NCT01124695已完成2 期
A Phase II Prospective Trial Correlating Progression Free Survival With CYP2D6 Activity in Patients With Metastatic Breast Cancer Treated With Single Agent Tamoxifen
ECOG-ACRIN Cancer Research Group294 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2011年1月7日最近更新:
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
- 入组人数
- 124
- 试验地点
- 294
- 主要终点
- Progression-free Survival by CYP2D6 Status in 2 Categories
研究概览
简要总结
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate may fight cancer by blocking the use of estrogen by tumor cells.
PURPOSE: This phase II trial is studying how well tamoxifen citrate works in patients with metastatic or recurrent breast cancer.
详细描述
OBJECTIVES:
Primary
- To correlate CYP2D6 (Cytochrome P450 2D6) score (0 vs 1-2) and progression-free survival (PFS)
Secondary
- To correlate CYP2D6 score (0 vs 1 vs 2) and PFS
- To correlate CYP2D6 score (0 vs 1-2) and the proportion of these patients who are progression-free at 6 months.
- To correlate endoxifen concentration with response
- To correlate CYP2D6 with response
- To correlate the presence of candidate estrogen receptor (ESR) 1 and 2 variant alleles, UDP-glucuronosyltransferases (UGT) 7, sulfotransferases (SULT) 1A1, other candidate genes and biomarkers to PFS and other tamoxifen related outcomes
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed adenocarcinoma of the breast
- •Stage III (locally advanced), metastatic, or recurrent disease
- •Deemed not resectable
- •Estrogen-receptor and/or progesterone-receptor positive disease
- •Receptor status is based on most recent results
- •Measurable or non-measurable disease
- •ECOG performance status 0-2
- •History of central nervous system (CNS) metastasis allowed provided it has been treated (surgery, radiotherapy, or radiosurgery) within the past 4 weeks and does not require medications to control symptoms
- •Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5 times ULN (≤ 5 times ULN if liver metastases present)
- •Negative pregnancy test
- •Fertile patients must use effective nonhormonal contraception
- •Disease-free of prior invasive malignancies for ≥ 5 years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
- •Prior chemotherapy, trastuzumab, or bevacizumab in the adjuvant setting allowed provided it has been completed ≥ 4 weeks before study therapy; other prior non-hormonal investigational agents in the adjuvant setting must have been completed at least 4 weeks prior to study registration and should be discussed with the study PI
- •Prior tamoxifen as adjuvant treatment is allowed as long as the patient did not have disease relapse or progression while on adjuvant tamoxifen or within 4 weeks of last dose
- •Treatment in the advanced setting must have been completed at least 2 weeks prior to study initiation
- •Prior aromatase inhibitors (e.g., anastrozole, letrozole, exemestane, aminoglutethamide) are allowed in the adjuvant or metastatic setting
- •At least 2 weeks since prior and no concurrent medications that are strong to moderate inhibitors of CYP2D6 and may alter tamoxifen citrate metabolism including, but not limited to, any of the following:
- •Paroxetine (Paxil)
- •Fluoxetine (Prozac)
- •Bupropion (Wellbutrin)
- •Quinidine (Cardioquin)
- •Concurrent radiotherapy to painful sites of bone disease or areas of impending fractures allowed provided the following criteria are met:
- •Radiotherapy was initiated before study entry
- •Sites of measurable or non-measurable disease are outside the radiotherapy port
- •Recovered from prior radiotherapy
排除标准
- •Pregnant or nursing
- •Concurrent chemotherapy
- •Leptomeningeal disease
- •Non-protocol concurrent hormonal therapy
- •Medical or psychiatric conditions that would interfere with protocol compliance, the ability to provide informed consent, assessment of response, or anticipated toxicities
- •Prior tamoxifen for advanced disease
- •More than 2 lines of non-hormonal treatment in the locally advanced or metastatic setting, including trastuzumab (Herceptin), bevacizumab, or other biologics
- •Starting bisphosphonate therapy while receiving treatment on this study
- •Patients who have begun receiving bisphosphonate therapy prior to registration may continue at the same intervals used prior to study registration
研究组 & 干预措施
Tamoxifen
Experimental
Patients receive oral tamoxifen citrate once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicities.
干预措施: tamoxifen (Drug)
结局指标
主要结局
Progression-free Survival by CYP2D6 Status in 2 Categories
时间窗: Assessed every 3 months for 2 years, then every 6 months up to 5 years
Progression-free survival is defined as the time from registration to progression or death, whichever occurs first. Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) was used to evaluate progression. Progression is defined as appearance of one or more new lesions or unequivocal progression of existing non-target lesions or at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
次要结局
- Progression-free Survival by CYP2D6 Status in 3 Categories(Assessed every 3 months for 2 years, then every 6 months up to 5 years)
- Proportion of Patients With Response(Assessed every 3 months for 2 years, then every 6 months up to 5 years)
- Progression-free Survival From 3 Months Post Registration(Assessed every 3 months for 2 years, then every 6 months up to 5 years)
- Proportion of Patients Progression-free at 6 Months(Assessed every 3 months for 6 months)
- Endoxifen Concentration by Response(Endoxifen was assessed at cycle 3; response was assessed every 3 months for 2 years, then every 6 months up to 5 years)
研究者
研究点 (294)
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