EUCTR2004-002832-24-DE进行中（未招募）不适用
Influence of Zoledronic acid (Zometa®) on bone mineral density and bone ultrasonometry in premenopausal women with hormone receptor positive breast cancer and neoadjuvant or adjuvant chemoendocrine or endocrine treatment - ProBONE II
ovartis Pharma GmbH0 个研究点开始时间: 2005年11月29日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Female patients with histologically confirmed incident invasive breast cancer (T1-4).
- •No evidence of distant metastasis (M0)
- •Patients under adjuvant chemoendocrine or endocrine therapy: Node negative (pN-) and Node positive (pN+; <= 4 positive lymph nodes) patients
- •Patients under neoadjuvant chemotherapy: no clinical evidence for nodal involvement
- •Hormone receptor status (ER and/or PgR) is positive (defined as >=10% receptor positive cells or >=10fmol receptor protein/mg cytosol protein or IRS >2)
- •Age >= 18 years
- •Patient is premenopausal: determined by spontaneous and regular menses at diagnosis of breast cancer or by premenopausal estradiol levels (>20ng/L) at diagnosis of breast cancer
- •Patient receives neoadjuvant chemotherapy or adjuvant standard chemoendocrine or endocrine therapy
- •Bone density at study entry > -2.5 T-Score
- •Patient has given written informed consent prior to any study-specific procedure
- •Patient should be available for Follow-up
- •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
- •History of treatment or disease affecting bone metabolism (e.g., Paget’s disease, primary hyperparathyroidism)
- •Known visceral metastasis or bone metastases
- •Prior treatment with bisphosphonates
- •Previous or concomitant malignancy (not breast cancer) within the past 5 years except adequaetely treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix. Patients who have had a previous other malignancy must have been disease-free for five years
- •Severe physical or psychological concomitant diseases that might impair compliance with the provisions of the study protocol or that might impair the assessment of drug or patient safety, e.g. clinically significant ascites, cardiac failure, NYHA III or IV, clinically relevant pathologic findings in ECG
- •Other known concurrent, severe medical disorder jeopardizing the life of the patient in the immediate future (e.g., myocardial infarction in previous six months, angina pectoris despite treatment, uncontrolled severe arterial hypertension, progressive cardiac or respiratory failure)
- •Known hypersensitivity to bisphosphonates
- •Abnormal renal function as evidenced by a calculated creatinine clearance < 30 mL/minute. Creatinine clearance (CrCl) is calculated using the Cockcroft-Gault formula:
- •CrCl= [140-age (years)] x weight (kg) {x 0.85 for female patients}
- •[72 x serum creatinine (mg/dL)]
- •Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.
- •Recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants)
- •Use of other investigational drugs (drugs not marketed for any indication) within 6 months before start of study and participation in other clinical study.
- •Pregnancy or lactation
- •Women of childbearing potential not applying a medically recognized form of contraception (i.e., oral contraceptives or implants, IUD, vaginal diaphragm or sponge, or condom with spermicide)
- •Known history or present abuse of alcohol or drugs (accepted social alcohol usage will not exclude the patient)
- •History of noncompliance to medical regimens and patients who are considered potentially unreliable or incapable of giving informed consent as judged by the investigator
研究者
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