NL-OMON38563已完成4 期
prediction of everolimus-induced interstitial lung disease in breast cancer patients; maximizing efficacy by reducing toxicity - PREVENT
niversitair Medisch Centrum Sint Radboud0 个研究点目标入组 100 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Eligible for inclusion are women who are planned to start treatment with everolimus in combination with exemestane as decided by their treating physician, if the patient is willing and able to sign the Informed Consent Form. The following general criteria can be used to determine whether a patient is suitable for treatment with everolimus and exemestane. Renal insufficiency and pulmonary disease are not considered an exclusion criterion.
- •- Adult women with metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy.
- •- Histological or cytological confirmation of estrogen-receptor positive (ER+) breast cancer
- •- Postmenopausal women. Postmenopausal status is defined either by:
- •o Age * 55 years and one year or more of amenorrhea
- •o Age < 55 years and one year or more of amenorrhea, with an estradiol assay < 20 pg/ml
- •o Surgical menopause with bilateral oophorectomy
- •- Radiological or clinical evidence of recurrence or progression on last systemic therapy prior to enrollment
- •- Resistance to treatment with a non-steroidal aromatase inhibitor
- •- Serum platelets * 100x10E9/l
- •- Everolimus dose adjustment is recommended for patients with hepatic impairment (Child-Pugh A/B/C)
- •- Performance status ECOG 0 - 2 (Karnofsky index: 60 - 100)
排除标准
- •- Patients with a HER2-overexpressing tumor by local laboratory testing (IHC 3+ staining or amplification defined as locus/centromere ratio > 2.2 on fluorescent situ hybridization (FISH) or cytochromic in situ hybridization (CISH))
- •- Known hypersensitivity to mTOR inhibitors, e.g. sirolimus (rapamycin).
- •- Patients with a known history of HIV seropositivity or hepatitis B or C
- •- Uncontrolled diabetes mellitus
- •- Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drugs (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome)
- •- Patients being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A
研究者
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