EUCTR2004-000015-25-GB进行中（未招募）1 期
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: 2005年2月14日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 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
- •Physiological Menopause: < 60 years of age and amenorrheic for >=12 months prior to day 1
- •< 60 years of age, amenorrheic for < 12 months prior to day 1, and LH and FSH values within postmenopausal range. LH/FSH values must not be influenced by effects of medication (not chemically dependent, i.e., LHRH agonist)
- •Surgical Menopause: Prior bilateral oophorectomy
- •Prior radiation castration with amenorrhea for at least 6 months
- •3. Histologically and/or cytologically confirmed initial diagnosis of locally advanced (not amenable to curative surgery and/or radiation) or metastatic breast cancer (Stage 3B, 3C, 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. Screening laboratory values within the following parameters:
- •ANC >=1.5x109/L (1500/mm3)
- •Platelet count >=100x109/L (100,000/mm3)[ >=80x109/L (80,000/mm3)] for subjects residing in mainland China
- •Hemoglobin >=8.0 g/dL (80g/L)
- •Serum creatinine =<1.5x upper limit of normal (ULN)
- •Total bilirubin =<1.5xULN
- •AST and ALT =<3xULN [=<5x ULN if liver metastases are present]
- •Fasting serum cholesterol =<350 mg/dL (9.0 mmol/L)
- •Fasting serum triglycerides =<400 mg/dL (4.56 mmol/L)
- •Serum calcium=<12.5 mg/dL (3.1 mmol/L) [value may have been obtained following initiation of treatment with bisphosphonates]
- •7. Karnofsky performance status (KPS) >=60 % (corresponds to Eastern Cooperative Oncology Group [ECOG] performance status 0 to 2).
- •8. Life expectancy of at least 6 months.
- •9. Ability to swallow whole tablets.
- •10. Signed and dated institutional review board (IRB) or independent ethics committee (IEC) approved informed consent form before any protocol-specific screening procedures.
- •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, known or suspected 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. History of inflammatory breast cancer (IBC).
- •4. Any other cancer within 5 years prior to screening with the exception of contralateral breast carcinoma, appropriately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin.
- •5. Presence of unstable angina, recent myocardial infarction (within 6 months prior to screening), use of ongoing maintenance therapy for life-threatening ventricular arrhythmia, or known pulmonary hypertension.
- •6. More than 1 regimen of chemotherapy (including antibody, immunotherapy, biological, and/or cytotoxic therapy) in the locally advanced or metastatic setting. (Note: patients must have documented progression following chemotherapy in the locally advanced or metastatic setting. However, in the case of patients who receive not more than 1 cycle of the prescribed chemotherapy regimen in the locally advanced or metastatic setting, documented progression is not required). Subjects may have received prior adjuvant or neoadjuvant chemotherapy.
- •7. 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.
- •8. Hormonal treatment (including aromatase inhibitors) in the locally advanced or metastatic setting with the exception of prior short-term (< 14 days consecutive) use. Surgical menopause (e.g. oophorectomy) after diagnosis of locally advanced or metastatic disease is considered as a line of hormonal therapy.
- •9. Adjuvant trastuzumab (Herceptin) or tamoxifen =<2 weeks prior to day 1 of treatment on study.
- •10. Aromatase inhibitors as adjuvant therapy =<12 months prior to day 1 of treatment on study.
- •11. Disease refractory (i.e., PD within 6 months from initiation of therapy) to previous adjuvant antiestrogen therapy.
- •12. 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.
- •13. Immunocompromised subjects, including subjects known to be human immunodeficiency virus (HIV) positive and/or acute or chronic hepatitis B (HbsAg) positive or hepatitis C virus (anti-HCV) positive.
- •14. Prior treatment with mTOR inhibitors.
- •15. Known hypersensitivity to letrozole or CCI-779.
- •16. Any investigational agents =< 4 weeks prior to day 1 of treatment on study
- •17. Any other illness that, in the investigator’s judgment, will substantially increase the risk associated with the patient’s participation in the study.
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