NCT00498901终止2 期
Phase II Pilot of Aromatase Inhibitor Therapy With Femara® (Letrozole) and Ovarian Suppression in Premenopausal Estrogen Receptor Positive Women With Stage IV Carcinoma of the Breast
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 4
- 主要终点
- Overall response rate as measured by RECIST
研究概览
简要总结
RATIONALE: Aromatase inhibitors, such as letrozole, prevent the formation of estradiol, a female hormone. Giving letrozole together with goserelin, leuprolide, or surgery may be an effective treatment in women with hormone-dependent breast cancer.
PURPOSE: This phase II trial is studying how well giving letrozole together with goserelin or leuprolide works in treating premenopausal estrogen receptor-positive patients with stage IV breast cancer.
详细描述
OBJECTIVES:
Primary
- To measure overall response rate (ORR) in premenopausal women treated with an aromatase inhibitor (AI) and ovarian suppression (OS).
Secondary
- To measure time to treatment failure (TTF) in premenopausal women treated with an AI and OS.
- To measure time to progression (TTP) in premenopausal women treated with an AI and OS.
- To measure time to death in premenopausal women treated with an AI and OS.
- To assess the clinical benefit rate (CBR) in premenopausal women treated with an AI and OS.
- To measure the qualitative and quantitative toxicity of an AI and OS.
- To determine whether ORR, TTP, and CBR are similar to what is seen in postmenopausal women treated with an AI.
- To determine whether ORR, TTP, and CBR are similar to what is seen in premenopausal women treated with tamoxifen and OS.
- To determine if levels of estrogen (i.e., estradiol or estrone) are adequately suppressed in premenopausal women on an AI and OS.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed carcinoma of the breast
- •Metastatic disease
- •Measurable disease (i.e., unidimensional by RECIST)
- •No rapidly progressing visceral involvement (e.g., liver or lymphangitic lung disease)
- •No known marrow involvement as evidenced by diffuse uptake by imaging studies or bone marrow biopsy or aspirate
- •No evidence of CNS metastases
- •Estrogen- and/or progesterone-receptor positive status confirmed in primary breast tumor or in recent biopsy of metastatic site
- •PATIENT CHARACTERISTICS:
- •Premenopausal*, as defined by the following criteria:
- •Less than 12 months from last menstrual period or premenopausal estradiol within the past 12 months
- •No prior bilateral oophorectomy
- •45 years old or younger with intact ovaries and not a candidate for aromatase inhibitor therapy alone due to the potential for recurrent ovarian function NOTE: *Women are considered premenopausal after prior hysterectomy if they have intact ovaries and follicular hormone levels consistent with the institutional normal values for the premenopausal state
- •Women meeting premenopausal criteria prior to receiving ovarian suppression are eligible
- •ECOG performance status 0-2
- •Life expectancy ≥ 3 months
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective nonhormonal contraception during and for 12 weeks after discontinuation of study therapy
- •ANC ≥ 500 cells/mm³
- •Platelet count ≥ 50,000 cells/mm³
- •Hematocrit ≥ 28%
- •In the absence of liver metastases:
- •AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- •Alkaline phosphatase ≤ 2.5 times ULN
- •In the presence of liver metastases:
- •AST and ALT ≤ 5 times ULN
- •Alkaline phosphatase ≤ 5 times ULN
- •In the presence of bone metastases:
- •AST and ALT ≤ 10 times ULN
- •Alkaline phosphatase ≤ 10 times ULN
- •Total bilirubin ≤ 2 times ULN
- •No significant comorbid conditions, including any of the following:
- •Clinically significant cardiac disease not well controlled with medication (e.g., congestive heart failure, symptomatic coronary artery disease, or cardiac arrhythmias)
- •Myocardial infarction within the past 12 months
- •Serious concurrent infection
- •No lack of physical integrity of the upper gastrointestinal tract
- •No inability to swallow or malabsorption syndrome
- •No other carcinoma within the past 5 years except nonmelanoma skin cancer and treated in situ cervical cancer
- •No mental illness
- •No known hypersensitivity to luteinizing hormone-releasing hormone (LHRH), LHRH-agonist analogues, or any of the components in goserelin
- •PRIOR CONCURRENT THERAPY:
- •No concurrent chemotherapy and/or additional hormonal therapy
- •Concurrent trastuzumab (Herceptin®) for patients with HER2 overexpression allowed
排除标准
- 未提供
结局指标
主要结局
Overall response rate as measured by RECIST
次要结局
- Time to treatment failure
- Time to progression
- Time to death
- Clinical benefit rate
- Qualitative and quantitative toxicity as assessed by NCI CTCAE v3.0
- Disease-free survival
- Overall survival
- Safety
- Comparison of response with results of previous studies of postmenopausal women treated with aromatase inhibitor (AI) therapy and of premenopausal women treated with ovarian suppression (OS) and tamoxifen
- Determination of adequacy of estrogen suppression by AI therapy and OS
研究者
研究点 (4)
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