EUCTR2004-000015-25-LV进行中（未招募）不适用
A phase 3 randomized, placebo-controlled, double-blind study of oral CCI-779 administered in combination with letrozole vs. letrozole alone as first line hormonal therapy in postmenopausal women with locally advanced or metastatic breast cancer - HORIZON trial
Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical Research and Development0 个研究点目标入组 1,236 人开始时间: 2004年8月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,236
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1. Women aged >18 years.
- •2. Postmenopausal subjects, defined by at least one of the following:
- •- >= 60 years of age
- •- < 60 years of age and amenorrheic for >12 months prior to day 1
- •- < 60 years of age, without a uterus, and luteinizing hormone (LH) and follicle stimulating hormone (FSH) values within postmenopausal range
- •- < 60 years of age, amenorrheic for < 12 months prior to day 1, and LH and FSH values within postmenopausal range
- •- Prior bilateral oophorectomy
- •- Prior radiation castration with amenorrhea for at least 6 months
- •3. Histologically and/or cytologically confirmed diagnosis of locally advanced (not amenable to curative surgery and/or radiation) or metastatic breast cancer (Stage 3B or 4 respectively by American Joint Committee on Cancer Criteria).
- •4. Documented estrogen receptor positive (ER+) and/or progesterone positive (PR+) tumors based on most recently analyzed biopsy.
- •5. At least 1 measurable lesion as defined by the Response Evaluation Criteria in Solid Tumors (RECIST).
- •6. Karnofsky performance status (KPS) >60 % (corresponds to Eastern Cooperative Oncology Group [ECOG] performance status 0 to 2).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Extensive visceral disease including bilateral diffuse lymphangitic involvement of
- •the lung with more than 50% lung involvement, evidence of symptomatic central nervous system (CNS) metastases, extensive hepatic involvement defined as involvement of more than one third of the liver confirmed by sonogram and/or CT scan
- •2. Subjects with bone as the only site of disease.
- •3. Prior radiation therapy to the site of measurable disease for subjects with a solitary measurable lesion.
- •4. History of inflammatory breast cancer (IBC).
- •5. More than 1 regimen of chemotherapy (including antibody and/or cytotoxic therapy) in the metastatic setting. Subjects may have received prior adjuvant or neoadjuvant chemotherapy.
- •6. Chemotherapy or immunosuppressive agents <=2 weeks prior to day 1 of treatment on study, with the exception of systemic corticosteroids administered for physiologic replacement, or as an antiemetic after discussion with the medical monitor.
- •7. Hormonal treatment (including aromatase inhibitors) in the metastatic setting with
- •the exception of prior short-term (< 14 days consecutive) use.
- •8. Adjuvant trastuzumab (Herceptin) or tamoxifen <= 2 weeks prior to day 1 of treatment on study.
- •9. Aromatase inhibitors as adjuvant therapy <= 12 months prior to day 1 of treatment on study.
- •10. Disease refractory (i.e., PD within 6 months from initiation of therapy) to previous adjuvant antiestrogen therapy.
- •11. Major surgery, biological therapy, immunologic therapy or local radiotherapy (subjects must not have had prior cumulative radiotherapy to more than 25% of the marrow) <= 2 weeks prior to day 1 of treatment on study.
研究者
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