prediction of everolimus-induced interstitial lung disease in breast cancer patients; maximizing efficacy by reducing toxicity - PREVENT

Radboud University Nijmegen Medical Centre0 个研究点目标入组 100 人开始时间: 2013年8月15日最近更新: 2019年2月28日

适应症

试验速览

暂无简介。

•- Adult women (= 18 years of age) 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:
•oAge = 55 years and one year or more of amenorrhea
•oAge < 55 years and one year or more of amenorrhea, with an estradiol assay < 20 pg/ml
•oSurgical menopause with bilateral oophorectomy
•- Radiological or clinical evidence of recurrence or progression on last systemic therapy prior to enrollment.
•- Progression following a non-steroidal aromatase inhibitor
•- Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 5 x ULN
•- Adequate renal function: calculated creatinine clearance (as estimated by GFR using the MDRD formula) is MDRD = 30ml/min/1.73m2
•- Performance status ECOG 0 - 2 (Karnofsky index: 60 - 100)
•- Patient is willing and able to sign the Informed Consent Form prior to screening evaluations
•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 75
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 25

•- HER2-overexpressing patients by local laboratory testing (IHC 3+ staining or in situ hybridization positive).
•- Previous treatment with exemestane or mTOR inhibitors. Except for the treatment with exemestane in the adjuvant setting.
•- Known hypersensitivity to mTOR inhibitors, e.g. sirolimus (rapamycin).
•- Patients with a known history of HIV seropositivity.
•- Any severe and / or uncontrolled medical conditions such as:
•oUnstable angina pectoris, serious uncontrolled cardiac arrhythmia
•oPatients with severe hepatic impairment (Child-Pugh A/B/C)
•oUncontrolled diabetes mellitus
•oImpairment 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 who test positive for hepatitis B or C (Patients who test negative for HBV-DNA, HBsAg, and HBcAb but positive for HBsAb with prior history of vaccination against Hepatitis B will be eligible). Only patients at higher risk for hepatitis B or C will be tested.
•- Patients being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A within the last 5 days prior to enrollment
•- History of non-compliance to medical regimens
•- Patients unwilling to or unable to comply with the protocol

发起方

Radboud University Nijmegen Medical Centre