratified, Multi-Centre Trial Comparing the Nolvadex 20 Mg And Placebo Combination To The Nolvadex 20 Mg and ZD1839 (IRESSA™) 250 MG Combination In Patients With Metastatic Breast Cancer And Estrogen Receptor (ER) and/or Progesterone (PR) Positive Tumours
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 317
- 试验地点
- 1
- 主要终点
- Strata 1: To compare the time to progression between 2 treatment arms (ZD1839/Nolvadex vs placebo/Nolvadex)
研究概览
简要总结
This study is being carried out to see if ZD1839 is effective in treating metastatic breast cancer in combination with Nolvadex, and if so, how it compares with Nolvadex alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 130 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed metastatic adenocarcinoma of the breast (seeTNM staging Appendix I) that is ER and/or PR positive as determined in local laboratories at each investigator site (central verification of ER status will be performed after the patient starts treatment
- •A tissue block from either the metastatic or primary tumor site is required.
- •WHO performance status (PS) 0-2
- •Patients must not be pregnant or breast-feeding. A negative pregnancy test is required within 7 days prior to randomization if pre- or peri-menopausal. Postmenopausal patients are defined as:
- •natural menopause with last menses > 1 year ago,
- •radiation induced oophorectomy with last menses > 1 year ago,
- •chemotherapy induced menopause with 1 year interval since last menses, or
- •serum FSH and LH and plasma estradiol levels in the postmenopausal range for the institution.
- •bilateral oophorectomy
排除标准
- •Patients cannot be on hormone replacement therapy or received prior chemotherapy for metastatic disease.
- •Patients previously treated with a Tyrosine Kinase inhibitor or have evidence of an active interstitial lung disease are not eligible.
- •Treatment with LH-RH analog.
- •Laboratory values as follow Bilirubin >1.5 times upper limit of normal ULN, alanine amino transferase (ALT) or aspartate amino transferase (AST) >2.5 times the ULN if no demonstrable liver metastases, or >5 times the ULN in the presence of liver metastases
- •Bone marrow function: WBC <1500 mm3
研究组 & 干预措施
1
Experimental
ZD1839 + Nolvadex
干预措施: Gefitinib (Drug)
1
Experimental
ZD1839 + Nolvadex
干预措施: Tamoxifen (Drug)
2
Other
Nolvadex + placebo
干预措施: Tamoxifen (Drug)
结局指标
主要结局
Strata 1: To compare the time to progression between 2 treatment arms (ZD1839/Nolvadex vs placebo/Nolvadex)
时间窗: Time to progression (progressive disease or death; equivalent to progression-free survival)
Strata 2: To compare the clinical benefit rate between 2 treatment arms (ZD1839/Nolvadex vs placebo/Nolvadex)
时间窗: Overall clinical benefit rate: Complete Response, Partial Response or Stable Disease > 24weeks after each combination
次要结局
- To compare the clinical benefit rate between 2 treatment arms (ZD1839/Nolvadex vs placebo/Nolvadex) in Strata 1 and overall(Overall clinical benefit rate: Complete Response, Partial Response or Stable Disease >24 weeks after each combination. Objective tumour resp defined according to RECIST criteria)
- To estimate duration of response for the ZD1839/Nolvadex and placebo/Nolvadex treatments in each strata and overall(Duration of response (CR and PR))
- To compare time to progression between 2 treatment arms (ZD1839/Nolvadex vs placebo/Nolvadex) in Strata 2 and overall(Time to progression (progressive disease or death))
- To compare the objective response rate between ZD1839/Nolvadex and placebo/Nolvadex in each strata and overall(Objective tumour response (OR) defined according to RECIST criteria)
- To obtain tumour tissue for biologic studies in this patient population(ER receptor, ErbB-1 &2 (immunohistochemistry) and other biological markers including Her2/neu, AIB1)
- To compare overall survival between the ZD1839/Nolvadex and placebo/Nolvadex in each strata(Overall survival)
- To assess whether patients with high tumour levels of HER-2 and/or AIB1 demonstrate de novo resistance to Nolvadex therapy or have shorter TTP or response duration when compared with Nolvadex/ZD1839 treatment(Time to progression (progressive disease or death), duration of response (CR and PR))
- To compare the objective response rate between the ZD1839/Nolvadex and placebo/Nolvadex treatment arms in the subset of all patients with ER+ tumours staining 2+/3+ for Her2neu by IHC(Objective tumour response (OR) defined according to RECIST criteria)
- To compare the safety and tolerability of ZD1839/Nolvadex to placebo/Nolvadex(Safety (frequency and severity of adverse events))
- To determine steady-state plasma trough concentrations of tamoxifen in all patients and to compare between the ZD1839/Nolvadex and placebo/Nolvadex treatment arms(Tamoxifen (Cmin) steady-state plasma concentration)
- To determine steady-state plasma trough concentrations of ZD1839 and relate values to historical data(ZD1839 (Cmin) steady-state plasma concentration)
- To relate steady-state plasma trough concentrations of ZD1839 to demographic, response, and safety variables(ZD1839 (Cmin) steady-state plasma concentration)
- To assess the quality of life (QOL) and symptom relief based on the Functional Assessment of Cancer Therapy - Breast (FACT-B) on both treatment arms(FACT-B questionnaire, FBSI (FACT-B Symptom Index))
- To investigate subject hospital resource use and health status(Hospitalisations and EQ-5D)
- Characterization of specific adverse events(Characterization of adverse events such as alopecia, rash and diarrhea)
研究者
研究点 (1)
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